Daily Regimen of Tenofovir/Emtricitabine as Prevention for COVID-19 in Health Care Personnel in Colombia
Status:
Not yet recruiting
Trial end date:
2021-04-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Hospital Universitario San Ignacio
Collaborators:
Colsanitas Fundación Universitaria Autónoma de Las Américas Hospital de la Samaritana, Sede Bogotá y Sede Zipaquirá Hospital Universitario Nacional de Colombia Hospital Universitario San Jorge, Pereira. Pontificia Universidad Javeriana Universidad Tecnológica de Pereira