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

NCT04405271 | Terminated Phase 3 DMC

• 1 other identifier: 5616
• Study Type: interventional
• Target: 1,378
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthcare Workers; COVID-19; SARS-CoV 2

Keywords

SARS Virus, SARS-CoV-2, COVID-19, Health Personnel

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of asymptomatic SARS-CoV-2 (Covid-19) infections confirmed by serology

  During treatment (12 weeks)

• Severity of symptomatic COVID-19

  During treatment (12 weeks)

• Respiratory symptom duration in days

  During treatment (12 weeks)

• Relation between treatments and symptoms duration

  During treatment (12 weeks)

• Time course of specific IgM/IgG seroconversion

  During treatment (12 weeks)

Study Arms (2)

FTC/TAF

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Emtricitabine/Tenofovir Alafenamide 200 MG-25 MG Oral Tablet DRUG

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

Also known as: FTC/TAF

FTC/TAF

Placebo DRUG

A dose of 1 tablet per day will be administered for a total of 12 weeks.

Also known as: Placebo comparator

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead
• Sociedad Argentina de Infectología (SADI) (Argentine Society of Infectious Diseases): collaborator

Study Sites (1)

Sociedad Argentina de Infectología, A. J. Carranza 974

Buenos Aires, Buenos Aires F.D., C1085, Argentina

Location

Related Publications (2)

• Elfiky AA. Anti-HCV, nucleotide inhibitors, repurposing against COVID-19. Life Sci. 2020 May 1;248:117477. doi: 10.1016/j.lfs.2020.117477. Epub 2020 Feb 28.

  PMID: 32119961 BACKGROUND

• Castillo-Mancilla JR, Meditz A, Wilson C, Zheng JH, Palmer BE, Lee EJ, Gardner EM, Seifert S, Kerr B, Bushman LR, MaWhinney S, Anderson PL. Reduced immune activation during tenofovir-emtricitabine therapy in HIV-negative individuals. J Acquir Immune Defic Syndr. 2015 Apr 15;68(5):495-501. doi: 10.1097/QAI.0000000000000529.

  PMID: 25763783 BACKGROUND

Related Links

• Sala de Situación Coronavirus online - Ministerio de Salud de la Nación
• Reasons for healthcare workers becoming infected with novel coronavirus disease 2019 (COVID-19) in China
• Nucleotide Analogues as Inhibitors of SARS-CoV-2 Polymerase
• Nucleotide Analogues as Inhibitors of Viral Polymerases
• Triphosphates of the Two Components in DESCOVY and TRUVADA are Inhibitors of the SARS-CoV-2 Polymerase
• THE PHASE 3 DISCOVER STUDY: DAILY F/TAF OR F/TDF FOR HIV PREEXPOSURE PROPHYLAXIS
• 1962\. Renal Outcomes for Participants Taking F/TAF vs. F/TDF for HIV PrEP in the DISCOVER Trial

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome

Interventions

Emtricitabine; tenofovir alafenamide

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Waldo H Belloso, MD

  Hospital Italiano de Buenos Aires

  STUDY CHAIR

• 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)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized (1:1), double-blind, placebo-controlled clinical trial

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: May 28, 2020
• Study Start: July 31, 2020
• Primary Completion: November 15, 2020
• Study Completion: November 15, 2020
• Last Updated: September 9, 2025

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)