Safety and efficacy of hydroxychloroquine for treatment of non‑severe COVID‑19 among adults in Uganda: a randomized open label phase II clinical trial
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Date
2021
Journal Title
Journal ISSN
Volume Title
Publisher
BMC Infectious Diseases
Abstract
Several repurposed drugs such as hydroxychloroquine (HCQ) have been investigated for treatment of COVID-19, but none was confirmed to be efficacious. While in vitro studies have demonstrated antiviral properties of HCQ, data from clinical trials were conflicting regarding its benefit for COVID-19 treatment. Drugs that limit viral replication may be beneficial in the earlier course of the disease thus slowing progression to severe and critical illness.
Design: We conducted a randomized open label Phase II clinical trial from October–December 2020. Methods: Patients diagnosed with COVID-19 using RT-PCR were included in the study if they were 18 years and above and had a diagnosis of COVID-19 made in the last 3 days. Patients were randomized in blocks, to receive either HCQ 400 mg twice a day for the first day followed by 200 mg twice daily for the next 4 days plus standard of care (SOC) treatment or SOC treatment alone. SARS COV-2 viral load (CT values) from RT-PCR testing of samples collected using nasal/orapharyngeal swabs was performed at baseline, day 2, 4, 6, 8 and 10. The primary outcome was median time from randomization to SARS COV-2 viral clearance by day 6.
Description
Keywords
COVID-19, Hydroxychloroquine, Outcomes, Treatment, Safety, Efficacy
Citation
Byakika-Kibwika, P., Sekaggya-Wiltshire, C., Semakula, J. R., Nakibuuka, J., Musaazi, J., Kayima, J., ... & Bazeyo, W. (2021). Safety and efficacy of hydroxychloroquine for treatment of non-severe COVID-19 among adults in Uganda: a randomized open label phase II clinical trial. BMC Infectious Diseases, 21(1), 1-11. https://doi.org/10.1186/s12879-021-06897-9