Efficacy of convalescent plasma for treatment of COVID-19 in Uganda
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 tr...
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BMJ Publishing Group
2021-01-01
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| Series: | BMJ Open Respiratory Research |
| Online Access: | https://bmjopenrespres.bmj.com/content/8/1/e001017.full |
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| author | Trishul Siddharthan Bruce Kirenga Cissy Kityo Henry Ddungu Winters Muttamba Levicatus Mugenyi Winceslaus Katagira Hellen Aanyu-Tukamuhebwa Alex Kayongo John Lusiba Fred Nakwagala Rebecca Nantanda Ivan Kimuli Bernard Sentalo Bagaya Rogers Sekibira Esther Buregyeya Noah Kiwanuka Moses Lutaakome Joloba Baterana Byarugaba Henry Mwebesa William Bazeyo Pauline Byakika-Kibwika Charles Olaro Namakula Olive Loryndah Angella Atukunda Raymond Mugume Francis Ssali Dorothy Kyeyune Susan Acana Wilberforce Kabweru |
| author_facet | Trishul Siddharthan Bruce Kirenga Cissy Kityo Henry Ddungu Winters Muttamba Levicatus Mugenyi Winceslaus Katagira Hellen Aanyu-Tukamuhebwa Alex Kayongo John Lusiba Fred Nakwagala Rebecca Nantanda Ivan Kimuli Bernard Sentalo Bagaya Rogers Sekibira Esther Buregyeya Noah Kiwanuka Moses Lutaakome Joloba Baterana Byarugaba Henry Mwebesa William Bazeyo Pauline Byakika-Kibwika Charles Olaro Namakula Olive Loryndah Angella Atukunda Raymond Mugume Francis Ssali Dorothy Kyeyune Susan Acana Wilberforce Kabweru |
| author_sort | Trishul Siddharthan |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-b8e2a923c4a14a599e0a917bd451b3cd |
| institution | OA Journals |
| issn | 2052-4439 |
| language | English |
| publishDate | 2021-01-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open Respiratory Research |
| spelling | doaj-art-b8e2a923c4a14a599e0a917bd451b3cd2025-08-20T02:22:29ZengBMJ Publishing GroupBMJ Open Respiratory Research2052-44392021-01-018110.1136/bmjresp-2021-001017Efficacy of convalescent plasma for treatment of COVID-19 in UgandaTrishul Siddharthan0Bruce Kirenga1Cissy Kityo2Henry Ddungu3Winters Muttamba4Levicatus Mugenyi5Winceslaus Katagira6Hellen Aanyu-Tukamuhebwa7Alex Kayongo8John Lusiba9Fred Nakwagala10Rebecca Nantanda11Ivan Kimuli12Bernard Sentalo Bagaya13Rogers Sekibira14Esther Buregyeya15Noah Kiwanuka16Moses Lutaakome Joloba17Baterana Byarugaba18Henry Mwebesa19William Bazeyo20Pauline Byakika-Kibwika21Charles Olaro22Namakula Olive Loryndah23Angella Atukunda24Raymond Mugume25Francis Ssali26Dorothy Kyeyune27Susan Acana28Wilberforce Kabweru29Pulmonary and Critical Care, Johns Hopkins University, Baltimore, Maryland, USALung Institute, Makerere University College of Health Sciences, Kampala, UgandaJoint Clinical Research Centre, Kampala, UgandaResearch Department, Uganda Cancer Institute, Kampala, Uganda, UgandaMakerere University Lung Institute, Makerere University College of Health Sciences, Kampala, UgandaLung Institute, Makerere University College of Health Sciences, Kampala, UgandaLung Institute, Makerere University College of Health Sciences, Kampala, UgandaClinical services, Mulago National Referral Hospital, Kampala, Uganda, Kampala, Uganda, UgandaLung Institute, Makerere University College of Health Sciences, Kampala, UgandaClinical services, Uganda Heart Institute, Kampala, Uganda, UgandaClinical services, Mulago National Referral Hospital, Kampala, Uganda, Kampala, Uganda, UgandaMakerere University College of Health Sciences, Kampala, UgandaMakerere University Lung Institute, Makerere University, Kampala, UgandaImmunology and Molecular Biology, Makerere University College of Health Sciences, Kampala, Uganda, UgandaMakerere University Lung Institute, Makerere University College of Health Sciences, Kampala, UgandaDepartment of research, School of Public Health, College of Health Sciences, Makerere University, Kampala, Uganda, UgandaSchool of Public Heatlh, Makerere University College of Health Sciences, Kampala, UgandaImmunology and Molecular Biology, Makerere University College of Health Sciences, Kampala, Uganda, UgandaClinical services, Mulago National Referral Hospital, Kampala, Uganda, Kampala, Uganda, UgandaClinical services, Ministry of Health, Kampala, Uganda, UgandaDepartment of research, School of Public Health, College of Health Sciences, Makerere University, Kampala, Uganda, Uganda8 Department of Internal Medicine, Makerere University College of Health Sciences, Kampala, Uganda7 Ministry of Health, Kampala, UgandaMakerere University Lung Institute, Makerere University College of Health Sciences, Kampala, UgandaClinical services, Mulago National Referral Hospital, Kampala, Uganda, Kampala, Uganda, UgandaMakerere University Lung Institute, Makerere University College of Health Sciences, Kampala, UgandaJoint Clinical Research Centre, Kampala, UgandaClinical services, Uganda Blood Transfusion Services, Kampala, Uganda, UgandaClinical services, Uganda Blood Transfusion Services, Kampala, Uganda, UgandaClinical services, Ministry of Health, Kampala, Uganda, UgandaRationale 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.https://bmjopenrespres.bmj.com/content/8/1/e001017.full |
| spellingShingle | Trishul Siddharthan Bruce Kirenga Cissy Kityo Henry Ddungu Winters Muttamba Levicatus Mugenyi Winceslaus Katagira Hellen Aanyu-Tukamuhebwa Alex Kayongo John Lusiba Fred Nakwagala Rebecca Nantanda Ivan Kimuli Bernard Sentalo Bagaya Rogers Sekibira Esther Buregyeya Noah Kiwanuka Moses Lutaakome Joloba Baterana Byarugaba Henry Mwebesa William Bazeyo Pauline Byakika-Kibwika Charles Olaro Namakula Olive Loryndah Angella Atukunda Raymond Mugume Francis Ssali Dorothy Kyeyune Susan Acana Wilberforce Kabweru Efficacy of convalescent plasma for treatment of COVID-19 in Uganda BMJ Open Respiratory Research |
| title | Efficacy of convalescent plasma for treatment of COVID-19 in Uganda |
| title_full | Efficacy of convalescent plasma for treatment of COVID-19 in Uganda |
| title_fullStr | Efficacy of convalescent plasma for treatment of COVID-19 in Uganda |
| title_full_unstemmed | Efficacy of convalescent plasma for treatment of COVID-19 in Uganda |
| title_short | Efficacy of convalescent plasma for treatment of COVID-19 in Uganda |
| title_sort | efficacy of convalescent plasma for treatment of covid 19 in uganda |
| url | https://bmjopenrespres.bmj.com/content/8/1/e001017.full |
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