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All Studies   All Outcomes    Recent:   

Randomized controlled trial of convalescent plasma therapy against standard therapy in patients with severe COVID-19 disease

AlQahtani et al., Scientific Reports, doi:10.1038/s41598-021-89444-5 (date from preprint), NCT04356534
Nov 2020  
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Mortality 50% Improvement Relative Risk Noninvasive or mechanic.. 33% primary Hospitalization time 22% Conv. Plasma  AlQahtani et al.  LATE TREATMENT  RCT Is late treatment with convalescent plasma beneficial for COVID-19? RCT 40 patients in Bahrain (April - July 2020) Lower mortality (p=0.55) and ventilation (p=0.47), not sig. c19early.org AlQahtani et al., Scientific Reports, Nov 2020 Favorsconv. plasma Favorscontrol 0 0.5 1 1.5 2+
Small RCT with 40 hospitalized patients in Bahrain, 20 treated with convalescent plasma, not showing significant differences.
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, study period 19 April, 2020 - 9 July, 2020, trial NCT04356534 (history).
This PaperConv. PlasmaAll
Randomized controlled trial of convalescent plasma therapy against standard therapy in patients with severe COVID-19 disease
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
Scientific Reports, doi:10.1038/s41598-021-89444-5
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 (SARS-CoV-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 deaths 1 . 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 recovery 2 . 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 disease 3 . This has been shown to be effective in severe acute respiratory syndrome 4 , Ebola virus infection 5 and in H1N1 influenza 6 . 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 transfusion 7 . 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 China 8 . Similarly, an open label randomized trial in the Netherlands was stopped prematurely due to the detection of baseline neutralizing..
Author contributions A.A., A.A. and S.L.A. analyzed the data and wrote the manuscript. S.Y.A., A.Z., A.H., P.W. and M.A. performed data collection, S.O. interpreted data and edited the manuscript. R.C. performed the statistical analysis. M.A.Q. supervised data collection, data analysis and edited the manuscript. All authors reviewed and approved the final version of the manuscript. M.A. is the guarantor of this work. Competing interests The authors declare no competing interests.
References
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Hung, Triple combination of interferon beta-1b, lopinavir-ritonavir, and ribavirin in the treatment of patients admitted to hospital with COVID-19: An open-label, randomised, phase 2 trial, Lancet, doi:10.1016/s0140-6736(20)31042-4
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Soo, Retrospective comparison of convalescent plasma with continuing high-dose methylprednisolone treatment in SARS patients, Clin. Microbiol. Infect, doi:10.1111/j.1469-0691.2004.00956.x
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Convalescent plasma in the management of moderate ' 'covid-19 in adults in India: Open label phase II multicentre randomised ' 'controlled trial (PLACID Trial). BMJ 371, m3939. ' 'https://doi.org/10.1136/bmj.m3939 (2020).', 'journal-title': 'BMJ'}, { 'key': '89444_CR27', 'doi-asserted-by': 'publisher', 'DOI': '10.1101/2020.07.01.20139857', 'author': 'A Gharbharan', 'year': '2020', 'unstructured': 'Gharbharan, A. et al. Convalescent plasma for COVID-19. A randomized ' 'clinical trial. medRxiv https://doi.org/10.1101/2020.07.01.20139857 ' '(2020).', 'journal-title': 'medRxiv'}, { 'issue': '7', 'key': '89444_CR28', 'doi-asserted-by': 'publisher', 'first-page': '619', 'DOI': '10.1056/NEJMoa2031304', 'volume': '384', 'author': 'VA Simonovich', 'year': '2021', 'unstructured': 'Simonovich, V. A. et al. A randomized trial of convalescent plasma in ' 'Covid-19 severe pneumonia. N. Engl. J. Med. 384(7), 619–629. ' 'https://doi.org/10.1056/NEJMoa2031304 (2021).', 'journal-title': 'N. Engl. J. Med.'}], 'container-title': 'Scientific Reports', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://www.nature.com/articles/s41598-021-89444-5.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://www.nature.com/articles/s41598-021-89444-5', 'content-type': 'text/html', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://www.nature.com/articles/s41598-021-89444-5.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2022, 12, 3]], 'date-time': '2022-12-03T08:01:55Z', 'timestamp': 1670054515000}, 'score': 1, 'resource': {'primary': {'URL': 'https://www.nature.com/articles/s41598-021-89444-5'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2021, 5, 11]]}, 'references-count': 28, 'journal-issue': {'issue': '1', 'published-online': {'date-parts': [[2021, 12]]}}, 'alternative-id': ['89444'], 'URL': 'http://dx.doi.org/10.1038/s41598-021-89444-5', 'relation': { 'has-preprint': [ { 'id-type': 'doi', 'id': '10.1101/2020.11.02.20224303', 'asserted-by': 'object'}]}, 'ISSN': ['2045-2322'], 'subject': ['Multidisciplinary'], 'container-title-short': 'Sci Rep', 'published': {'date-parts': [[2021, 5, 11]]}, 'assertion': [ { 'value': '11 December 2020', 'order': 1, 'name': 'received', 'label': 'Received', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '23 April 2021', 'order': 2, 'name': 'accepted', 'label': 'Accepted', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '11 May 2021', 'order': 3, 'name': 'first_online', 'label': 'First Online', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': 'The authors declare no competing interests.', 'order': 1, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Competing interests'}}], 'article-number': '9927'}
Late treatment
is less effective
Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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