Gilead will test remdesivir in children with COVID-19

Gilead Sciences has said it will start trials soon of its antiviral drug remdesivir in children – from newborns to adolescents – who have moderate-to-severe COVID-19.

The company said that while children seem to be much less affected by COVID-19 than adults, there have been “concerning reports…documented of children and young adults being hospitalised with COVID-19 and related autoimmune symptoms.”

The phase 2/3 trial will test remdesivir in around 50 subjects, with more than 30 clinical sites in the US and Europe included in order to hit that recruitment target as quickly as possible. It is due to start this month and complete before the end of the year.

Gilead says it has already been providing the drug to children with COVID-19 on a compassionate-use basis and under emergency-use programmes.

Infection with COVID-19 has been reported across all age groups, but studies consistently show that children under the age of 18 make up only around 2% of total cases worldwide.

Some experts suggest that is because children get a mild form which means they are less likely to be tested for SARS-CoV-2, the virus that causes COVID-19, but others think it could be because they are also less vulnerable to infection.

That said, some children do however seem to be developing a poorly-understood complication of coronavirus infection called multisystem inflammatory syndrome in children (MIS-C), which as it name suggest involves widespread inflammation of organs including the heart, blood vessels, kidneys, digestive system, brain, skin or eyes.

Remdesivir was the first drug to get emergency authorisation as a treatment for COVID-19 patients, in the US and Japan last month, with a similar approval in Europe due shortly.

It was also the only therapy with evidence of efficacy from a controlled trial until the steroid dexamethasone was found to cut mortality in the large-scale RECOVERY study earlier this week.

In a key clinical trial, Veklury was found to reduce the time to recovery from COVID-19 from 15 to 11 days, but wasn’t able to show a significant improvement over placebo on mortality,

Now, some researchers suggest combination use of remdesivir and dexamethasone could be the way forward, although others – including Peter Bach, a pulmonary physician and intensive care specialist at Memorial Sloan Kettering Cancer Centre in New York – are less convinced.

Bach said on Twitter that “guesses on synergy” with combination treatment are often wrong, adding that dexamethasone should probably now be considered the new standard of care for very sick COVID-19 patients.

[embed]https://twitter.com/peterbachmd/status/1272895505148887049[/embed]

The relative scarcity of Gilead’s drug at present compared to the steroid – which is widely available as a cheap generic – could also play a major factor.

Gilead is providing remdesivir free-of-charge to healthcare systems at the moment, but analysts have suggested it could charge up to $5,000 for a course of the drug.