Status:
COMPLETED
Effect of Tenofovir/Emtricitabine in Patients Recently Infected With SARS-COV2 (Covid-19) Discharged Home
Lead Sponsor:
University Hospital, Caen
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 shor...
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 sy...
Eligibility Criteria
Inclusion
- 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
- \- Diagnosis of pregnancy during treatment
Key Trial Info
Start Date :
November 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04685512
Start Date
November 18 2020
End Date
May 1 2021
Last Update
July 1 2021
Active Locations (2)
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1
Caen University Hospital
Caen, Calvados, France, 14000
2
Regional Hospital
Orléans, France, 45100