University Hospitals in Cleveland, US is set to conduct two clinical trials of remdesivir to treat adult Covid-19 patients hospitalised due to pneumonia.
Remdesivir is an investigational antiviral drug developed by Gilead Sciences. The drug showed a promising profile with good safety and tolerability in animal studies.
Gilead is currently assessing the drug in several clinical trials for the treatment of novel coronavirus infection.
The University Hospitals trials will be conducted by the UH Clinical Research Center.
UH Cleveland Medical chief clinical and scientific officer and president Daniel Simon said: “Our UH research team has worked closely with the manufacturer, Gilead, in recent days to secure the studies. We are grateful to be one of the first sites in the US to participate in these clinical trials.
“Both trials are now approved by the Food and Drug Administration (FDA) and our Institutional Review Board, and we are expecting shipment of the experimental drug remdesivir in the next couple of days.”
One trial will involve patients with moderate illness and will compare the efficacy of two remdesivir regimens to standard of care.
The efficacy will be determined as the proportion of patients discharged on or before day 14 of hospitalisation.
Meanwhile, the second trial will recruit patients with more severe illness who may need intensive care.
The second study’s primary objective is the efficacy of two different dosing regimens of the drug and their ability to normalise patients’ temperature and oxygen saturation to day 14.
All trial participants will be administered with remdesivir intravenously and will be randomised to five days or ten days of treatment regimen.
University Hospitals hopes to open the studies at UH Ahuja, Parma, and St John medical centres. The organisation is also exploring other trials.