BENGALURU: The first-ever trial of therapy using convalescent plasma transfusion in Karnataka on a 60-year-old Covid-19 male patient turned out to be a ‘failure’, as the patient passed away on Thursday morning in Bengaluru. His death came just a few days after the Indian Council for Medical Research (ICMR) cleared the last hurdle to conduct a multicentric phase-2 trial, using convalescent plasma on patients with moderate illness.
Now, the team of doctors working on clinical trials of convalescent plasma therapy in Karnataka have transformed this into an experimental case to determine how to make this treatment better for moderate or critically-ill Covid patients, and whether this therapy is effective. However, Dr US Vishal Rao, senior head and neck oncologist from HCG Hospital, who was the first in Karnataka to get ICMR’s approval for the treatment, said, “This can’t be termed failure of treatment. That’s the reason we are doing ‘clinical trials’ only on chosen categories of patients and approval is not given for all patients.” He said the real test now for researchers would be to find out how this treatment would help critically-ill patients who fall in the 86 per cent of severe cases who, irrespective of plasma therapy, will not survive.
Trials will now focus on understanding four elements of the therapy. First, researchers will find out whether plasma therapy can be used to save critically-ill patients. “We will further categorise them into the 86 per cent with several comorbidities whom the virus doesn’t kill, but their other diseases do, or the 14 per cent who are critically ill but have chances of recovery,” Dr Rao said. The second is to know the dose (ml) of convalescent plasma to be administered. The next would be to find out the amount of neutralizing antibody that has to be transfused into patients in addition to maximal supportive care and antiviral agents.
And finally, to see what level of viral load the patient has and to what level plasma therapy can help.
“This trial is being done under close supervision of the World Health Organisation and several protocols are to be followed. Several senior doctors are on the team. We will also find out where we failed or where the therapy failed,” Dr Rao said. The patient was a resident of Anantpur, Andhra Pradesh, and admitted to Bengaluru’s Victoria Hospital with severe pneumonia, respiratory distress, hypotension, and was a known case of diabetes mellitus, and passed away due to cardiac arrest.
Bangalore Medical College & Research Institute director-cum-dean Dr CR Jayanthi said, “The patient was a SARI case with pneumonia and septicaemia. We tried plasma therapy on May 11 and waited for 48 hours. Until Wednesday evening, the patient was fine and oxygen saturation levels had also improved. However, he suffered a cardiac arrest and passed away on Thursday morning. We tried it only once and cannot call it a failure.” Minister Suresh Kumar also stated that it was too soon to conclude about the effectiveness of plasma therapy.
Therapy only for trial purpose
Convalescent plasma therapy, about a century old, has shown some benefits in treating measles, chicken pox and rabies. Studies have shown faster clearance of virus in case of MERS and SARS, if given early in the course of the disease, but no randomised controlled studies have been carried out. “In the absence of any effective treatment or vaccine, the pandemic provides an opportunity to ascertain the clinical benefits of plasma therapy through randomised controlled trials only,” explained a senior doctor.