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Vaccine availability precluded further recruitment
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| Name | Class |
|---|---|
| Sociedad Argentina de InfectologÃa (SADI) (Argentine Society of Infectious Diseases) | UNKNOWN |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FTC/TAF | Experimental | 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 | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emtricitabine/Tenofovir Alafenamide 200 MG-25 MG Oral Tablet | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Severity of symptomatic COVID-19 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Waldo H Belloso, MD | Hospital Italiano de Buenos Aires | Study Chair |
| 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) |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sociedad Argentina de InfectologÃa, A. J. Carranza 974 | Buenos Aires | Buenos Aires F.D. | C1085 | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32119961 | Background | 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. | |
| 25763783 | Background | 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. |
| Label | URL |
|---|---|
| Sala de Situación Coronavirus online - Ministerio de Salud de la Nación | View source |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D045169 | Severe Acute Respiratory Syndrome |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000068679 | Emtricitabine |
| C442442 | tenofovir alafenamide |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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Randomized (1:1), double-blind, placebo-controlled clinical trial
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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.
|
| Placebo | Drug | A dose of 1 tablet per day will be administered for a total of 12 weeks. |
|
|
Severity of symptomatic SARS-CoV-2 (Covid-19) infections as defined by the following categories:
| During treatment (12 weeks) |
| Respiratory symptom duration in days | Respiratory symptom duration in days | During treatment (12 weeks) |
| Relation between treatments and symptoms duration | Relation between treatments and symptoms duration | During treatment (12 weeks) |
| Time course of specific IgM/IgG seroconversion | Time course of specific IgM/IgG seroconversion | During treatment (12 weeks) |
| Principal Investigator |
| Gustavo D Lopardo, MD | Hospital Bernardo Houssay | Principal Investigator |
| Gonzalo Corral, MD | Hospital Alende (Mar del Plata) | Principal Investigator |
| Reasons for healthcare workers becoming infected with novel coronavirus disease 2019 (COVID-19) in China | View source |
| Nucleotide Analogues as Inhibitors of SARS-CoV-2 Polymerase | View source |
| Nucleotide Analogues as Inhibitors of Viral Polymerases | View source |
| Triphosphates of the Two Components in DESCOVY and TRUVADA are Inhibitors of the SARS-CoV-2 Polymerase | View source |
| THE PHASE 3 DISCOVER STUDY: DAILY F/TAF OR F/TDF FOR HIV PREEXPOSURE PROPHYLAXIS | View source |
| 1962\. Renal Outcomes for Participants Taking F/TAF vs. F/TDF for HIV PrEP in the DISCOVER Trial | View source |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |