Clinical Experimentation With Tenofovir Disoproxyl Fumarate and Emtricitabine for COVID-19 (ARTAN-C19)
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|ClinicalTrials.gov Identifier: NCT04712357|
Recruitment Status : Recruiting
First Posted : January 15, 2021
Last Update Posted : January 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Covid19||Drug: Vitamin C 500 MG Oral Tablet Drug: Tenofovir disoproxyl fumarate 300 MG Oral Tablet Drug: Tenofovir disoproxyl fumarate 300 MG plus emtricitabine 200 MG Oral Tablet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||219 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Control case|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Randomized double-blind|
|Official Title:||Clinical, Control, Double-blind, Randomized Experimentation With Tenofovir Disoproxyl Fumarate and Emtricitabine for COVID-19|
|Actual Study Start Date :||November 9, 2020|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2023|
Placebo Comparator: Placebo (Vitamin C)
Control placebo (Vitamin C - 500mg / day, for 10 days)
Drug: Vitamin C 500 MG Oral Tablet
Vitamin C 500 MG per day for 10 days
Active Comparator: Tenofovir disoproxyl fumarate (TDF)
Tenofovir disoproxyl fumarate (TDF; 300 mg / day, for 10 days)
Drug: Tenofovir disoproxyl fumarate 300 MG Oral Tablet
Tenofovir disoproxyl fumarate 300 MG per day for 10 days
Active Comparator: TDF + FTC
Tenofovir disoproxyl fumarate (TDF; 300 mg / day, for 10 days) plus emtricitabine (FTC; 200 mg / day, for 10 days)
Drug: Tenofovir disoproxyl fumarate 300 MG plus emtricitabine 200 MG Oral Tablet
Tenofovir disoproxyl fumarate 300 MG plus emtricitabine 200 MG per day for 10 days
- The time to recovery, defined at day 7 days follow up after enrollment, on which a patient met the criteria for category 1, 2, or 3 on the eight-category ordinal scale. [ Time Frame: Day 7 follow up after enrollment. ]The categories are as follows: 1 - No signals and symptoms; 2 - One signal or symptom; 3 - Two signals or symptoms; 4 - Three or more signals or symptoms; 5 - Hospitalized, no active medical problems; 6 - Hospitalized, not on oxygen; 7 - Hospitalized, on oxygen; and 8 - Hospitalized, on high flow oxygen.
- SARS-CoV-2 RNA viral load measurements change. [ Time Frame: Change between Day 1 and Day 7 follow up after enrollment. ]Molecular diagnostic analyzes will be done by Real-Time PCR (qPCR) based on official guidelines determined by the American CDC (CDC-006-00019, Revision: 03; https://www.fda.gov/media/134922/download). The nasopharyngeal swab samples collected (Covid-19 test) will proceed to the nucleic acid isolation (NuAc). All qPCR reactions will be by uniplex diagnosis. Results will be reported in copies of RNA / mL.
- Proportion of patients with qualitative serum IgM / IgG. [ Time Frame: Proportion of positive patients at Day 28 for IgM / IgG (N; %). ]The IgM / IgG immune response to SARS-CoV-2 will be qualitative measure using rapid diagnostic test provide by Eco Diagnóstica (Nova Lima, MG, Brazil).
- Biomarkers (IL-6, MCP-3, D-dimer, IL1-RA, IL-10, GCSF, TNF-α, MCP-1, IL-2R, MIP-1 alpha, IP-10, IL-8, NT-proBNP, Troponin I, CRP and procalcitonin) measurements change. [ Time Frame: Change between Day 1 and Day 14 follow up after enrollment. ]We will use the Luminex XMAP Technology (MAGPIX® System, Merck Co., Kenilworth, NJ) which includes the simultaneous analysis, in the same plasma sample (volume of 25 uL), of a panel of protein markers of pro and anti-inflammatory activity (IL-6, MCP-3, D-dimer, IL1-RA, IL-10, GCSF, TNF-α, MCP-1, IL-2R, MIP-1 alpha, IP-10, IL-8, NT-proBNP, Troponin I). Specific antibodies covalently linked to the carboxylated microspheres containing different specific fluorochromes will be used. Standard curves will be constructed for each protein and then their quantification. Results will be reported in pg / mL.
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): NCT04712357
|Contact: Aldo AM Lima, Ph.D.||firstname.lastname@example.org|
|Contact: Alexandre H Binda, Ph.D.||email@example.com|