“Bronchitis During Pregnancy: Prevention and Treatment - Verywell Health” plus 3 more

“Bronchitis During Pregnancy: Prevention and Treatment - Verywell Health” plus 3 more


Bronchitis During Pregnancy: Prevention and Treatment - Verywell Health

Posted: 13 May 2021 11:32 AM PDT

While people who are pregnant are not truly immunosuppressed, the delicate balance of the immune system during pregnancy can be upset by viral infections, including bronchitis.

LittleBee80 / Getty Images

Bronchitis Symptoms

Bronchitis often develops along with a viral infection. Symptoms may include:

  • A cough that may be dry or productive of sputum. When mucus is present, it may be clear, yellow, or green.
  • Sore throat
  • Sinus congestion
  • A low-grade fever (usually less than 100.5 degrees F) and chills
  • Body aches

Less commonly (and sometimes a sign of a complication), you may experience:

Prevention Tips

An ounce of prevention is definitely worth a pound of cure when it comes to contracting bronchitis during pregnancy. Although you may not be able to prevent bronchitis entirely, there are a number of ways that you can reduce your risk. These include:

  • Avoiding friends or family members who are ill (yes, we understand this can be challenging if you have small children)
  • Avoiding crowded events, especially during cold and flu season
  • Frequent handwashing, or using hand sanitizer when needed
  • Avoiding cigarette smoke
  • Wearing a mask if you will be exposed to dust/fumes (such as wood dust) or if you may be around people who have cold and flu symptoms
  • Minimizing outdoor activity if the air pollution level in your area is high (traffic-related air pollution is an important risk factor for bronchitis during cold season)

Vaccination

Getting your annual flu shot is also important, and the Centers for Disease Control and Prevention (CDC) recommends that pregnant people get the flu vaccine (it doesn't matter which trimester). In addition, women who develop symptoms of influenza should contact their doctor.

Getting your flu vaccine not only helps you, but can help your developing baby. Antibodies are passed from a mother to her infant both through the placenta and via breast milk (in those who are nursing), and can protect babies until 6 months of age when they become eligible for vaccination.

For people ages 19 to 64 who smoke or have certain medical conditions, the pneumonia vaccine (in this case, PPSV 23) may be recommended. Make sure your obstetrician is aware of your past medical history. Even though women who are pregnant may be hesitant to tell their doctor that they smoke, this is one reason why speaking up honestly is important, as the pneumonia vaccine is recommended for anyone who smokes.

Control of Coexisting Conditions

If you have other medical conditions—such as asthma—that can lead to complications of viral infections, it's important to make sure these conditions are controlled as well as possible during pregnancy as they can increase the risk of complications from viral infections.

Related Complications

While bronchitis often runs its course in the general population as well as among women who are pregnant, some may develop complications such as severe illness. These complications, though uncommon, can range from pneumonia to problems that affect pregnancy directly such as miscarriage or premature labor.

Timing of Bronchitis

Timing of bronchitis during pregnancy can impact how it affects the pregnant person and their baby:

  • Bronchitis during the first trimester holds the greatest risk of congenital infections.
  • Bronchitis during the third trimester holds the greatest risk to the pregnant person.

A number of different viruses that cause bronchitis symptoms may be responsible for bronchitis during pregnancy. Some of these include:

  • Human rhinoviruses
  • Influenza virus
  • Respiratory syncytial virus

Pneumonia

During pregnancy, the immune system operates on a fine balance between tolerating a "foreign" entity (the baby) and remaining competent to fight off infectious organisms such as viruses and bacteria. Viral infections can disrupt this balance by causing changes in inflammation, immune cells, and more.

The most common complication of bronchitis is a secondary bacterial pneumonia, which occurs in roughly 1.5 of every one thousand pregnancies.

Not all women are at the same risk. Pneumonia is more likely to occur:

  • When people become ill with viral infections during the fall and winter months
  • When they have underlying conditions (such as asthma)

That said, anyone could potentially develop pneumonia as a complication of bronchitis, thus it's important to be aware (but not unduly worried) about this complication. When diagnosed early, pneumonia during pregnancy is generally treatable.

Acute Respiratory Distress Syndrome (ARDS)

Influenza is an important cause of bronchitis and, in pregnant people, can be a risk factor for acute respiratory distress syndrome (ARDS).

While very uncommon, ARDS due to influenza in pregnant women can be very serious or lead to death. It is much more common in women toward the end of pregnancy and shortly after delivery.

