Trial NCT04321616
Publication 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 ( / ) Definition of Standard care: Local SoC changed as a result of the RECOVERY trial and updated WHO guidelines recommending systemic steroids for severe and critical COVID-19 (September 4th 2020). | |
| Participants | |
| Randomized 101 participants (n1=43 / n2= 58) | |
| Characteristics of participants N=101 Mean age : 58.8 72 males Severity : Mild: n=* / Moderate: n=*/ Severe: n=* Critical: n=* | |
| 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 stated 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. |