Trial NCT04321616
Publication NOR-SOLIDARITY - Barratt-Due A, Ann Intern Med (2021) (published paper)
Dates: 2020-04-07 to 2020-10-04
Funding: Mixed (National Clinical Therapy Research in the Specialist Health Services, Norway; Gilead Sciences (drug donation))
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Multicenter / Norway
Follow-up duration (days): 90
Inclusion criteria
  • Adults (≥18 years)
  • laboratory-confirmed SARS-CoV-2 infection
  • admitted to the hospital ward or the intensive care unit
  • with no anticipated transfer to a non-study hospital within 72 hours of inclusion.
Exclusion criteria
  • Severe co-morbidity with life expectancy <3 months
  • AST/ALT > 5 times the upper limit of normal
  • QTc-time >470 ms
  • pregnancy
  • breast-feeding
  • acute co-morbidity occurrence in a 7-day period before inclusion
  • known intolerance to study drugs
  • participation in a potentially confounding trial or concomitant medications interfering with the study drugs.
Interventions
Treatment
Remdesivir
Initial dose: 200 mg/day IV- Maintenance dose: 100 mg/day for up to 9 days
Control
Standard care

Participants
Randomized
participants :
Remdesivir=43
Standard care=58
Characteristics of participants
N= 101
Mean age : NR
72 males
Severity : Mild: n=* / Moderate: n=* / Severe: n=* Critical: n=*
Number of vaccinated participants: NR
Primary outcome
In the register
All cause in-hospital mortality [Time Frame: 3 weeks]
In the report
In-hospital mortality (i.e. death during the original hospitalization; follow-up ceased at discharge), regardless of whether death occurred before or after day 28
Documents
available

Protocol

Yes. In English

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
Low
General comment In addition to the peer-reviewed journal and pre-print articles, the study registry and protocol were used in data extraction and risk of bias assessment. NOR-Solidarity includes additional data collected beyond the WHO Solidarity core follow-up. Whereas the remdesivir arm was continued in the WHO Solidarity trial, it was stopped in the NOR-Solidarity study, on October 5th due to 1) general low mortality in hospitalized patients in Norway, 2) the potential for untoward effects in ventilated patients, and 3) potentially little, if any, effect of remdesivir for patients with mild disease. Some outcomes were reported at a different follow-up point than pre-specified in the registry. In-hospital mortality is reported.
On 27th of July, 2021, this study was updated based on the published article.