Covid 19 Research using Clinical Trials (Home Page)
Vitamin DWiki
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (14)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1018 | Guided online support program Wiki | 0.38 |
| drug1015 | Group1 Wiki | 0.38 |
| drug1551 | NG test Wiki | 0.38 |
| drug220 | Aspirin 81 mg Wiki | 0.38 |
| drug1044 | Helmet non-invasive ventilation (NIV) Wiki | 0.38 |
| drug677 | Covid-19 Antibody testing (IgG and IgM) Wiki | 0.38 |
| drug2220 | Self-questionnary Wiki | 0.38 |
| drug2676 | WHO recommendations (waiting condition) Wiki | 0.38 |
| drug2715 | Zinc Wiki | 0.31 |
| drug387 | Blood test Wiki | 0.27 |
| drug2662 | Vitamin C Wiki | 0.23 |
| drug1086 | Hydroxychloroquine Wiki | 0.11 |
| drug262 | Azithromycin Wiki | 0.06 |
| drug1822 | Placebo Wiki | 0.04 |
Correlated MeSH Terms (6)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D004211 | Disseminated Intravascular Coagulation NIH | 0.19 |
| D014808 | Vitamin D Deficiency NIH | 0.17 |
| D018352 | Coronavirus Infections NIH | 0.08 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.08 |
| D003141 | Communicable Diseases NIH | 0.06 |
| D007239 | Infection NIH | 0.06 |
Correlated HPO Terms (2)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0005521 | Disseminated intravascular coagulation HPO | 0.19 |
| HP:0100512 | Low levels of vitamin D HPO | 0.17 |
There are 7 clinical trials
Clinical Trials
1 Effect of Vitamin D Administration on Prevention and Treatment of Mild Forms of Suspected Covid-19
The new outbreak of the SARS-CoV-2 coronavirus is causing an important pandemic affecting a large number of people all-over the world. Vitamin D is a hormone precursor produced by our own body with the help of sunlight which has an important role on adaptive immunity and cellular differentiation, maturation and proliferation of several immune cells. Reduced levels of vitamin D in calves were positioned as the main cause of bovine coronavirus infection in the past. Therefore, it seems plausible that the use of vitamin D as a nutritional ergogenic aid could be a potential intervention to fight against COVID-19 infected patients which remain asymptomatic or which have non-severe and severe symptoms. This study aims to investigate whether the use of vitamin D as an immune modulator agent induces significant improvements of health status and outcomes in non-severe symptomatic patients infected with COVID-19 as well as preventing COVID-19 health deterioration. We hypothesize that vitamin D will significantly improve hard endpoints related to COVID-19 deleterious consequences compared with a usual care control group.
NCT04334005 Patients Infected With COVID-19 Dietary Supplement: Vitamin D
Primary Outcomes
Measure: Composite of cumulative death (i.e. mortality) for all causes and for specific causes. Time: Through study completion, an average of 10 weeksSecondary Outcomes
Measure: Necessity of invasive assisted ventilation Time: Through study completion, an average of 10 weeksMeasure: Necessity of non-invasive assisted ventilation Time: Through study completion, an average of 10 weeks
Measure: Intensive care unit admission Time: Through study completion, an average of 10 weeks
Measure: Post-anesthesia care unit admission Time: Through study completion, an average of 10 weeks
Measure: Hospital admission Time: Through study completion, an average of 10 weeks
Measure: Medical consultation Time: Through study completion, an average of 10 weeks
Measure: Home care and isolation time Time: Through study completion, an average of 10 weeks
Measure: Bed rest time Time: Through study completion, an average of 10 weeks
Measure: symptoms' duration (i.e. cough, fever, nasal congestion, gastrointestinal symptoms, fatigue, anosmia, ageusia, diarrhea or alternative signs of COVID-19) Time: Through study completion, an average of 10 weeks
Description: It will be measure by questionnaire
Measure: Subjective perception of recovery Time: Through study completion, an average of 10 weeks2 A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of Quintuple Therapy to Treat COVID-19 Infection
This is a Phase II interventional study will test the efficacy of quintuple therapy (Hydroxychloroquine, Azithromycin, Vitamin C, Vitamin D, and Zinc) in the treatment of patients with COVID-19 infection).
