Efficacy of convalescent plasma for treatment of COVID-19 in Uganda
Dr Bruce Kirenga, Pauline Byakika-Kibwika, Winters Muttamba, Alex Kayongo, Namakula Olive Loryndah, Levicatus Mugenyi, Noah Kiwanuka, John Lusiba, Angella Atukunda, Raymond Mugume, Francis Ssali, Henry Ddungu, Winceslaus Katagira, Rogers Sekibira, Cissy Kityo, Dorothy Kyeyune, Susan Acana, Hellen Aanyu-Tukamuhebwa, Wilberforce Kabweru, Fred Nakwagala, Bernard Sentalo Bagaya, Ivan Kimuli, Rebecca Nantanda, Esther Buregyeya, Baterana Byarugaba, Charles Olaro, Henry G Mwebesa, Moses Lutaakome Joloba, Trishul Siddharthan, William Bazeyo
BMJ Open Respiratory Research, doi:10.1136/bmjresp-2021-001017
Rationale Convalescent plasma (CCP) has been studied as a potential therapy for COVID-19, but data on its efficacy in Africa are limited. Objective In this trial we set out to determine the efficacy of CCP for treatment of COVID-19 in Uganda. Measurements Patients with a positive SARS-CoV-2 reverse transcriptase (RT)-PCR test irrespective of disease severity were hospitalised and randomised to receive either COVID-19 CCP plus standard of care (SOC) or SOC alone. The primary outcome was time to viral clearance, defined as having two consecutive RT-PCR-negative tests by day 28. Secondary outcomes included time to symptom resolution, clinical status on the modified WHO Ordinal Clinical Scale (≥1-point increase), progression to severe/ critical condition (defined as oxygen saturation <93% or needing oxygen), mortality and safety. Main results A total of 136 patients were randomised, 69 to CCP+SOC and 67 to SOC only. The median age was 50 years (IQR: 38.5-62.0), 71.3% were male and the median duration of symptom was 7 days (IQR=4-8). Time to viral clearance was not different between the CCP+SOC and SOC arms (median of 6 days (IQR=4-11) vs 4 (IQR=4-6), p=0.196). There were no statistically significant differences in secondary outcomes in CCP+SOC versus SOC: time to symptom resolution (median=7 (IQR=5-7) vs 7 (IQR=5-10) days, p=0.450), disease progression (9 (22.0%) vs 7 (24.0%) patients, p=0.830) and mortality (10 (14.5%) vs 8 (11.9%) deaths, p=0.476). Conclusion In this African trial, CCP therapy did not result in beneficial virological or clinical improvements. Further trials are needed to determine subgroups of patients who may benefit from CCP in Africa. Trial registration number NCT04542941.
Competing interests None declared. Patient consent for publication Not required. Ethics approval Trial ethical and regulatory approvals were obtained from the Mulago Hospital Research and Ethics Committee (MHREC) under reference number MHREC 1902, the National Drug Authority, and the Uganda National Council for Science and Technology under reference number HS816 ES. This study was conducted according to the principles of the Declaration of Helsinki and Good Clinical Practice. Provenance and peer review Not commissioned; externally peer reviewed. Data availability statement Data are available upon reasonable request. Data collected for this trial, including de-identified individual participant data and a data dictionary defining each field in the set, will be made available to others upon reasonable request. Additional, related documents including study protocol, statistical analysis plan and informed consent forms will be made available upon reasonable request. A formal request should be sent via email to the clinical trial principal investigator Dr Bruce Kirenga at brucekirenga@ yahoo. com. After approval of a proposal by an institutional research board with a signed data access agreement, data will be made available.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not..
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'relation': {},
'ISSN': ['2052-4439'],
'subject': ['Pulmonary and Respiratory Medicine'],
'container-title-short': 'BMJ Open Resp Res',
'published': {'date-parts': [[2021, 8]]}}