Randomized controlled trial of convalescent plasma therapy against standard therapy in patients with severe COVID-19 disease
AlQahtani et al.
, Randomized controlled trial of convalescent plasma therapy against standard therapy in patients with severe..
, Scientific Reports, doi:10.1038/s41598-021-89444-5 (date from earlier preprint), NCT04356534
Small RCT with 40 hospitalized patients in Bahrain, 20 treated with convalescent plasma, not showing significant differences. NCT04356534 (history)
risk of death, 50.0% lower, RR 0.50, p = 0.55, treatment 1 of 20 (5.0%), control 2 of 20 (10.0%), NNT 20.
noninvasive or mechanical ventilation, 33.3% lower, RR 0.67, p = 0.47, treatment 4 of 20 (20.0%), control 6 of 20 (30.0%), NNT 10, primary outcome.
hospitalization time, 21.9% lower, relative time 0.78, p = 0.12, treatment 20, control 20.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
AlQahtani et al., 4 Nov 2020, Randomized Controlled Trial, Bahrain, peer-reviewed, 11 authors, trial NCT04356534 (history)
Randomized controlled trial
of convalescent plasma therapy
against standard therapy
in patients with severe COVID‑19
Manaf AlQahtani1,6*, Abdulkarim Abdulrahman2, Abdulrahman Almadani1,
Salman Yousif Alali1, Alaa Mahmood Al Zamrooni3, Amal Hamza Hejab4, Ronán M. Conroy5,
Pearl Wasif6, Sameer Otoom6, Stephen L. Atkin6 & Manal Abduljalil1
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.
Coronavirus disease 2019 (COVID-19) is caused by the severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) and has developed into a pandemic with serious global public health and economic sequelae. As of 25
February 2021, more than 113 million cases have been confirmed worldwide leading to over 2.5 million d
There have been a number of reports of medications, such as remdesivir, with antiviral properties that have shown
efficacy against SARS-CoV-2 with shorter time to recovery2. Whilst there are now several effective vaccines
emerging and being used globally, the rate of COVID-19 disease and its complications currently remain high.
Plasma therapy using Convalescent Plasma (CP) transfusion refers to a form of passive therapy, where neutralizing antibodies from a recovered donor are injected into the infected patient with the aim of altering the
course of the d
isease3. This has been shown to be effective in severe acute respiratory s yndrome4, Ebola virus
infection5 and in H1N1 i nfluenza6. More recently, there has been a report of the use of CP in the treatment of five
mechanically ventilated COVID-19 patients with the suggestion of expedited recovery as the patients improved
one week after the transfusion7. A randomized trial with CP therapy in severely and critically ill COVID-19
patients undertaken in China was stopped early as recruitment slowed down due to the decrease in COVID-19
cases in China8. Similarly, an open label randomized trial in the Netherlands was stopped prematurely due to
the detection of baseline neutralizing antibodies in the majority of patients, with antibody titers similar to that
of the d
onors9. An open label Expanded Access..
is less effective
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