Gilead Sciences will begin evaluating the effectiveness of the antiviral remdesivir in hospitalized pediatric patients with moderate-to-severe cases of Covid-19, the company said in a statement Wednesday.
The phase 2 and 3 trial will test the efficacy of the drug with approximately 50 pediatric patients, from newborns through adolescents.
Remdesivir has emerged as a potentially effective therapeutic against Covid-19, with a peer-reviewed study published in May in the New England Journal of Medicine finding that the drug reduced median recovery time from the coronavirus from 15 days to 11.
Gilead says it’s provided the drug for pediatric patients under its compassionate use program.
Remdesivir is currently the only drug with emergency use authorization to treat Covid-19 after the Food and Drug Administration withdrew authorization this week for two antimalarial drugs, chloroquine and hydroxychloroquine.
While the elderly are the most affected by the coronavirus, children can still contract the disease, though symptoms are typically milder. In an analysis of around 1.3 million cases between January 22 and May 30 by the Centers for Disease Control and Prevention, children 9 and younger saw an incidence rate of 51 cases per 100,000 people. However, children are also contracting a less understood condition called multisystem inflammatory syndrome in children (MIS-C). Symptoms are similar to a condition known as Kawasaki disease, which causes inflammation in walls of blood vessels. Many patients that contracted MIS-C also have antibodies indicating a prior infection of Covid-19.
Hydroxychloroquine lost its emergency use order because the FDA determined its benefits were outweighed by potentially serious side effects. The drug was frequently touted by President Trump during White House briefings, and he took the drug for two weeks prophylactically in May. The U.S. government now has a massive surplus of the drug in its Strategic National Stockpile—63 million doses, according to CNN.
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