PUNE’S Sassoon Hospital and BJ Government Medical College is seeking to become Maharashtra’s first hospital to use the experimental convalescent plasma therapy in treating critical COVID-19 patients, but various procedural modalities are still to be completed before the Indian Council of Medical Research (ICMR) and the Drugs Controller General of India give the go-ahead. The DCGI will also have to relax rules pertaining to blood donation by convalescents, for the specific purpose of the clinical trials and to the extent of participating institutions.
Facing a high mortality rate, the Pune hospital has responded to the ICMR’s call for applications from institutions for a clinical trial to study the safety and effectiveness of therapeutic plasma exchange (TPE) and convalescent plasma therapy in treating COVID-19 cases.
TPE uses enrichment with healthy donor plasma, while convalescent plasma therapy seeks to treat critical patients with donated plasma from COVID-19 survivors, with the protective antibodies formed by the latter expected to be beneficial.
This Monday, the US Food and Drug Administration (USFDA) has also issued guidelines on investigational use of convalescent plasma in treating critical cases, as well as recommendations to blood establishments on collection of COVID-19 convalescent plasma. The USFDA and the ICMR concur that convalescent plasma therapy is, for now, only to be regulated as an investigational product in approved clinical trials.
While Kerala, the first state to apply to the ICMR for clinical trials, is hoping to start the experimental treatment after registering with the ICMR, green-lighting the trials will not be possible until there is clarity on availability of kits to establish the convalescent plasma’s neutralising titre, and until detailed guidelines are formulated on several aspects including patient and donor eligibility.
The US FDA’s guidelines say, for example, that donor must be completely recovered with no symptoms for 28 days, or show no symptoms for 14 days alongside a negative test result. It says convalescent plasma must have SARS-CoV-2 neutralising antibody titres of at least 1:160. The neutralising titre helps arrive at a recommended dosage.
“Since the ICMR has called for institutions to apply for the trials, we assume that the kits are available but we haven’t started receiving them,” said Dr Aravind R, head of department of infectious disease at Thiruvananthapuram Medical College in Kerala, one of the institutions waiting to start the trials, and also member of the state’s expert committee for COVID-19. “We will then need to check if there are legalities regarding the collection of convalescent plasma, as donation is currently not allowed for a period of time after recovery.”
The guidelines released on March 25 by the National Blood Transfusion Council regarding blood transfusion services in the light of the COVID-19 pandemic lists at-risk donors who are currently excluded from donation — those with travel history, contact history and confirmed cases who must not donate until full recovery “including radiological and virological clearance”. Officials at the NBTC said the DCGI will have to specifically relax rules for approved clinical trials to the extent of the participating institutions and for the specific purpose of the trials.
“Then there is the issue of developing detailed protocols on recipient selection even among the critical patients,” said Dr Raghukumar. This could be dyspnoea or acute respiratory trouble, blood oxygen saturation levels, percentage of lung infiltrates, etc.
In the US, the FDA has allowed emergency access to convalescent plasma for patients with immediately life-threatening conditions, and Dr Aravind said it may be considered to administer the therapy for critical cases here under an access protocol on compassionate grounds.
The district administration of Pune, which has recorded 437 positive cases and 40 death as of Wednesday, is keen to also get approved for the clinical trials in order to curb the death rate. Sassoon Hospital has recorded among the highest mortality rates of COVID-19 positive patients. The high mortality rate has led officials in Pune’s district administration to believe that the experimental plasma therapy could be a game-changer for the district’s fight against COVID-19.
Convalescent plasma has been used and its use studied in other outbreaks, including major respiratory diseases such as the 2003 SARS epidemic and 2009 H1N1 epidemic, and Pune officials are hoping that the ICMR will fast-track the pending modalities.
Ayush Prasad, CEO of the Pune Zilla Parishad, said the district administration is working closely with Pune’s hospitals to provide whatever infrastructure and equipment may help reduce the high death rate in the district. “This is cutting-edge technology that has already been purchased, the machine will arrive in Pune in the next two days. Also, it will have uses beyond COVID-19, so it will enable us to upgrade medical infrastructure in government hospitals,” he said.
The machine is to be supplied by Terumo, a US-Japanese company with an Indian subsidiary. A representative of Thiruvananthapuram-based Terumo Penpol said the machine can collect plasma antibodies, though it is also used in several hospitals across India for platelet collection.
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