|drug2507||Placebo (1 tablet daily during 60 days) + Personal Protective Equipment (PPE) Wiki||1.00|
|drug3439||The PREPARE program Wiki||1.00|
|D045169||Severe Acute Respiratory Syndrome NIH||0.04|
|D018352||Coronavirus Infections NIH||0.04|
There is one clinical trial.
Effectiveness of the use of Tenofovir/Emtricitabine in addition to personal protective equipment for the prevention of the transmission of SARS-COV-2 to health care personnel. A Randomized Clinical Trial. This is an experimental study whose aim is to evaluate the effectiveness of a drug to prevent infection with the virus that causes COVID-19 (SARS-CoV-2), in health care workers. The drug under study is Tenofovir /Emtricitabine, a well-known antiretroviral, which is safe and is used as prophylaxis and treatment for HIV and other viral infections such as Hepatitis. Several laboratory-based studies indicate that this drug has the potential to inhibit SARS-CoV-2 replication. In addition, one study in HIV infected persons found that those taking Tenofovir /Emtricitabine tended to have a lower occurrence of COVID-19. In this study, we will compare the occurrence of infection with SARS-CoV-2/ COVID19 in health care workers between those assigned to an intervention group and those assigned to a control group. The intervention group will receive Tenofovir /Emtricitabine during 60 days in addition to the use of personal protective equipment (PPE), and the control group will receive a placebo during 60 days in addition to the use of personal protective equipment (PPE). The study will recruit 950 health professionals above 18 and less than 70 years, working in the emergency room, COVID wards and intensive care units of seven hospitals in Colombia. To make the comparison groups very similar, the participants will be assigned through a random mechanism to either the intervention (475), or the control (475) groups. In order to prevent biases in the evaluation of the results, neither the participants nor the clinical investigators, data managers, analysts and support personnel will know which intervention the participants are receiving. To determine the occurrence of infection with the virus the study will use both molecular tests that detect the presence of viral genes in respiratory secretions, and serological tests that detect the response of the immune system to the virus. The study will evaluate also the safety of this drug determining the occurrence of adverse events.
Description: Positivity of RT-PCR in nasopharyngeal samples in any of the measurements during follow up, or in symptomatic participants at any time. Positive IgG antibodies against SARS- CoV-2 in any of the measurements during follow upMeasure: SARS-CoV-2 infection Time: At any time during follow up 75 days ( 60 days of intervention + final follow-up 15 days post-intervention)
Description: Reported Serios and non serious adverse events during follow upMeasure: Serious and non-serious adverse events Time: At any time during follow up 75 days ( 60 days of intervention + final follow-up 15 days post-intervention)
Description: To discontinue the intervention during follow upMeasure: Discontinuation of using TDF/FTC for any reason Time: At any time during follow up 75 days ( 60 days of intervention + final follow-up 15 days post-intervention)
Description: number of tablets taken/total number of dispensed tabletsMeasure: Adherence to TDF/FTC Time: At any time during the 60 days of intervention
Description: Severity of SARS-CoV-2 infections according to the following categories: Asymptomatic infection Mild symptomatic SARS-CoV-2 infection with no need for hospitalization Moderate symptomatic SARS-CoV-2 infection that requires hospitalization, but no ICU Severe SARS-CoV-2 infection: dyspnea with other SARS-CoV-2 symptoms requiring ICU hospitalizationMeasure: Severity of SARS-CoV-2 infection Time: At any time during follow up 75 days ( 60 days of intervention + final follow-up 15 days post-intervention)
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