The US National Institutes of Health has reported that a new study, IMPAACT 2032, will analyse remdesivir in pregnant women who have been prescribed the drug for the treatment of Covid-19.
The study is funded by the NIH units: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Allergy and Infectious Diseases (NIAID), and the National Institute of Mental Health.
It will be carried out by the NIH-funded International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network at 17 sites in the continental US and Puerto Rico.
The study will analyse the pharmacokinetics of remdesivir. It will also evaluate any potential side effects and adverse events of the drug.
The plasma and umbilical cord samples will be analysed in women who received the drug within five days of delivery to understand remdesivir’s pharmacokinetics in the placenta. Furthermore, breast milk of the lactating women will be tested for the drug.
NICHD director Diana Bianchi said: “Pregnant women with Covid-19 are at high risk for hospitalisation, for intensive care admission, and for needing ventilator support.
“There is an urgent need to identify effective treatments for this population and to determine whether drugs prescribed for other adults are appropriate for use in pregnancy.”
Remdesivir was initially developed for Ebola and Marburg virus treatment. It has demonstrated to speed up recovery in patients with advanced Covid-19 in an NIAID-funded clinical trial.
In addition, it is approved by the US Food and Drug Administration for treating Covid-19 in individuals aged 12 years and above.
At present, the drug is not approved specifically for use in pregnancy but can be prescribed by physicians to pregnant women.