Interim analysis of 300 patients has not been done so far: official
The study on plasma therapy (PLACID trial) by the Indian Council of Medical Research (ICMR) is still ongoing, and the results will be shared on completion of the study from a scientific perspective, a senior official of the ICMR said on Tuesday.
“The sample size for the study is 452, and an interim analysis of 300 patients has not been conducted so far,” the official said.
Also Read | Uddhav opens plasma therapy trial centre
The PLACID trial is a Phase II, open-label, randomised controlled trial to assess the safety and efficacy of convalescent plasma to limit the complications caused by COVID-19 in moderate cases. It has been registered with the Clinical Trial Registry of India (CTRI) and has received approval from the COVID-19 National Ethics Committee (CONEC).
“The generic protocol for this study has also been approved by the Drugs Controller-General of India and the Central Drugs Standard Control Organisation. The sample size of the study is 452. The clinical trial liability insurance has been bought centrally by the ICMR,” noted a senior official of the ICMR.
The ICMR on Tuesday said 2,10,292 samples had been tested in the last 24 hours, and the total number of samples tested thus far stood at 86,08,654.
The Health Ministry’s National Blood Transfusion Council has issued the second interim guidance to conduct blood transfusion services so as to maintain a safe and adequate blood supply during the pandemic. The latest note is in the suppression of the first guidance issued on March 25. The guidelines cover managing the supply chain system for commodities required in blood transfusion services.
Also Read | Delhi govt. to set up plasma bank for COVID-19 treatment
The guidelines said that for the collection of convalescent plasma, a system should be in place to facilitate re-entry of recovered COVID-19 patients. “The treatment of COVID-19 patients using convalescent plasma is under clinical trial, and currently, no evidence of the efficacy of convalescent plasma as a treatment modality for COVID-19 is established,” the note adds.
The National Botanical Research Institute (NBRI), Lucknow, has established an advanced virology laboratory for COVID-19 testing. The facility has been developed based on the guidelines of the ICMR, the World Health Organization (WHO) and the Ministry of Health and Family Welfare, said a release from the Union government.
It said this is a Biosafety Level (BSL)-3 facility. “Biosafety levels are assigned to a facility depending on the pathogen it deals with. According to the ICMR guidelines, a BSL-2 facility is recommended for COVID-19, but this is an advanced version,” said Samir Sawant, senior principal scientist, NBRI.
Also Read | Antibodies from convalescent plasma protect against COVID-19
This advanced version has a negative pressure, which means it has a suction facility that can suck any aerosol and pass it through filters. It can filter virus or bacteria. It reduces the possibility of infection at culturing facilities.
NBRI Director S.K. Barik said the facility would add to the testing capacity of Uttar Pradesh. At present, the State is testing 20,000 samples a day.
“To follow the protocol, we will start testing 100 samples a day in the first week and later we will scale it up to 500 samples a day,” Dr. Sawant said.
Professor Barik also informed that a team of scientists and researchers from the Central Institute of Medicinal and Aromatic Plants (CIMAP), Lucknow, will join the NBRI team for the testing of samples.
Source: Read Full Article