DCGI gives permission for approval of protocol for a multi-center two arm prospective, phase-II open labeled randomized controlled trial of convalescent plasma in COVID-19 patients.
This clinical trial shall be registered with the Clinical Trial Registry of India maintained by the Indian Council of Medical Research before enrolling the first subject for the trial. Clinical trial shall be conducted in accordance with the approved clinical trial protocol and other related documents and as per requirements of Good Clinical Practices guidelines and the provisions of these rules.
ICMR launched the call for intent forthe study titled “A Phase II, Open Label, Randomized Controlled Study to Assess the Safety and Efficacy of Convalescent Plasma to Limit COVID-19 Associated Complications”on April 12th, 2020. The response has been overwhelming and ICMR have received 99 applications form institutes which are interested in participating in this study.
What is convalescent plasma therapy?
Convalescent blood products, obtained by collecting whole blood or plasma from a patient who has survived a previous infection and developed humoral immunity against the pathogen responsible for the disease and it can be a possible source of specific antibodies of human origin.
Same may be possible as a therapy option for COVID-19. The plasma will be obtained from people who have recovered from COVID-19 infection. This plasma is rich in antibodies which is transffered in patients with acute COVID-19 infection and hope for a cure and possible treatment option.
History of convalescent plasma therapy
Convalescent blood products were used to prevent and treat many bacterial and viral infections from around 1880s. In 1890, the first rational approach exploited by the physiologists von Behring and Kitasato to treat diphtheria was blood serum; initially, it was produced from immunised animals but soon whole blood or serum from recovered donors with a specific humoral immunity were identified as a possible source of specific antibodies of human origin.
Also during Spanish flu, studies conducted between 1918 to 1920 which suggested that the use of Convalescent blood therapy might be effectiveand for the first time convalescent plasma was identified as a potential therapy for a number of viral infections
Recent Advances in convalescent plasma therapy
First reports of successful treatment with passive immune therapy date back to the early 1900s, convalescent plasma has materialized as a possible therapy for patients who develop infection from one of the emerging infectious diseases such as EVD or MERS-CoV, although the efficacy of such therapy has yet to be proven in clinical trials.
FDA's Step for convalescent plasma therapy
Recently, USFDA encourages recovered patients to donate plasma for development of blood-Related Therapies. Convalescent plasma is an antibody-rich product made from blood donated by people who have recovered from the disease caused by the virus. Prior experience with respiratory viruses and limited data that have emerged from China suggest that convalescent plasma has the potential to lessen the severity or shorten the length of illness caused by COVID-19. It is important that we evaluate this potential therapy in the context of clinical trials, through expanded access, as well as facilitate emergency access for individual patients, as appropriate.
A number of clinical trials are also taking place to evaluate the safety and efficacy of convalescent plasma and the FDA has granted numerous single patient emergency investigational new drug (eIND) applications as well.
REFERENCE: Marano G, Vaglio S, Pupella S, et al. Convalescent plasma: new evidence for an old therapeutic tool?. Blood Transfus. 2016;14(2):152–157. doi:10.2450/2015.0131-15
