1. Convalescent plasma therapy in patients with moderate-to-severe COVID-19: A study from Indonesia for clinical research in low- and middle-income countries
- Author
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Vininta Fazharyasti, David H. Muljono, Frilasita A. Yudhaputri, Marliana S. Rejeki, Nana Sarnadi, Wisvici Y. Samin, Edison Johar, Novilia S. Bachtiar, Neni Nurainy, and Retno Wihastuti
- Subjects
Moderate to severe ,medicine.medical_specialty ,moderate ,Convalescent plasma ,Coronavirus disease 2019 (COVID-19) ,coronavirus ,Disease ,01 natural sciences ,World health ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,Medicine ,In patient ,low- and middle-income countries ,030212 general & internal medicine ,0101 mathematics ,SARS-CoV-2 ,business.industry ,010102 general mathematics ,COVID-19 ,severe ,LMIC ,General Medicine ,Coronavirus ,Clinical research ,Indonesia ,Low and middle income countries ,convalescent plasma ,business ,Research Paper - Abstract
Background We explored the outcome of convalescent plasma (CP) treatment in patients with moderate and severe coronavirus disease 2019 (COVID-19) and investigated variables for the design of further trials in Indonesia. Methods Hospitalised patients with moderate (n = 5) and severe (n = 5) COVID-19 were recruited and transfused with CP from donors who recovered from mild (n = 5), moderate (n = 5), or severe (n = 1) COVID-19. Neutralising antibodies (NAbs) to the virus were measured at the end of the study using a surrogate virus neutralisation test as an alternative to the plaque reduction assay. Clinical improvement was assessed based on the modified World Health Organization Research and Development Blueprint six-point scale, Brixia Chest-X-Ray scoring, and laboratory parameters. The study was registered at ClinicalTrials.gov (NCT04407208). Findings CP transfusion in three doses of 3 mL/kg of recipient body weight at 2-day intervals was well tolerated. Good clinical improvement was achieved in all patients with moderate disease and in two patients with severe disease. Most patients at baseline had detectable NAbs with median inhibition rates comparable to those of the donors (90·91% vs. 86·31%; p = 0·379). This could be due to the unavailability of pre-donation NAb testing and postponed CP administration that required communal consent. Interpretation This study highlights the safety of CP therapy. Although improvements were observed, we could not conclude that the outcomes were solely due to CP treatment. Further randomised controlled trials that cover different disease stages with pre-donation NAb measurements using locally applicable strategies are warranted. Funding The study was supported by PT Bio Farma, Indonesia.
- Published
- 2021
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