Trial NCT04685512; EuraCT 2020-001867-94
Publication Parientia JJ, EClinicalMedicine (2021) (published paper)
Dates: 2020-11-20 to 2021-03-19
Funding: Public/non profit (Caen University Hospital)
Conflict of interest: Yes

Methods
RCT
Blinding: Unblinded
Location : Multicenter / France
Follow-up duration (days): 14
Inclusion criteria
  • SARS CoV-2 infected adults confirmed by nasopharyngeal swab RT-PCR test
  • symptoms of COVID-19 for less than 7 days before enrollment
  • did not require immediate hospitalization.
Exclusion criteria
  • breastfeeding
  • positive pregnancy test
  • estimated glomerular filtration rate <80 mL/min per 1.73 m2, as requested by the ANSM
  • living with HIV
  • hepatitis B
  • hepatitis C
  • contraindication to use the experimental drugs
  • capillary oximetry less than 95%
  • clinical evaluation by investigators leading to hospitalisation
  • use of non-steroid antiinflammatory or any nephrotoxic drugs during the past 7 days.
Interventions
Treatment
TDF+FTC
Initial dose: TDF 490 mg/day + FTC 400 mg/day on day 1; Maintenance dose: TDF 245 mg/day + FTC 200 mg/day on days 2-7 orally.
Control
Standard care

Participants
Randomized
participants :
TDF+FTC=30
Standard care=30
Characteristics of participants
N= 60
Mean age : NR
26 males
Severity : Mild: n= 60/ Asymptomatic: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
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 ]
In the report
variation of SARS-CoV2 viral load burden from baseline assessed by the variation of the number of cycle thresholds (Ct) of RT-PCR from nasopharyngeal samples at day-4 compared to baseline.
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:

Yes
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Some concerns
General comment In addition to the preprint, the study registry was used in data extraction and risk of bias assessment. 5% of included outpatients were reported to have moderate COVID-19 at baseline (but were outpatients). There are no substantive changes from the registry in the study population, procedures, outcomes, intervention and control treatments. 10% of intervention participants discontinued treatment due to adverse events. Unblinded study. Total adverse events are not reported. The study achieved the target sample size specified in the trial registry.