AIIMS plans to conduct clinical trial of plasma therapy

The All India Institute Of Medical Sciences (AIIMS) is planning to conduct a clinical trial of the convalescent plasma therapy in the treatment of COVID-19 and modalities of taking approvals from the Drug Controller General of India are being worked out.

AIIMS Director Dr Randeep Guleria said the mode of treatment in COVID-19 is still at an “experimental stage” and there is a need for good and well conducted research trials before its benefit and this mode of therapy can be recommended for routine use in coronavirus patients.

“AIIMS is working with the ICMR to conduct a clinical trial on the efficacy of convalescent plasma therapy in COVID-19 patients,” he said.

The doctor said it is necessary for all institutes to take necessary approvals from the Indian Council of Medical Research (ICMR) and the Drug Controller General of India and follow proper clinical practice guidelines for this research.

“In very limited studies, globally, convalescent plasma as an adjunct to other supportive therapies and treatments has shown some benefit in the management of severe patients of COVID-19,” Guleria said.

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He also underlined that plasma has to be tested for its safety and it should have sufficient antibodies to be useful for giving it to COVID-19 patients.

“Giving plasma from a recovered patient without testing whether it has enough antibody titer or not may cause more harm than good as it can cause transfusion-related reactions,” he said.

Dr Vivek Nangia, Director and Head, Pulmonology, Medical Critical Care and Sleep Disorders at Fortis hospital here, said the health ministry has made the “right move to dispel any notion attached to plasma therapy” as far as COVID-19 is concerned, and added there is no specific treatment for the disease as of now. “One should not be giving false hope to patients,” he stated.

“This is a new virus and no specific treatment for this disease, whether it is hydroxychloroquine or plasma therapy. These are all conjectural therapies or experimental therapies,” he said.

Dr Neeraj Nischal, Associate Professor in the department of medicine at AIIMS, said that in the absence of any specific antiviral medications for the treatment of COVID-19, convalescent plasma (plasma from patients who have recovered from the illness) is being seen as a promising therapeutic option.

But for plasma therapy to be effective, plasma must contain sufficient amount of neutralising antibody against that infection.

“This therapy is not foolproof and is associated with risks like inadvertent transfer of blood-borne infections and reactions to serum constituents, including immunological reactions such as serum sickness, and may worsen the clinical condition,” Dr Nischal said.

Plasma constitutes about 55 per cent of the total blood component and has high concentration of neutralising antibodies. When transfused, it acts as a passive immunisation and provides immediate immunity to susceptible or infected persons by neutralising the virus or by dampening the cytokine storm, he said.

Plasma therapy has a history going back to 1890s and was the only means of treating certain infectious diseases like diphtheria, pertussis and tetanus prior to the development of effective antimicrobial therapy, Dr Nishchal explained.

Related news | Use plasma therapy only for trial till ICMR concludes study: Health Ministry

“The convalescent plasma has also been tried in Spanish flu of 1918 and in more recent SARS and H1NI epidemics. It has also been used in the deadly Ebola disease, which affected the African countries,” he said.

The health ministry on Tuesday said currently plasma therapy is at an experimental stage and there is no evidence yet to support that it can be used as a treatment for COVID-19.

It further said the ICMR has launched a national-level study to learn efficacy of plasma therapy in treatment of COVID-19 and till the apex health research body concludes its study and a robust scientific proof is available, plasma therapy should be used only for research or trial purpose.

“If plasma therapy is not used in a proper manner under proper guidelines, then it can also cause life threatening complications,” Lav Agarwal, joint secretary in the Ministry of Health, said at a press briefing on Tuesday.

The death toll due to COVID-19 rose to 1,007 and the number of cases climbed to 31,332 in the country on Wednesday, according to the Union health ministry.