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Randomized controlled trial of convalescent plasma therapy against standard therapy in patients with severe COVID-19 disease.
AlQahtani, Manaf; Abdulrahman, Abdulkarim; Almadani, Abdulrahman; Alali, Salman Yousif; Al Zamrooni, Alaa Mahmood; Hejab, Amal Hamza; Conroy, Ronán M; Wasif, Pearl; Otoom, Sameer; Atkin, Stephen L; Abduljalil, Manal.
  • AlQahtani M; Bahrain Defence Force Hospital, Riffa, Bahrain. mqahtani@rcsi-mub.com.
  • Abdulrahman A; Royal College of Surgeons in Ireland-Bahrain, Busaiteen, Bahrain. mqahtani@rcsi-mub.com.
  • Almadani A; Mohammed Bin Khalifa Cardiac Centre, Awali, Bahrain.
  • Alali SY; Bahrain Defence Force Hospital, Riffa, Bahrain.
  • Al Zamrooni AM; Bahrain Defence Force Hospital, Riffa, Bahrain.
  • Hejab AH; Salmaniya Medical Complex, Manama, Bahrain.
  • Conroy RM; Bahrain Specialist Hospital, Manama, Bahrain.
  • Wasif P; Royal College of Surgeons in Ireland, Dublin, Ireland.
  • Otoom S; Royal College of Surgeons in Ireland-Bahrain, Busaiteen, Bahrain.
  • Atkin SL; Royal College of Surgeons in Ireland-Bahrain, Busaiteen, Bahrain.
  • Abduljalil M; Royal College of Surgeons in Ireland-Bahrain, Busaiteen, Bahrain.
Sci Rep ; 11(1): 9927, 2021 05 11.
Article in English | MEDLINE | ID: covidwho-1225516
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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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Adult / Aged / Female / Humans / Male / Middle aged Language: English Journal: Sci Rep Year: 2021 Document Type: Article Affiliation country: S41598-021-89444-5

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Adult / Aged / Female / Humans / Male / Middle aged Language: English Journal: Sci Rep Year: 2021 Document Type: Article Affiliation country: S41598-021-89444-5