The Indian Council of Medical Research (ICMR) has approved21 institutions for participating in a randomised controlled study to assessthe safety and efficacy of convalescent plasma to limit complicationsassociated with COVID-19. The sample size of the study is 452.
Once 400 patients areenrolled, no more sites will be added. The clinical trial liability insurance has been boughtcentrally by the ICMR.The therapy involves taking antibodies from the blood of aperson who has recovered from COVID-19 and transfusing those antibodies into anactive coronavirus patient to help kickstart the immune system to fight theinfection.
“The ICMR has initiated a multi-centre clinical trial,titled ‘A Phase II, Open Label, Randomized Controlled Trial to Assess theSafety and Efficacy of Convalescent Plasma to Limit COVID-19 Associated Complicationsin Moderate Disease (PLACID Trial)’,” the apex health research body said. “We have received an overwhelming response. Expressionof interest was received from 111 institutions.
As of May 4, the ICMR hasapproved 21 institutions in the PLACID trial,” the official said.The PLACID trial protocol has been registered with theClinical Trial Registry of India (CTRI). The study has also received approvalfrom the COVID-19 National Ethics Committee (CONEC) and the generic protocolwas approved by the Drug Controller General of India. Those medical facilitieswhich have been given approval to be a part of the trial include PostgraduateInstitute of Medical Education and Research in Chandigarh, Madras MedicalCollege in Chennai, Smrt NHL Municipal Medical College in Ahmedabad, BJMedical College and Civil Hospital in Ahmedabad, Sawai Man Singh MedicalCollege in Jaipur, Government Medical College, Nagpur, Gandhi MedicalCollege, Telangana and Gandhi Medical College, Bhopal.
Besides, 90more hospitals have applied to be a part of the trial and are underconsideration depending upon the completion of necessary documents, officialssaid. Convalescent plasma therapy is at an experimental procedure for COVID-19patients. As per the guidelines, hospitals and institutions planningto provide this modality of treatment should do so in a clinical trial withprotocols which are cleared by the Institutional Ethics Committee, the ICMR hadsaid earlier while seeking participation in the trial. At this moment, the ICMRdoes not recommend this as a treatment option outside of clinical trials.
The Union Health Ministry recently warned against its use,saying that the plasma therapy for treatment of coronavirus patients is at anexperimental stage and has the potential to cause life-threateningcomplications. There is no evidence yet to support that plasma therapy canbe used as treatment for COVID-19 and till the apex health research bodyconcludes its study and a robust scientific proof is available, plasmatherapy should be used only for research or trial purpose. AIIMS director Dr Randeep Guleria had also stressed on theneed to have good and well conducted research trials before the mode of therapycan be recommended for routine use in coronavirus infected patients.