Maha’s 1st plasma therapy trial: Covid-positive man was treated on compassionate grounds, says doctor

A senior doctor closely involved in Maharashtra’s first trial for convalescent plasma therapy for Covid-19 treatment told HT on Saturday that the patient did not

A senior doctor closely involved in Maharashtra’s first trial for convalescent plasma therapy for Covid-19 treatment told HT on Saturday that the patient did not meet the inclusion criteria mentioned in the protocol. “Instead,” he said, “the patient was allowed to be treated on compassionate grounds, and as the last resort.” The 53-year-old male patient died on April 30, five days after the plasma transfusion.

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Convalescent plasma therapy involves injecting patients with plasma from recovered patients. The plasma, which would have developed antibodies to fight invading viruses (in this case, the coronavirus), theoretically boosts a patient’s immunity response to Sars-CoV-2. A patient needs to meet required parameters such as adequate oxygen flow in the body, normal pulse rate and a lack of co-morbid health issues to qualify for the therapy.

In this case, however, the patient was in critical condition. Doctors in the city feel that convalescent plasma therapy needs to be used in patients that are in better condition.

The Brihanmumbai Municipal Corporation (BMC), under infectious disease expert Dr Om Srivastava, started the clinical therapy at Kasturba Gandhi Hospital after receiving an approval from the Indian Council of Medical Research (ICMR). BYL Nair Hospital extracted the plasma from a recovered patient, which was later sent to Lilavati Hospital for the clinical therapy.

The 53-year-old patient from Kurla had tested positive on April 19 and was admitted to Lilavati Hospital on April 20. As his condition was critical, he was put on ventilator support in the hospital’s intensive care unit (ICU).

His diagnosis revealed that he had developed acute respiratory distress syndrome (ARDS) with pneumonia. The man developed Cytokine Release Syndrome (CRS) after which the team headed by Dr Om Srivastava gave the approval, the doctor said. CRS is a form of systemic inflammatory response syndrome when the immune system attacks the organs in the body.

“He didn’t meet the inclusion criteria, but approval was given on grounds of compassion,” said the doctor.

On April 25, a 200ml of plasma was transfused into the patient, after which the oxygen intake improved, but he soon went into shock. He developed a bacterial infection that did not respond to antibiotics. He died on April 30.

Lilavati Hospital said the patient was brought in a critical condition. He was given anti-viral medicines, but he didn’t respond, hospital authorities said. “We kept him on immunosuppressants, but they didn’t have much effect. We wanted to give him another 400ml of plasma, but his condition deteriorated to such an extent that we couldn’t. We tried our best to save him, but his condition was very critical,” said Lilavati Hospital CEO Dr V Ravishankar.

BMC commissioner Praveen Pardeshi was reportedly informed that the patient could either improve or succumb to the underlying infection. He was also informed that if the patient dies, it would be considered a failure of the plasma therapy and generate inappropriate reactions. Pardeshi could not be reached for a comment.

Talking to HT, the patient’s son said, “They told us that it was the only way to save my father as medicines were ineffective.”

This comes in the backdrop of Lav Agarwal, joint secretary, Union health and family welfare ministry, saying convalescent plasma therapy is not an approved way to treat Covid-19 patients. Medical experts, however, say it should be used only for patients whose condition is better.

“The antibodies may neutralise the Sars-CoV-2, but the underlying inflammation will kill the patient,” said Dr Lancelot Pinto, an epidemiologist from Hinduja Hospital.

“It is important to run the therapy among patients with a better chance of survival to understand if plasma therapy is effective. It is a study [in this case], but a proven treatment [otherwise], which can be used to save lives.”

Meanwhile, Suresh Kakani, additional commissioner, BMC, said, “Six more cured patients have donated their blood. Once we get a suitable patient, we will conduct the second trial. Seven Hills hospital has got a patient for plasma transfusion.”