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
Tenofovir+Emtricitabine 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 ( / ) Definition of Standard care: * | |
| Participants | |
| Randomized 60 participants (n1=30 / n2= 30) | |
| Characteristics of participants N=60 Mean age : 41.3 26 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=0 | |
| 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 stated
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| 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. |