The Indian Council of Medical Research (ICMR) has announced that it has given consent for a clinical trial of convalescent plasma therapy and has started preparing the protocol to implement it.
The therapy, touted as a possible treatment for Coronavirus, is in final stage but has not currently been prescribed.
“ICMR is finalising the protocol and after that we will take approval from Drug Controller General of India (DCGI) before conducting any clinical trial. It is not currently prescribed to give all patients. It will be used as clinical trial mode before it is recommended for all other patients,” a senior ICMR official said.
The approval of the regulator, Drug Controller General of India, is required before human trails can begin.
“In other countries, it is found as successful in limited clinical trial and this is only for very severe patients who are on ventilators not for milder cases,” official added.
Earlier in the day, Kerala —the state where the first case was reported — requested permission for clinical trials of the therapy. In total, India has reported 5,865 positive cases and 478 successful recoveries.
Convalescent Plasma Therapy involves the transfusion of plasma from recovered patients which contains antibodies.
Earlier this week, a major consortium was established to develop a "hyperimmune" therapy with centres in Europe and America.
The first stage of the project would be developed as an “antibody-specific analytic test” to understand whether the plasma of the recovered patients had sufficient "neutralising antibody" to eliminate the coronavirus.
Besides Australian blood product giant CSL, Japanese Takeda, German Biotest, British group BPL, France's LFB and Swiss manufacturer Octapharma are part of the consortium to develop the first stage test in the next six weeks.
On 7 April, South Korea also reported its first successful recovery of a patient using convalescent plasma therapy treatment.