During years in which influenza seasons are particularly bad, the risk of ARDS was found to be twice as high in pregnant women as in women who were not pregnant. This may sound alarming, but studies have looked primarily at years when the influenza rate was very high, and complications were much more likely to occur in those who had underlying risk factors.

Premature Labor or Pregnancy Loss

In addition to pneumonia and other lung issues, viral infections may also increase the risk of premature labor and delivery (often due to the secondary infections that follow the viral infection).

There are a number of reasons why a viral infection (or subsequent bacterial secondary infections) could be a problem. These include:

  • The oxygen level in the mother falls (hypoxia), resulting in less oxygen to the fetus.
  • Some bacterial infections (that can follow a viral infection) can directly increase the risk of premature labor.

While not looked at separately in many studies, the same principles (hypoxia or direct bacterial effect) could also increase the risk of miscarriage.

Premature Birth Risk

Complications such as preterm birth are very uncommon with bronchitis, but it's still important for women to be alert to the signs and symptoms of premature labor, regardless of whether or not they develop bronchitis.

Congenital Infections

Though the viral infections that lead to bronchitis are uncommon as far as causes of congenital infections (infections that affect babies and can lead to problems such as birth defects), it's important to note that some viruses—such as herpes simplex, cytomegalovirus, and others—can be associated with these problems.

When to Call Your Doctor

Certainly, it's important to call your doctor if you have any concerns at all about your health, but there are some symptoms that should prompt you to call your doctor right away. These include:

  • Symptoms that are persistent: If you continue to have symptoms for more than two weeks, and especially after three weeks, it's important to contact your doctor.
  • Symptoms that improve and worsen again: If you feel you are getting better and then your symptoms worsen again, you could have a secondary bacterial infection.
  • High temperature: A low-grade fever is common with bronchitis, but a fever greater than 101 degrees F may be a sign of a secondary infection.
  • Wheezing: Slight wheezing is common with bronchitis, but loud or persistent wheezing suggests airway obstruction (reactive airway disease).
  • Shortness of breath: Many women feel mild shortness of breath due to pregnancy, but if you notice the sudden onset or worsening of symptoms, you should contact your doctor.
  • Rapid respiratory rate: While some shortness of breath can be normal in pregnancy, the rate of your breathing (respiratory rate) should remain the same (respiratory rate does not change in pregnancy, but volume of air taken with each breath is mildly increased). If you notice you are breathing faster than usual (tachypnea) or if your breathing is shallow, talk to your doctor right away.
  • Coughing up blood: Coughing up blood, even a trace, is a reason to contact your doctor right away.
  • Chest pain/tightness: A feeling of chest tightness is common with pneumonia. While coughing can cause some discomfort, it's best to talk to your doctor.
  • Lightheadedness: If you feel lightheaded or faint, it could be a sign that you aren't getting enough oxygen.
  • Decreased fetal movement: If your baby seems to be moving less often than usual, call your doctor.

Treatment

Generally, bronchitis will clear up on its own in time, though if it is due to a bacterial infection (or if you develop a secondary infection), antibiotics may be needed.

The mainstay of "treatment" most of the time will be home remedies to control your symptoms while the illness runs its course. The caveat is that many pregnant women, especially those who have young children at home, are accustomed to taking care of others rather than themselves. If you are one of those, giving yourself a "prescription" to rest and be pampered may be just what the doctor ordered.

Comfort measures can include:

  • Rest: It's harder to overstate the importance of resting, even if that means a nap in the middle of the day. If you need to lean on family and friends to find the time, don't hesitate. If you feel you need permission, tell yourself you are doing it for the baby, but please rest.
  • Drink enough fluids: Fluid requirements increase during pregnancy, and studies suggest that many women are insufficiently hydrated. Having an infection can further increase your water needs, and being dehydrated may increase your risk for kidney infections. To ensure an adequate daily intake of water (64 to 96 ounces or 8 to 12 cups), some women place a container of water in the fridge containing that amount each morning. Later in pregnancy, some women hesitate to drink more fluids since it means more trips to the restroom while trying to rest. This is another reason to lean on people who have offered to help.
  • Try a cold air humidifier: A humidifier can help with congestion, but make sure it is cleaned properly before use. You should also avoid adding anything (such as Vicks) to the water.
  • Try a teaspoon of honey: While people have used honey for a century to combat cold symptoms, a 2021 review of studies found that evidence backs this old wives' tale. Honey actually worked better than over-the-counter cough suppressants and other remedies to control the frequency and severity of coughing.
  • Sip on a cup of warm tea: Warm liquids can be soothing if your throat is sore from coughing. Adding a little honey and lemon may actually help reduce your cough.
  • Use medications sparingly: While both Tylenol (acetaminophen) and some cough and cold medications can be used safely during pregnancy, use these only as needed. A low-grade fever, as long as you're not uncomfortable, actually helps fight infections. If you feel you need a cough or cold preparation, call your obstetrician to learn about their recommendations.
  • Try a saline nasal flush: Some people find a saline flush can help with nasal congestion, and Neti Pots are now available at most pharmacies. A caveat is that it's important to only use sterile saline to avoid the rare risk of serious infection.

