“Vitamin D and Covid‐19: From potential therapeutic effects to unanswered questions - Wiley” plus 1 more

“Vitamin D and Covid‐19: From potential therapeutic effects to unanswered questions - Wiley” plus 1 more

Vitamin D and Covid‐19: From potential therapeutic effects to unanswered questions - Wiley

Posted: 28 Aug 2020 01:46 PM PDT

Title: Vitamin D and COVID‐19 Management
NCT04385940 64 Patients with COVID‐19: ≥ 17 years old/Both sexes Patients with dementia, learning disability, mental health needs and alcohol or drug dependency, pregnant women/Patients with sarcoidosis, hypercalcemia, known vitamin D intolerance ‐ Interventional/Treatment Phase 3
Title: Investigating the Role of Vitamin D in the Morbidity of COVID‐19 Patients
NCT04386044 1000 In‐patient admitted to Tameside General Hospital. Clinical diagnosis of COVID‐19 – not necessary for SARS‐CoV‐2 swab to be positive/Patients on vitamin D treatment to be included, but this will be adjusted for in analysis Final clinical diagnosis NOT COVID‐19 United Kingdom Observational Not yet recruiting
Title: Vitamin D Supplementation in the Prevention and Mitigation of COVID‐19 Infection (VitD‐COVID19)
NCT04482673 140 Adults aged 50 years of age or older who presents to MUSC or its affiliate hospitals (or associated testing centers) for COVID‐19 testing during the recruitment period is eligible for participation. Hospitalization at the time of study recruitment/Any individual less than 50 years of age United state Interventional Recruiting
Title: Covid‐19 and Vitamin D in Nursing‐home (COVIT‐EHPAD)
NCT04435119 96 Being suspected or diagnosed with COVID‐19 (RT‐PCR, chest CT scan) Opposition of the resident and/or relatives to the use of anonymized clinical‐biological data France Observational Completed
Title: Vitamin D Supplementation in Patients With COVID‐19
NCT04449718 200 Diagnosis of flu syndrome with hospitalization criteria/Respiratory rate ≥ 24irpm and/or saturation < 93% in room air, or belonging to the risk group for complications: (a) Chronic diseases: heart disease, diabetes mellitus, systemic arterial hypertension and neoplasms,(b) Immunosuppression, (c) Pulmonary tuberculosis; (d) Obesity; Tomographic findings compatible with coronavirus disease. Patient admitted already under invasive mechanical ventilation/Patient admitted with severe acute respiratory syndrome and diagnosed with an etiologic agent other than SARS‐CoV‐2/Prior vitamin D supplementation (above 1000 IU/day)/Renal failure requiring dialysis or creatinine ≥2.0 mg/dL/Admitted patients with expected hospital discharge in less than 24 hoursours/Patient unable to sign the consent form. Brazil Interventional Not Applicable
Title: Vitamin D Testing and Treatment for COVID 19
NCT04407286 100

Part 1: Adult age 18 or older/Previous positive test result for COVID 19

Part 2: Participation in Part 1/Vitamin D level below 30 ng/mL/No abnormalities on the comprehensive metabolic panel that are clinically significant to increasing the risk of an adverse reaction to vitamin D supplementation

Part 1: None

Part 2: Liver impairment/Clinical opinion of study physician that vitamin D supplementation could be harmful to the participant./Pregnancy/No symptoms for 2 weeks after positive COVID 19 test/Recovered from symptoms

