Gilead Sciences is set to conduct a Phase II/III clinical trial of its investigational antiviral drug remdesivir to treat paediatric patients hospitalised with Covid-19.
The open-label, single-arm has been designed in coordination with the US Food and Drug Administration (FDA). Patient enrolment will commence soon.
It will assess the safety, tolerability, pharmacokinetics and efficacy of remdesivir in around 50 paediatric patients suffering from moderate-to-severe Covid-19, including newborns and adolescents, at more than 30 sites across the US and Europe.
The primary outcome measures of the trial will be the proportion of patients with treatment-emergent adverse events and graded laboratory abnormalities, along with plasma concentrations of remdesivir and metabolites.
Meanwhile, secondary outcomes will include oxygenation use, mechanical ventilation, clinical improvement, and time to discharge from hospital.
The trial is expected to be completed in December this year.
Gilead Sciences chief medical officer Merdad Parsey said in a statement: “From the onset of the pandemic, Gilead has advanced the development of our investigational antiviral remdesivir for the treatment of Covid-19, in parallel with emerging knowledge about the disease.
“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 hospitalised with Covid-19 and related autoimmune symptoms.”
Since February this year, the company has offered remdesivir to paediatric patients with severe Covid-19 under its compassionate use programme and emergency use authorisation (EUA) granted by the FDA last month.
The drug is already being developed as a potential treatment for adults with Covid-19.
Earlier this month, Gilead reported positive top-line data from the Phase III SIMPLE trial of remdesivir in hospitalised adults with moderate Covid-19 pneumonia.
According to the data, patients on the five-day remdesivir course were 65% more likely to have clinical improvement at day 11 compared to those on the standard of care treatment.