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

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ClinicalTrials.gov Identifier: NCT04405271
Recruitment Status : Not yet recruiting
First Posted : May 28, 2020
Last Update Posted : July 28, 2020
Sponsor:
Collaborator:
Sociedad Argentina de Infectología (SADI) (Argentine Society of Infectious Diseases)
Information provided by (Responsible Party):
Waldo Horacio Belloso, Hospital Italiano de Buenos Aires

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1378 participants
Allocation: Randomized
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.
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


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 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
Drug: Placebo
A dose of 1 tablet per day will be administered for a total of 12 weeks.
Other Name: Placebo comparator




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Respiratory symptom duration in days [ Time Frame: During treatment (12 weeks) ]
    Respiratory symptom duration in days

  4. Relation between treatments and symptoms duration [ Time Frame: During treatment (12 weeks) ]
    Relation between treatments and symptoms duration

  5. Time course of specific IgM/IgG seroconversion [ Time Frame: During treatment (12 weeks) ]
    Time course of specific IgM/IgG seroconversion



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Waldo H Belloso, MD +541149590200 waldo.belloso@hiba.org.ar
Contact: Gustavo D Lopardo, MD +541149590200 glopardo@intramed.net

Locations
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Argentina
Sociedad Argentina de Infectología, A. J. Carranza 974
Ciudad Autonoma de Buenos Aires, Capital Federal, Argentina, C1085
Contact: Waldo H Belloso, MD    +541149590200    waldo.belloso@hiba.org.ar   
Contact: Diego H Giunta, PhD    +54 9 11 5825-6489    diego.giunta@hospitalitaliano.org.ar   
Sponsors and Collaborators
Hospital Italiano de Buenos Aires
Sociedad Argentina de Infectología (SADI) (Argentine Society of Infectious Diseases)
Investigators
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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)
Additional Information:
Publications:
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Responsible Party: Waldo Horacio Belloso, Principal Investigator, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT04405271    
Other Study ID Numbers: 5616
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Waldo Horacio Belloso, Hospital Italiano de Buenos Aires:
SARS Virus, SARS-CoV-2, COVID-19, Health Personnel
Additional relevant MeSH terms:
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Tenofovir
Emtricitabine
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents