Convalescent Plasma Therapy for COVID-19


Convalescent plasma can be transfused to patients suffering from same infection or to prepare immunoglobulin concentrates. Plasma from recovered patients can be a valuable alternative during the COVID-19 pandemic for supporting its treatment within randomized clinical trial framework or case-control or observational studies of plasma transfusion and for preparing plasma-derived biological products. WHO Blood Regulators Network highlighted that a systematic approach for collection of convalescent plasma from patients recovered from COVID-19 can provide a useful intervention. Its safety and effectiveness are being assessed by structured clinical trials. The convalescent plasma therapy is still in experimental stage and is currently not included in interim clinical guidelines of WHO. However, an emergency investigational new drug application (eIND) process has been inducted so as to ensure availability of COVID-19 convalescent plasma to the patients with severe or life-threatening COVID-19 conditions. USFDA is regularly amending its guidance as new results and best practices are emerging.  The write up provides an overview of convalescent plasma, from regulatory considerations viewpoint, systematic work flow protocol and a cross section of clinical trials underway.

Keywords: : Passive immunization, transfusion safety, convalescent plasma, COVID-19, Plasmapheresis.


1. Liang T. Handbook of COVID-19 Prevention and Treatment. University School of Medicine, Zhejiang 2020 Mar 18; 35-36.
2. Marano G, Vaglio S, Pupella S, Facco G, Catalano L, Liumbruno GM, et al. Convalescent plasma: new evidence for an old therapeutic tool? Blood Transfus 2016; 14: 152-157. DOI 10.2450/2015.0131-15
3. Rajam G, Sampson J, Carlone GM, Ades EW. An augmented passive immune therapy to treat fulminant bacterial infections. Recent Pat Antiinfect Drug Discov. 2010; 5: 157-167.
4. Keller MA, Stiehm ER. Passive immunity in prevention and treatment of infectious diseases. Clin Microbiol Rev 2000; 13: 602-14.
5. Yadav R, Pathak K, Pathak D, Kumar R. Chemoprophylatic. Ayurvedic, Homeopathic and Unani approaches for COVID-19 prophylaxis. Pharm Biomed Res. 2020 (Forthcoming).
6. COVID-19: What Is Convalescent Plasma? Health, The Sciences. 2020 April 24.
7. Arabi YM, Hajeer AH, Luke T, Raviprakash K, et al. Feasibility of Using Convalescent Plasma Immunotherapy for MERS-CoV Infection, Saudi Arabia. Emerg Infect Dis 2016; 22(9):1554-1561.
8. Investigational COVID-19 Convalescent Plasma, Guidance for Industry. 2020 April 13.
9. Joyner M. Expanded Access to Convalescent Plasma for the Treatment of Patients with COVID-19. 2020 May 15.
10. Efficacy of Convalescent Plasma Therapy in Severely Sick COVID-19 Patients. Institute of Liver and Biliary Sciences, India. 2020 June 12.
11. Smid WM, Burnouf T, Epstein J, Kamel H, Sibinga CS, Somuah D, et al. Points to consider in the preparation and transfusion of COVID-19 convalescent plasma in low- and middle- income countries. 2020 April.
12. An EU programme of COVID-19 convalescent plasma collection and transfusion: Guidance on collection, testing, processing, storage, distribution and monitored use. European Commission, Directorate-General for Health and Food Safety. 2020 June 23. :
13. Recommendations for Investigational COVID-19 Convalescent Plasma. USFDA. 2020 May 01.
14. Bloch EM, Bailey JA, Tobian AAR. Deployment of convalescent plasma for the prevention and treatment of COVID-19. J Clin Invest. 2020 June 1;130 (6):2757-2765.
15. Chen L, Xiong J, Bao L, and Shi Y. Convalescent plasma as a potential therapy for COVID-19. Lancet Infect Dis. 2020; 20(4):398-400. doi:10.1016/S1473-3099(20)30141-9.
16. Pan American Health Organization (PAHO). Regulatory considerations on authorization of the use of convalescent plasma (PC) to address the COVID-19 emergency. 2020 April 22.
17. World Health Organization. Guidelines on good manufacturing practices for blood establishments. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Forty- fifth Report. Geneva, WHO. 2011.
18. Protocol for the use of convalescent plasma for the treatment COVID-19 infected patients. 2020 April.
19. Accorsi P, Berti P, Angelis VD, Silvestro GD, Mascaretti L, Ostuni A. “Position paper” on the preparation of immune plasma to be used in the treatment of patients with COVID-19. Blood Transfus. 2020;18(3):163-166. doi: 10.2450/2020.0124-20.
20. CDSCO. Information on Convalescent Plasma in COVID-19. 2020 July 01. NoticesFiles/MoHFWConvalescentPlasmainCOVIDdraft.pdf
22. Shen C, Wang Z, Zhao F, Yang Y, Li J, Yuan J, Wang F, et al. Treatment of 5 Critically ill Patients With COVID-19 With Convalescent Plasma. JAMA. 2020 Apr 28; 323(16): 1582–1589. doi:10.1001/jama.2020.478326
23. Zhang B, Liu S, Tan T, Huang W, Dong Y, Chen L, et al. Treatment with convalescent plasma for critically ill patients with SARS-CoV-2 infection. Chest. 2020; 158(1): e9-e13 doi:10.1016/j.chest.2020.03.039
24. CDSCO. A Phase II, Open Label, Randomized Controlled Trial to Assess the Safety and Efficacy of Convalescent Plasma to Limit COVID-19 Associated Complications in Moderate Disease. 2020 April 22.
25. India’s CDSCO permits convalescent plasma trial for Covid-19. 2020 April 20.
26. Convalescent plasma for COVID-19 patients not responding to steroids: CDSCO. 2020 July 20.
27. Dong Y, Mo X, Hu Y, Qi X, Jiang F, Jiang Z, et al. Epidemiological Characteristics of 2143 Pediatric Patients With 2019 Coronavirus Disease in China. Pediatrics. 2020; doi: 10.1542/peds.2020-0702
28. Pathak K, Pathak D, Yadav R, Kumar R. COVID-19: An Update on therapeutics and Clinical trials. Int J Pharm Sci Drug Res. 2020 July; 12(4).
29. U.S. National Library of medicine. Accessed on July 20, 2020. Available from:
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How to Cite
Porwal, A., K. Pathak, D. Pathak, and R. Yadav. “CONVALESCENT PLASMA THERAPY FOR COVID-19 PATIENTS: REGULATORY GUIDANCE ON COLLECTION, TESTING, PROCESSING, STORAGE, DISTRIBUTION, AND CLINICAL TRIALS: Convalescent Plasma Therapy for COVID-19”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 14, no. 2, Jan. 2021,
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