In­dia to re­cruit 1,500 pa­tients for WHO’s sol­i­dar­ity trial

Hindustan Times (Jalandhar) - - SPOTLIGHT - Rhythma Kaul let­ters@hin­dus­tan­times.com

NEWDELHI: In­dia will be re­cruit­ing at least 1500 pa­tients in about 30 hos­pi­tals across the coun­try for the World Health Or­gan­i­sa­tion’s (WHO) global sol­i­dar­ity trial for treat­ment of the Covid-19.

The In­dian Coun­cil of Med­i­cal Re­search (ICMR), which is co­or­di­nat­ing tri­als on be­half of the coun­try has al­ready be­gun fast­track­ing the process of re­cruit­ing pa­tients for the multi-coun­try trial to com­pare four treat­ment op­tions to as­sess their rel­a­tive ef­fec­tive­ness against Covid-19.

The tri­als in­clude four po­ten­tial anti-vi­ral drugs, remde­sivir,

THE TRIAL AIMS TO RAPIDLY DIS­COVER WHETHER ANY OF THE DRUGS SLOW DIS­EASE PRO­GRES­SION OR IM­PROVE SUR­VIVAL

chloro­quine/hy­drox­y­chloro­quine, lopinavir-ri­ton­avir and lopinavir-ri­ton­avir with in­ter­feron. By en­rolling pa­tients in mul­ti­ple coun­tries, the trial aims to rapidly dis­cover whether any of the drugs slow dis­ease pro­gres­sion or im­prove sur­vival.

“Right now, we are re­ally fol­low­ing the num­bers, so the trial sites will be in ar­eas from where most cases are be­ing re­ported. Nine of the sites have al­ready been ap­proved and four more sites are very close to be­ing ap­proved. Though 1500 pa­tient is the ini­tial num­ber, there is no cap and we can al­ways re­cruit more pa­tients for the trial, if re­quired,” said Dr Sheela God­bole, head, di­vi­sion of epi­demi­ol­ogy, ICMRNa­tional AIDS Re­search In­sti­tute, which is the nodal cen­tre for co­or­di­nat­ing the tri­als in In­dia.

“Fast-track­ing means try­ing to add as many sites as pos­si­ble in a short span of time, and at the same time com­ply­ing will all the lo­cal eth­i­cal and other reg­u­la­tions meant for such re­searches.

The ethics com­mit­tees are minutely look­ing at each ap­pli­ca­tion and ap­provals are be­ing given after due dili­gence. Fast­track­ing the process does not mean we will be com­pro­mis­ing on qual­ity,” she added.

On March 28, ICMR an­nounced that In­dia will be par­tic­i­pat­ing in the WHO Sol­i­dar­ity trial, for which over 100 coun­tries have re­quested par­tic­i­pa­tion to find ef­fec­tive ther­a­peu­tics as soon as pos­si­ble, via the trial.

“The par­tic­i­pa­tion of mul­ti­ple clin­i­cal trial units or hos­pi­tals in mul­ti­ple coun­tries will en­sure ad­e­quate en­rol­ment of par­tic­i­pants in the short­est pos­si­ble time. This will help fast-track iden­ti­fi­ca­tion of cor­rect treat­ment op­tions for the Covid-19 dis­ease,” said ICMR in a state­ment.

How­ever, pa­tients who give their con­sent to par­tic­i­pate will not get to choose which arm of the trial they be­come a part of. It will be a ran­domised al­lo­ca­tion of medicines for pa­tients. All drugs to be tried in the tri­als, ex­cept for remde­sivir, have al­ready been in use in In­dia for var­i­ous other health con­di­tions.

“The re­sults will be based on global en­roll­ment-- data from pa­tients re­cruited from all coun­tries will be an­a­lysed . It won’t be based on only what the re­sults were among In­dian pa­tients.,” Dr God­bole said.

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