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Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug303 | Anti-COVID-19 human immunoglobulin Wiki | 0.33 |
| drug1494 | FSD201 Wiki | 0.33 |
| drug1779 | Hydroxychloroquine + Metabolic cofactor supplementation Wiki | 0.33 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1489 | FLOW intervention Wiki | 0.33 |
| drug359 | Aspirin 81 mg Wiki | 0.33 |
| drug1780 | Hydroxychloroquine + Sorbitol Wiki | 0.33 |
| drug3698 | Standard (specific) therapy for COVID-19 Wiki | 0.33 |
| drug4335 | Zinc Wiki | 0.24 |
| drug791 | COViage Wiki | 0.19 |
| drug3837 | Suspension of heat killed (autoclaved) Mycobacterium w Wiki | 0.19 |
| drug4249 | Vitamin C Wiki | 0.18 |
| drug764 | COVID-19 convalescent plasma Wiki | 0.15 |
| drug1775 | Hydroxychloroquine Wiki | 0.10 |
| drug2916 | Placebo Wiki | 0.07 |
| drug421 | Azithromycin Wiki | 0.05 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D004211 | Disseminated Intravascular Coagulation NIH | 0.17 |
| D009164 | Mycobacterium Infections NIH | 0.17 |
| D014808 | Vitamin D Deficiency NIH | 0.12 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0005521 | Disseminated intravascular coagulation HPO | 0.17 |
| HP:0100512 | Low levels of vitamin D HPO | 0.12 |
| HP:0011947 | Respiratory tract infection HPO | 0.05 |
Navigate: Correlations HPO
There are 9 clinical trials
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.
Description: It will be measure by questionnaire
Measure: Subjective perception of recovery Time: Through study completion, an average of 10 weeksThis 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).
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 weeksThis is a Phase II interventional study testing whether treatment with hydroxychloroquine, Vitamin C, Vitamin D, and Zinc can prevent symptoms of COVID-19
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 weeksAlthough 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.
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.
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.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.
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 daysDescription: 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.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.
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 monthDescription: 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 monthDescription: 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: BaselineIn this 16-week randomized control study, health care workers will receive a bolus dose followed by a weekly dose of vitamin D or a placebo bolus and weekly dose. This study will test whether high-dose of vitamin D supplementation decreases the incidence of laboratory-confirmed COVID19 infection (primary outcome), reduces illness severity, duration, as well as work absenteeism among health care workers (HCW) in setting at high-risk of contact with COVID-19 cases in high COVID-19 incidence areas.
Description: self-obtained mid-turbinate nasopharyngeal (NP) swabs analysed by reverse transcriptase quantitative polymerase chain reaction (RT-qPCR) nucleic acid amplification test (NAAT), following standard operating procedures certified by the Quebec Public Health Laboratory of the National Public Health Institute (complemented by NP swabs obtained clinically for screening or diagnostic purposes analyzed using the same technique.
Measure: Change in incidence of laboratory-confirmed COVID-19 infection Time: up to 16 weeksDescription: 5-category ordinal variable [asymptomatic, mild (managed at home); moderate (hospitalisation without supplemental oxygen; severe (oxygen supplementation); critical (mechanical ventilation/death)
Measure: Distribution of disease severity Time: up to 16 weeksDescription: Duration of COVID+ test: that is, between first COVID+ test to first COVID- test
Measure: Duration of COVID-19 positivity Time: up to 16 weeksDescription: SARS-CoV-2 IgG Diasorin on Liaison XL platform
Measure: Number of participants with COVID-19 positive IgG serology Time: up to 16 weeksDescription: Participant-reported; reported by Direction of Human Resource (or for physicians, Direction des services professionnelles) databases
Measure: Number of workday absences due to COVID-19 suspected/confirmed infection Time: up to 16 weeksDescription: Participant-reported; reported by Direction of Human Resource (or for physicians, Direction des services professionnelles) databases
Measure: Number of workday absences for any reason Time: up to 16 weeksDescription: Number and distribution of adverse health events
Measure: Changes in adverse health events Time: up to 16 weeksCORONAVIT is an open-label, phase 3, randomised clinical trial testing whether implementation of a test-and-treat approach to correction of sub-optimal vitamin D status results in reduced risk and/or severity of COVID-19 and other acute respiratory infections.
