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#Children with coronavirus to be enrolled in remdesivir clinical trial

#Children with coronavirus to be enrolled in remdesivir clinical trial

June 19, 2020 | 12:58pm

Gilead Sciences’ antiviral drug remdesivir will soon be given to pediatric patients with moderate to severe cases of COVID-19 as part of a clinical trial of the experimental medication, the drugmaker has announced.

“While the novel coronavirus appears to disproportionally affect adults — especially the elderly and those with underlying health conditions — concerning reports have been documented of children and young adults being hospitalized with COVID-19 and related autoimmune symptoms,” Gilead Chief Medical Officer Merdad Parsey said in a statement.

The company said it will begin enrolling about 50 patients ranging from newborns to adolescents across more than 30 locations in the US and Europe, Reuters reported.

Remdesivir could be helpful in some patients after data showed it could shorten the recovery time.

The Food and Drug Administration granted an emergency use authorization on May 1 for the drug to treat hospitalized COVID-19 patients with severe illness.

On Monday, the FDA warned “health care providers about a newly discovered potential drug interaction” involving remdesivir.

“Co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir,” the agency said.

“The safety and efficacy of remdesivir for the treatment of COVID-19 continue to be evaluated, and preliminary clinical trial results have shown that on average, patients treated with remdesivir had more rapid time to recovery,” the FDA added.

Gilead Sciences is already running a late-stage study testing the drug in 6,000 patients with severe cases of the disease.

Earlier this month, the company said remdesivir showed signs of helping certain patients in a study showing better results from a shorter course of treatment.

Patients with moderate COVID-19 pneumonia who took a five-day treatment of the drug were 65 percent more likely to show “clinical improvement” at day 11 than people who received standard care, according to the study.

Remdesivir, which was developed to treat Ebola, has been “generally well-tolerated” among the moderately sick patients, though some experienced nausea, diarrhea and headache, the company has said.

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