NCT04334512 COVID-19 Corona Virus Infection Coronavirus-19 Sars-CoV2 Drug: Hydroxychloroquine Drug: Azithromycin Dietary Supplement: Vitamin C Dietary Supplement: Vitamin D Dietary Supplement: Zinc MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome
Primary Outcomes
Description: Number of days from COVID-19 diagnosis to recovery via RT-PCR
Measure: The rate of recovery of mild or moderate COVID-19 in patients using Quintuple Therapy Time: 12 weeksDescription: Reduction and/or progression of symptomatic days, reduction of symptom severity
Measure: Reduction or Progression of Symptomatic Days Time: 12 weeksDescription: Assess the symptom response to study therapy as measured by the survey in the EDC
Measure: Assess the safety of Quintuple Therapy Time: 12 weeksDescription: Pulse from baseline to 12 weeks
Measure: Assess the safety of Quintuple Therapy via pulse Time: 12 weeksDescription: Oxygen saturation from baseline to 12 weeks
Measure: Assess the safety of Quintuple Therapy via oxygen saturation Time: 12 weeksDescription: EKG response from baseline to 12 weeks
Measure: Assess the safety of Quintuple Therapy via EKG Time: 12 weeksDescription: Assess Adverse Events and Serious Adverse Events due to Quintuple Therapy
Measure: Assess Tolerability of Quintuple Therapy Time: 12 weeks3 A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of Hydroxychloroquine, Vitamin C, Vitamin D, and Zinc for the Prevention of COVID-19 Infection
This is a Phase II interventional study testing whether treatment with hydroxychloroquine, Vitamin C, Vitamin D, and Zinc can prevent symptoms of COVID-19
NCT04335084 COVID-19 Coronavirus Infection Sars-CoV2 Corona Virus Infection COVID Coronavirus Coronavirus-19 Coronavirus 19 Drug: Hydroxychloroquine Dietary Supplement: Vitamin C Dietary Supplement: Vitamin D Dietary Supplement: Zinc MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome
Primary Outcomes
Description: Any symptoms of COVID-19 will be recorded in a daily diary. Symptoms (including fever measured in degrees Fahrenheit, dry cough, productive cough, difficulty speaking, wheezing, dry mouth, headache, chest tightness, difficulty with exertion, shortness of breath, sore throat, malaise, and diarrhea) will be rated as not present, mild, moderate, or severe.
Measure: Prevention of COVID-19 symptoms as recorded in a daily diary Time: 24 weeksDescription: To assess the presence or absence of side effects (graded 1-5), and whether they are tolerable (grade 1-2). AE and SAE will be recorded.
Measure: Safety as determined by presence or absence of Adverse Events and Serious Adverse Events Time: 24 weeks4 The LEAD COVID-19 Trial: Low-risk, Early Aspirin and Vitamin D to Reduce COVID-19 Hospitalizations
Although the novel SARS-CoV-2 virus (COVD-19) is classified as an acute respiratory infection, emerging data show that morbidity and mortality are driven by disseminated intravascular coagulopathy. Untreated CAC leads to microangiopathic thromboses, causing multiple systems organ failure and consuming enormous healthcare resources. Identifying strategies to prevent CAC are therefore crucial to reducing COVID-19 hospitalization rates. The pathogenesis of CAC is unknown, but there are major overlaps between severe COVID-19 and vitamin D insufficiency (VDI). We hypothesize that VDI is a major underlying contributor to CAC. Preliminary data from severe COVID-19 patients in New Orleans support this hypothesis. The purpose of the proposed multi-center, prospective, randomized controlled trial is to test the hypothesis that low-risk, early treatment with aspirin and vitamin D in COVID-19 can mitigate the prothrombotic state and reduce hospitalization rates.
NCT04363840 COVID Vitamin D Deficiency Coagulopathy Disseminated Intravascular Coagulation Drug: Aspirin 81 mg Dietary Supplement: Vitamin D MeSH:Disseminated Intravascular Coagulation Vitamin D Deficiency
HPO:Disseminated intravascular coagulation Low levels of vitamin D
Primary Outcomes
Description: Hospitalization for COVID-19 symptoms
Measure: Hospitalization Time: 2 weeks
5 Randomized, Double-Blind, Controlled Trial of Hydroxychloroquine vs Placebo as Post-Exposure Prophylaxis Against COVID-19 Infection
Primary Outcomes
Description: Hospitalization for COVID-19 symptoms
Measure: Hospitalization Time: 2 weeksThis is a prospective, double-blind, randomized, placebo-controlled study in two distinct cohorts to evaluate the efficacy and safety of hydroxychloroquine in the prevention of COVID-19 infection.
NCT04372017 COVID-19 SARS-CoV 2 Drug: Hydroxychloroquine Dietary Supplement: Vitamin D MeSH:Infection
Primary Outcomes
Description: Determine whether post-exposure prophylaxis with hydroxychloroquine can prevent COVID-19 in healthcare workers who have been exposed to a known case of COVID-19.
