tetano
Editor, Senior Moderator
EClinicalMedicine
. 2021 Jun 4;100931.
doi: 10.1016/j.eclinm.2021.100931. Online ahead of print.
Convalescent plasma therapy in patients with moderate-to-severe COVID-19: A study from Indonesia for clinical research in low- and middle-income countries
Marliana S Rejeki[SUP] 1 [/SUP], Nana Sarnadi[SUP] 1 [/SUP], Retno Wihastuti[SUP] 1 [/SUP], Vininta Fazharyasti[SUP] 1 [/SUP], Wisvici Y Samin[SUP] 1 [/SUP], Frilasita A Yudhaputri[SUP] 2 [/SUP], Edison Johar[SUP] 2 [/SUP], Neni Nurainy[SUP] 3 [/SUP], Novilia S Bachtiar[SUP] 3 [/SUP], David H Muljono[SUP] 2 4 5 [/SUP]
Affiliations
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.
Keywords: COVID-19; Indonesia; SARS-CoV-2; convalescent plasma; coronavirus; low- and middle-income countries; moderate; severe;LMIC.
. 2021 Jun 4;100931.
doi: 10.1016/j.eclinm.2021.100931. Online ahead of print.
Convalescent plasma therapy in patients with moderate-to-severe COVID-19: A study from Indonesia for clinical research in low- and middle-income countries
Marliana S Rejeki[SUP] 1 [/SUP], Nana Sarnadi[SUP] 1 [/SUP], Retno Wihastuti[SUP] 1 [/SUP], Vininta Fazharyasti[SUP] 1 [/SUP], Wisvici Y Samin[SUP] 1 [/SUP], Frilasita A Yudhaputri[SUP] 2 [/SUP], Edison Johar[SUP] 2 [/SUP], Neni Nurainy[SUP] 3 [/SUP], Novilia S Bachtiar[SUP] 3 [/SUP], David H Muljono[SUP] 2 4 5 [/SUP]
Affiliations
- PMID: 34104878
- PMCID: PMC8175127
- DOI: 10.1016/j.eclinm.2021.100931
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.
Keywords: COVID-19; Indonesia; SARS-CoV-2; convalescent plasma; coronavirus; low- and middle-income countries; moderate; severe;LMIC.