Study will evaluate remdesivir for COVID-19 in pregnant women
A new study will evaluate remdesivir as a COVID-19 treatment in pregnant women, the NIH said.
The study, called IMPAACT 2032, will be conducted by the NIH-funded International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network. The NIH said the study will evaluate remdesivir’s pharmacokinetics in pregnant women and nonpregnant women of childbearing potential who receive the drug for COVID-19 treatment.
“This study is extremely important. Because of safety concerns, pregnant women have traditionally been excluded from clinical trials of many new drugs and vaccines,” Nahida Chakhtoura, MD, program official for the study and a medical officer in the Maternal and Pediatric Infectious Branch at the NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, told Healio.
“However, once a treatment is approved, pregnant women and their providers are often left without any evidence applying specifically to them and their infants as to whether to take advantage of the new treatment,” Chakhtoura said.
The NIH said samples from the plasma and umbilical cord of women who received remdesivir within 5 days of delivery will be analyzed for insight into the drug’s pharmacokinetics in the placenta. Additionally, the breast milk of women who are lactating will be tested for remdesivir. Researchers will also document potential side effects and adverse events.
Remdesivir was initially developed to treat Ebola and Marburg virus infections but has since been approved by the FDA as the first COVID-19 treatment for adults and children aged older than 12 years. Around the time of approval, clinical trial results demonstrated that remdesivir shortened recovery time in hospitalized patients with COVID-19, although mortality remained high.
A WHO guideline committee recommended against the use of remdesivir in patients hospitalized with COVID-19, regardless of disease severity, because of data suggesting that it had no important effect on mortality, need for mechanical ventilation or time to clinical improvement. However, the Infectious Diseases Society of America continues to recommend remdesivir over no antiviral treatment in patients with severe COVID-19. IDSA members cited results from the ACCT-1 trial, mentioned above, as the primary reason for the recommendation.
Although remdesivir has not been approved specifically for use in pregnant women, the NIH said it can be prescribed to pregnant women if their physician believes the drug may benefit them despite a lack of efficacy and safety data, which that the IMPAACT 2032 aims to provide.
“The ideal outcome for the study would be to obtain evidence-based data needed to inform the clinical care of pregnant and lactating women with COVID-19,” Chakhtoura said.
Enrollment has not yet begun for IMPAACT 2032, but researchers hope to have the trial completed and data available by January 2022.