COVID-19, Healthcare Workers, SARS-CoV 2
Conditions
Keywords
SARS Virus, SARS-CoV-2, COVID-19, Health Personnel
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.
Interventions
DRUGEmtricitabine/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
DRUGPlacebo
A dose of 1 tablet per day will be administered for a total of 12 weeks.
Sponsors
Sociedad Argentina de Infectología (SADI) (Argentine Society of Infectious Diseases)
Hospital Italiano de Buenos Aires
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, 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.
Intervention model description
Randomized (1:1), double-blind, placebo-controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COVID-19 incident cases | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of asymptomatic SARS-CoV-2 (Covid-19) infections confirmed by serology | During treatment (12 weeks) | Number of asymptomatic SARS-CoV-2 (Covid-19) infections confirmed by serology |
| Severity of symptomatic COVID-19 | 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 |
| Respiratory symptom duration in days | During treatment (12 weeks) | Respiratory symptom duration in days |
| Relation between treatments and symptoms duration | During treatment (12 weeks) | Relation between treatments and symptoms duration |
| Time course of specific IgM/IgG seroconversion | During treatment (12 weeks) | Time course of specific IgM/IgG seroconversion |
Countries
Argentina
Outcome results
None listed