University Hospitals in US to conduct coronavirus clinical trials

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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 SBECD-enabled investigational antiviral drug developed by Gilead Sciences. The drug showed a promising profile with good safety and tolerability in animal studies and humans so far. 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. Both trials are now approved by the Food and Drug Administration (FDA) and shipment of the experimental drug remdesivir is expected 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.
Coronavirus cure hopes have been raised after an infected Italian man in his 70s recovered with the help of the experimental Ebola drug. Doctors gave the unidentified 79-year-old remdesivir, which researchers around the world have tested in their desperate scramble to find a cure. He had recovered and could go home after 12 days in hospital. The drug also showed success in a critically-ill woman in the US and 14 Americans who tested positive for the coronavirus after catching it on the Diamond Princess cruise ship.

In the meantime, Gilead Sciences has temporarily stopped granting patients access to remdesivir citing overwhelming demand. The company said in a statement that it is focused on processing previously approved requests, and that it is developing a new system that it says will allow patients to get the drug in a similar timeframe to what it would have taken to work through the requests it has received. It will make exceptions for pregnant women and children under 18 years of age with confirmed Covid-19 and “severe manifestations” of the disease. The new approach will speed up access for severely ill patients and enable the company to collect data from all patients. These programs are under “rapid development” with regulators worldwide.

This comes after scientists hunting a cure for COVID-19 were dealt a blow by a failed trial of another promising drug – one used to treat HIV patients. Virologists described the results of the study on lopinavir–ritonavir, a combination which is branded as Kaletra and Aluvia, as ‘disappointing’.

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