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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04405271
• Other study ID #: 5616
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: July 31, 2020
• Est. completion date: November 15, 2020

Study information

• Verified date: July 2020
• Source: Hospital Italiano de Buenos Aires
• Contact: Waldo H Belloso, MD
• Phone: +541149590200
• Email: waldo.belloso[@]hiba.org.ar
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1378
• Est. completion date: November 15, 2020
• Est. primary completion date: November 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Healthcare Workers
• SARS-CoV 2

Intervention

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

Locations

Country	Name	City	State
Argentina	Sociedad Argentina de Infectología, A. J. Carranza 974	Ciudad Autonoma de Buenos Aires	Capital Federal

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Italiano de Buenos Aires	Sociedad Argentina de Infectología (SADI) (Argentine Society of Infectious Diseases)

Country where clinical trial is conducted

Argentina, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

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

External Links

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