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Efficacy of convalescent plasma therapy in the patient with COVID-19: a randomised control trial (COPLA-II trial)

IMPORTANCE: No proven treatment is available for severely ill COVID-19. Therapeutic use of COVID-19 convalescent plasma (COPLA) is under investigation. OBJECTIVE: To compare the efficacy of COPLA with standard medical therapy (SMT) alone in severe COVID-19 patients. DESIGN, SETTING AND PARTICIPANTS:...

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Autores principales: Bajpai, Meenu, Maheshwari, Ashish, Dogra, Vikas, Kumar, Suresh, Gupta, Ekta, kale, Pratibha, Saluja, Vandana, Thomas, Sherin S, Trehanpati, Nirupama, Bihari, Chhagan, Agarwal, Reshu, Bharti, Praveen, Shankar, Prabha, Hussain, Javid, Chhabra, Karan, Gupta, Amita, Narayanan, Ashad, Agarwal, Sarika, Jain, Shruti, Bhardwaj, Ankit, Kumar, Guresh, Yadav, Birendra Kumar, Sarin, Shiv Kumar
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8987237/
https://www.ncbi.nlm.nih.gov/pubmed/35387813
http://dx.doi.org/10.1136/bmjopen-2021-055189
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author Bajpai, Meenu
Maheshwari, Ashish
Dogra, Vikas
Kumar, Suresh
Gupta, Ekta
kale, Pratibha
Saluja, Vandana
Thomas, Sherin S
Trehanpati, Nirupama
Bihari, Chhagan
Agarwal, Reshu
Bharti, Praveen
Shankar, Prabha
Hussain, Javid
Chhabra, Karan
Gupta, Amita
Narayanan, Ashad
Agarwal, Sarika
Jain, Shruti
Bhardwaj, Ankit
Kumar, Guresh
Yadav, Birendra Kumar
Sarin, Shiv Kumar
author_facet Bajpai, Meenu
Maheshwari, Ashish
Dogra, Vikas
Kumar, Suresh
Gupta, Ekta
kale, Pratibha
Saluja, Vandana
Thomas, Sherin S
Trehanpati, Nirupama
Bihari, Chhagan
Agarwal, Reshu
Bharti, Praveen
Shankar, Prabha
Hussain, Javid
Chhabra, Karan
Gupta, Amita
Narayanan, Ashad
Agarwal, Sarika
Jain, Shruti
Bhardwaj, Ankit
Kumar, Guresh
Yadav, Birendra Kumar
Sarin, Shiv Kumar
author_sort Bajpai, Meenu
collection PubMed
description IMPORTANCE: No proven treatment is available for severely ill COVID-19. Therapeutic use of COVID-19 convalescent plasma (COPLA) is under investigation. OBJECTIVE: To compare the efficacy of COPLA with standard medical therapy (SMT) alone in severe COVID-19 patients. DESIGN, SETTING AND PARTICIPANTS: A multicentric, open-labelled, phase-III randomised controlled trial conducted at two treatment centres with COPLA collected at the third dedicated centre in North-India, the coordinating centre during trial from June 2020 to December 2020. The study population comprised 400 participants in the ratio of 1:1 in each treatment group. INTERVENTION: One group received COPLA with SMT (n=200), and another group received SMT only (n=200). MAIN OUTCOME MEASURES: Primary outcome was time to clinical improvement measured by a two-point reduction in the ordinal scale. Secondary outcomes included duration of O(2) therapy, the proportion of patients on mechanical ventilation at day-7, mortality, SARS-CoV-2 antibody levels, cytokine levels and incidence of adverse events. RESULTS: The median time to a two-point reduction in the ordinal scale in both groups was 9 days (IQR=7–13) (p=0.328). The median duration of O(2) therapy was 8 days (IQR=6–12) in COPLA and 10 days (IQR=6–12) in SMT group (p=0.64). The PaO(2)/FiO(2) ratio showed significant improvement at 7 days in COPLA group(p=0.036). There was no difference in mortality till 28 days in both groups (p=0.62). However, if COPLA was given within 3 days of hospital admission, a significant reduction in ordinal scale was observed (p=0.04). Neutralising antibody titres in COPLA group (80 (IQR 80–80)) were higher than SMT group (0 (IQR 0–80)) at 48 hours (p=0.001). COPLA therapy led to a significant reduction in TNF-α levels at 48 hours (p=0.048) and D-dimer at 7 days (p=0.02). Mild allergic reactions were observed in 3 (1.5%) patients in COPLA group. CONCLUSION AND RELEVANCE: Convalescent plasma with adequate antibody titres should be transfused in COVID-19 patients along with SMT in the initial 3 days of hospitalisation for better clinical outcomes. TRIAL REGISTRATION NUMBER: NCT04425915.
