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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 rever...

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Autores principales: Kirenga, Bruce, Byakika-Kibwika, Pauline, Muttamba, Winters, Kayongo, Alex, Loryndah, Namakula Olive, Mugenyi, Levicatus, Kiwanuka, Noah, Lusiba, John, Atukunda, Angella, Mugume, Raymond, Ssali, Francis, Ddungu, Henry, Katagira, Winceslaus, Sekibira, Rogers, Kityo, Cissy, Kyeyune, Dorothy, Acana, Susan, Aanyu-Tukamuhebwa, Hellen, Kabweru, Wilberforce, Nakwagala, Fred, Bagaya, Bernard Sentalo, Kimuli, Ivan, Nantanda, Rebecca, Buregyeya, Esther, Byarugaba, Baterana, Olaro, Charles, Mwebesa, Henry, Joloba, Moses Lutaakome, Siddharthan, Trishul, Bazeyo, William
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8354811/
https://www.ncbi.nlm.nih.gov/pubmed/34376401
http://dx.doi.org/10.1136/bmjresp-2021-001017
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author Kirenga, Bruce
Byakika-Kibwika, Pauline
Muttamba, Winters
Kayongo, Alex
Loryndah, Namakula Olive
Mugenyi, Levicatus
Kiwanuka, Noah
Lusiba, John
Atukunda, Angella
Mugume, Raymond
Ssali, Francis
Ddungu, Henry
Katagira, Winceslaus
Sekibira, Rogers
Kityo, Cissy
Kyeyune, Dorothy
Acana, Susan
Aanyu-Tukamuhebwa, Hellen
Kabweru, Wilberforce
Nakwagala, Fred
Bagaya, Bernard Sentalo
Kimuli, Ivan
Nantanda, Rebecca
Buregyeya, Esther
Byarugaba, Baterana
Olaro, Charles
Mwebesa, Henry
Joloba, Moses Lutaakome
Siddharthan, Trishul
Bazeyo, William
author_facet Kirenga, Bruce
Byakika-Kibwika, Pauline
Muttamba, Winters
Kayongo, Alex
Loryndah, Namakula Olive
Mugenyi, Levicatus
Kiwanuka, Noah
Lusiba, John
Atukunda, Angella
Mugume, Raymond
Ssali, Francis
Ddungu, Henry
Katagira, Winceslaus
Sekibira, Rogers
Kityo, Cissy
Kyeyune, Dorothy
Acana, Susan
Aanyu-Tukamuhebwa, Hellen
Kabweru, Wilberforce
Nakwagala, Fred
Bagaya, Bernard Sentalo
Kimuli, Ivan
Nantanda, Rebecca
Buregyeya, Esther
Byarugaba, Baterana
Olaro, Charles
Mwebesa, Henry
Joloba, Moses Lutaakome
Siddharthan, Trishul
Bazeyo, William
author_sort Kirenga, Bruce
collection PubMed
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.
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spelling pubmed-83548112021-08-13 Efficacy of convalescent plasma for treatment of COVID-19 in Uganda Kirenga, Bruce Byakika-Kibwika, Pauline Muttamba, Winters Kayongo, Alex Loryndah, Namakula Olive Mugenyi, Levicatus Kiwanuka, Noah Lusiba, John Atukunda, Angella Mugume, Raymond Ssali, Francis Ddungu, Henry Katagira, Winceslaus Sekibira, Rogers Kityo, Cissy Kyeyune, Dorothy Acana, Susan Aanyu-Tukamuhebwa, Hellen Kabweru, Wilberforce Nakwagala, Fred Bagaya, Bernard Sentalo Kimuli, Ivan Nantanda, Rebecca Buregyeya, Esther Byarugaba, Baterana Olaro, Charles Mwebesa, Henry Joloba, Moses Lutaakome Siddharthan, Trishul Bazeyo, William BMJ Open Respir Res Respiratory Infection 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. BMJ Publishing Group 2021-08-09 /pmc/articles/PMC8354811/ /pubmed/34376401 http://dx.doi.org/10.1136/bmjresp-2021-001017 Text en © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Respiratory Infection
Kirenga, Bruce
Byakika-Kibwika, Pauline
Muttamba, Winters
Kayongo, Alex
Loryndah, Namakula Olive
Mugenyi, Levicatus
Kiwanuka, Noah
Lusiba, John
Atukunda, Angella
Mugume, Raymond
Ssali, Francis
Ddungu, Henry
Katagira, Winceslaus
Sekibira, Rogers
Kityo, Cissy
Kyeyune, Dorothy
Acana, Susan
Aanyu-Tukamuhebwa, Hellen
Kabweru, Wilberforce
Nakwagala, Fred
Bagaya, Bernard Sentalo
Kimuli, Ivan
Nantanda, Rebecca
Buregyeya, Esther
Byarugaba, Baterana
Olaro, Charles
Mwebesa, Henry
Joloba, Moses Lutaakome
Siddharthan, Trishul
Bazeyo, William
Efficacy of convalescent plasma for treatment of COVID-19 in Uganda
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
topic Respiratory Infection
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8354811/
https://www.ncbi.nlm.nih.gov/pubmed/34376401
http://dx.doi.org/10.1136/bmjresp-2021-001017
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