The United States, on Thursday, announced phase 3 clinical trials of two experimental drugs to treat hospitalized COVID-19 patients when combined with existing treatments, said the National Institute for Allergy and Infectious Diseases (NIAID) (local time).
"The trials are part of the ACTIV-3 master protocol, which has an adaptive design allowing investigators to add new sub-studies of additional investigational agents," the release read.
According to the NIAID, participants in the new ACTIV-3 sub-studies will share a control group and be randomized 1:1:1 to receive either a saline placebo control, VIR-7831 or the Brii combination.
ACTIV-3 refers to an NIAID protocol designed to test treatments using multiple drugs administered simultaneously, with trial participants either receiving the investigative agent or a placebo in addition to standard treatments, which typically include the antiviral drug remdesivir, the statement stated, reported by Sputnik.
The statement further said that initially, researchers will enrol approximately 450 volunteers (150 per group) who have been hospitalized with mild-to-moderate COVID-19 with fewer than 13 days of symptoms.
Sputnik citing the release reported that one sub-study will evaluate VIR-7831, a monoclonal antibody developed by GlaxoSmithKline in the United Kingdom and Vir Biotechnology in the United States. The other sub-study will evaluate a combination of BRII-196 and BRII-198, two monoclonal antibodies manufactured by Brii Biosciences in Beijing and the state of North Carolina, the release added. Monoclonal antibodies are grown in a lab as copies of naturally occurring proteins produced by the human immune system.
"If both VIR-7831 and the Brii combination appear to be safe and effective, based on the ordinal outcomes assessed at five days, enrollment in the trial will be expanded. An additional 1,050 participants will be enrolled and randomized to the three groups, for a total of 1,500 participants enrolled by the trial's conclusion," the statement read.
These additional enrollments may include participants with more severe illness so that researchers can evaluate the primary endpoint of sustained recovery, it stated and added that participants will have met this endpoint when they have been discharged from the hospital and lived at home for 14 consecutive days, prior to 90 days of follow-up.
Sputnik reported that The United States previously authorized use of other antibody-based COVID-19 treatments, including one developed by Regeneron that was given to President Donald Trump.
This comes after Advisors to the US Food and Drug Administration (FDA) voted in favour to recommend that the agency must give Emergency Use Authorisation (EUA) to Moderna's COVID-19 vaccine.
According to CNN, top FDA officials said that they planned to quickly move ahead with the EUA.
The FDA, last week, approved Pfizer's COVID-19 vaccine for emergency use across the country. COVID-19 cases in the US have breached the 17 million cases mark, as per the latest update by Johns Hopkins University.
( With inputs from ANI )
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