 United States Interventional Treatment Phase 1
Title: VITACOV: Vitamin D Polymorphisms and Severity of COVID‐19 Infection (VITACOV)
NCT04370808 500 Adults of 18 years and above/COVID‐19 patients admitted with mild to severe disease (admission to isolation room) or critical patients (admission to ICU) Patients diagnosed with COVID‐19 not admitted to hospital. Portugal Polymorphisms ‐
Title: Vitamin D on Prevention and Treatment of COVID‐19 (COVITD‐19)
NCT04334005 200 Non‐severe symptomatic patients who present cough, fever, nasal congestion, gastrointestinal symptoms, fatigue, anosmia, or alternative signs of respiratory infections. Patients presenting severe respiratory and or multi‐systemic symptoms compatible with advanced COVID‐19 and inter‐current acute or severe chronic diseases (ie, active cancer). Spain Interventional Treatment ‐
Title: Increased Risk of Severe Coronavirus Disease 2019 in Patients With Vitamin D Deficiency (COVIT‐D)
NCT04403932 500 >18 years old/symptoms suggestive of COVID‐19 positive reverse‐transcriptase polymerase chain reaction or antibodies for SARS‐CoV‐2 Bacterial community acquired pneumonia Spain Observational ‐
Title: Randomized Proof‐of‐Concept Trial to Evaluate the Safety and Explore the Effectiveness of Resveratrol for COVID‐19
NCT04400890 200 Outpatients presenting to a Mount Carmel Health System (MCHS) Emergency Department (ED) or drive‐through COVID‐19 testing station, the Enhanced Urgent Care center in Hilliard (EUC), or other ambulatory MCHS facility who test positive for infection with SARS‐CoV‐2/Age ≥ 45 years/Symptom duration ≤7 days Asymptomatic patients (eg, patients who were screened without symptoms but tested positive)/Patients on warfarin, Novel Oral/Anticoagulants, HIV Protease Inhibitors, immunosuppressants, hydroxychloroquine, chloroquine/Comorbidities with a high likelihood of hospitalization within 30 days (eg, current cancer treatment, severe COPD or CHF) End stage liver disease or Hepatitis/Allergy to grapes or rice/pregnant United States Interventional Treatment Phase 2
Title: International ALLIANCE Study of Therapies to Prevent Progression of COVID‐19
NCT04395768 200 Age ≥ 18 years/Provision of informed consent in writing, can be electronic/Diagnosis of active COVID‐19 Known G6PD deficiency/Contra‐indication to hydroxychloroquine, azithromycin or vitamin C: allergy to study interventions, epilepsy, serious hearing, or visual problems, history of severe depression, calcium oxalate stones, advanced liver disease, pregnancy or lactating/History of fever (eg, night sweats, chills) and/or acute respiratory infection (eg, cough, shortness of breath, sore throat) of more than 7 days' duration. Note, if study numbers not quickly reached, the investigators may decide to include those with symptoms of longer than 7 days/Calculated creatinine clearance of <30 mL/receiving chloroquine, azithromycin, >3 g vitamin C daily or an experimental antivirals/Receipt of a drug known to increase QTc: quetiapine, amiodarone/Baseline ECG showing: QTc ≥470 for males, QTc ≥480 for females Australia Interventional Treatment Phase 2
Title: Impact of Zinc and Vitamin D3 Supplementation on the Survival of Aged Patients Infected With COVID‐19 (ZnD3‐CoVici)
NCT04351490 3140 Institutionalized Life expectancy <1 month independently of Covid‐19 infection (overall subjects)/Known hypercalcemia/History of renal lithalsas France Interventional/Treatment Not Applicable
Title: Do Vitamin D Levels Really Correlated With Disease Severity in COVID‐19 Patients? (COVIDVIT)
NCT04394390 100 To find out vitamin D levels and it's relation with the disease severity serum 25‐hydroxy‐vitamin D levels will be measured in nearly 100 confirmed COVİD‐19 patients. İntensive care unit patients Turkey Observational ‐
Title: Evaluation of the Relationship Between Zinc Vitamin D and b12 Levels in the Covid‐19 Positive Pregnant Women
NCT04407572 45 Covid‐19 positive pregnant women/under 18 or more than 45 years old vitamin D, Vitamin B12 or Zinc supplement use/Multivitamine use/use of medicines for vitamin deficiency/having metabolic disease covid‐19 negative pregnant women Turkey Observational Completed
Title: A Study of Hydroxychloroquine, Vitamin C, Vitamin D, and Zinc for the Prevention of COVID‐19 Infection (HELPCOVID‐19)
NCT04335084 600 Informed consent, provided electronically via the EDC, demonstrating the subject understands the procedures required for the study and the purpose of the study/Male or female patients 18 years of age or older that are considered to be high‐risk individuals. High‐risk individuals are defined as all health care workers in hospitals, clinics, and emergency rooms, and medical facilities/Subjects must agree to practice at least two highly effective methods of birth control for the duration of the study This includes condoms with spermicide, oral birth control pills, contraceptive implants, intra‐uterine devices, or diaphragms. At least one of these must be a barrier method. Subjects not of reproductive potential will be exempt (eg, post‐menopausal, surgically sterilized) Refusal to provide informed consent/Any previous positive test for COVID‐19 by RT‐PCR/Symptomatic for COVID‐19/Diarrhea prior to the start of treatment/Type I or II diabetes/Atherosclerotic Coronary Artery Disease/Any contraindication for treatment with hydroxychloroquine including: Hypoglycemia, G6PD deficiency, Porphyria, Anemia, Neutropenia/Alcoholism, Myasthenia Gravis, Skeletal muscle disorder, Maculopathy, Changes in the visual field, Liver disease, with ALT/AST > 2.5 upper limit normal and total bilirubin >2.5 upper limit normal, Psoriasis/Any contraindicated medications found in Appendix 2 Any comorbidities which, in the opinion of the investigator, constitute health risk for the subject. United State Interventional/Prevention Phase 2
Title: COvid‐19 and Vitamin D Supplementation: a Multicenter Randomized Controlled Trial of High Dose vs Standard Dose Vitamin D3 in High‐risk COVID‐19 Patients (CoVitTrial)
NCT04344041 260 Age ≥ 70 years old/Infection with COVID‐19 diagnosed with RT‐PCR SARS‐CoV‐2 or with CT‐scan of the chest suggesting viral pneumonia of peripheral predominance in a clinically relevant context/Having at least one of the following two risk factors for complications: Peripheral capillary oxygen saturation (SpO2) ≤ 94% ambient air, or a partial oxygen pressure (PaO2) to fraction of inspired oxygen (FiO2) ratio ≤ 300 mmHg, Diagnosed within the preceding 3 days age ≥ 75 years Organ failure requiring admission to a resuscitation or high dependency unit/Comorbidity that is life‐threatening in the short‐term (life expectancy <3 months)/Vitamin D supplementation in the previous month, with the exception of treatment providing less than 800 IU of vitamin D per day/Participation in another simultaneous trial/Peripheral capillary oxygen saturation (SpO2) ≤92% in spite of an oxygen therapy >5 L/min France Interventional/Treatment Phase 3
Title: Hydroxychloroquine as Post‐Exposure Prophylaxis Against COVID‐19 Infection
NCT04372017 1739