Measure: Cohort A: Percentage of COVID-19 exposed healthcare workers treated with hydroxychloroquine with a positive COVID-19 test. Time: At enrollment completion outcome 1 will be analyzed.Description: Determine whether post-exposure prophylaxis with hydroxychloroquine can prevent COVID-19 in high-risk individuals who have been exposed to a known case of COVID-19.
Measure: Cohort B: Percentage of COVID-19 exposed high-risk individuals treated with hydroxychloroquine with a positive COVID-19 test. Time: At enrollment completion outcome 2 will be analyzed.6 Randomized Controlled Trial of High Dose of Vitamin D as Compared With Placebo to Prevent Complications Among COVID-19 Patients
The recent inception of the coronavirus SARS-CoV-2, responsible for the coronavirus disease (COVID-19), has caused thousands of deaths globally. The most frequently reported complications among COVID-19 patients are from respiratory involvement. Vitamin D has immunomodulatory effects that could protect against COVID-19 infection. Indeed, there is good evidence from randomized clinical trials suggesting that high doses of vitamin D administered during cold seasons prevent viral respiratory infections in at risk individual, and more recently, observational studies suggested that the mortality rate from COVID-19 is inversely correlated with levels of serum 25(OH)vitamin D. The hypothesis of the study is that a high dose of vitamin D given orally to patients admitted to the hospital for COVID-19 will prevent the occurrence of respiratory deragement and other adverse clinical events. To evaluate the aforementioned hypothesis, a randomized, controlled, double-blind, clinical trial comparing a 500.000 UI dose of vitamin D versus placebo among COVID-19 patients at moderate risk, requiring hospitalization but without requirements of critical care at admission was designed. The intervention will be one dose of 500.000 UI given orally or matching placebo. The trial has a sequential design with two steps: - The first step, projected to include 200 patients, will assess the effects of the intervention on the respiratory SOFA; and - If there is a detectable effects, the second step, projected to include 1265 patients, will assess the effects on a combined event that includes need of high dose of oxygen or mechanical ventilation. All study outcomes will be measured during the index hospitalization.
NCT04411446 COVID Drug: Vitamin D Drug: Placebo
Primary Outcomes
Description: Is the respiratory component of the sequential organ failure assessment score (SOFA score). It is a 4 points scale, each point indicate a deeper respiratory impairment. The score is based on the relationship between the arterial pressure of oxygen (PaO2) and inspired fraction of oxygen (FiO2), as the ratio of both (PaFi). In the cases were arterial blood gas are not measured, the pulse oximetry will be used instead. The respiratory SOFA is as follows: 1: PaO2/FiO2 >=300; 2: PaO2/FiO2 >=200 and <300; 3: PaO2/FiO2 >=100 and <200; 4: PaO2/FiO2 <300. The minimum respiratory SOFA score will be record on daily basis during first week or to death or discharge, whichever occur first. This outcome is the primary outcome of the first study phase.
Measure: Respiratory SOFA. Time: One weekDescription: The start of oxygen supplementation at FiO2 >40% or the initiation of invasive through orotracheal intubation) or non-invasive ventilation (Continuous positive airway pressure or Bilevel positive airway ventilation). This outcome will be recorded during hospitalization to 30 days, the death or discharge, whichever occur first. This is the primary outcome of the second study phase.
Measure: Need of a high dose of oxygen or mechanical ventilation. Time: 30 daysSecondary Outcomes
Description: Difference between the oxygen saturation at study entry and the lowest oxygen saturation measured during the first week, the death or discharge, whichever occur first. The oxygen saturation will be measured by pulse oximetry using commercially available devices.
Measure: Change in oxygen saturation. Time: One weekDescription: Oxygen saturation equal or less than 90% in any moment during the hospitalization. This outcome will be measured by pulse oximetry using commercially available devices. The outcome will be measured during the first week, the death or hospital discharge, whichever occur first.
Measure: Oxygen desaturation. Time: One weekDescription: The difference between the Quick SOFA score at study entry and the highest value recorded during the hospitalization. The outcome will be measured during the hospitalization until 30 days, the death or discharge whichever occur first.
Measure: Change in Quick SOFA score. Time: 30 days.Description: Myocardial infarction is defined as suspicious symptoms with new Q waves in the EKG and enzymatic elevations compatible with the Fourth MI Definition. The outcome will be measured during the hospitalization until 30 days, the death or discharge whichever occur first.
Measure: Myocardial infarction. Time: 30 daysDescription: Stroke is defined as a focal neurological loss lasting >24 hs as reported by treating physician. The outcome will be measured during the hospitalization until 30 days, the death or discharge whichever occur first.
Measure: Stroke. Time: 30 daysDescription: Acute kidney injury is defined as an increase of at least 50% in serum creatinine levels (as compared with any previous value during the hospitalization). The outcome will be measured during the hospitalization until 30 days, the death or discharge whichever occur first.
