In a first, Kerala will shortly launch a testing drive to detect community transmission of COVID-19 besides setting up a surveillance mechanism to keep a tab on respiratory disorders using mobile apps, a senior state government official said, adding that the southern state will also approach the Centre to help it acquire Interferon Alpha inhalational drugs, popularly known as the ‘Cuban wonder drug’, to fight the pandemic. “All this follows approval for our four plans by ICMR to fight COVID-19,” the official said, emphasizing that the foremost among them is the nod for the protocol for blood plasma therapy.
Open had reported on April 4 that Kerala had prepared and submitted a protocol for the convalescent serum therapy with Indian Council for Medical Research (ICMR). This therapy involves using the blood plasma of Covid-19 patients to treat new cases. ICMR has granted approval for the purpose along with the state’s plans to acquire Interferon Alpha, do a seroprevalence study to verify community transmission and monitor acute respiratory infections.
Kerala is the first state in the country to secure ICMR’s approval for each of these anti-COVID-19 measures.
The seroprevalence study entails doing antibody tests to detect if someone had been infected with COVID-19 without being aware of it. If the random trials establish any such case, it means that community spread has already occurred in the area where antibodies to SARS-COV-2 virus were found in a person’s blood. This test is called “serological enzyme-linked immunosorbent assay”, also called ELISA.
As part of this initiative, all hospitals and health centres in the state will be linked to a main centre controlled by the state health department, which will implement this plan. According to a person close to the matter, the state health department already has data on “vulnerable people”, especially those aged 70 and above, who will be covered in the first stage of random testing.
Besides, to check respiratory infections, scientists at the Achutha Menon Centre for Health Science Studies at Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, will monitor any marked rise in pneumonia or respiratory infections across the state thanks to ICMR’s approval. As soon as they get the alert through a mobile app (which all doctors treating such illnesses have to mandatorily install), health staff will spring into action to do tests to either confirm or rule out a fresh COVID-19 outbreak in a region.
Interestingly, Interferon Beta, a drug in injectable form, is already a part of the WHO protocol for treating COVID-10 patients. Which means by being part of WHO’s Solidarity programme, India can avail of this drug. “Solidarity”, according to WHO’s own definition, is an international clinical trial by the organization and its partners to help find an effective treatment for COVID-19.
The WHO websites adds, “The Solidarity trial will compare four treatment options against standard of care, to assess their relative effectiveness against COVID-19. By enrolling patients in multiple countries, the Solidarity trial aims to rapidly discover whether any of the drugs slow disease progression or improve survival. Other drugs can be added based on emerging evidence.”
India will also be able to get access to anti-Ebola drug Remdesivir, which is now not available in India, once it is part of the Solidarity trial. Remdesivir is manufactured by US company Gilead Sciences Inc.
ICMR has confirmed that India will take part in the multi-country “Solidarity trial”. Its head scientist Dr Raman Gangakhedkar, however, did not respond to mails for updates on this matter.
WHO’s current drug options include Interferon Beta; hydroxychloroquine; lopinavir/ritonavir; and Tocilizumab. Interferon Alpha, produced originally by Cuba, is manufactured since 2003 by Cuba in collaboration with China. Cuba has successfully used interferon techniques to treat dengue fever as early as the 1980s and later in HIV, human papillomavirus, Hepatitis B, Hepatitis C and so on.
“Kerala will need only Interferon Beta and Remdesivir protocols from WHO,” Dr Anoop Kumar AS, Consultant Intensivist and Chief, Critical Care Medicine at Baby Memorial Hospital, Kozhikode, told Open.
Kumar is a member of the expert panel helping the state government with battling the COVID-19 pandemic. He is an award-winning critical care specialist who first identified the outbreak of Nipah virus in the state in 2018 and then helped prevent the spread of the viral disease with a monstrously high fatality rate.
Meanwhile, transportation of medicines and health equipment is a major hurdle amid this global lockdown. Within India, under the Centre’s Lifeline Udan initiative, public and private airliners carry tonnes of essential medical supplies to the country’s remote parts.
On the blood plasma trials, Kumar says the state now also needs to get a few exemptions from Drug Controller General of India whose rules insist that a person should not have had fever/respiratory infection and made no foreign travel three months prior to donating his or her blood. “This is not possible in the case of a COVID-19 survivor. So, some waivers are required for us to start our trials,” Kumar notes.
Thiruvananthapuram-based Rajiv Gandhi Centre for Biotechnology has already made an antibody testing kit. “Over the next five days it should be ready for use,” says Kumar, adding, “Once both these are done (DCGI permission and formal launch of the kit), we will be able to start human trials.”
There are conditions for human trials, though. The patient should be more than 18 years. He should meet blood donor requirements (other than those in cases of foreign travel, fever and respiratory infection). He or she can donate blood only 14 days after testing negative twice for COVID-19.
“If the person is more than 55 kg, we can take 800 ml of plasma from his body and each patient requires only 200 ml for treatment. The plasma collected can be stored up to one year,” explains Kumar, adding that “a person can donate plasma the second time after a two-week gap and following an antibody test.”