Inclusion Criteria Cohort A:

≥ 18 years old/Employee of healthcare organization in South Dakota or Sanford Health employee in any location and with exposure to a person with COVID‐19 within the last 5 days/Criteria according to Center for Disease Control (CDC) guidelines/Community exposure (within 6 ft for at least 15 minutes)/No prior COVID‐19 positive diagnosis (eligible if previous testing is negative and meets all other inclusion and exclusion)

Inclusion Criteria – Cohort B

≥ 18 years old/High‐risk person defined by: Age 18‐44 with 2 or more comorbidities listed below, Age 45‐79 with any comorbid condition listed below/Age 80 and above/Occupational exposure as determined by the participant's employee health department (ie, not wearing the proper Personal Protective Equipment)/High‐risk person who had close contact (ie, within 6 ft for at least 15 minutes) with a COVID‐19 positive person within the last 5 days and is a South Dakota resident or high‐risk person with close household contact of a COVID‐19 positive Sanford employee/Co‐morbid list: Congestive Heart Failure (CHF). Chronic lung disease (Includes any of the following: asthma, chronic obstructive pulmonary disease, emphysema), Solid organ transplant or, Chronic Kidney Disease, or End Stage Renal Disease, Diabetes mellitus, Cardiovascular disease/Hypertension/Smoking/Vaping/Obesity (calculated by height and weight per participant report)/Hyperlipidemia/

