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FDA Gives Go Ahead for Trial of Experimental COVID-19 Drug


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https://www.newsweek.com/fda-trial-experimental-drug-ventilator-1507045
The U.S. Food and Drug Administration (FDA) has given the go ahead for a pharmaceutical company to start a clinical trial exploring whether an experimental drug could prevent hospitalized COVID-19 patients from becoming so sick they need a ventilator to breathe.

Doctors will give participants PB1046 once a week via an injection. The drug contains a type of molecule found in the body which, among other things, is known to have anti-inflammatory and anti-scarring properties, as well as the ability to open the airways.

The company hopes to enrol 210 patients at 20 sites across the U.S. and start the double-blind, parallel group, randomized trial by the end of June. It is aims to report results by late fall.

“Early mitigation by PB1046 of the effects of inflammatory cytokines that can cause acute lung injury, is a promising strategy that could prevent patients from declining to the point where they require mechanical ventilation and help alleviate the strain on critical care infrastructure that we're witnessing," Lee said.

 

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