Trial NCT05041907
Publication PLATCOV - Jittamala P, medRxiv (2022) (preprint)
Dates: 2021-09-30 to 2022-06-10
Funding: Public/non profit (Wellcome Trust)
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Multicenter / Thailand, Brazil
Follow-up duration (days): 28
Inclusion criteria
  • Previously healthy adults
  • aged between 18 and 50 years
  • early symptomatic COVID-19 (i.e. reported symptoms for <4 days), oxygen saturation ≥96%
  • unimpeded in activities of daily living
  • fully informed consent
  • SARS-CoV-2 positivity defined either as a nasal lateral flow antigen test which became positive within two minutes (STANDARDâ„¢ Q COVID-19 Ag Test, SD Biosensor, Suwon-si, Korea) or a positive PCR test within the previous 24hrs with a cycle threshold value (Ct) <25 (all viral gene targets), both suggesting high viral loads
Exclusion criteria
  • Taking any potential antivirals or pre-existing concomitant medications
  • chronic illness or significant comorbidity
  • hematological or biochemical abnormalities
  • pregnancy (a urinary pregnancy test was performed in females)
  • breastfeeding
  • contraindication or known hypersensitivity to any of the study drugs
Interventions
Treatment
Remdesivir
Initial dose: 200 mg IV infusion on day 1 - Maintenance dose: 100 mg IV infusion daily days 2-5
Control
Standard care

Participants
Randomized
participants :
Standard care=69
Remdesivir=67
Characteristics of participants
N= 136
Mean age : NR
59 males
Severity : Mild: n=136 / Moderate: n=0 / Severe: n=0 Critical: n=0
Number of vaccinated participants: Y
Primary outcome
In the register
Rate of viral clearance for newly available and repurposed drugs [ Time Frame: Days 0-7 ] ; Rate of viral clearance for positive controls (e.g. monoclonal antibodies) [ Time Frame: Days 0-7 ] ; Rate of viral clearance for small novel molecule drugs [ Time Frame: Days 0-7 ]
In the report
Viral clearance rate derived from the slope of the log10 oropharyngeal viral clearance curve over the first 7 days following randomization. The treatment effect is defined as the multiplicative change in viral clearance rate relative to the no study drug arm.
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

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 pre-print article, the trial registry, protocol, statistical analysis plan and supplementary appendices were used in data extraction and assessment of risk of bias. A target sample size was not pre-specified in this adaptive platform trial. There is no change from the trial registration in the intervention and control treatments. The registry primary outcome reflects the reported primary outcome. Total adverse events are not reported.