Manipal Hospitals and Narayana Health that gave 2-DG, or 2-deoxy-D-glucose, to three severely ill Covid patients have found the results to be reassuring.
Although Manipal’s critical care unit gave a thumbs-up to the drug supplied by the patient’s families, researchers following the drug’s release are questioning the absence of published clinical trial data even in the pre-prints (without the peer review).
Dr Sunil Karanth, HOD, critical care, Manipal Hospitals (Old Airport Road), said the hospital has administered the drug — repurposed by the Defence Research and Development Organisation (DRDO) and manufactured by Dr Reddy’s Laboratories, Hyderabad, — to two patients. “And not more, since the drug isn’t available in the market yet,” he added.
“One of the recipients, a 45-year-old woman who was on the ventilator, has already been discharged, while the second patient, a 66-year-old man, has been moved to the ward,” Dr Karanth said.
He said the drug had been administered within 10 days of the illness and they received the drug on the fourth day in the ICU. The dosage has been fixed as 45 milligram per kilogram. It comes in a 5.9-gram sachet costing Rs 990 and is given to the patient after being dissolved in 100 ml of water.
For a patient weighing 60 kilograms, for instance, the dosage is three grams, which is half of the sachet. The drug is administered only once. It is ideal to administer the drug before the seventh day when the viral replication begins to happen.
“After the drug being administered, the need for oxygen reduced and oxygen levels got better,” Dr Karanth said, adding that both patients were on feeding tube and the medicine was sent down through that route.
“One patient was taken off the ventilator within 48 to 72 hours, while the other patients were taken off the high-flow nasal oxygen in three days. This drug starves the virus of oxygen and concentrates on infected cells,” he further said.
At Narayana Health, Bommasandra, a 37-year-old man who received 2-DG made a recovery.
The man had Covid pneumonia, lung fibrosis, had high oxygen requirement and was on ECMO (Extracorporeal membrane oxygenation).
His treating doctor and the hospital’s critical care specialist Dr Sanjay Orathi Patangi said it was too early to say if the treatment outcome was because of 2-DG or if it was due to other antiviral drugs the patient was on.
Manuscript of trial not out: Researcher
Siddhartha Das, a postdoctoral researcher at the Université Libre de Bruxelles, a research university in Brussels, Belgium, who has been tracking the release of the drug, told DH: “No critical patients were a part of the clinical trial, so the risks are unknown.”
Insisting that reducing mortality was not the endpoint of the clinical trial, Das said the manuscript of the trial is not out, except for a press release.
“If the phase 3 trial results are still being compiled, then what was submitted to the Drugs Controller General of India (DCGI) exactly?” he asked. “The trial was conducted on 220 Covid-positive patients.”