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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-18

Study Completion Date

2021-05-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Phase 2B: 30 treated, 30 untreated - 1 interim analysis planned after inclusion of 30 patients / Phase 3: 90 treated, 90 untreated - 2 interim analyses planned after inclusion of 60 and 120 patients

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Biologists in Endpoint Adjudication committee

Study Groups

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TDF / FTC

2 tablets on Day-1 then 1 tablet/day for 6 days

Group Type EXPERIMENTAL

tenofovir disoproxil and emtricitabine

Intervention Type DRUG

Experimental drugs administration of 7-day short course TDF/FTC

usual care

Standard of Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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tenofovir disoproxil and emtricitabine

Experimental drugs administration of 7-day short course TDF/FTC

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients 18 years and over
* SARS-CoV2 Infection confirmed by PCR
* Patients who do not require immediate hospitalization
* Signed informed consent

* 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