A Word From Verywell

Coping with bronchitis can be tiring during pregnancy, and hearing about potential complications can be frightening. For the vast majority of people, the infection clears up without problems and is quickly forgotten.

The most important thing to keep in mind if you develop symptoms of bronchitis is to communicate with your obstetrician. Not only can they give you ideas on how to cope with the symptoms and let you know if and when you should be concerned, but they may give you something else that's priceless when you're pregnant: the reassurance that you aren't alone, and that multitudes of people have similarly experienced this speed bump in pregnancy and gone on to forget it even happened as they hold their newborn treasure.

Beyond Air® Presents Data in Hospitalized Patients with Viral Lung Infections (including COVID-19) from LungFit® PRO Programs at ATS 2021 - StreetInsider.com

Posted: 13 May 2021 05:18 AM PDT


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Interim analysis from the ongoing, open-label, randomized acute viral pneumonia (including COVID-19) pilot study shows 150 ppm nitric oxide (NO) administered with LungFit® PRO is well-tolerated with no treatment-related adverse events, and demonstrates encouraging efficacy signals

Further analysis of 3 previously reported pilot studies in bronchiolitis at 150-160 ppm NO demonstrates a favorable safety profile and consistent efficacy across multiple endpoints

Entirety of data at 150-160 ppm NO in both adult and infant patient populations supports further development of LungFit® PRO in patients hospitalized with viral pneumonia

GARDEN CITY, N.Y., May 13, 2021 (GLOBE NEWSWIRE) -- Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and gaseous NO (gNO) for the treatment of solid tumors, today announced the presentation of data at the American Thoracic Society (ATS) International Conference 2021, which is being held virtually from May 14 – May 19. The data from both LungFit® PRO programs, acute viral pneumonia (including COVID-19) and bronchiolitis, show a favorable safety profile and encouraging efficacy trends using high concentration inhaled NO for the treatment of acute viral lung infections in hospitalized patients.

"We have now demonstrated a consistently favorable safety profile at high concentrations of nitric oxide in both adult and infant populations with acute viral lung infections," said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. "The new data from the acute viral pneumonia pilot trial in adults, taken together with our three previously completed pilot clinical trials in bronchiolitis, enable Beyond Air to prepare for a pivotal study for high concentration NO in a viral indication."

"The interim analysis of patients in the acute viral pneumonia (including COVID-19) pilot study shows a favorable safety profile and encouraging efficacy signals in this adult patient population treated with 150 ppm NO generated and delivered by LungFit® PRO," commented Andrew Colin, M.D., Batchelor Family Professor of Cystic Fibrosis and Pediatric Pulmonology Director, Division of Pediatric Pulmonology, Miller School of Medicine, University of Miami. "Given these current data, I believe the results support the continued development of high concentration inhaled NO that can be delivered with ease by LungFit® for the treatment of viral pneumonia including COVID-19. LungFit® PRO is a revolutionary device that can allow for the treatment of this diverse patient population on a large scale".

Summary of Interim Results of Acute Viral Pneumonia (including COVID-19) Pilot Trial

The ongoing acute viral pneumonia pilot study is a multi-center, open-label, randomized clinical trial in Israel with an emphasis on enrolling patients infected with SARS-CoV-2. Patients are randomized in a 1:1 ratio to receive inhalations of 150 ppm NO given intermittently for 40 minutes four times per day for up to seven days in addition to standard supportive treatment (NO + SST) or standard supportive treatment alone (SST, control group). At the time of the cut off for these data, a total of 23 COVID-19 subjects were enrolled. The intent-to-treat (ITT) analysis population included 19 patients (9 NO + SST vs 10 SST).

