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Covid19Phase 2/3AR0-CORONANCT04685512

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

A Phase 2/3 study testing tenofovir disoproxil and emtricitabine in people with Covid19, run by University Hospital, Caen at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19
What is being tested?
tenofovir disoproxil and emtricitabine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesFrance
Study dates
18 Nov 2020to 1 May 2021
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 18Show fewer
  • 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

Who cannot join

  • Diagnosis of pregnancy during treatment

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Caen University Hospital

    Caen, Calvados, 14000

  • Regional Hospital

    Orléans, 45100

Other trials in France

About this study

Official title: Effect of Tenofovir/Emtricitabine Short Course on Viral Clearance in Patients Recently Infected With SARS-COV2 (Covid-19) Not Requiring Hospitalization: a Phase IIB/III Multicenter Open-label Randomized Controlled Trial

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.

Read the detailed 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.

Conditions
Covid19
Being tested
tenofovir disoproxil and emtricitabine
Keywords
COVID-19, TDF/FTC, ambulatory patients, Replication rate of the virus
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tenofovir disoproxil and emtricitabineDrug

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

Study groups in NCT04685512
Study groupRoleWhat they receive
TDF / FTCExperimental2 tablets on Day-1 then 1 tablet/day for 6 days
Receives: Drug: tenofovir disoproxil and emtricitabine
usual careNo interventionStandard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 2B: Reduction of SARS-CoV2 viral load assessed by Ct PCR at day-4 adjusted on Ct PCR SARS-CoV2 viral load at baseline (ANCOVA)

    Nasopharyngeal swab performed at baseline and day-4 with RT-PCR for SARS-CoV2

    Measured: Day-4 after the start of study

  2. Phase 3: Rate of non-contagious nasopharyngeal sample for SARS-CoV2 by PCR on Day-4 with Ct > or = 28

    Nasopharyngeal swab performed at day-4 with RT-PCR for SARS-CoV2

    Measured: Day-4 after the start of study

Secondary outcomes (4)

  1. Phase 2B/3: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Number of adverse events according to the CTCAE grade

    Measured: From the start of the study to Day-7

  2. Phase 3: Symptoms score

    Self-reported COVID-19 related symptoms

    Measured: From the start of the study to Day-7

  3. Phase 3: Proportion of secondary hospitalization

    Assessed by investigators up to day-15

    Measured: Day-15

  4. Phase 3: Rate of non-contagious nasopharyngeal sample for SARS-CoV2 by PCR on Day-7 with Ct > or = 28

    Nasopharyngeal swab performed at day-7 with RT-PCR for SARS-CoV2

    Measured: Day-7 after the start of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2020
  2. Study start18 Nov 2020
  3. Primary completion1 Apr 2021
  4. Study completion1 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04685512
Sponsor's protocol ID
20-070
Acronym
AR0-CORONA
Status last verified
Jun 2021
First submitted
16 Nov 2020
Last updated
1 Jul 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We encourage contact the corresponding author for academic IPD sharing

Publications

  • Parienti JJ et al. EClinicalMedicine 2021: https://authors.elsevier.com/sd/article/S2589-5370(21)00273-X

  • Parienti JJ, Prazuck T, Peyro-Saint-Paul L, Fournier A, Valentin C, Brucato S, Verdon R, Seve A, Colin M, Lesne F, Guinard J, Ar Gouilh M, Dina J, Vabret A, Hocqueloux L. Effect of Tenofovir Disoproxil Fumarate and Emtricitabine on nasopharyngeal SARS-CoV-2 viral load burden amongst outpatients with COVID-19: A pilot, randomized, open-label phase 2 trial. EClinicalMedicine. 2021 Aug;38:100993. doi: 10.1016/j.eclinm.2021.100993. Epub 2021 Jun 27.

    PubMed 34222849

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing tenofovir disoproxil and emtricitabine in people with Covid19, run by University Hospital, Caen at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 2B: Reduction of SARS-CoV2 viral load assessed by Ct PCR at day-4 adjusted on Ct PCR SARS-CoV2 viral load at baseline (ANCOVA) (time frame: Day-4 after the start of study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04685512, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2021.

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