Effect of Tenofovir/Emtricitabine in Patients Recently Infected With SARS-COV2 (Covid-19) Discharged Home (AR0-CORONA)

Caen University Hospital

Status and phase

Completed

Phase 3

Phase 2

Conditions

Covid19

Treatments

Drug: tenofovir disoproxil and emtricitabine

Study type

Interventional

Funder types

Other

Identifiers

NCT04685512

20-070

Details and patient eligibility

About

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.

Full description

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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