Convalescent plasma therapy in patients with moderate-to-severe COVID-19 : A study from Indonesia for clinical research in low- and middle-income countries
© 2021 The Author(s)..
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.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2021 |
|---|---|
| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:36 |
|---|---|
| Enthalten in: |
EClinicalMedicine - 36(2021) vom: 04. Juni, Seite 100931 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Rejeki, Marliana S [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
COVID-19 |
|---|
| Anmerkungen: |
Date Revised 07.11.2023 published: Print-Electronic ClinicalTrials.gov: NCT04407208 Citation Status PubMed-not-MEDLINE |
|---|
| doi: |
10.1016/j.eclinm.2021.100931 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM32652973X |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM32652973X | ||
| 003 | DE-627 | ||
| 005 | 20231225194808.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231225s2021 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1016/j.eclinm.2021.100931 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1088.xml |
| 035 | |a (DE-627)NLM32652973X | ||
| 035 | |a (NLM)34104878 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Rejeki, Marliana S |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Convalescent plasma therapy in patients with moderate-to-severe COVID-19 |b A study from Indonesia for clinical research in low- and middle-income countries |
| 264 | 1 | |c 2021 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Revised 07.11.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT04407208 | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a © 2021 The Author(s). | ||
| 520 | |a 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 | ||
| 520 | |a 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) | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a FUNDING: The study was supported by PT Bio Farma, Indonesia | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a COVID-19 | |
| 650 | 4 | |a Indonesia | |
| 650 | 4 | |a SARS-CoV-2 | |
| 650 | 4 | |a convalescent plasma | |
| 650 | 4 | |a coronavirus | |
| 650 | 4 | |a low- and middle-income countries | |
| 650 | 4 | |a moderate | |
| 650 | 4 | |a severe;LMIC | |
| 700 | 1 | |a Sarnadi, Nana |e verfasserin |4 aut | |
| 700 | 1 | |a Wihastuti, Retno |e verfasserin |4 aut | |
| 700 | 1 | |a Fazharyasti, Vininta |e verfasserin |4 aut | |
| 700 | 1 | |a Samin, Wisvici Y |e verfasserin |4 aut | |
| 700 | 1 | |a Yudhaputri, Frilasita A |e verfasserin |4 aut | |
| 700 | 1 | |a Johar, Edison |e verfasserin |4 aut | |
| 700 | 1 | |a Nurainy, Neni |e verfasserin |4 aut | |
| 700 | 1 | |a Bachtiar, Novilia S |e verfasserin |4 aut | |
| 700 | 1 | |a Muljono, David H |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t EClinicalMedicine |d 2018 |g 36(2021) vom: 04. Juni, Seite 100931 |w (DE-627)NLM289300495 |x 2589-5370 |7 nnns |
| 773 | 1 | 8 | |g volume:36 |g year:2021 |g day:04 |g month:06 |g pages:100931 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1016/j.eclinm.2021.100931 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 36 |j 2021 |b 04 |c 06 |h 100931 | ||