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

  • STATUS
    Recruiting
  • days left to enroll
    28
  • participants needed
    180
  • sponsor
    University Hospital, Caen
Updated on 28 January 2021

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.

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.

Details
Condition COVID19
Treatment tenofovir disoproxil and emtricitabine
Clinical Study IdentifierNCT04685512
SponsorUniversity Hospital, Caen
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have COVID19??
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
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