Safety and Tolerability

  • 150 ppm NO treatment administered via LungFit® PRO was safe and well tolerated.
  • NO2 levels were below 4 ppm at all timepoints (safety threshold is 5 ppm).
  • MetHb levels were below 4% at all times (safety threshold is 10%).
  • A total of 15 adverse events were reported in 8 subjects (5 NO + SST vs. 3 SST) and two serious adverse events were reported in the NO + SST group – both were related to the underlying condition of the subject and were assessed to be unrelated to study treatment.
  • There were no treatment-related, or possibly related, adverse events or severe adverse events.

Effect on Duration of Hospital Stay Intent to Treat Population

  LungFit 150 ppm NO + SST SST
Duration of hospital stay (days) N 9 10
Mean 2.7 3.1
Median 2.2 2.1
Min 1.2 0.1
Max 4.9 7.9

Intent to Treat Population with Exclusion of Extreme Values*

  LungFit 150 ppm NO + SST SST*
Duration of hospital stay (days) N 9 8
Mean 2.7 3.8
Median 2.2 2.2
Min 1.2 1.0
Max 4.9 7.9

*2 subjects discharged from hospital within 6 hours of study enrollment were excluded from analysis.

Effect on Oxygen Support Requirements

  LungFit 150 ppm NO + SST SST
Duration of Oxygen Support (days) N 9 10
Mean 3.2 5.2
Median 1.9 4.9
Min 0.0 0.0
Max 12.0 16.7
  • In the ITT population (n=19), 22.2% of subjects in the NO + SST group required oxygen support beyond their hospital stay, compared with 40% of control subjects.

Additional detailed study results will be submitted for presentation at an upcoming scientific meeting.

Summary of Analysis of 3 Completed Bronchiolitis Pilot Trials

"To date, over 90 patients hospitalized with a viral lung infection have received 150-160 ppm inhaled NO, dosed intermittently, without any reported treatment-related serious adverse events," said Asher Tal, M.D. Professor Emeritus, Pediatrics, Soroka University Medical Center; Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel. "Overall, the data show that 150 ppm NO given intermittently via inhalation is effective in the treatment of patients with bronchiolitis, while data at the lower concentration of 85 ppm show no benefits. I look forward to further development of the program using a minimum concentration of 150 ppm NO, noting that a reduction in time spent in the hospital by these patients would be clinically meaningful."

Beyond Air has assessed inhaled NO in three pilot clinical trials in bronchiolitis. 198 infants (43% females; 57% males) participated across the three programs, with a mean age of 3.9 months (range 0.3 – 11.9 months). Inhaled NO treatments were given intermittently for 30 to 40 minute durations, from 4 to 5 times daily for up to 5 days. Data from patients in the SST group were pooled across the 3 studies for safety analysis.

Studies Included in the Analysis

  Trial 1 Trial 2 Trial 3
Treatment groups 160 ppm NO + SSTSST alone (control) 160 ppm NO + SSTSST alone (control) 150 ppm NO + SST85 ppm NO + SSTSST alone (control)
Total Intent to Treat (ITT) Subjects Enrolled & Evaluated as the Safety Population 43 68 87
Study Treatment Protocol Inhaled NO was given for 30 minutes, 5 times per day for up to 5 days Inhaled NO was given for 30 minutes, 5 times per day for up to 5 days Inhaled NO was given for 40 minutes, 4 times per day for up to 5 days
Primary objective Safety Efficacy(Length of Stay) Efficacy(Time to Fit for Discharge)

Safety and Tolerability

  SST (N=82) 85 ppm NO + SST (N=32) 150 ppm NO + SST (N=29) 160 ppm NO + SST (N=55) All (N=198)
  N % N % N % N % N %
Any AE 45 54.9% 20 62.5% 18 62.1% 25 45.5% 108 54.5%
Any SAE 10 12.2% 1 3.1% 3 10.3% 11 20.0% 25 12.6%
  • NO treatment administered intermittently was generally safe and well tolerated across the three pilot trials, with the adverse event rates similar among treatment groups.

