Clinical Experimentation With Tenofovir Disoproxyl Fumarate and Emtricitabine for COVID-19

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.