Efficacy of Convalescent Plasma Therapy compared to Fresh Frozen Plasma in Severely ill COVID-19 Patients: A Pilot Randomized Controlled Trial
Dr Meenu Bajpai, Dr Suresh Kumar, Dr Ashish Maheshwari, Dr Karan Chhabra, Pratibha Kale, Dr Amita Gupta, Dr Ashad Narayanan, Dr Ekta Gupta, Dr Nirupama Trehanpati, Dr Chhagan Bihari, Dr Reshu Agarwal, Kamini Gupta, Upendra Kumar Gupta, Dr Ankit Bhardwaj, Dr Guresh Kumar, M.Sc Mojahidul Islam, Ravinder Singh, M.Sc Pushpa Yadav, Dr Rakhi Maiwall, Dr Shiv Kumar Sarin
doi:10.1101/2020.10.25.20219337
All rights reserved. No reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
Conflict of Interest: None declared. Acknowledgements: We thank Mr Pankaj Jain for his technical support in the trial.
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'abstract': '<jats:title>Abstract</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>The '
'role of convalescent plasma (COPLA) for the treatment of severely ill Corona Virus '
'Disease-2019 is under investigation. We compared the efficacy and safety of convalescent '
'plasma with fresh frozen plasma (FFP) in severe COVID-19 '
'patients.</jats:p></jats:sec><jats:sec><jats:title>Methods and '
'findings</jats:title><jats:p>This was an open-label, single-centre phase II RCT on 29 '
'patients with severe COVID-19 from India. One group received COPLA with standard medical care '
'(SMC) (n=14), and another group received FFP with SMC (n=15). A total of 29 patients were '
'randomized in the two treatment groups. Eleven out of 14 (78.5%) patients remained free of '
'ventilation at day seven in the intervention arm while the proportion was 14 out of 15 (93.3 '
'%) in the control arm (p= 0.258). The median reductions in RR per min at 48-hours in '
'COPLA-group and FFP group were -6.5 and -3 respectively [p=0.004] and at day seven were -14.5 '
'and -10 respectively (p=0.008). The median improvements in percentage O2 saturation at '
'48-hours were 6.5 and 2 respectively [p=0.001] and at day seven were 10 and 7.5 respectively '
'(p=0.026). In the COPLA-group, the median improvement in PaO2/FiO2 was significantly superior '
'to FFP at 48-hours [41.94 and 231.15, p=0.009], and also at day-7 [5.55 and 77.01 '
'p<0.001]. We did not find significant differences in hospitalization duration between the '
'groups (0.08).</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>COPLA '
'therapy resulted in rapid improvement in respiratory parameters and shortened time to '
'clinical recovery, although no significant reduction in mortality was observed in this pilot '
'trial. We need larger trials to draw conclusive evidence on the use of Convalescent plasma in '
'COVID-19. This trial is registered with <jats:ext-link '
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