NEW DELHI :
India is now a part of the AustralaSian covid-19 Trial (ASCOT), that aims to generate clinical evidence about treatment for covid-19.
Expanded to India, first patients were recruited for the clinical trial last week to the first two sites, Christian Medical College and Hospital Ludhiana in Punjab and Sterling Multispecialty Hospital in Pune, Maharashtra.
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The evidence from the University of Melbourne sponsored multi-centre, open-label, randomised controlled adaptive platform trial, can be applied during the pandemic to reduce mortality or the need for mechanical ventilation in hospitalised but not yet critically ill patients with covid-19.
India, like many other middle and low-income countries, is facing a severe epidemic of covid-19. The number of patients with covid-19 in India remains significantly higher than in Australia and New Zealand, and access to experimental treatments is limited.
ASCOT has partnered with the George Institute for Global Health to oversee the trial in India given its substantial experience operating clinical trials in the country with a presence in 21 states.
Bala Venkatesh, Professorial Fellow at the George Institute for Global Health, said that while there are other ongoing clinical trials in India for covid-19, the novel combinations of treatments included in ASCOT will provide greater opportunities to patients for accessing new treatments.
ASCOT aims to discover which existing treatments are most effective in patients hospitalised with covid-19 and whether they will prevent patients deteriorating to the point of needing a ventilator in the Intensive Care Unit.
ASCOT Principal Investigator, Associate Professor Steven Tong, a Royal Melbourne Hospital infectious diseases clinician and co-lead of clinical research at the Doherty Institute said that while ASCOT began as an Australian and New Zealand trial, expanding internationally to allow more widespread access to investigational treatments was crucial.
“A key principle of the trial is equity in terms of access to experimental treatments that could potentially have benefits for patients,” Tong said.
“The ASCOT Management Team and Leadership Group recognised early in the course of the trial that in order for it to have generalisability, external validity and be adequately powered, it would need to be expanded to international sites,” said Tong.
The trial aims to generate results quickly. After the trial begins, results will be continually analysed, so that ineffective therapies can be stopped and new therapies can be evaluated as part of the trial.
“The study questions being asked are of priority to Indian patients and participating trial sites, and feasible to address in India,” said Professor Venkatesh.
One new treatment that’s recently been added to ASCOT is nafamostat, which in laboratory experiments has shown to block SARS-COV-2 from entering human cells and be far more potent than remdesivir.
“Nafamostat is mainly used in Korea and Japan as a treatment for acute pancreatitis and some blood clotting conditions. Of all drugs with potency data from laboratory studies using human cell lines, nafamostat appears to be the most potent against SARS-CoV-2 and may be the only drug where blood concentrations almost always exceed levels required to stop the virus from replicating,” said Tong.
“It is also likely that nafamostat will reach high levels in the lungs where the SARS-CoV-2 virus causes so much of its problems. What’s more, it has a favourable safety profile, Tong said.
The ASCOT Steering Committee recently made the decision to cease enrolment into the convalescent plasma arm of the trial following a media release issued by the UK’s RECOVERY trial, which reported no benefit to patients compared with standard of care.