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

NCT04685512 | Completed Phase 2 DMC

• 1 other identifier: 20-070
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Covid19

Keywords

COVID-19; TDF/FTC; ambulatory patients; Replication rate of the virus

Outcome Measures

Primary Outcomes (2)

• 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

  Day-4 after the start of study

• 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

  Day-4 after the start of study

Secondary Outcomes (4)

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

  From the start of the study to Day-7

• Phase 3: Symptoms score

  From the start of the study to Day-7

• Phase 3: Proportion of secondary hospitalization

  Day-15

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

  Day-7 after the start of study

Study Arms (2)

TDF / FTC

EXPERIMENTAL

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

Drug: tenofovir disoproxil and emtricitabine

usual care

NO INTERVENTION

Standard of Care

Interventions

tenofovir disoproxil and emtricitabine DRUG

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

TDF / FTC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• \- Diagnosis of pregnancy during treatment

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (2)

Caen University Hospital

Caen, Calvados, 14000, France

Location

Regional Hospital

Orléans, 45100, France

Location

Related Publications (2)

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

  RESULT

• 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.

  PMID: 34222849 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Jean-Jacques Parienti

  University Hospital, Caen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Biologists in Endpoint Adjudication committee
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: December 28, 2020
• Study Start: November 18, 2020
• Primary Completion: April 1, 2021
• Study Completion: May 1, 2021
• Last Updated: July 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share

Locations

FR (2)