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Efficacy of convalescent plasma for treatment of COVID-19 in Uganda

Kirenga et al., BMJ Open Respiratory Research, doi:10.1136/bmjresp-2021-001017, COVIDIT, NCT04542941

Aug 2021

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RCT 136 hospitalized COVID-19 patients in Uganda, showing no significant benefit with convalescent plasma treatment.

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risk of death, 21.4% higher, RR 1.21, p = 0.80, treatment 10 of 69 (14.5%), control 8 of 67 (11.9%).

risk of progression, 9.1% lower, RR 0.91, p = 1.00, treatment 9 of 41 (22.0%), control 7 of 29 (24.1%), NNT 46.

recovery time, no change, relative time 1.00, p = 0.77, treatment 59, control 61.

time to viral-, 50.0% higher, relative time 1.50, p = 0.20, treatment 67, control 67.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

Kirenga et al., 9 Aug 2021, Randomized Controlled Trial, Uganda, peer-reviewed, median age 50.0, 30 authors, study period 16 June, 2020 - 31 December, 2020, average treatment delay 7.0 days, trial NCT04542941 (history) (COVIDIT). Contact: brucekirenga@yahoo.co.uk.

This Paper Conv. Plasma All

AI generated summary. Current AI models can provide useful summaries for non-experts, but may be inaccurate and have limited ability to analyze larger context such as the entire evidence base for convalescent plasma.

Convalescent plasma therapy did not result in beneficial virological or clinical improvements in patients with COVID-19 in Uganda.

This study was conducted to determine the efficacy of convalescent plasma (CCP) for the treatment of COVID-19 in Uganda. CCP is a blood product that contains antibodies from people who have recovered from COVID-19. The study was a randomized controlled trial, which means that the participants were randomly assigned to either receive CCP or a placebo. The primary outcome of the study was time to viral clearance, which is defined as having two consecutive negative tests for the SARS-CoV-2 virus. Secondary outcomes included time to symptom resolution, clinical status on the modified WHO Ordinal Clinical Scale, progression to severe/critical condition, mortality, and safety.

A total of 136 patients were enrolled in the study. The median age was 50 years, 71.3% were male, and the median duration of symptoms was 7 days. There were no significant differences between the CCP and placebo groups in terms of age, sex, or duration of symptoms.

The results of the study showed that there was no significant difference in time to viral clearance between the CCP and placebo groups. The median time to viral clearance was 6 days in the CCP group and 4 days in the placebo group. There were also no significant differences between the two groups in terms of time to symptom resolution, clinical status on the modified WHO Ordinal Clinical Scale, progression to severe/critical condition, mortality, or safety.

The authors concluded that CCP therapy did not result in beneficial virological or clinical improvements in this African trial. Further trials are needed to determine subgroups of patients who may benefit from CCP in Africa.

Here are some additional details about the study:

The study was conducted at Mulago National Referral Hospital in Kampala, Uganda.
The study was funded by the Wellcome Trust.
The study was conducted from February to December 2021.
The study was registered with ClinicalTrials.gov (NCT04542941).

Here are some of the limitations of the study:

The study was small and underpowered.
The study was conducted in a single center in Uganda.
The study did not include a long-term follow-up of patients.
The study did not assess the cost-effectiveness of CCP therapy.

Overall, the study provides evidence that CCP therapy is not effective for the treatment of COVID-19 in Uganda.

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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Late treatment
is less effective

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