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In an attempt to treat mild to moderate COVID-19 affected patients, the HCG Cancer Hospital in Bengaluru has received permission from Drug Controller General of India (DGCI) to conduct cytokine therapy trials on humans following the conclusion of animal studies that showed positive results. This significant development comes more than a fortnight after the hospital began phase 1 clinical trials for convalescent plasma therapy for critical patients.
“We received permission to conduct clinical trials employing Cytokine therapy. First in Human clinical trials would be initiated shortly to assess safety in healthy individuals. At the front end of this effort, we have Dr. Gururaj Rao, a Cell and Molecular Biologist, Dr. Jythosna Rao, an Immunologist and former research associate of Nobel Laureate Dr Ralph Steinman and myself. We have made a concoction of cytokines–consisting of IF-gamma, along with cytokines which are released by our immune system against the virus attack and have been known to be effective against COVID-19 too. Patients infected with the COVID-19 virus are unable to produce them. So, this unique concoction was made using healthy donors.” says Dr. Vishal Rao, principal investigator of the clinical trial, speaking to The Better India.
— Vishal Rao (@drvishalrao) May 7, 2020
What are cytokines?
These “small secreted proteins released by cells have a specific effect on the interactions and communications between cells,” according to this peer-reviewed study.
As per the HCG Hospital, “cytokine therapy is essentially a mix of chemical messengers that helps accentuate the switch from passive to active immunity.”
This treatment also enhances the release of Interferons, which play a crucial role in the early phases of the infection and for symptomatic patients.
Role of Thymus in Activating Immune System
Researchers at HCG Hospital in Karnataka found that children with an immature immune system recover very well from COVID 19 infection and tend to have milder symptoms.
“While elderly 65+ who have a more mature immune system are proving to be fatal when the virus attacks them. A logical explanation to this could be the active thymus gland which is well developed in children in the mother’s womb itself and gets active soon after birth. In the age group above 65, the thymus has degenerated,” says Dr. Vishal Rao.
What the thymus gland does is maintain the memory of a virus infection and prepares the cells for sustained and long term fight.
“When a virus infects the human body, the immediate immune response is provided by the broad passive immune system (Innate Immunity) in cells. The response builds over two to three days and tries to curtail the infection. Around this time the stronger and more specific active immune system (Acquired Immunity) from the Thymus should take over to counter the viral infection. The switch from the passive to active immunity is mediated by chemical messengers called cytokines released from the immune cells derived from Thymus gland. SARS CoV 2, like any other viral infection, incites a similar response,” he says.
Dr. Vishal Rao goes on to explain that the failure of this switch from passive to active immunity leads to severe infection and eventually becomes fatal. Those affected by the virus above the age of 65 are particularly vulnerable because their thymus has degenerated. A major moderator of active immune response is the Thymus gland. As explained earlier, the gland is active in children and regresses in function and size as one ages especially after 65.
Self-evidently, the thymus also plays a key role in bridging the gap between passive and active immunity. “A drug that can help accelerate this switch could potentially hold the key to successful treatment of COVID 19 by preventing the fulminant phase to set in. We have initiated a study to inject a cytokine mixture derived from the thymus origin cells that holds promise to reactivate this memory and help eliminate the virus,” he says.
Having said that, conducting regular clinical trials to conduct cytokine therapy will be a challenge considering the lockdown and the restrictions put in place.
“Additionally, this also puts the trial participants, donors, investigators and ground staff at risk of infection. A credible option at this juncture would be to use the digital technology and expertise from past handling of clinical trials and merging the two to create a virtual trial platform. We will be adopting Virtual clinical trial monitoring for the first time in the country for better safety of the subjects and personnel involved in the trial,” states the hospital’s release.
(Edited by Saiqua Sultan)