Trial NCT04321616
Publication Barratt-Due A, Ann Intern Med, 2021 (published paper)
Dates: 2020-03-28 to 2020-06-08
Funding: Mixed (National Clinical Therapy Research in the Specialist Health Services, Norway; Mylan (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; informed consent. |
| 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
Hydroxychloroquine Initial dose: 800 mg orally 2 times a day for the first 24 hours- Maintenance dose: 400 mg orally 2 times a 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 108 participants (n1=54 / n2= 54) | |
| Characteristics of participants N=108 Mean age : 59.8 65 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 |
Some concerns |
| General comment |
NOR-Solidarity includes additional data collected beyond the WHO Solidarity core follow-up. HCQ was removed as a treatment arm after advice from the NOR-Solidarity steering committee on June 8th 2020 due to lack of evidence of its effectiveness, confirmed both in internal WHO interim analyses and an external report from the Recovery study. 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. A statistical analysis plan was not available. There were no substantive differences between the article and trial registry in population, procedures, interventions. Some secondary outcomes from the registry (e.g. viral clearance as assessed by SARS-CoV-2 PCR) are not reported in the paper, though the supplementary material is not currently accessible. Mortality is in-hospital mortality.
On 27th of July, 2021, this study was updated based on published article. |