Trial NCT04316377
Publication NO COVID-19 - Lyngbakken MN, Nature (2020) (published paper)
Dates: 2020-03-25 to 2020-05-25
Funding: Public/non profit (University Hospital, Akershus;European Virus Archive Global (EVA-GLOBAL) project [publication])
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Single center / Norway
Follow-up duration (days): 30
Inclusion criteria
  • All reverse transcriptase polymerase chain reaction (RT-qPCR) SARS-CoV-2 positive patients 18 years of age or older were eligible for study inclusion if they had moderately severe COVID-19 at admission (National Early Warning Score 2 [NEWS2] of 6 or less). For patients who tested positive for SARS‐CoV-2 before admission, SARS-CoV-2 status was verified with the external laboratory.
Exclusion criteria
  • (1) the need of admission to intensive care unit on hospital admission,
    (2) history of psoriasis,
    (3) reduced hearing/tinnitus,
    (4) visual impairment,
    (5) known adverse reaction to hydroxychloroquine sulphate,
    (6) pregnancy, or
    (7) prolonged corrected QT interval (>450 ms)
Interventions
Treatment
Hydroxychloroquine
400 mg orally twice daily for 7 days
Control
Standard care

Participants
Randomized
participants :
Hydroxychloroquine=27
Standard care=26
Characteristics of participants
N= 53
Mean age : NR
35 males
Severity : Mild: n=* / Moderate: n=* / Severe: n=* Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Rate of decline in SARS-CoV-2 viral load, Time Frame: Baseline (at randomization) and at 96 hours
In the report
Rate of decline in SARS-CoV-2 viral load in the oropharynx from baseline through the first 96 hours after randomization
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 published and pre-print articles, the supplementary materials, study registry, protocol, and statistical analysis plan were used in data extraction and risk of bias assessment. Additionally, an open source repository of the trial used for data extraction. The trial was terminated early by the study sponsor (University Hospital, Akershus) after the first planned interim analysis due to rapidly decreasing incidence of COVID-19 in Norway. Some planned outcomes in the protocol and registry were not reported in the paper. There was no change from the trial registration in the intervention and control treatments. Time point at termination of the study (30 days expected) are not reported.
This study (complete result section and Risk of Bias assessment) was updated on 04/11/2020.