Safety and Efficacy of Hydroxychloroquine for Treatment of Non-Severe COVID-19 in Adults in Uganda: A Randomized Open Label Phase II Clinical Trial
Byakika-Kibwika et al.,
Safety and Efficacy of Hydroxychloroquine for Treatment of Non-Severe COVID-19 in Adults in Uganda: A..,
Research Square, doi:10.21203/rs.3.rs-506195/v1 (Preprint)
Small 105 patient RCT in Uganda showing no significant differences. No mortality was reported. The patients were very young (median age 32), recovering in a median time of 3 days with standard of care, so there is little room for a treatment to make improvements. Time since symptom onset is not specified, but the distribution of symptoms at baseline suggests that the enrollment is relatively late within a cohort of low risk patients.
recovery time, no change, relative time 1.00, p = 0.91, treatment 36, control 29.
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relative improvement in Ct value, 29.3% better, RR 0.71, p = 0.47, treatment 15, control 15.
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risk of no viral clearance, 2.6% higher, RR 1.03, p = 1.00, treatment 35 of 55 (63.6%), control 31 of 50 (62.0%), day 6.
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risk of no viral clearance, 6.7% higher, RR 1.07, p = 0.85, treatment 27 of 55 (49.1%), control 23 of 50 (46.0%), day 10.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Byakika-Kibwika et al., 4 Jun 2021, Randomized Controlled Trial, Uganda, preprint, 17 authors.
Abstract: Safety and Efficacy of Hydroxychloroquine for
Treatment of Non-Severe COVID-19 in Adults in
Uganda: A Randomized Open Label Phase II Clinical
Trial
Pauline Byakika-Kibwika ( pbyakika@gmail.com )
Makerere University College of Health Sciences
Christine Sekaggya-Wiltshire
Mulago National Referral Hospital
Jerome Roy Semakula
Makerere University College of Health Sciences
Jane Nakibuuka
Mulago National Referral Hospital
Joseph Musaazi
Makerere University College of Health Sciences
James Kayima
Makerere University College of Health Sciences
Cornelius Sendagire
Makerere University College of Health Sciences
David Meya
Makerere University College of Health Sciences
Bruce Kirenga
Makerere University College of Health Sciences
Sarah Nanzigu
Makerere University College of Health Sciences
Arthur Kwizera
Makerere University College of Health Sciences
Fred Nakwagala
Mulago National Referral Hospital
Ivan Kisuule
Mulago National Referral Hospital
Misaki Wayengera
Makerere University College of Health Sciences
Henry G Mwebesa
Ministry of Health
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Moses Kamya
Makerere University College of Health Sciences
William Bazeyo
Makerere University College of Health Sciences
Research Article
Keywords: COVID-19, Hydroxychloroquine, outcomes, treatment, safety, efficacy.
Posted Date: June 4th, 2021
DOI: https://doi.org/10.21203/rs.3.rs-506195/v1
License: This work is licensed under a Creative Commons Attribution 4.0 International License.
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Abstract
Background
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 400mg twice a day for the first day followed by 200mg twice daily for the next 4 days
plus standard of care (SOC) treatment or SOC treatment alone. SARS COV-2 viral load 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.
Results
Of the 105 participants enrolled, 55 were assigned to the intervention group (HCQ plus SOC) and 50 to the
control group (SOC only). Baseline characteristics were similar across treatment arms. Viral clearance did
not differ by treatment arm, 20 and 19 participants respectively had SARS COV-2 viral load clearance by
day 6 with no significant difference, median (IQR) number of days to viral load clearance between the two
groups was 4(3-4) vs 4(2-4): p=0.457. There were no significant differences in secondary outcomes
(symptom resolution and adverse events) between the intervention group and the control group. There
were no significant differences in specific adverse events such as elevated alkaline phosphatase,
prolonged QTc interval on ECG, among patients in the intervention group as compared to the control
group.
Conclusion
Our results show that HCQ..
Late treatment
is less effective
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