Efficacy Conclusions

  Trial 2 Trial 3
  Comparison Hazard Ratio1 (p value) Comparison Hazard Ratio1 (p value)
Dose 160 ppm NO vs. SST 150 ppm NO vs. SST
Time to Fit for Discharge N/A2 2.32 (0.049)*
Hospital Length of Stay (LOS) 1.92 (0.048)* 2.28 (0.043)*
Time to Oxygen Saturation of ≥ 92% 2.23 (0.057) 2.62 (0.039)*

*Met statistical significance (p

  • Analysis across the studies demonstrated that a short course of treatments with intermittent high concentration inhaled NO (150 – 160 ppm) was effective in shortening hospital length of stay and accelerating time to fit for discharge – a composite endpoint of clinical signs and symptoms to indicate readiness to be evaluated for hospital discharge.
  • Inhaled NO (150 -160 ppm) was also effective in accelerating time to stable oxygen saturation without supplemental oxygen – measured as SpO2 ≥ 92% in room air.
  • In Trial 3, NO at a dose of 85 ppm NO showed no difference compared to control for all efficacy endpoints, while 150 ppm NO showed statistical significance when compared to control. Statistical significance was seen on time to fit for discharge and LOS when 150 ppm NO was compared to 85 ppm NO, while the p value for time to oxygen saturation was 0.055.
  • By reducing the times to improvement in hospital length of stay, fit for discharge, and SpO2, 150 – 160 ppm NO given intermittently via inhalation demonstrates clinically meaningful efficacy for the treatment of infants with bronchiolitis.

About Beyond Air, Inc.Beyond Air, Inc. is a clinical-stage medical device and biopharmaceutical company developing a revolutionary NO Generator and Delivery System, LungFit®, that uses NO generated from ambient air to deliver precise amounts of NO to the lungs for the potential treatment of a variety of pulmonary diseases. LungFit® can generate up to 400 ppm of NO, for delivery either continuously or for a fixed amount of time and has the ability to either titrate dose on demand or maintain a constant dose. The Company is currently applying its therapeutic expertise to develop treatments for pulmonary hypertension in various settings, in addition to treatments for respiratory tract infections that are not effectively addressed with current standards of care. Beyond Air is currently advancing its revolutionary LungFit® for clinical trials for the treatment of severe lung infections such as SARS-CoV-2 and nontuberculous mycobacteria (NTM). Additionally, Beyond Air is using ultra-high concentrations of NO with a proprietary delivery system to target certain solid tumors in the pre-clinical setting. For more information, visit www.beyondair.net.

About Nitric Oxide (NO)Nitric Oxide (NO) is a powerful molecule, naturally synthesized in the human body, proven to play a critical role in a broad array of biological functions. In the airways, NO targets the vascular smooth muscle cells that surround the small resistance arteries in the lungs. Currently, exogenous inhaled NO is used in adult respiratory distress syndrome, post certain cardiac surgeries and persistent pulmonary hypertension of the newborn to treat hypoxemia. Additionally, NO is believed to play a key role in the innate immune system and in vitro studies suggest that NO possesses anti-microbial activity not only against common bacteria, including both gram-positive and gram-negative, but also against other diverse pathogens, including mycobacteria, viruses, fungi, yeast and parasites, and has the potential to eliminate multi-drug resistant strains.

About LungFit®*Beyond Air's LungFit® is a cylinder-free, phasic flow nitric oxide generator and delivery system and has been designated as a medical device by the US Food and Drug Administration (FDA). The ventilator compatible version of the device can generate NO from ambient air on demand for delivery to the lungs at concentrations ranging from 1 part per million (ppm) to 80 ppm. LungFit® system could potentially replace large, high-pressure NO cylinders providing significant advantages in the hospital setting, including greatly reducing inventory and storage requirements, improving overall safety with the elimination of NO2 purging steps, and other benefits. LungFit® can also deliver NO at concentrations at or above 80 ppm for potentially treating severe acute lung infections in the hospital setting (e.g. COVID-19, bronchiolitis) and chronic, refractory lung infections in the home setting (e.g. NTM). With the elimination of cylinders, Beyond Air intends to offer NO treatment in the home setting.

* Beyond Air's LungFit® is not approved for commercial use. Beyond Air's LungFit® is for investigational use only. Beyond Air is not suggesting NO use over 80 ppm or use at home.

About BronchiolitisThe majority of hospital admissions of infants with bronchiolitis are caused by respiratory syncytial virus (RSV). RSV is a common and highly transmissible virus that infects the respiratory tract of most children before their second birthday. While most infants with RSV present with minor respiratory symptoms, a small percentage develop serious lower airway infections, termed bronchiolitis, which can become life-threatening. The absence of treatment options for bronchiolitis limits the care of these sick infants to largely supportive measures. Beyond Air's system is designed to effectively deliver 150 - 400 ppm NO, for which preliminary studies indicate may eliminate bacteria, viruses, fungi and other microbes from the lungs.

