Trial ChiCTR2200056817
Publication Zou R, Front Pharm (2022) (published paper)
Dates: 2022-03-03 to 2022-03-21
Funding: Mixed (National Key Research and Development Project, Shenzhen Science and Technology Research and Development Project, and in part from the National Science and Technology Major Projects. Molnupiravir was provided by HUAHAI Pharmaceutical. Carelink Pharmaceutical Co., Ltd. provided statistical analysis. )
Conflict of interest: No

Methods
RCT
Location : Single center / China
Follow-up duration (days): 21
Inclusion criteria
  • Confirmed mild/moderate COVID-19
  • Male or nonpregnant females
  • Aged ≥18 years and ≤80 years
  • Tested positive for SARS-CoV-2 Omicron variant
  • Had initial onset of symptoms for ≤5 days prior to the day of treatment
Exclusion criteria
  • Severe vomiting or intolerance of oral drugs for other reasons
  • Pregnancy or lactation
  • Patients retesting positive for COVID-19
  • Those who had received antibody therapy, plasma therapy, or other investigational drugs for SARS-CoV-2
Interventions
Treatment
Molnupiravir
800 mg orally twice per day for 5 days
Control
Standard care

Participants
Randomized
participants :
Molnupiravir=80
Standard care=36
Characteristics of participants
N= 116
Mean age : NR
60 males
Severity : Mild: n= */ Asymptomatic: n=0
Number of vaccinated participants: 70
Primary outcome
In the register
Percentage of negative nucleic acid tests (Nasopharyngeal swabs/respiratory secretions). Measure time point of outcome: 10 days after the first dose. Measure method: RT-PCR.
In the report
time of viral RNA clearance measured using RT-PCR analysis of pharyngeal swab.
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 published article and its supplement, the study registry was used in data extraction and risk of bias assessment. The study did not achieve the target sample size (N=150) specified in the trial registry. There is no change from the trial registration in the intervention and control treatments. The registry primary outcome does not reflect the reported primary outcome.