Trial NCT04316377
Publication 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 Definition of Standard care: Protocol: "Standard of care will apply to both treatment arms at the discretion of the treating physician. Due to the lack of randomized evidence based therapy in COVID-19 and possibly a large proportion of patients who will present with serious to life-threatening disease, treatment by compassion will be allowed at any time at the discretion of the treating physician." | |
| Participants | |
| Randomized 53 participants (n1=27 / n2= 26) | |
| Characteristics of participants N=53 Mean age : 60.3 35 males Severity : Mild: n=* / Moderate: n=*/ Severe: n=* Critical: n=0 | |
| 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 stated NR |
| 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. |