About Acute Viral PneumoniaIn adults, viruses have been identified as the causative agents in approximately 100 million cases of community-acquired pneumonia per year. While viral pneumonia in adults is most commonly caused by rhinovirus, respiratory syncytial virus (RSV) and influenza virus, newly emerging viruses (including SARS-CoV-1, SARS-CoV-2, avian influenza A, and H1N1 viruses) have been identified as pathogens contributing to the overall burden of adult viral pneumonia. Patients aged 65 years or older are at particular risk for death from the disease, as are patients with other underlying health conditions or weakened immune systems. There is no consensus regarding the use of antiviral drugs to treat viral pneumonia, and specific preventative measures are currently limited to the influenza vaccine. Given that current treatment recommendations are largely limited to supportive care, there is an unmet medical need for effective treatment options.

About COVID-19COVID-19 (coronavirus disease 2019) is an infectious disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). COVID-19 first emerged in December of 2019. Those affected develop fever, cough, shortness of breath and/or difficulty breathing. While the majority of cases result in mild symptoms, some can progress to pneumonia and multi-organ failure. Older adults and people who have serious chronic medical conditions are at an increased risk of developing severe complications from COVID-19. There is no specific treatment approved for COVID-19 and patients are managed with supportive care. NO may prove to be a treatment as the impact on the lung should result in bronchodilation, reduction in inflammation and inhibition of the viral replication process1,2,3. As of May 12, 2021 more than 160 million confirmed cases of COVID-19 and more than 3.3 million deaths have been reported globally.

[1] Tripathi et al, FEMS Immunology and Medical Microbiology, December 2017[2] Saura, M., et al., An antiviral mechanism of nitric oxide: inhibition of a viral protease. Immunity, 1999. 10(1): p. 21-8.[3] Akerström S et al. Nitric oxide inhibits the replication cycle of severe acute respiratory syndrome coronavirus. J Virol. 2005; 79(3):1966-9.

Forward Looking StatementsThis press release contains "forward-looking statements" concerning inhaled nitric-oxide and the Company's LungFit® product, including statements with regard to potential regulatory developments, the potential impact on patients and anticipated benefits associated with its use. Forward-looking statements include statements about our expectations, beliefs, or intentions regarding our product offerings, business, financial condition, results of operations, strategies or prospects. You can identify such forward-looking statements by the words "anticipates," "expects," "intends," "impacts," "plans," "projects," "believes," "estimates," "likely," "goal," "assumes," "targets" and similar expressions and/or the use of future tense or conditional constructions (such as "will," "may," "could," "should" and the like) and by the fact that these statements do not relate strictly to historical or current matters. Rather, forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. These forward-looking statements are only predictions and reflect our views as of the date they are made with respect to future events and financial performance. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including risks related to: our approach to discover and develop novel drugs, which is unproven and may never lead to efficacious or marketable products; our ability to fund and the results of further pre-clinical and clinical trials; obtaining, maintaining and protecting intellectual property utilized by our products; our ability to enforce our patents against infringers and to defend our patent portfolio against challenges from third parties; our ability to obtain additional funding to support our business activities; our dependence on third parties for development, manufacture, marketing, sales, and distribution of products; the successful development of our product candidates, all of which are in early stages of development; obtaining regulatory approval for products; competition from others using technology similar to ours and others developing products for similar uses; our dependence on collaborators; our short operating history and other risks identified and described in more detail in the "Risk Factors" section of the Company's most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on our website. We undertake no obligation to update, and we do not have a policy of updating or revising, these forward-looking statements, except as required by applicable law.

CONTACTS:Steven Lisi, Chief Executive Officer Beyond Air, Inc. Slisi@beyondair.net

Maria Yonkoski, Head of Investor RelationsBeyond Air, Inc.Myonkoski@beyondair.net

Corey Davis, Ph.D.LifeSci Advisors, LLCCdavis@lifesciadvisors.com (212) 915-2577

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Source: Beyond Air™

Motherly advice in the age of COVID-19 | Penn State University - Penn State News

Posted: 13 May 2021 05:54 AM PDT

HERSHEY, Pa. — Dr. Catharine Paules was torn.

The pandemic, for which she'd been preparing since she was 10 years old, was at its most severe. Thousands were dying every day. And she, a Penn State Health Milton S. Hershey Medical Center infectious diseases physician, was pregnant.

Pfizer's COVID-19 vaccine had just been authorized for emergency use, and health care professionals everywhere were lining up for the injections many hoped would mark the beginning of the end of the scourge.

