Trial NCT04860284
Publication 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 | Aged 18 years and above; diagnosed with COVID-19 using RT-PCR in the last 3 days. |
| Exclusion criteria | Known allergies to HCQ or chloroquine; on medications that have clinically significant interactions with HCQ; a positive rapid test for malaria; diagnosed with severe/critically ill COVID-19 (WHO Ordinal Scale of ≥ 5); QTc prolongation of > 450ms for males and > 470ms for females; pregnant or breastfeeding; on chronic HCQ use. Participants found to have hypo- or hyperkalemia at baseline were withdrawn from the study. |
| 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 ( / ) Definition of Standard care: The SOC treatment at the time included vitamin C and zinc supplementation. Symptomatic patients also received azithromycin and analgesics if necessary. Participants who progressed to WHO ordinal scale ≥ 5 (severe or critical disease) during the study were managed according to the national clinical guidelines for COVID-19 which includes intravenous antibiotics and anticoagulation with low molecular weight heparin. | |
| Participants | |
| Randomized 105 participants (n1=55 / n2= 50) | |
| Characteristics of participants N=105 Mean age : NR 77 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=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 stated
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| 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 |
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| General comment |