Randomized controlled trial of convalescent plasma therapy against standard therapy in patients with severe COVID-19 disease
Abstract Convalescent plasma (CP) therapy in COVID-19 disease may improve clinical outcome in severe disease. This pilot study was undertaken to inform feasibility and safety of further definitive studies. This was a prospective, interventional and randomized open label pilot trial in patients with...
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2021
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oai:doaj.org-article:a115eff395224fdea2740b4a1bd82e472021-12-02T16:57:37ZRandomized controlled trial of convalescent plasma therapy against standard therapy in patients with severe COVID-19 disease10.1038/s41598-021-89444-52045-2322https://doaj.org/article/a115eff395224fdea2740b4a1bd82e472021-05-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-89444-5https://doaj.org/toc/2045-2322Abstract Convalescent plasma (CP) therapy in COVID-19 disease may improve clinical outcome in severe disease. This pilot study was undertaken to inform feasibility and safety of further definitive studies. This was a prospective, interventional and randomized open label pilot trial in patients with severe COVID-19. Twenty COVID-19 patients received two 200 ml transfusions of convalescent patient CP over 24-h compared with 20 who received standard of care. The primary outcome was the requirement for ventilation (non-invasive or mechanical ventilation). The secondary outcomes were biochemical parameters and mortality at 28 days. The CP group were a higher risk group with higher ferritin levels (p < 0.05) though respiratory indices did not differ. The primary outcome measure was required in 6 controls and 4 patients on CP (risk ratio 0.67, 95% CI 0.22–2.0, p = 0.72); mean time on ventilation (NIV or MV) did not differ. There were no differences in secondary measures at the end of the study. Two patients died in the control and one patient in the CP arm. There were no significant differences in the primary or secondary outcome measures between CP and standard therapy, although a larger definitive study is needed for confirmation. However, the study did show that CP therapy appears to be safe in hospitalized COVID-19 patients with hypoxia. Clinical trials registration NCT04356534: 22/04/2020.Manaf AlQahtaniAbdulkarim AbdulrahmanAbdulrahman AlmadaniSalman Yousif AlaliAlaa Mahmood Al ZamrooniAmal Hamza HejabRonán M. ConroyPearl WasifSameer OtoomStephen L. AtkinManal AbduljalilNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-8 (2021) |
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Medicine R Science Q |
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Medicine R Science Q Manaf AlQahtani Abdulkarim Abdulrahman Abdulrahman Almadani Salman Yousif Alali Alaa Mahmood Al Zamrooni Amal Hamza Hejab Ronán M. Conroy Pearl Wasif Sameer Otoom Stephen L. Atkin Manal Abduljalil Randomized controlled trial of convalescent plasma therapy against standard therapy in patients with severe COVID-19 disease |
| description |
Abstract Convalescent plasma (CP) therapy in COVID-19 disease may improve clinical outcome in severe disease. This pilot study was undertaken to inform feasibility and safety of further definitive studies. This was a prospective, interventional and randomized open label pilot trial in patients with severe COVID-19. Twenty COVID-19 patients received two 200 ml transfusions of convalescent patient CP over 24-h compared with 20 who received standard of care. The primary outcome was the requirement for ventilation (non-invasive or mechanical ventilation). The secondary outcomes were biochemical parameters and mortality at 28 days. The CP group were a higher risk group with higher ferritin levels (p < 0.05) though respiratory indices did not differ. The primary outcome measure was required in 6 controls and 4 patients on CP (risk ratio 0.67, 95% CI 0.22–2.0, p = 0.72); mean time on ventilation (NIV or MV) did not differ. There were no differences in secondary measures at the end of the study. Two patients died in the control and one patient in the CP arm. There were no significant differences in the primary or secondary outcome measures between CP and standard therapy, although a larger definitive study is needed for confirmation. However, the study did show that CP therapy appears to be safe in hospitalized COVID-19 patients with hypoxia. Clinical trials registration NCT04356534: 22/04/2020. |
| format |
article |
| author |
Manaf AlQahtani Abdulkarim Abdulrahman Abdulrahman Almadani Salman Yousif Alali Alaa Mahmood Al Zamrooni Amal Hamza Hejab Ronán M. Conroy Pearl Wasif Sameer Otoom Stephen L. Atkin Manal Abduljalil |
| author_facet |
Manaf AlQahtani Abdulkarim Abdulrahman Abdulrahman Almadani Salman Yousif Alali Alaa Mahmood Al Zamrooni Amal Hamza Hejab Ronán M. Conroy Pearl Wasif Sameer Otoom Stephen L. Atkin Manal Abduljalil |
| author_sort |
Manaf AlQahtani |
| title |
Randomized controlled trial of convalescent plasma therapy against standard therapy in patients with severe COVID-19 disease |
| title_short |
Randomized controlled trial of convalescent plasma therapy against standard therapy in patients with severe COVID-19 disease |
| title_full |
Randomized controlled trial of convalescent plasma therapy against standard therapy in patients with severe COVID-19 disease |
| title_fullStr |
Randomized controlled trial of convalescent plasma therapy against standard therapy in patients with severe COVID-19 disease |
| title_full_unstemmed |
Randomized controlled trial of convalescent plasma therapy against standard therapy in patients with severe COVID-19 disease |
| title_sort |
randomized controlled trial of convalescent plasma therapy against standard therapy in patients with severe covid-19 disease |
| publisher |
Nature Portfolio |
| publishDate |
2021 |
| url |
https://doaj.org/article/a115eff395224fdea2740b4a1bd82e47 |
| work_keys_str_mv |
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