There is one clinical trial.
The goal of this clinical trial is to investigate the therapeutic efficacy of rapidly correcting vitamin D deficiency in adults with the use of 25-hydroxyvitamin D3 [25(OH)D3] for reducing the risk of acquiring the SARS-CoV-2 (COVID-19) viral infection and mitigating morbidity and mortality associated with this infection. This evidence-based hypothesis is related to several observations. Macrophages, activated T and B lymphocytes have a vitamin D receptor and 1,25-dihydroxyvitamin D3 induces defensin protein synthesis, influences immunoglobulin production and modulates T-cell cytokine production and functions. 1,25-dihydroxyvitamin D3 also reduces the angiotensin-converting enzyme 2 (ACE2) that is believed to serve as the binding site and gateway for COVID-19 to become infectious. This is a multicenter randomized3 doubleblinded placebo-controlled study aimed at determining the benefits of 25(OH)D3 treatment for the prevention of COVID-19 infection and improving clinical outcomes in infected patients. The investigators plan to recruit 1500 subjects in 3 study groups that include hospital health providers, patients with a positive test for COVID-19 and their relatives with a negative test. Eligible subjects in each study group with a documented serum level of 25(OH)D < 20 ng/mL will be randomized. Recruited subjects will be given 25 mcg of 25(OH)D3 daily or an identically appearing placebo at the time of randomization for two months. Three hospitals will participate and the sample size is foreseen to be equally distributed between the three. Since the clinical trial is designed as minimal risk a formal committee for data monitoring is not foreseen. However, potential toxicity will be monitored every 4 weeks with a serum calcium, albumin and creatinine by the PI and the study coordinators. If the corrected serum calcium increases above 10.6 mg/dl and a repeat confirms that the calcium is above 10.6 mg/dL the subject will be dropped from the study and referred to his or her PCP. Early signs and symptoms of vitamin D toxicity associated with hypercalcemia are increased thirst, increase in frequency of urination, especially at night. The subjects will be followed up weekly by phone to ask about their sign and symptoms.
Description: Percentage of patients with acute respiratory tract infection symptoms (e.g. fever, cough, dyspnea) with no other etiology that fully explains the clinical presentation accompanied by chest computed tomography (CT) scan findings compatible with Covid-19 or patients with a COVID-19 positive test by the polymerase chain reaction (PCR)Measure: COVID-19 (SARA-Cov-2) infection Time: 60 days
Description: Percentage of mild, moderate and sever forms of COVID-19 based on WHO criteriaMeasure: Severity of COVID-19 (SARA-Cov-2) infection Time: 60 days
Description: Percentage of patients who need to be hospitalizedMeasure: Hospitalization Time: 60 days
Description: Days from the first symptom/positive test to discharge from hospital/negative testMeasure: Disease duration Time: 60 days
Description: Rate of death due to COVID-19 during the studyMeasure: Death Time: 60 days
Description: Percentage of COVID patients who need oxygen supportMeasure: Oxygen support Time: 60 days
Description: Percentage of COVID patients who require each: Nasal cannula, Non-invasive ventilation or high-flow nasal cannula, Invasive mechanical ventilation, Invasive mechanical ventilation and ECMOMeasure: Type of oxygen support Time: 60 days
Description: Percentage of COVID patients who display each: fever, dry cough, coughing sputum or blood, sore throat, headache, diarrhea and shortness of breathMeasure: Symptoms of COVID-19 Time: 60 days
Description: Serum Levels of 25-hydroxyvitamin D3 (ng/ml) by HPLCMeasure: Serum Levels of 25-hydroxyvitamin D3 Time: 60 days
Description: Serum calcium concentration (mg/dl)Measure: Serum levels of calcium Time: 60 days
Description: Serum phosphorus concentration (mg/dl)Measure: Serum levels of phosphorus Time: 60 days
Description: Serum creatinine concentration (mg/dl)Measure: Serum levels of creatinine Time: 60 days
Description: Serum albumin concentration (g/dl)Measure: Serum levels of albumin Time: 60 days
Description: Serum concentration of the blood urea nitrogen (mg/dl)Measure: Serum levels of the blood urea nitrogen (BUN) Time: 60 days
Description: Serum concentration of the parathyroid hormone (pg/ml)Measure: Serum levels of the parathyroid hormone (PTH) Time: 60 days
Data processed on January 01, 2021.
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