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Melbourne's Doherty Institute expands COVID-19 trials to India

Indian Health Minister Dr. Harsh Vardhan and wife Nutan Goel after receiving their first dose of the COVID-19 vaccine. Source: Naveen Sharma / SOPA Images/Sipa USA

With the number of COVID-19 patients rising significantly in India, the University of Melbourne-sponsored AustralaSian COVID-19 Trial (ASCOT) has been expanded into India at an opportune moment. Researchers say this novel combination of treatments will provide greater opportunities to patients for accessing new treatments.

The University of Melbourne recently announced that it has identified patients for their sponsored COVID-19 treatment trial at two sites in India. 

The AustralaSian COVID-19 Trial (ASCOT) has been extended to Christian Medical College and Hospital, Ludhiana in Punjab and Sterling Multispecialty Hospital in Pune, Maharashtra.


Highlights:

  • The University of Melbourne-sponsored AustralaSian COVID-19 Trial (ASCOT) reaches India
  • Patients have been identified at hospitals in Ludhiana and Pune for the study
  • ASCOT seeks most effective COVID-19 treatment for hospitalised patients with the aim to prevent need of ventilator in ICU

statement by the university said, “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,” the statement added.

India has registered more than 11 million cases of COVID-19 with over 157,000 deaths.

ASCOT has partnered with the George Institute for Global Health to oversee the trial in India given its substantial experience operating clinical trials.
ASCOT has partnered with the George Institute for Global Health to oversee the trial in India.
Paul Burtson/University of Melbourne

Maharashtra, one of the two states chosen for the ASCOT trial, has registered almost one-third (50,000) of the total number of COVID-related deaths in India. Cases are also on the rise in Punjab.

'Priority to Indian patients'

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 combination 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.

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 Australia and New Zealand trial, expanding internationally to allow more widespread access to investigational treatments was crucial.

People wait for their turn to be vaccinated against COVID-19 inside the vaccination centre at Shatabdi Hospital in Mumbai, India, 30 January 2021.
People wait for their turn to be vaccinated against COVID-19 inside the vaccination centre at Shatabdi Hospital in Mumbai, India, 30 January 2021.
AAP

“A key principle of the trial is equity in terms of access to experimental treatments that could potentially have benefits for patients,” said Prof. Tong.

ASCOT Study

The ASCOT study, also known as ‘Multi-Centre Randomised Adaptive Platform Clinical Trial to Assess Clinical, Virological and Immunological Outcomes in Patients With SARS-CoV-2 Infection (COVID-19)’ had started on 28 July 2020 and is estimated to be completed by 31 December 2022.

The collaborators of the study estimate an enrolment of 2,400 patients.

“Participants enrolled into the study have the option of deciding whether to be randomised in one or more (if available) treatment domains concurrently if they meet the eligibility criteria,” the collaborators stated on their paper submitted to the US National Library of Medicine.

“In the initial implementation of the adaptive platform, recruiting sites have the option to participate in one or more of three treatment domains. Consented participants will then be able to choose whether to be enrolled into one or more available domains concurrently,” reads the paper.

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