Description: Secondary efficacy outcome
Measure: Proportion of participants seroconverting to SARS-CoV-2 (i.e. with test results for antibodies to SARS-CoV-2 transitioning from negative at baseline to positive at follow-up) Time: Over 6 monthsDescription: Secondary efficacy outcome
Measure: Proportion of participants developing antigen test-positive COVID-19 Time: Over 6 monthsDescription: Secondary efficacy outcome
Measure: Proportion of participants developing 'probable COVID-19', as adjudged using a validated symptom score Time: Over 6 monthsDescription: Secondary efficacy outcome
Measure: Proportion of participants developing antigen test-positive influenza Time: Over 6 monthsDescription: Secondary efficacy outcome
Measure: Proportion of participants reporting symptoms of acute respiratory infection Time: Over 6 monthsDescription: Secondary efficacy outcome
Measure: Proportion of participants who are prescribed one or more courses of antibiotic treatment for acute respiratory infection Time: Over 6 monthsDescription: Secondary efficacy outcome
Measure: Proportion of participants with asthma who experience one or more exacerbations of asthma requiring treatment with oral corticosteroids and/or requiring hospital treatment Time: Over 6 monthsDescription: Secondary efficacy outcome
Measure: Proportion of participants with COPD who experience one or more exacerbations of COPD requiring treatment with oral corticosteroids and/or antibiotics, and/or requiring hospital treatment Time: Over 6 monthsDescription: Secondary efficacy outcome
Measure: Proportion of participants who have had antigen test- or antibody test-confirmed SARS-CoV-2 infection who report symptoms of COVID-19 lasting more than 4 weeks after onset Time: Over 6 monthsDescription: Secondary efficacy outcome
Measure: Mean MRC dyspnoea score at the end of the study in people who have had antigen test- or antibody test-confirmed SARS-CoV-2 infection Time: 6 monthsDescription: Secondary efficacy outcome
Measure: Mean FACIT Fatigue Scale score at the end of the study in people who have had antigen test- or antibody test-confirmed SARS-CoV-2 infection Time: 6 monthsDescription: Secondary efficacy outcome
Measure: Mean COVID-19 Recovery Questionnaire score at the end of the study in people who have had antigen test- or antibody test-confirmed SARS-CoV-2 infection Time: 6 monthsDescription: Secondary efficacy outcome
Measure: Proportion of participants who experience one or more acute respiratory infections requiring hospitalisation Time: Over 6 monthsDescription: Secondary efficacy outcome
Measure: Proportion of participants who experience COVID-19 requiring hospitalisation Time: Over 6 monthsDescription: Secondary efficacy outcome
Measure: Proportion of participants hospitalised for COVID-19 requiring ventilatory support Time: Over 6 monthsDescription: Secondary efficacy outcome
Measure: Proportion of participants who experience influenza requiring hospitalisation Time: Over 6 monthsDescription: Secondary efficacy outcome
Measure: Proportion of participants dying of any cause during participation in the trial Time: Over 6 monthsDescription: Secondary efficacy outcome
Measure: Proportion of participants dying of acute respiratory infection during participation in the trial Time: Over 6 monthsDescription: Secondary efficacy outcome
Measure: Proportion of participants dying of COVID-19 during participation in the trial Time: Over 6 monthsDescription: Secondary efficacy outcome
Measure: Proportion of participants dying of influenza during participation in the trial • mean end-study 25(OH)D concentrations (sub-set of participants having end-study tests of vitamin D status) Time: Over 6 monthsDescription: Secondary efficacy outcome
Measure: mean end-study 25(OH)D concentration (sub-set of participants having end-study tests of vitamin D status) Mean end-study 25(OH)D concentration (sub-set of participants having end-study tests of vitamin D status) Time: 6 monthsDescription: Secondary safety outcome
Measure: Proportion of participants experiencing known hypercalcaemia Time: Over 6 monthsDescription: Secondary safety outcome
Measure: Proportion of participants experiencing a probable or definite adverse reaction to vitamin D supplementation Time: Over 6 monthsDescription: Secondary safety outcome
Measure: Proportion of participants experiencing a serious adverse event of any cause Time: Over 6 monthsAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports