HCG to begin clinical trials of cytokine-mediated anti-Covid therapy

Three days after a critical Covid-19 patient who received plasma therapy died due to comorbidity, the HCG Hospital is beginning clinical trials to develop treatment for moderate Covid-19
patients.

On Tuesday or Wednesday, the hospital will administer cytokine injections to six healthy individuals. An investigator said they are not anticipating any side effects.

Cytokines are a group of proteins secreted by cells in the immune system belonging to a category of signaling molecules that mediates and regulates immunity and inflammation.

When the hospital receives the approval letter from its ethics committee, it would forward the same to the Drug Controller General of India (DCGI) for approval. Once the nod is given, the six volunteers will be given the injection and will be monitored for 10 days. The injection will then be given to moderate Covid-19 patients, if they give their
consent.

“The injections are ready, and the ethics committee has also given its approval,” Dr Vishal Rao, principal investigator of the clinical trial, told DH. “But we are yet to receive the letter (from the hospital panel) and forward it to the DCGI. We hope to begin administering the injections by Tuesday or Wednesday.”

A pre-screening has been done and the six individuals have volunteered. “NGOs typically help us identify the individuals either for a small fee or pro bono to support a social cause. When news (of the trial) came, many individuals volunteered, including some doctors,” Dr Rao said.

Experiments on animals

The investigator said animal results showed no complications from the injection. “The animal toxicology reports showed no adverse reactions, toxicity, heart attacks, deaths or any kind of infection. The injection is meant only to reactivate the immune system. It is meant to give the system a booster shot,” he added.

Investigators are hoping that the trial results will be ready in 10 days. “We are going to monitor (the volunteers) for 10 days. This is a safety study. It should indicate that it is safe to use (the injections) on healthy human beings, produces no side effects and can be used on moderate Covid-19 patients,” Dr Rao said.