Kerala is all set to begin a clinical trial of convalescent-plasma therapy, which involves transfusion of the blood plasma of recovered Coronaviris patients to treat critically ill COVID-19 cases. Kerala is the first state to get approval from the Indian Council for Medical Research (ICMR) to conduct the therapy. Plasma therapy is a promising option for COVID-19 treatment, Dr Anoop Kumar, tells Outlook in an Interview. Dr. Kumar is a key member of the task force for plasma therapy, set up by the state government. An intensivist at Baby Memorial Hospital Kozhikode, Dr. Kumar has also won awards for his efforts to identify and prevent the deadly Nipah virus outbreak in the state. Excerpts:

Q) Kerala is the first state to get approval from ICMR to commence plasma treatment. How significant is the treatment in fighting COVID-19?

Kerala had submitted the protocol for plasma therapy to the ICMR a week before the US Food and Drug Administration (FDA) approved the use of plasma therapy on April 3. Plasma therapy appears to be helpful in the short-term until definitive and effective treatments are found. Since physicians currently do not have any other options of definitive management for critically ill patients with Covid-19, any new possibility should be looked into as a hopeful one, with only limited space for organised clinical trials. Kerala is much ahead in containing COVID-19 on many fronts. We are waiting for ICMR’s approval in getting ‘Interferon Alpha’ from Cuba. The drug is known as ‘magical drug’ in the treatment of COVID-19.

Q) How efficient is the therapy and what is its success rate in other countries?

We have only limited studies, say five or six, available in this regard. The studies have shown significant improvement in the clinical signs, symptoms and laboratory parameters after the use of plasma in severely affected patients. Now, British PM Boris Johnson has also received the treatment.  The treatment was tried in China, South Korea and now the US and the UK has also approved it. We need more comprehensive studies on the efficacy of the therapy.  All the therapies at present including the hydroxychloroquine trials are done without any conclusive evidence.

Q) What is the procedure involved in plasma therapy treatment?

The rationale behind plasma therapy is that the recovered patients have significant neutralizing antibodies which can help in the disappearance of virus in the blood if given to a patient severely affected by COVID-19. For more than a century, convalescent plasma has been used for the prevention and treatment of many infectious diseases such as SARS, MERS and H1N1.

Q) Who can be the donors and how will you work out the modalities?

The survivors have to be confirmed as ‘coronavirus free’ in two consecutive tests. Then, they will be put in home isolation for another 14 days. And if they are found to be fit, we can extract 600 to 800 ml plasma depending on their body weight. A person weighing 70 kg can donate 800 ml of plasma. Then it is divided into three or four batches of 200 ml and can be stored. We can also conduct a special ELISA test to see whether these donors have adequate antibodies in their blood. This blood can be used to treat moderate to severe patients.  It’s not advised for mild groups of patients. Proper counseling is mandatory to appraise the donor-patient about the process, management with convalescent plasma and their continuous support for the cause.

Q) When are you starting the clinical trial in the state?

We are planning to start the clinical trial in two days after getting permission from the Drug Controller General of India and some other bodies. We have more than 100 recovered patients and we need consent from them. Up to four patients can receive plasma from one donor. We can keep the plasma for one year. In Kerala, we are planning to collect plasma from all blood groups, though other countries are collecting it only from AB blood group. They are the universal plasma donors.

Q) What are the challenges for plasma therapy at present?

The main challenge is that we have to get approval from the Drug Controller General of India. Usually, the blood donation rules stipulate that the donor should not have traveled abroad in the last three months, shouldn’t have fever and respiratory infection three months prior to blood donation. Most of the COVID-19 survivors don’t fulfill all three conditions. So we are waiting for a special waiver from the DCGI. Another obstacle is the availability of antibody kits. A team of medical experts at the Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) in collaboration with Rajiv Gandhi Centre for Biotechnology already developed a separate ELISA kit for this purpose.