ICMR eyes trial to study efficacy of therapies used in Covid treatment
The Indian Council of Medical Research (ICMR) is planning an adaptive clinical trial of mild Covid-19 patients to test the safety and efficacy of several therapies used in treatment, including antiviral drugs that have been allowed under restricted use.
For the process, ICMR has floated an expression of intent for hospitals and institutions to participate in the initiative, on which it will be collaborating with the Drugs for Neglected Diseases Initiative (DNDi) to execute the project.
“ICMR along with Drugs for Neglected Diseases Initiative (DNDi) is proposing to conduct a multi-centre, adaptive platform trial in mild COVID-19 patients, titled ‘An open-label, multicentre, randomised, adaptive platform trial of the safety and efficacy of several therapies, including antiviral therapies, versus control in mild cases of COVID-19’,” says the document uploaded on ICMR’s website.
In an adaptive clinical trial there is flexibility of making modifications in either dose, or regimen, etc prospectively based on the response as the process goes forward. It will be a phase 3 trial as therapies are already used to treat some other health conditions, and have been repurposed to treat Covid-19.
According to the proposal document, the intervention arms to start with will be a combination of oral nitazoxanide (anti-parasitic) and inhaled ciclesonide (corticosteroid); and a fixed dose combination of artesunate and amodiaquine (anti-malarial), and Ivermectin (anti-parasitic).
The control arm will be the standard of care arm, which is the basic care needed as opposed to the intervention arm that has new treatment options included for the disease or health condition.
“An expression of intent from institutions, hospitals and other organisations interested with the facilities and capacity available to participate in the above-mentioned clinical trial, which will enrol participants from the community,” says the document.
The primary objective of the trial is to compare the efficacy of alternative treatment strategies versus control on the risk of progression to moderate or severe respiratory disease.
The secondary objectives are: to compare the safety of each study arm to control, up to day 21 of follow up; to compare the rate of hospitalisations due to Covid-19; to compare the time to hospitalisation due to Covid-19; to compare the rate of hospitalisations for other reason than Covid-19; to compare the disease-free rate in each study arm versus control; to compare the death rate; to compare time to worsening of oxygen saturation (SpO2 < 93); to compare the capacity to prevent severe progression between study arms; and to identify risk factors for severe progression.
The study duration will be 22 days, and according to the proposal document, between 2,000 and 3,000 patients will be included… with approximately 700 participants meant to be enrolled per arm of intervention.
“It’s just an expression of intent at the moment that’s put out for those who might be interested in participating in this adaptive trial that is being planned,” said an official familiar with the developments, on condition of anonymity.
The deadline for receiving responses from those eager to participate is June 15.