Trial NCT04321616
Publication NOR-SOLIDARITY - 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

Participants
Randomized
participants :
Hydroxychloroquine=54
Standard care=54
Characteristics of participants
N= 108
Mean age : NR
65 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
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.