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

Primary Purpose

Healthcare Workers, COVID-19, SARS-CoV 2

Status

Unknown status

Phase

Phase 3

Locations

Argentina

Study Type

Interventional

Intervention

Emtricitabine/Tenofovir Alafenamide 200 MG-25 MG Oral Tablet

Placebo

About this trial

This is an interventional prevention trial for Healthcare Workers focused on measuring SARS Virus, SARS-CoV-2, COVID-19, Health Personnel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Sociedad Argentina de Infectología, A. J. Carranza 974

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

FTC/TAF

Placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Respiratory symptom duration in days

Relation between treatments and symptoms duration

Time course of specific IgM/IgG seroconversion

Full Information

NCT ID

NCT04405271

First Posted

May 26, 2020

Last Updated

July 27, 2020

Sponsor

Hospital Italiano de Buenos Aires

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04405271

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Unknown status

Study Start Date

July 31, 2020 (Anticipated)

Primary Completion Date

November 15, 2020 (Anticipated)

Study Completion Date

November 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Italiano de Buenos Aires

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthcare Workers, COVID-19, SARS-CoV 2

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantCare ProviderInvestigatorOutcomes 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.

Allocation

Randomized

Enrollment

1378 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

FTC/TAF

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Emtricitabine/Tenofovir Alafenamide 200 MG-25 MG Oral Tablet

Other Intervention Name(s)

FTC/TAF

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Placebo comparator

Intervention Description

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

Primary Outcome Measure Information:

Title

COVID-19 incident cases

Description

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

Time Frame

During treatment (12 weeks)

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

During treatment (12 weeks)

Title

Severity of symptomatic COVID-19

Description

Time Frame

During treatment (12 weeks)

Title

Respiratory symptom duration in days

Description

Respiratory symptom duration in days

Time Frame

During treatment (12 weeks)

Title

Relation between treatments and symptoms duration

Description

Relation between treatments and symptoms duration

Time Frame

During treatment (12 weeks)

Title

Time course of specific IgM/IgG seroconversion

Description

Time course of specific IgM/IgG seroconversion

Time Frame

During treatment (12 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Waldo H Belloso, MD

Phone

+541149590200

waldo.belloso@hiba.org.ar

First Name & Middle Initial & Last Name or Official Title & Degree

Gustavo D Lopardo, MD

Phone

+541149590200

glopardo@intramed.net

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Waldo H Belloso, MD

Organizational Affiliation

Hospital Italiano de Buenos Aires

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Ventura Simonovich, MD

Organizational Affiliation

HIBA

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Esteban Nannini, MD

Organizational Affiliation

Sanatorio Britanico

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Wanda Cornistein, MD

Organizational Affiliation

Hospital Austral

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Marcelo Figueiras, MD

Organizational Affiliation

Richmond Laboratorio

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Elvira Zini, MD

Organizational Affiliation

Richmond Laboratorio

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Fernando Riera, MD

Organizational Affiliation

Sanatorio Allende (Córdoba)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Omar Sued, MD

Organizational Affiliation

HUESPED

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Santiago Ramirez Borga, MD

Organizational Affiliation

Hospital Italiano de La Plata

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Gustavo Costilla Campero, MD

Organizational Affiliation

Hospital Padilla (Tucumán)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Gustavo D Lopardo, MD

Organizational Affiliation

Hospital Bernardo Houssay

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Gonzalo Corral, MD

Organizational Affiliation

Hospital Alende (Mar del Plata)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sociedad Argentina de Infectología, A. J. Carranza 974

City

Ciudad Autonoma de Buenos Aires

State/Province

Capital Federal

ZIP/Postal Code

C1085

Country

Argentina

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Waldo H Belloso, MD

Phone

+541149590200

waldo.belloso@hiba.org.ar

First Name & Middle Initial & Last Name & Degree

Diego H Giunta, PhD

Phone

+54 9 11 5825-6489

diego.giunta@hospitalitaliano.org.ar

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32119961

Citation

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.

Results Reference

background

PubMed Identifier

25763783

Citation

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.

Results Reference

background

Links:

URL

https://www.argentina.gob.ar/salud/coronavirus-COVID-19/sala-situacion

Description

Sala de Situación Coronavirus online - Ministerio de Salud de la Nación

URL

https://doi.org/10.1016/j.jhin.2020.03.002

Description

Reasons for healthcare workers becoming infected with novel coronavirus disease 2019 (COVID-19) in China

URL

https://doi.org/10.1101/2020.03.18.997585

Description

Nucleotide Analogues as Inhibitors of SARS-CoV-2 Polymerase

URL

https://www.biorxiv.org/content/biorxiv/early/2020/01/31/2020.01.30.927574.full.pdf

Description

Nucleotide Analogues as Inhibitors of Viral Polymerases

URL

https://doi.org/10.1101/2020.04.03.022939

Description

Triphosphates of the Two Components in DESCOVY and TRUVADA are Inhibitors of the SARS-CoV-2 Polymerase

URL

https://www.croiconference.org/abstract/phase-3-discover-study-daily-ftaf-or-ftdf-hiv-preexposure-prophylaxis/

Description

THE PHASE 3 DISCOVER STUDY: DAILY F/TAF OR F/TDF FOR HIV PREEXPOSURE PROPHYLAXIS

URL

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6808931/

Description

1962. Renal Outcomes for Participants Taking F/TAF vs. F/TDF for HIV PrEP in the DISCOVER Trial

Learn more about this trial

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

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