 Known allergy to hydroxychloroquine or quinine/Known history of long QT syndrome/Known history of arrhythmia or dysrhythmia/Known current QTc >500 ms/Known G6PD deficiency/Known history of hypoglycemia/Pregnant or Nursing by patient history/Use of any of the following concomitant medications: See Appendix D for Exclusion medication list/Concurrent diagnosis of dermatitis, porphyria, or psoriasis/History of chronic liver disease, including cirrhosis and/or diagnosis of hepatitis (infectious, idiopathic, or immune)/History of chronic kidney disease/Pre‐existing retinopathy/Already taking hydroxychloroquine/Any condition or medication in the opinion of the investigator that would prohibit the use of hydroxychloroquine/Enrollment in another clinical with investigational drug or device/Inability to swallow pills United state Interventional/Prevention Phase 3
Title: A Study of Quintuple Therapy to Treat COVID‐19 Infection (HAZDpaC)
NCT04334512 600 Male or female subjects 18 years of age and up/Subjects must agree to practice at least two highly effective methods of birth control for the duration of the study/This includes condoms with spermicide, oral birth control pills, contraceptive implants, intra‐uterine devices, or diaphragms/At least one of these must be a barrier method/Subjects not of reproductive potential will be exempt (eg, post‐menopausal, surgically sterilized)/Diagnosis of COVID‐19 by RT‐PCR Diarrhea prior to infection/Any comorbidities which, in the opinion of the investigator, constitute health risk for the subject/Any contraindications for treatment with hydroxychloroquine/Hypoglycemia, Known G6PD deficiency, Anemia, Alcoholism, Skeletal muscle disorders, Changes in visual field/Neutropenia/Maculopathy/Psoriasis/Abnormal EKG with QT prolongation acquired or from birth/Allergies to 4‐Aminoquinolines/History of jaundice or high fevers prior to developing COVID‐19/Treatment with any other drug not listed that affects the QT interval/Treatment with any anti‐epileptic drug, whether prescribed for seizures or otherwise/Pregnant or breastfeeding women United state Interventional/Treatment Phase 2
Title: Oral 25‐hydroxyvitamin D3 and COVID‐19
NCT04386850 1500 Older than 18 years old and younger than 75 years old for all study groups/Meet the diagnostic criteria of COVID‐19 for different types (including ordinary type, heavy type and critical type) in infected patients/No medications or disorders that would affect vitamin D metabolism/Ability and willingness to give informed consent and comply with protocol requirements Ongoing treatment with pharmacologic doses of vitamin D, vitamin D metabolites or analogs/Pregnant or lactating women/History of elevated serum calcium >10.6 mg/dL; that is corrected for albumin concentration or subjects with a history of hypercalciuria and kidney stones/Supplementation with over the counter formulations of vitamin D2 or vitamin D3/Consuming medication affecting vitamin D metabolism or absorption (anticonvulsants, anti‐tuberculosis medication glucocorticoids, HIV medications and cholestyramine), Subjects with a history of an adverse reaction to orally administered vitamin D, vitamin D metabolites or analogs, Inability to give informed consent Iran Interventional/Prevention Phase 2 Phase 3
Title: The Effects of Standard Protocol With or Without Colchicine in Covid‐19 Infection
NCT04360980 80 Patients >18 years old with nasopharyngeal swab confirmed COVID‐19 PCR, CT involvement compatible with COVID, Fever, and Dyspnea without hypoxemia. Patient who is not willing to enter in study/Known hypersensitivity to colchicine/Hepatic failureRenal failure with eGFR<20 mL/min Iran Interventional/Treatment Phase 2
Title: Prevention and Treatment With Calcifediol of COVID‐19 Induced Acute Respiratory Syndrome (COVIDIOL)
NCT04366908 1008 Age ≥ 18 and < 90 years/PCR confirmed diagnosis of COVID‐19/Radiological image compatible with inflammatory pleuropulmonary exudate Being treated with Calcifediol or Cholecalciferol in any of its presentations and dosages/Intolerance or allergy to Calcifediol or its components/Pregnancy Spain Interventional/Treatment Phase 2
Title: Use of UC‐MSCs for COVID‐19 Patients
NCT04355728 Patients > = 18 years old diagnosed with COVID‐19 (as evaluated by PCR test confirming infection with SARS‐CoV‐2/All the following criteria must be present within a 24‐hour time period at the time of enrollment: Acute onset of a need for positive pressure ventilation by an endotracheal or tracheal tube with a PaO2/FiO2 ratio < 300 mmHg with at least 5 cm H2O positive end‐expiratory airway pressure (PEEP), No clinical evidence of left atrial hypertension or significant left heart failure Greater than 24 h since first meeting ARDS criteria (Berlin definition) or 72 hours of ICU admission/PaO2/FiO2 ≥ 300 with PEEP ≤5 cm H2O at the time of enrollment Anticipated extubation within 24 hours of enrollment in the study/Use of any investigational products within 4 weeks of enrollment/A previous MSC infusion not related to this trial/Pregnant or lactating patient/Unstable arrhythmia/Patients with previous lung transplant/Patients currently receiving chronic dialysis for chronic kidney disease/Presence of any active malignancy (other than non‐melanoma skin cancer) that required treatment within the last 1 year/Moderate to severe liver failure (Childs‐Pugh Score > 12)/Severe chronic respiratory disease with a PaCO2 > 50 mmHg or the use of home oxygen/Moribund patient not expected to survive >24 hours United States Interventional/Treatment Phase 1 Phase 2
Title: Proflaxis Using Hydroxychloroquine Plus Vitamins‐Zinc During COVID‐19 Pandemia
NCT04326725 80 person who are working as health professional with contact to known COVID positive case/Their first degree relatives (child, spouse, or parents) Already using plaquenil for other reasons (RA etc)/person with the diagnosis of COVID infection/Documented allergic history to chloroquine/Documented history of chronic liver and kidney diseases/Documented history of retina or hearing dysfunction history of hematological system diseases; Documented history of cardiac arrhythmia or chronic heart diseases; Documented history of mental illnesses; 10. Use of digitalis due to the previous disease. Turkey Observational ‐

Monday, August 31, 2020 - Kaiser Health News

Posted: 31 Aug 2020 06:12 AM PDT

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