Paules welcomed the vaccine with the same sense of relief as her colleagues. Still, the question gnawed at her.

Should she get the shot? Little testing had been done on the possible side effects of the vaccine for pregnant women and their unborn babies. During all the uncertainty of COVID-19, few were as well-prepared for the pandemic as Paules, a former National Institutes of Health (NIH) fellow with ties to the likes of Dr. Anthony Fauci. But there was little to go on to make an educated decision about protecting two lives intertwined.

In the end, she sought out the steady, supportive hand that has shown her the way since the very beginning — Sherri Paules, her mom.

"She has this way of listening," Paules said of her mom, "and making you feel supported. I know way more about COVID-19 and vaccines than my mom does. But talking to her gave me confidence in making that decision."

Paules grew up in York County, one of three sisters. The Paules girls were athletes. Paules and one sister played basketball, and the other swam, competitively.

"Mom hated sports," Paules said, laughing. But when the girls began to play, she gritted her teeth and set out to learn. Soon, she was spending every week poolside or courtside cheering along in crowds. If she thought any discouraging words, Paules' mom kept them to herself.

She took a similar tack when Catharine, jazzed about the movie "Outbreak," which featured doctors battling a pandemic, said she wanted to battle killer diseases for a living. She was 10. "I wanted to be in a position to help people if there was an awful disaster," she said.

Sherri Paules listened in her supportive way, the way that helped her daughter whittle down mountains. As Paules' interest grew, her mom began to read up on diseases and their treatments. The steady reassurance was there, helping her daughter through medical school at the University of Nebraska, a residency in Maryland, a NIH fellowship and eventual employment by Fauci at the National Institute of Allergy and Infectious Diseases.

At NIH, Paules researched emerging respiratory viruses like Middle East Respiratory Syndrome (a form of coronavirus) and influenza. She worked on fighting the Zika virus and pushed forward research to develop a universal influenza vaccine.

When a position became available that allowed her to share her expertise with her hometown through the Milton S. Hershey Medical Center, Paules went for it.

When COVID-19 invaded the region, Penn State Health tapped Paules to help formulate the health system's response. She served as Hershey's principal investigator on clinical trials for new treatments such as Remdesivir and Baricitinib.

In Hershey Medical Center's intensive care units, she saw some of the region's first cases and the horror of COVID-19 — the sharp, downward turns patients take from relatively good health to needing life support. In the hallways, she and her colleagues looked at one another, stunned.

"It was scary," she said. "It's a total lie to say it's not scary. Even if you thought you were prepared, you can't really be prepared for it."

Like many doctors on the front lines, Paules didn't do much to practice self-care. She climbed aboard the pandemic's treadmill and kept at it for most of the year. She became a voice her community came to rely on, participating in dozens of interviews with the media. Days off were rare. Some weeks, she saw the number of hours she spent working rise to the triple digits.

She leaned on colleagues in Infectious Disease, the Undifferentiated Respiratory Failure team, the Emergency Department, ICU and others. "Without working together," she said, "none of us would have made it through this year."

She became pregnant with her second child during the spring of 2020. She went through emotions you might expect — veering between joy and worry. Working with expectant mothers who had contracted the illness, watching them living through all the risks took an emotional toll.

When the vaccine arrived in late 2020, Paules was among its advocates. But she also pointed out to her pregnant patients that information about the vaccine's effects on mothers-to-be was limited.

What data exists is largely observational, which means what's been found in pregnant women who received the vaccine and reported back their findings. Randomized controlled clinical trials of the vaccine and its potential side effects haven't included pregnant women.

Paules advocates for including more pregnant women in these types of studies in the future. "Of course, we want to make sure we're not putting women in a position where they can do potential harm to themselves," she said. "However, they should be given the option to decide."

By the time Paules called her mother, she'd made up her mind on whether to get the vaccine. Still, she needed her mom's reassurance that she was choosing the right thing.

At week 36 of her pregnancy, Paules got her first shot. The second came at week 39.

In February, she gave birth to her daughter, Eliza.

Paules' reasoning for getting the vaccine: The possible effects of the vaccine on a pregnant woman were still a mystery. But what wasn't a mystery were the symptoms it protected against, the virus for which she'd spent her whole life preparing.

"As an infectious diseases physician I have seen severe illness, death, and long-term consequences of COVID-19," Paules said. "I chose to get vaccinated myself and enthusiastically recommend the same to my family and the vast majority of my patients. In certain circumstances, such as pregnancy, or if someone has concerns about COVID-19 vaccines, I encourage them to talk with their health care provider so that they can make an informed decision regarding vaccination."

