Trial NCT04860284
Publication HONEST - Byakika-Kibwika P, BMC Infect Dis (2021) (published paper)
Dates: 2020-09-18 to 2021-02-28
Funding: Public/non profit (Government of Uganda through the Makerere University Research and Innovation Fund)
Conflict of interest: No
Methods | |
RCT Blinding: Unblinded | |
Location :
Single center / Uganda Follow-up duration (days): 10 | |
Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Treatment
Hydroxychloroquine Initial dose: 400mg orally twice a day for the first day - Maintenance dose: 200mg orally twice daily for the next 4 days. |
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Control
Standard care | |
Participants | |
Randomized participants : Hydroxychloroquine=55 Standard care=50 | |
Characteristics of participants N= 105 Mean age : NR 77 males Severity : Mild: n= */ Asymptomatic: n=* Number of vaccinated participants: 0 | |
Primary outcome | |
In the register SARS COV-2 viral clearance [ Time Frame: From randomization to day 6 ] | |
In the report Median time from randomization to SARS COV-2 viral clearance by day 6 | |
Documents available |
Protocol NR 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 |
In addition to the published and pre-print articles, the retrospective registry was used in data extraction and assessment of risk of bias. Neither study protocol nor statistical analysis plan was available. The primary outcome in the article and registry were similar. The secondary outcomes in the article (the proportion of PCR negative conversion by day 6 and day 10, and proportion of participants with 25% reduction of SARS COV-2 viral load from baseline at day 6, change in SARS COV-2 viral load over time, time to symptom clearance by day 10, safety outcomes like incident elevated ALT, incident elevated QTc interval, incident color vision loss/deficiency and adverse events) differed somewhat from the registry (clinical and laboratory adverse events day 6, time to symptom clearance day 10, pharmacokinetic-pharmacodynamic model demonstrating drug concentration day 8, sero-reversion to negative antibody test day 90). The trial was stopped because of the national roll-out of HCQ as standard of care by the Uganda Ministry of Health. As a result the study (n = 105) did not achieve its target sample size (n = 284).
This study was updated on April 27th, 2022 with data from the peer-reviewed report. |