TAF/FTC for Pre-exposure Prophylaxis of COVID-19 in Healthcare Workers (CoviPrep Study)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04405271|
Recruitment Status : Not yet recruiting
First Posted : May 28, 2020
Last Update Posted : July 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Healthcare Workers COVID-19 SARS-CoV 2||Drug: Emtricitabine/Tenofovir Alafenamide 200 MG-25 MG Oral Tablet Drug: Placebo||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1378 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized (1:1), double-blind, placebo-controlled clinical trial|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||The treatment will be the same in both arms: 1 tablet per day will be administered for a total of 12 weeks. Placebo and the active principle will be indistinguishable.|
|Official Title:||Randomized, Double-blind, Placebo-controlled Trial of TAF/FTC for Pre-exposure Prophylaxis of COVID-19 in Healthcare Workers (CoviPrep Study)|
|Estimated Study Start Date :||July 31, 2020|
|Estimated Primary Completion Date :||November 15, 2020|
|Estimated Study Completion Date :||November 15, 2020|
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
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
Other Name: FTC/TAF
Placebo Comparator: 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
A dose of 1 tablet per day will be administered for a total of 12 weeks.
Other Name: Placebo comparator
- COVID-19 incident cases [ Time Frame: 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
- Number of asymptomatic SARS-CoV-2 (Covid-19) infections confirmed by serology [ Time Frame: During treatment (12 weeks) ]Number of asymptomatic SARS-CoV-2 (Covid-19) infections confirmed by serology
- Severity of symptomatic COVID-19 [ Time Frame: 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 [ Time Frame: During treatment (12 weeks) ]Respiratory symptom duration in days
- Relation between treatments and symptoms duration [ Time Frame: During treatment (12 weeks) ]Relation between treatments and symptoms duration
- Time course of specific IgM/IgG seroconversion [ Time Frame: During treatment (12 weeks) ]Time course of specific IgM/IgG seroconversion
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04405271
|Contact: Waldo H Belloso, MDemail@example.com|
|Contact: Gustavo D Lopardo, MDfirstname.lastname@example.org|
|Sociedad Argentina de Infectología, A. J. Carranza 974|
|Ciudad Autonoma de Buenos Aires, Capital Federal, Argentina, C1085|
|Contact: Waldo H Belloso, MD +541149590200 email@example.com|
|Contact: Diego H Giunta, PhD +54 9 11 5825-6489 firstname.lastname@example.org|
|Study Chair:||Waldo H Belloso, MD||Hospital Italiano de Buenos Aires|
|Principal Investigator:||Ventura Simonovich, MD||HIBA|
|Principal Investigator:||Esteban Nannini, MD||Sanatorio Britanico|
|Principal Investigator:||Wanda Cornistein, MD||Hospital Austral|
|Principal Investigator:||Marcelo Figueiras, MD||Richmond Laboratorio|
|Principal Investigator:||Elvira Zini, MD||Richmond Laboratorio|
|Principal Investigator:||Fernando Riera, MD||Sanatorio Allende (Córdoba)|
|Principal Investigator:||Omar Sued, MD||HUESPED|
|Principal Investigator:||Santiago Ramirez Borga, MD||Hospital Italiano de La Plata|
|Principal Investigator:||Gustavo Costilla Campero, MD||Hospital Padilla (Tucumán)|
|Principal Investigator:||Gustavo D Lopardo, MD||Hospital Bernardo Houssay|
|Principal Investigator:||Gonzalo Corral, MD||Hospital Alende (Mar del Plata)|