NCT04519125

Daily Regimen of Tenofovir/Emtricitabine as Prevention for COVID-19 in Health Care Personnel in Colombia

Status unknown Phase 2, PHASE3 Last updated 19 August 2020

What this trial tests

Phase 2, PHASE3 trial testing Tenofovir/ Emtricitabine ( 300 mg / 200 mg daily during 60 days) + Personal Protective Equipment (PPE) in Severe Acute Respiratory Syndrome Coronavirus 2 in 950 participants. Status unknown.

Timeline

30 August 2020

Primary endpoint
31 December 2020

1 April 2021

Quick facts

Lead sponsor	Hospital Universitario San Ignacio
Phase	Phase 2, PHASE3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	950
Start date	30 August 2020
Primary completion	31 December 2020
Estimated completion	1 April 2021

Drugs / interventions tested

• Tenofovir/ Emtricitabine ( 300 mg / 200 mg daily during 60 days) + Personal Protective Equipment (PPE)
• Placebo (1 tablet daily during 60 days) + Personal Protective Equipment (PPE)

Conditions studied

• Severe Acute Respiratory Syndrome Coronavirus 2 — all drugs for Severe Acute Respiratory Syndrome Coronavirus 2 →
• COVID-19 — all drugs for COVID-19 →

Sponsor

Hospital Universitario San Ignacio

Who can join

Adults 18 to 70, any sex, with Severe Acute Respiratory Syndrome Coronavirus 2 or COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. COVID-19: Characteristics and Therapeutics.
   Chilamakuri R, Agarwal S. · · 2021 · cited 192× · PMID 33494237 · DOI 10.3390/cells10020206
2. SARS-CoV-2 RNA-dependent RNA polymerase as a therapeutic target for COVID-19.
   Vicenti I, Zazzi M, Saladini F. · · 2021 · cited 77× · PMID 33475441 · DOI 10.1080/13543776.2021.1880568
3. Races of small molecule clinical trials for the treatment of COVID-19: An up-to-date comprehensive review.
   Hu S, Jiang S, Qi X, Bai R, et al · · 2022 · cited 68× · PMID 34762760 · DOI 10.1002/ddr.21895
4. Tenofovir, Another Inexpensive, Well-Known and Widely Available Old Drug Repurposed for SARS-COV-2 Infection.
   Zanella I, Zizioli D, Castelli F, Quiros-Roldan E. · · 2021 · cited 33× · PMID 34064831 · DOI 10.3390/ph14050454
5. Antiretroviral drug activity and potential for pre-exposure prophylaxis against COVID-19 and HIV infection.
   Copertino DC, Casado Lima BC, Duarte RRR, Powell TR, et al · · 2022 · cited 21× · PMID 33734021 · DOI 10.1080/07391102.2021.1901144
6. A Comprehensive Summary of the Knowledge on COVID-19 Treatment.
   Peng Y, Tao H, Satyanarayanan SK, Jin K, et al · · 2021 · cited 18× · PMID 33532135 · DOI 10.14336/ad.2020.1124
7. Potential Prophylactic Treatments for COVID-19.
   Ben-Zuk N, Dechtman ID, Henn I, Weiss L, et al · · 2021 · cited 9× · PMID 34372498 · DOI 10.3390/v13071292
8. SARS-CoV-2 pre-exposure prophylaxis: A potential COVID-19 preventive strategy for high-risk populations, including healthcare workers, immunodeficient individuals, and poor vaccine responders.
   Ouyang J, Zaongo SD, Harypursat V, Li X, et al · · 2022 · cited 7× · PMID 36003629 · DOI 10.3389/fpubh.2022.945448