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

• Status: Completed
• Trial end date: 2021-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Caen
• Treatments: Emtricitabine; Tenofovir

Criteria

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

Exclusion Criteria:

• Diagnosis of pregnancy during treatment