2-Deoxy-D-glucose
On May 8, 2021, the Drugs Controller General of India approved an oral drug, based on 2-deoxy-D-glucose, for emergency use as adjunct therapy in moderate to severe coronavirus patients.1)2) It was developed by the Institute of Nuclear Medicine and Allied Sciences Laboratory of DRDO along with Dr. Reddy's Laboratories, who claimed via a press release, that the drug “helps in faster recovery of hospitalized patients and reduces supplemental oxygen dependence”.3)4)5) The Wire as well as The Hindu noted that the approval was based on poor evidence; no journal publication (or preprint) concerning efficacy and safety are yet available.6)7)
Based on a successful in vitro study at Centre for Cellular and Molecular Biology in April 2020, wherein 2-DG exhibited anti-COVID properties, permission was granted for Phase II trials which were supposedly conducted over 110 patients across multiple sites in two phases from May 2020 to October 2020 but yet did not feature over Clinical Trials Registry of India (CTRI).8)9)10) The logged Phase II trial featured a cohort of 40 patients only; the primary end point was taken as days needed to improve on WHO's Clinical Progression Scale and received criticism for not being an objective parameter.11)12) The Phase-3 trial happened in 220 patients across 26 sites from December 2020 to March 2021; the CTRI entry did not record any primary endpoint.13) Both the two trials did not blind the clinicians.14) At doses lower than the prescribed regimen, older trials had recorded grade 3 QT prolongation and hyperglycemia.15)
Dr. Reddy's Laboratories will be manufacturing the drug for treating patients in India's second wave of COVID.16)