Clinical trial NCT04712357: Clinical Experimentation With Tenofovir Disoproxyl Fumarate and Emtricitabine for COVID-19
Official title: Clinical, Control, Double-blind, Randomized Experimentation With Tenofovir Disoproxyl Fumarate and Emtricitabine for COVID-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Keywords: Tenofovir
Emtricitabine
COVID-19
Clinical trial
Lead sponsor: Universidade Federal do Ceara
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: São José Hospital for Infectious Diseases - HSJ
name: Central Laboratory of Public Health of Ceará - Lacen-CE
First posted: 2021-01-15
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control case
Primary purpose: TREATMENT

Brief summary: Clinical, control, double-blind, randomized trial with tenofovir disoproxyl fumarate and emtricitabine for Covid-19

Detailed description: Several therapeutic agents have been evaluated for the treatment of Covid-19, and only one using an antiviral drug called remdesivir administered intravenously has shown efficacy to reduce the duration of the disease in 26.7% in critically ill patients. This proposal has as its primary objective (a) Determine the effect of TDF and TDF + FTC on the duration of Covid-19 evaluated in the 14th. day of follow-up at the outpatient clinic in the hospital, duration of the disease observing clinical signs and symptoms, as well as evaluating the RT-PCR viral load tests on the 1st, 7th, 14th. and 28th. days of the study protocol. In addition, the proposal assesses several secondary objectives: (b) Assess the action of TDF and TDF + FTC on the immune response using the rapid ELISA test (IgM / IgG) to be performed on the 7th. and 28th. days of monitoring the experimental protocol; (c) Determine the effect of clinical interventions with the drugs TDF and TDF + FTC in the short and medium term on the viral load of SARS-CoV-2; and (d) Assess the effect of TDF and TDF + FTC on inflammation biomarkers cytokines and chemokines (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) in the blood of patients collected in the 1st, 14th. and 28th. study days. The study will be a prospective, double-blind, placebo control and randomized clinical trial of a total of 219 patients with mild to moderate disease, aged 18 years or over, with clinical signs and symptoms of Covid-19 and certified after the RT-PCR test for the detection of SARS-CoV-2 viral load. The study will be carried out at the outpatient clinic of Hospital São José, Fortaleza, CE. The random groups will be: (1) Group - Placebo control (Vitamin C - 500mg / day, for 10 days); (2) Group - tenofovir disoproxyl fumarate (TDF; 300 mg / day, for 10 days); and (3) Group - TDF + emtricitabine (FTC; 200 mg / day, for 10 days). The study aims to evaluate the efficacy of tenofovir alone or combined with emtricitabine in the duration of mild to moderate Covid-19 cases. The study will also assess the effect of drugs on viral load and immune-inflammatory response. In this sense, the study has the perspective of minimizing the evolution of the disease to severe cases, thus relieving the collapse of the health system and minimizing the social, economic and health disorders of the pandemic by SARS-CoV-2.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Day 7 follow up after enrollment.
Secondary outcomes:
measure: SARS-CoV-2 RNA viral load measurements change.
timeFrame: Change between Day 1 and Day 7 follow up after enrollment.
measure: Proportion of patients with qualitative serum IgM / IgG.
timeFrame: Proportion of positive patients at Day 28 for IgM / IgG (N; %).
measure: 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.
timeFrame: Change between Day 1 and Day 14 follow up after enrollment.
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Núcleo de Biomedicina - NUBIMED
state: Ceará
Study officials:
References: