Trial ISRCTN30448031; EudraCT: 2021-005748-31
Publication PANORAMIC - Butler C, SSRN (2022) (preprint)
Dates: 2021-12-08 to 2022-04-27
Funding: Public/non profit (NIHR)
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Multicenter / UK
Follow-up duration (days): 28
Inclusion criteria
  • Aged ≥50 years, or ≥18 years with comorbidities
  • Had ongoing symptoms from COVID-19 that had started within the previous five days
  • positive polymerase chain reaction (PCR) or rapid antigen SARS-CoV-2 test within the past seven days
Exclusion criteria
  • Pregnant or breastfeeding
  • Were of childbearing potential and unwilling to use effective contraception
  • Were already taking molnupiravir
  • Allergic to molnupiravir
Interventions
Treatment
Molnupiravir
800 mg twice daily for 5 days
Control
Standard care

Participants
Randomized
participants :
Molnupiravir=12821
Standard care=12962
Characteristics of participants
N= 25783
Mean age : NR
10675 males
Severity : Mild: n= 25783/ Asymptomatic: n=0
Number of vaccinated participants: 12591
Primary outcome
In the register
Non-elective hospitalisations/deaths in higher risk, symptomatic patients with confirmed COVID-19 within 28 days of randomisation measured using patient records.
In the report
All-cause, non-elective hospital admission and/or death within 28 days of randomisation.
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
High
General comment In addition to the pre-print article, the study protocol, statistical analysis plan and registry were used in data extraction and risk of bias assessment. This is an interim analysis of an ongoing study. There is no change from the trial registration in the intervention and control treatments. The registry primary outcome reflects the reported primary outcome. Some outcomes from the registry are not reported in the paper (e.g. all adverse events).