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)
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.
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. |
Country | Name | City | State |
---|---|---|---|
Argentina | Sociedad Argentina de Infectología, A. J. Carranza 974 | Ciudad Autonoma de Buenos Aires | Capital Federal |
Lead Sponsor | Collaborator |
---|---|
Hospital Italiano de Buenos Aires | Sociedad Argentina de Infectología (SADI) (Argentine Society of Infectious Diseases) |
Argentina,
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
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) |
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