Centre sends out mixed signals on plasma therapy for Covid-19

Maitri Porecha New Delhi | Updated on June 30, 2020

Orders issued two days apart by different arms of the Ministry of Health and Family Welfare are sending contradictory signals on use of blood plasma transfusion therapy for sick Covid-19 patients.

The latest guidelines issued by National Blood Transfusion Council (NBTC) states that use of convalescent plasma for routine treatment of Covid-19 patients is not recommended at present.

Sunil Gupta, Additional Director General, Blood Transfusion Services, NACO, said, “The treatment of Covid-19 patients using convalescent plasma is under clinical trial and currently no evidence of the efficacy of the convalescent plasma as a treatment modality for SARS-COV-2 is established.”

Plasma therapy involves transfusing plasma from recovered patients into sick patients so that the latter may benefit from the possible antibodies generated in recovered patients’ blood, which help in recovery of the sick patients after transfusion.

But, the interim guidance given to all state blood transfusion councils by NBTC is contradictory to the Health Ministry’s clinical management protocol released on June 27 which says that ‘off-label,’ use of convalescent plasma may be considered in patients with moderate disease who are not improving despite use of steroids. They are to be transfused a single dose of 200 ml slowly over not less than two hours, the protocol states.

‘Off-label,’ use means unapproved use of a drug or a therapy for a disease or a medical condition.

While the Health Ministry has said that ‘off-label,’ use is allowed, NBTC has stated in its interim guidance that the necessary guidelines for collection of plasma from the recovered Covd-19 patients for the treatment of such cases will be issued as and when the efficacy of this form of treatment is established and approved by the competent bodies.

Multiple hospitals have registered with Clinical Trials Registry of India for using convalescent plasma in clinical trials.

The Indian Council for Medical Research’s study on plasma therapy on a sample size of 452 is still going on. The results will be revealed once the study is completed, said an ICMR official.

Max Hospital for instance has prospectively registered a trial on April 29 and targets to enrol 100 patients but has mentioned in the disclosure that it has not started recruiting subjects.

Another multi-centric trial involving 39 hospitals and medical colleges from the government sector across 12 States is yet to take off. Even after two to three months of registering the trials, there has been no publication of evidence supporting plasma as a therapy in any clinical trial so far.

Meanwhile, private hospitals in Delhi are administering plasma therapy to patients, by asking families of the sick kin to arrange for donors, and are charging exorbitant rates for every plasma transfusion cycle while classifying its use on ‘compassionate grounds.’

“There is confusion about how plasma therapy is being administered to patients — as part of clinical trials or off-label use. Some hospitals are certainly charging for plasma which would indicate off-label. In such cases, there is no clarity on what protocols are being followed,” said Malini Aisola, co-convenor, All India Drug Action Network.

Published on June 30, 2020

Follow us on Telegram, Facebook, Twitter, Instagram, YouTube and Linkedin. You can also download our Android App or IOS App.

This article is closed for comments.
Please Email the Editor