The Indian Council of Medical Research submitted a proposal of convalescent plasma therapy. Their proposal was approved for the purpose of a clinical trial by the Drug Controller General of India on April 17.
The nod, by the Drug Controller General, will require the usage of plasma from the recovered coronavirus patients, which shall be transfused into the virus positive patients so it could be studied and understood whether this might be a potential form of treatment for the pandemic.
The individuals who have recovered generates antibodies. These antibodies are hypothesised as a useful method of protection against the virus once the sick is transfused with that antibody laden plasma.
— Platocast (@platocast) April 22, 2020
How the study will be done?
The plasma transfusion trial will be given to a group of 226 coronavirus affected patients in an intervention group and another group of 226 patients who would not be given the treatment, will be known as the control group.
There shall be a phase 2, as said by the Drug Controller General of India. It shall be a randomized controlled trial with an open-label to access the safety and efficiency of the plasma in order to get control over the coronavirus related complications in cases of the moderate disease.
This implies that the trial is open and approved for only those who have a moderate disease.
The individuals who have recovered would be encouraged to donate their blood; the blood donation eligibility shall be 28 days after recovery. The plasma therapy requires the plasma to collected 28 days after the recovery of the individual.
Process of Plasma Therapy
The donor’s blood samples shall be assessed by taking rapid tests to mark the presence of IgG and IgM antibodies. The donors shall be required to donate not more than 1000 ml of their plasma per month. Also, they can be asked repeatedly to donate their plasma.
Indira VG Somani, the Drug Controller General of India, said that the accelerated approval process, under the Subject Expert Committee, has reviewed the trial and approved it in the light of prevailing coronavirus situation. The state of Maharashtra has shown their interest in taking a trial of the therapy. The United States Food and Drug Administration has approved this therapy for the virus infected patient for their treatment and to reduce its infections and implications.
While reviewing scientific evidence of the therapy under the clinical trial protocol, the Drug Controller General of India said that 5 critical, Acute Respiratory Disease syndrome and virus infected patients were treated with the plasma therapy, which contained the antibodies in the United States of America.
The clinical status of these 5 patients showed an improvement after the plasma was infused. It was reported that three of them were discharged, and the other two were in a stable condition on ventilation. One more case, where there were 4 infected people, including a pregnant woman, all four of them recovered.
One more case about this plasma therapy shows that ten virus positive individuals were transfused with 200 ml of the plasma, which eventually increased the neutralising antibodies and disappearance of the virus from the blood within a week and improvement within three days.
According to Drug Controller General of India, the convalescent plasma therapy has been used to cure various diseases in the past, such as flu, H1N1, Influenza, polio, etc., long before the availability of their vaccines.