Plus, evidence suggests the vaccine might allow for transmission of antibodies from mother to unborn child. It might protect her baby.

"It's hard to explain," she said. "From that moment [pregnancy] on, your entire focus is on doing what's best for that baby."

Look for These Symptoms in the Months After COVID Recovery - Healthline

Posted: 28 Apr 2021 12:00 AM PDT

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Experts are learning how a COVID-19 case can lead to long-term health effects. FG Trade/Getty Images
  • The findings of a new study suggest that even people with mild COVID-19 may develop long-term health complications that go well beyond the lungs.
  • Experts say there are clear signs of kidney and heart disease that people should be aware of.
  • Getting vaccinated is the best way to avoid developing COVID-19 and the potential for long-term side effects.

As more people are vaccinated, many of us are increasingly looking toward a future at the end of the pandemic.

But for some people, the long-term complications of the virus will last after the pandemic ends.

Now over a year from the start of the pandemic, the scientific community is learning more about the long-term complications and effects of COVID-19.

In a recent study published in the journal Nature, researchers found that individuals with more severe disease at the start of their illness have a greater risk of long-term complications such as heart and kidney disease secondary to COVID-19.

Through analysis of the U.S. Department of Veterans Affairs database, Dr. Ziyad Al-Aly, an assistant professor in the school of medicine at Washington University in Saint Louis, examined the health outcomes of individuals 6 months after having COVID-19.

They found that those who had the virus had a higher risk of several conditions, including heart disease, diabetes, and kidney complications.

Globally there have been more than 149 million cases of COVID-19, and research suggests that approximately 10 percent — or 14.9 million people —will be considered "long-haulers," those who experience symptoms more than 4 weeks after the onset of COVID-19.

Some people who've had COVID-19 may experience multiple conditions such as heart disease, diabetes, and kidney disorders, long into the future.

While the exact cause and link between COVID-19 and long-term complications isn't currently known, some experts suggest it could be a result of inflammation from the virus, or possibly a revelation of an underlying condition.

"There are several ways to interpret these findings," said Dr. Michael Goyfman, director of clinical cardiology at Long Island Jewish Forest Hills in Queens, New York.

"One is that COVID-19 directly resulted in these various health consequences due to either the inflammation caused by the virus, the body's response to the infection via the immune system, etc.," Goyfman explained.

"Another view is that these patients were somewhat sicker to begin with, so people who had a worse outcome with COVID were those who already had these conditions, and perhaps their hospitalization with COVID was merely the first sign of their underlying issues," Goyfman said.

Although COVID-19 largely affects the lungs, with the interconnected nature of the body, it's not unreasonable to see metabolic, cardiovascular, musculoskeletal, and neurological complications secondary to the disease.

While there are a number of symptoms to look out for with heart disease, kidney disease, and diabetes, here are a few of the important ones to be aware of:

Heart disease

  • chest discomfort
  • pain or pressure that spreads to your arm (right or left)
  • sweating for no obvious reason
  • sensation of an irregular heartbeat
  • exhaustion that comes on easily

Kidney disease

  • frequent need to urinate
  • urine that's foamy or bloody
  • swollen ankles and feet
  • dry and itchy skin
  • weight loss or poor appetite

Diabetes

  • extreme thirst without reason
  • numbness or tingling in your hands or feet
  • intense hunger
  • continued fatigue
  • frequent urination

At this point, health experts aren't sure who's going to have long-haul symptoms and who will not.

Some people who only had mild disease will still have a risk of developing long-term side effects.

At this point, the best bet to protect yourself is to get vaccinated — even if you've already had COVID-19.

A vaccine will likely protect you from reinfection with a potentially more dangerous strain or variant of the virus.

"The best practice for prevention of having COVID complications remains vaccination. Vaccines have shown to prevent severe COVID illness and protect people that may have had the infection previously from getting sick from a newer variant of the virus," said Dr. Thomas Gut, associate chair of medicine and director of ambulatory care services at Staten Island University Hospital in New York.

This new study's findings don't suggest that everyone will experience long-term COVID-19 side effects, but that even people with only mild disease may develop lasting consequences that go beyond the lungs.

Heart disease, diabetes, and kidney complications are all possible for those who've had COVID-19.

According to Gut, "Although much about the long-term COVID complications is still poorly understood, I'm confident as time passes, we will come up with more effective strategies and treatments for those suffering from lingering health problems."

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