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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

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
• Treatments: Emtricitabine; Tenofovir

Criteria

Inclusion Criteria:

• Medical doctor, Nurse ,Respiratory therapist or nurse assistant who work in the emergency room, general covid ward or intensive care unit

• Age : between 18-70 years

• RT-PCR and serology tests for SARS-CoV-2 negative at baseline evaluation

• Direct care of patients in the emergency room, general Covid wards or intensive care unit

• Informed consent signed

Exclusion Criteria:

• Two or more of the following : Body temperature higher than 38 Celsius, Cough of recent onset (in the previous 10 days), Dyspnea, Odinophagia, Malaise, fatigue, Acute diarrheal disease.

• History of COVID-19 confirmed by RT-PCR or IgG antibodies

• Family member with suspected or confirmed COVID 19

• Cohabitating with a suspected or confirmed case of COVID-19

• Hepatitis B anti-surface antigen antibodies lower than 10mU/ml at baseline evaluation

• Acute or chronic Hepatitis B

• Confirmed diagnosis of HIV infection either by clinical history or ELISA inmunassay at baseline evaluation

• Use of TDF/FTC in the last three months for other clinical conditions

• ALT or AST higher than 2 times the upper reference limit

• Serum hemoglobin <11g/dl or neutropenia<1.000cell/mm3

• Renal dysfunction defined as eGFR lower than 60ml/min (using the CKDEPI formula) or history of Chronic kidney disease Known hypersensitivity to TDF/FTC Serum phosphorus level <2.5mg/dl

• Diagnosed osteopenia or osteoporosis

• History of pathological fractures

• Pregnancy, lactation or pregnancy desire during the period of the study

• Being a participant in another Clinical trial of prevention for COVID-19

• Use of any of the following drugs: Cidofovir, Celecoxib, Diclofenac, Ibuprofen, Metadon, Naproxen, Nimesulide, Piroxicam, Amiodarone, Quinine, Amikacin, Cephalexin, Clarithromycin, Gentamicin, Piperacillin / Tazobazorcin, Flucomycin, Flucomycin, Sulfadiazine, Vancomycin , Ganciclovir, Ledipasvir / Sofosbuvir, Sofosbuvir / Velpatasvir, Furosemide, Hydralazine, Sacubitril, Verapamil, Interferon, Hydroxyurea, Dolutegravir / Lamivudine Abacavir, Didanosine, Lamivudine, Atazanavir / cobicistat, Atazanavir / ritonavir, Darunavir / ritonavir, Darunavir / cobicistat, Indinavir, Interferon, Hydroxyurea, Cyclosporine, Mycophenolate, Sirolimus, Tacrolimus, Acetazolamide Orlistat, Probenecid, Pyridostigmine, Sevelamer, Zoledronic acid.