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Posted On: 07/10/2021 12:09:26 PM
Post# of 653
$RLFTF $NRXP DD (opinion) by WONG on Yh0 - We are close to 3 months in on the ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19 (TESICO) run by the National Institute of Allergy and Infectious Diseases (NIAID) that had a start date of April, 20th 2021. According to this piece of information that I lifted from the trial design things are progressing positively.
"An independent Data and Safety Monitoring Board (DSMB) will review interim safety and efficacy data at least monthly. Pre-specified guidelines will be established to recommend early stopping of the trial for evidence of harm or substantial efficacy. The DSMB may recommend discontinuation of an investigational agent if the risks are judged to outweigh the benefits."
Data has been looked at 2-3 times at least already. We have not seen any discontinuation but what we have seen is an expansion of the trial with the addition of trial site locations that now stands at 30 sites. That points to positive outcomes so far with more sites being add to confirm the data they have seen.
"An independent Data and Safety Monitoring Board (DSMB) will review interim safety and efficacy data at least monthly. Pre-specified guidelines will be established to recommend early stopping of the trial for evidence of harm or substantial efficacy. The DSMB may recommend discontinuation of an investigational agent if the risks are judged to outweigh the benefits."
Data has been looked at 2-3 times at least already. We have not seen any discontinuation but what we have seen is an expansion of the trial with the addition of trial site locations that now stands at 30 sites. That points to positive outcomes so far with more sites being add to confirm the data they have seen.
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