Covid19 Clinical Trial
— ARTAN-C19Official title:
Clinical, Control, Double-blind, Randomized Experimentation With Tenofovir Disoproxyl Fumarate and Emtricitabine for COVID-19
Clinical, control, double-blind, randomized trial with tenofovir disoproxyl fumarate and emtricitabine for Covid-19
Status | Recruiting |
Enrollment | 219 |
Est. completion date | January 2023 |
Est. primary completion date | January 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient is > 18 years old - Patient diagnosed with COVID-19 Exclusion Criteria: - Patient is already receiving some of the study drugs - There is a hospitalization plan in the next 24h - Some study treatment is contraindicated - Patient has HIV infection - Patient has VHB infection - Patient lives in another city or state - Female patient, pregnant |
Country | Name | City | State |
---|---|---|---|
Brazil | Núcleo de Biomedicina - NUBIMED | Fortaleza | Ceará |
Lead Sponsor | Collaborator |
---|---|
Universidade Federal do Ceara | Central Laboratory of Public Health of Ceará - Lacen-CE, Conselho Nacional de Desenvolvimento Científico e Tecnológico, São José Hospital for Infectious Diseases - HSJ |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 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. | Day 7 follow up after enrollment. | |
Secondary | SARS-CoV-2 RNA viral load measurements change. | 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. | Change between Day 1 and Day 7 follow up after enrollment. | |
Secondary | Proportion of patients with qualitative serum IgM / IgG. | 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). | Proportion of positive patients at Day 28 for IgM / IgG (N; %). | |
Secondary | Biomarkers (IL-6, MCP-3, D-dimer, IL1-RA, IL-10, GCSF, TNF-a, MCP-1, IL-2R, MIP-1 alpha, IP-10, IL-8, NT-proBNP, Troponin I, CRP and procalcitonin) measurements change. | 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-a, 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. | Change between Day 1 and Day 14 follow up after enrollment. |
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