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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized, Double-blind, Placebo-controlled Trial of TAF/FTC for Pre-exposure Prophylaxis of COVID-19 in Healthcare Workers (CoviPrep Study)

Conditions
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Healthcare Workers, COVID-19, SARS-CoV 2

Intervention / Treatment
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* Drug: Emtricitabine/Tenofovir Alafenamide 200 MG-25 MG Oral Tablet
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthcare workers voluntarily deciding to participate in the study Understanding the study purpose Having between 18 and 70 years old 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. Not having a prior diagnosis of SARS-CoV-2 infection (COVID-19) Having a negative IgM/IgG antibodies test for SARS-CoV-2 (COVID-19) prior to study entry Negative pregnancy test for childbearing age women within 7 days prior to study entry. 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: Having symptoms compatible with COVID-19 Diagnosed HIV infection Current use of Pre-exposure prophylaxis for HIV Diagnosed Hepatitis B infection. Diagnosed renal insufficiency and or current hemodialysis need Diagnosed osteoporosis under pharmacological treatment. Weight < 40kg Current immunosuppressive or serious hematological condition Prior use of pre-exposure prophylaxis for SARS-CoV-2 Current pregnancy or pregnancy plan within the study course. Current breastfeeding Known hypersensitivity to any of the study medication components.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized (1:1), double-blind, placebo-controlled clinical trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FTC/TAF<br>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. | Drug: Emtricitabine/Tenofovir Alafenamide 200 MG-25 MG Oral Tablet<br>* 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<br>* Other names: FTC/TAF;|
| Placebo Comparator: Placebo<br>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 | Drug: Placebo<br>* A dose of 1 tablet per day will be administered for a total of 12 weeks.<br>* Other names: Placebo comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 incident cases | 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 | During treatment (12 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of asymptomatic SARS-CoV-2 (Covid-19) infections confirmed by serology | Number of asymptomatic SARS-CoV-2 (Covid-19) infections confirmed by serology | During treatment (12 weeks) | 
| Severity of symptomatic COVID-19 | 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 | During treatment (12 weeks) | 
| Respiratory symptom duration in days | Respiratory symptom duration in days | During treatment (12 weeks) | 
| Relation between treatments and symptoms duration | Relation between treatments and symptoms duration | During treatment (12 weeks) | 
| Time course of specific IgM/IgG seroconversion | Time course of specific IgM/IgG seroconversion | During treatment (12 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS Virus, SARS-CoV-2, COVID-19, Health Personnel