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

July 27, 2020 updated by: Waldo Horacio Belloso, Hospital Italiano de Buenos Aires

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

1378

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FTC/TAF
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 Names:
  • 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
Drug: Placebo
A dose of 1 tablet per day will be administered for a total of 12 weeks.
Other Names:
  • Placebo comparator

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Italiano de Buenos Aires

Collaborators

Sociedad Argentina de Infectología (SADI) (Argentine Society of Infectious Diseases)

Investigators

  • 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)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 31, 2020

Primary Completion (Anticipated)

November 15, 2020

Study Completion (Anticipated)

November 15, 2020

Study Registration Dates

First Submitted

May 26, 2020

First Submitted That Met QC Criteria

May 26, 2020

First Posted (Actual)

May 28, 2020

Study Record Updates

Last Update Posted (Actual)

July 28, 2020

Last Update Submitted That Met QC Criteria

July 27, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5616

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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