Measure: Acute kidney injury. Time: 30 daysDescription: Pulmonary thromboembolism is defined as the presence of suspicious symptoms (i.e. dyspnea) confirmed with objective evidence of a thrombus in the pulmonary tree by CT or MRI or Pulmonary Angiography. The outcome will be measured during the hospitalization until 30 days, the death or discharge whichever occur first.
Measure: Pulmonary thromboembolism. Time: 30 daysDescription: Combined outcome of the aforementioned events, Stroke is defined as a focal neurological loss lasting >24 hs as reported by treating physician. Myocardial infarction is defined as suspicious symptoms with new Q waves in the EKG and enzymatic elevations compatible with the Fourth MI Definition. Pulmonary thromboembolism is defined as the presence of suspicious symptoms (i.e. dyspnea) confirmed with objective evidence of a thrombus in the pulmonary tree by CT or MRI or Pulmonary Angiography. Acute kidney injury is defined as an increase of at least 50% in serum creatinine levels (as compared with any previous value during the hospitalization). The outcome will be measured during the hospitalization until 30 days, the death or discharge whichever occur first.
Measure: Combined endpoint (stroke, myocardial infarction, acute kidney injury and pulmonary thromboembolism. Time: 30 daysDescription: Admission to Intensive Care Unit due to clinical deterioration as judged by the treating physician. The outcome will be measured during the hospitalization until 30 days, the death or discharge whichever occur first.
Measure: Admission to ICU. Time: 30 daysDescription: The start of mechanical ventilation invasive during the hospitalization until 30 days, the death or discharge whichever occur first.
Measure: Invasive Mechanical Ventilation. Time: 30 daysDescription: Total duration of initial hospital stay in days. The outcome will be measured during the hospitalization until 30 days, the death or discharge whichever occur first. In the cases with hospital stays longer than 30 days, it will considered as 30 days.
Measure: Hospital Length of Stay. Time: 30 days.Description: Total duration of initial ICU stay in days. The outcome will be measured during the hospitalization until 30 days, the death or discharge whichever occur first. In the cases with ICU stays longer than 30 days, it will considered as 30 days.
Measure: ICU length of stay. Time: 30 daysDescription: Death of any cause during the hospitalization until 30 days or discharge whichever occur first.
Measure: Death Time: 30 days.7 Vitamin D Supplementation in Patients With COVID-19: A Randomized, Double-blind, Placebo-controlled Trial
Coronavirus disease 2019 (COVID-19) was declared an emergency public health problem by the World Health Organization (WHO) in March 2020. Since then, several initiatives by the medical and scientific community have sought alternatives to treat infected individuals, as well as identifying risk or protective factors for the contamination and prognosis of patients. In this perspective, vitamin D supplementation can improve some important outcomes in critically ill patients, being considered a potent immunomodulatory agent. Vitamin D deficiency is a common outcome in critically ill patients, thus making it a modifiable risk factor with great potential for reducing hospital stay and intensive care and mortality. The investigators speculate that vitamin D supplementation could have therapeutic effects in patients with COVID-19.
NCT04449718 COVID-19 Dietary Supplement: Vitamin D Dietary Supplement: Placebo
Primary Outcomes
Description: total number of days that patient remained hospitalized
Measure: Length of hospitalization Time: From date of randomization until the date of hospital discharge or death, which is usually less than 1 monthSecondary Outcomes
Description: number of patients that died
Measure: Mortality Time: From date of randomization until the date of hospital discharge or death, which is usually less than 1 monthDescription: total number of days that patient remained in ICU
Measure: Number of cases admitted to Intensive Care Unit (ICU) Time: From date of randomization until the date of hospital discharge or death, which is usually less than 1 monthDescription: total number of days that patient remained in mechanic ventilator
Measure: Length of use of mechanic ventilator Time: From date of randomization until the date of hospital discharge or death, which is usually less than 1 monthMeasure: Number and severity of symptoms Time: From date of randomization until the date of hospital discharge or death, which is usually less than 1 month
Description: C-reactive protein, IL-1alpha (pg/ml), IL-1beta (pg/ml), IL-6 (pg/ml), TNF-alpha (pg/ml), IL-1ra (pg/ml), IL-10 (pg/ml) concentration in the serum
Measure: Inflammatory markers Time: Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)Description: serum concentration
Measure: C-reactive protein Time: Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)Description: serum concentration
Measure: Vitamin D Time: Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)Description: serum concentration
Measure: Creatinine Time: Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)Description: serum concentration
Measure: Calcium Time: Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)Description: Baecke questionnaire (higher scores mean a higher physical activity level)
Measure: Physical activity Time: Baseline