AustralaSian COVID-19 Trial opens in India

New Delhi(India Science Wire) : AustralaSian COVID-19 Trial (ASCOT) has been
expanded into India, with the first patients recruited last week to the first two sites, Christian
Medical College and Hospital Ludhiana in Punjab and Sterling Multispecialty Hospital in Pune,
Maharashtra. Australasia is a region that comprises Australia, New Zealand, and some
neighboring islands.
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. George Institute for Global Health is an independent medical research institute
headquartered in Australia with offices in China, India and the United Kingdom.
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 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.

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,” Associate Professor Tong said.

“The ASCOT Management Team and Leadership Group recognised early in the course of the
trial that for it to have generalisability, external validity and be adequately powered, it would
need to be expanded to international sites.”

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.

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.

“We are confident that 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 maybe the only
drug where blood concentrations almost always exceed levels required to stop the virus from
replicating,” explained Associate Professor 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.”

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.

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