effect of tenofovir/emtricitabine in patients recently infected with sars-cov2 (covid-19) discharged home

Conditions: Covid19

Summary: covid-19 pandemic is currently affecting the globe. to date, there is no effective oral therapy against sars-cov2 infection. the investigators propose to test as a repurposing drug combination, a short course of tenofovir disoproxil and emtricitabine (tdf/ftc), as a proof-of-concept randomized open-label study to test its viral efficacy against sars-cov2.

the sars-cov2 pandemic is causing morbidity and mortality. there is no cure. remdesivir is a nucleotide analogue that has demonstrated its efficacy in vitro against sars-cov2 and in humans (shorten symptoms duration by 2 days without improving survival), but it is used parenterally. tdf belongs to the same therapeutic class, represents a promising avenue of research. tdf/ftc demonstrated in vivo efficacy against sars-cov2 in preclinical animal models and its use is associated with reduced risk of sars-cov2 infection in 2 large cohorts of hiv infected patients.the objective of this work is to evaluate the anti-viral efficacy of the tdf/ftc combination in short course in patients infected with sars-cov2 on an outpatient basis. the investigators propose a multicenter, open-label, phase 2b/3 randomized trial of a 7-day treatment with tdf / ftc (2 tablets on day-1 then 1 tablet / day for 6 days) according to the dosage used in pre-exposure prophylaxis for hiv. this study should include 60 outpatients (phase 2b) and 120 additional outpatients (phase iii) who were diagnosed with sars-cov2 positive and with no contraindication to tdf / ftc and without criteria for hospitalization. the primary endpoint of the phase 2b will be the sars-cov2 antiviral efficacy quantified by rt-pcr nasopharyngeal sample ct increase on day-4 compared to baseline. the primary endpoint of the phase 3 will be the rate of non-contagious pcr on day-4 from a nasopharyngeal sample. secondary endpoints will be tolerance, symptoms resolution, percentage of hospitalization and the rate of non-contagious pcr on day-7 from a nasopharyngeal sample. the investigators hypothesize that compared to no treatment, treatment with tdf/ftc reduces at day-4: * sars-cov2 viral load corresponding to a 4-point +/-5 increase in ct (phase 2b) * contagious carriage from 80% to 60% (phase 3). the ar0-corona investigators hope, through this study, to be able to validate an anti-viral treatment making it possible to reduce the duration of contagiousness and thus contribute to attenuating the r0 of recently infected patients carrying sars-cov2 who are isolated at home.

Eligibility criteria:
inclusion criteria: * patients 18 years and over * sars-cov2 infection confirmed by pcr * patients who do not require immediate hospitalization * signed informed consent non-inclusion criteria: * patients with hiv or hepatitis b * symptoms suggestive of a sars-cov2 infection that has been progressing for more than 7 days * asympomatic patients with unknown date of infection or date of infection\>7 days * chronic hcv infection * contraindication to the use of tdf/ftc * hypersensitivity to tenofovir, to emtricitabine or to any of the excipients (especially lactose) * glomerular filtration rate \<80ml / min * recent (less than 7 days) or concomitant use of nsaids or other nephrotoxic drugs (antiinfectives, immunosuppressants, allopurinol, lithium * need for hospitalization for contemporary decompensation of a comorbidity * need for hospitalization due to sars-cov2 infection: * capillary oximetry less than 95% * clinical evaluation by the investigating doctor leading to hospitalization * pregnant or breastfeeding women exclusion criteria: - diagnosis of pregnancy during treatment

Keywords: covid-19 tdf/ftc ambulatory patients replication rate of the virus