India’s largest private provider of cancer care, Healthcare Global Enterprises, Ltd (HCG), maintains 20 comprehensive cancer centers across India. Just days ago, HCG Bangalore lost a COVID-19 patient during a convalescent plasma procedure due to comorbidities. Now, HCG will commence a clinical trial to test a preventative treatment based on a cytokine-based cell therapy meant to trigger and boost the patient’s immune system in an effort to protect patients with mild COVID-19 cases from becoming escalated cases. The Bangalore Hospital has received approval from the ethics committee and soon that approval letter will be forwarded to the Drug Controller General of India (DCGI) for approval. Six health participants have signed up for the study and the investigational team is ready to commence upon DCGI approval. Dr. Vishal Rao, a prominent oncologist at HCG, leads the study.
To help protect mildly infected COVID-19 patients, a three-member team in the hospital developed the investigational treatment protocol, reported the Economic Times in India. This team included Dr. Jyothsna Rao, immunologist; Dr. Gururaj Rao, molecular and cell biologist; and Dr. Vishal Rao, oncologist who heads the Head & Neck Surgical oncology & Robotic surgery at the HGC Cancer Center. The investigational treatment involves the hospital investigator and staff administering cytokine cell injections to six health individuals. The hypothesis: by treating a mildly infected COVID-19 patient with interferons (IFN), a type of cytokine—a small molecular substance known for its antiviral attributes—during the early stages of the disease, they can potentially help patients avoid any worsening of SARS-CoV-2 by appropriately reactivating the patient’s immune system.
HCG Group chairman and CEO Dr. Ajai Kuman was quoted in Economic Times, ”We know interferon is definitely a treatment for this type of viral infection. We believe this immunomodulator can save lives. It, however, requires validation through a clinical trial, and we are ready for it if permitted by the regulators.”
Preclinical Animal Study
Apparently, this cytokine-based immunomodulatory therapy was experimented on animals in some preclinical study. Initial reports are that no complications post injection. Principal Investigator Vishal Rao reported that the animal study revealed no red flags (e.g. adverse events, cardiovascular problems, toxicity, etc.)
As reported in the Indian press, the hospital ethics committee has approved the protocol and now the investigational team is awaiting the actual approval letter currently with the hospital committee. Upon receipt from that administrative body, the letter is forwarded to the DCGI for the final official government green light. The process could happen any day.
Volunteer Spirit in the Age of COVID-19
In this HGC Bangalore hospital-initiated study led by Dr. Vishal Rao, the volunteers have been pre-screened and have come forth. Often the hospital uses NGOs to help with volunteer recruitment. However, when news of the trial was available many volunteers responded, including some doctors, reports principal investigator Dr. Rao.
Founded by Ajai Kumar, HealthCare Global Enterprises Ltd, a South Asian provider of cancer care, is one of India’s biggest cancer care providers with at least 20 hospitals distributed across the world’s second most populated nation. With many prominent rankings, HCG has grown rapidly managing a network of cancer centers across India with an emphasis on advanced technology, process and practice.
Recently, U.S.-based private equity group CVC Capital invested for 36% in the leading Indian company. Apparently, CVC is interested in a majority position as well. CVC Capital has a massive $111 billion secured under management.
Dr. Vishal Rao, Chief of Head & Neck Surgical oncology & Robotic surgery at the HCG Cancer Center