February 19, 2021
2 min read
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Chaktoura does not report any relevant financial information.
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A new study will evaluate remdesivir as a COVID-19 treatment in pregnant women, the NIH said.
The study, named IMPAACT 2032, is being carried out by the NIH-funded International Network for Clinical AIDS Studies in Children and Adolescents (IMPAACT). The NIH said the study will assess the pharmacokinetics of remdesivir in pregnant women and non-pregnant women of childbearing age who are receiving the drug to treat COVID-19.
The NIH-funded IMPAACT 2032 study examines the effects of remdesivir on the treatment of COVID-19 in pregnant women.
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“This study is extremely important. Traditionally, for safety reasons, pregnant women have been excluded from clinical trials of many new drugs and vaccines. ” Nahida Chaktoura, MD, The program officer for the study and a health worker in the maternal and pediatric infections division at the NIH’s Eunice Kennedy Shriver National Institute for Child Health and Human Development, Healio said.
“Once a treatment is approved, however, pregnant women and their carers often remain without evidence, specific to them and their infants, as to whether to take the new treatment,” Chaktoura said.
Nahida Chaktoura
According to the NIH, samples from the plasma and umbilical cord from women who received remdesivir within 5 days of delivery will be analyzed to gain insight into the pharmacokinetics of the drug in the placenta. In addition, breast milk is tested for remdesivir by breastfeeding women. The researchers will also document possible side effects and adverse events.
Remdesivir was originally 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 12 years and older. Around the time it was approved, clinical trial results showed that remdesivir reduced recovery time in hospitalized patients with COVID-19, although mortality remained high.
A WHO policy committee recommended the use of remdesivir in patients treated with COVID-19 in hospital, regardless of the severity of the disease, as data indicated that it did not significantly affect mortality, or the need for mechanical ventilation Had time to clinical improvement. However, the Infectious Diseases Society of America continues to recommend Remdesivir without antiviral treatment in patients with severe COVID-19. IDSA members cited the results of the above ACCT-1 study as the main reason for the recommendation.
Although remdesivir has not been specifically approved for use in pregnant women, the NIH says it can be prescribed to pregnant women if their doctor believes the drug can benefit them despite the lack of data on efficacy and safety that IMPAACT 2032 is supposed to provide .
“The ideal outcome for the study would be to obtain evidence-based data necessary for the clinical care of pregnant and breastfeeding women with COVID-19,” said Chaktoura.
Registration for IMPAACT 2032 has not yet started, but the researchers hope the study will be completed and the data will be available by January 2022.
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