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spelling pubmed-89872372022-04-07 Efficacy of convalescent plasma therapy in the patient with COVID-19: a randomised control trial (COPLA-II trial) Bajpai, Meenu Maheshwari, Ashish Dogra, Vikas Kumar, Suresh Gupta, Ekta kale, Pratibha Saluja, Vandana Thomas, Sherin S Trehanpati, Nirupama Bihari, Chhagan Agarwal, Reshu Bharti, Praveen Shankar, Prabha Hussain, Javid Chhabra, Karan Gupta, Amita Narayanan, Ashad Agarwal, Sarika Jain, Shruti Bhardwaj, Ankit Kumar, Guresh Yadav, Birendra Kumar Sarin, Shiv Kumar BMJ Open Haematology (Incl Blood Transfusion) IMPORTANCE: No proven treatment is available for severely ill COVID-19. Therapeutic use of COVID-19 convalescent plasma (COPLA) is under investigation. OBJECTIVE: To compare the efficacy of COPLA with standard medical therapy (SMT) alone in severe COVID-19 patients. DESIGN, SETTING AND PARTICIPANTS: A multicentric, open-labelled, phase-III randomised controlled trial conducted at two treatment centres with COPLA collected at the third dedicated centre in North-India, the coordinating centre during trial from June 2020 to December 2020. The study population comprised 400 participants in the ratio of 1:1 in each treatment group. INTERVENTION: One group received COPLA with SMT (n=200), and another group received SMT only (n=200). MAIN OUTCOME MEASURES: Primary outcome was time to clinical improvement measured by a two-point reduction in the ordinal scale. Secondary outcomes included duration of O(2) therapy, the proportion of patients on mechanical ventilation at day-7, mortality, SARS-CoV-2 antibody levels, cytokine levels and incidence of adverse events. RESULTS: The median time to a two-point reduction in the ordinal scale in both groups was 9 days (IQR=7–13) (p=0.328). The median duration of O(2) therapy was 8 days (IQR=6–12) in COPLA and 10 days (IQR=6–12) in SMT group (p=0.64). The PaO(2)/FiO(2) ratio showed significant improvement at 7 days in COPLA group(p=0.036). There was no difference in mortality till 28 days in both groups (p=0.62). However, if COPLA was given within 3 days of hospital admission, a significant reduction in ordinal scale was observed (p=0.04). Neutralising antibody titres in COPLA group (80 (IQR 80–80)) were higher than SMT group (0 (IQR 0–80)) at 48 hours (p=0.001). COPLA therapy led to a significant reduction in TNF-α levels at 48 hours (p=0.048) and D-dimer at 7 days (p=0.02). Mild allergic reactions were observed in 3 (1.5%) patients in COPLA group. CONCLUSION AND RELEVANCE: Convalescent plasma with adequate antibody titres should be transfused in COVID-19 patients along with SMT in the initial 3 days of hospitalisation for better clinical outcomes. TRIAL REGISTRATION NUMBER: NCT04425915. BMJ Publishing Group 2022-04-06 /pmc/articles/PMC8987237/ /pubmed/35387813 http://dx.doi.org/10.1136/bmjopen-2021-055189 Text en © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Haematology (Incl Blood Transfusion)
Bajpai, Meenu
Maheshwari, Ashish
Dogra, Vikas
Kumar, Suresh
Gupta, Ekta
kale, Pratibha
Saluja, Vandana
Thomas, Sherin S
Trehanpati, Nirupama
Bihari, Chhagan
Agarwal, Reshu
Bharti, Praveen
Shankar, Prabha
Hussain, Javid
Chhabra, Karan
Gupta, Amita
Narayanan, Ashad
Agarwal, Sarika
Jain, Shruti
Bhardwaj, Ankit
Kumar, Guresh
Yadav, Birendra Kumar
Sarin, Shiv Kumar
Efficacy of convalescent plasma therapy in the patient with COVID-19: a randomised control trial (COPLA-II trial)
title Efficacy of convalescent plasma therapy in the patient with COVID-19: a randomised control trial (COPLA-II trial)
title_full Efficacy of convalescent plasma therapy in the patient with COVID-19: a randomised control trial (COPLA-II trial)
title_fullStr Efficacy of convalescent plasma therapy in the patient with COVID-19: a randomised control trial (COPLA-II trial)
title_full_unstemmed Efficacy of convalescent plasma therapy in the patient with COVID-19: a randomised control trial (COPLA-II trial)
title_short Efficacy of convalescent plasma therapy in the patient with COVID-19: a randomised control trial (COPLA-II trial)
title_sort efficacy of convalescent plasma therapy in the patient with covid-19: a randomised control trial (copla-ii trial)
topic Haematology (Incl Blood Transfusion)
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8987237/
https://www.ncbi.nlm.nih.gov/pubmed/35387813
http://dx.doi.org/10.1136/bmjopen-2021-055189
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