TAF/FTC for Pre-exposure Prophylaxis of COVID-19 in Healthcare Workers (CoviPrep Study)

Phase 3

• Conditions: Healthcare Workers; COVID-19; SARS-CoV 2
• Interventions: Drug: Placebo; Drug: Emtricitabine/Tenofovir Alafenamide 200 MG-25 MG Oral Tablet

• Registration Number: NCT04405271
• Lead Sponsor: Hospital Italiano de Buenos Aires

Brief Summary

A randomized parallel double-blinded placebo-controlled clinical trial to evaluate the effect of Emtricitabine/Tenofovir alafenamide (FTC/TAF) compared with placebo on the risk of developing SARS-CoV-2 disease (COVID-19) in healthcare workers with high transmission risk in addition to currently recommended control measures.

Detailed Description

Randomized, double-blind, placebo-controlled clinical trial. Phase III clinical trial for a new indication

Rationale One of the most affected subgroups during the current pandemic is represented by healthcare workers. In Argentina between 14 and 17% of the total COVID-19 cases are represented by this subgroup. In this sense, it appears as an adequate strategy testing the efficacy of pharmacological PrEP approaches on top of the currently recommended control measures.

The use of placebo is warranted for two main reasons: all healthcare workers will be allowed and encouraged to comply with non-pharmacological infection control measures for the protection of viral transmission. On the other hand, the use of a blinded placebo is intended for avoiding relaxation of the non-pharmacological control measures.

Tenofovir has been identified by both docking and in vitro studies as an inhibitor of RdRp (RNA dependent RNA polymerase) of coronavirus.

FTC/TAF has the additional advantage that is already being used in a pre-exposure prophylaxis setting and its safety is widely known.

Main objective To evaluate the risk of developing SARS-CoV-2 disease (COVID-19) in healthcare workers with high transmission risk in addition to currently recommended control measures.

Study Timeline

• Study First Submitted: 2020-05-26
• Study First Submitted QC: 2020-05-26
• Study First Posted: 2020-05-28
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-27
• Last Update Posted: 2020-07-28
• Study Start: 2020-07-31
• Primary Completion: 2020-11-15
• Study Completion: 2020-11-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1378

Inclusion Criteria

1. Healthcare workers voluntarily deciding to participate in the study
2. Understanding the study purpose
3. Having between 18 and 70 years old
4. Having a high transmission risk for Covid-19. Physicians, nurses, lab technicians, physical therapists, or cleaning personnel working at COVID-19 areas, hospital emergency areas, or Intensive care units from healthcare institutions with the direct assistance of patients with Covid-19.
5. Not having a prior diagnosis of SARS-CoV-2 infection (COVID-19)
6. Having a negative IgM/IgG antibodies test for SARS-CoV-2 (COVID-19) prior to study entry
7. Negative pregnancy test for childbearing age women within 7 days prior to study entry.
8. Childbearing age males and females should comply with the use of a proven contraceptive method (double barrier methods, oral contraceptives or contraceptive hormone implants) during the course of the study and at least one month after study completion.

Exclusion Criteria

1. Having symptoms compatible with COVID-19
2. Diagnosed HIV infection
3. Current use of Pre-exposure prophylaxis for HIV
4. Diagnosed Hepatitis B infection.
5. Diagnosed renal insufficiency and or current hemodialysis need
6. Diagnosed osteoporosis under pharmacological treatment.
7. Weight < 40kg
8. Current immunosuppressive or serious hematological condition
9. Prior use of pre-exposure prophylaxis for SARS-CoV-2
10. Current pregnancy or pregnancy plan within the study course.
11. Current breastfeeding
12. Known hypersensitivity to any of the study medication components.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Identical tablets to the active experimental tablets with the same characteristics and packaging. A dose of 1 tablet per day will be administered for a total of 12 weeks
FTC/TAF	Emtricitabine/Tenofovir Alafenamide 200 MG-25 MG Oral Tablet	Emtricitabine/Tenofovir alafenamide (FTC/TAF) in 200 mg/25 mg tablets. A dose of 1 tablet per day will be administered for a total of 12 weeks.

Primary Outcome Measures

Name	Time	Method
COVID-19 incident cases	During treatment (12 weeks)	SARS-CoV-2 disease (COVID-19) with or without symptoms at week 12 of treatment as defined by the presence of specific antibodies against the virus. Positive cases will be confirmed by PCR

Secondary Outcome Measures

Name	Time	Method
Relation between treatments and symptoms duration	During treatment (12 weeks)	Relation between treatments and symptoms duration
Number of asymptomatic SARS-CoV-2 (Covid-19) infections confirmed by serology	During treatment (12 weeks)	Number of asymptomatic SARS-CoV-2 (Covid-19) infections confirmed by serology
Severity of symptomatic COVID-19	During treatment (12 weeks)	Severity of symptomatic SARS-CoV-2 (Covid-19) infections as defined by the following categories: * Mild symptoms: malaise, fever, cough, arthralgia myalgias,; * Moderate symptoms: same as above plus shortness of breath; * Severe symptoms: clinical status requiring admission in Intensive care unit
Respiratory symptom duration in days	During treatment (12 weeks)	Respiratory symptom duration in days
Time course of specific IgM/IgG seroconversion	During treatment (12 weeks)	Time course of specific IgM/IgG seroconversion

Trial Locations

Locations (1)

Sociedad Argentina de Infectología, A. J. Carranza 974; 🇦🇷 Ciudad Autonoma de Buenos Aires, Capital Federal, Argentina