IMPAACT 2032 was a Phase IV prospective, open label, non-randomized opportunistic study. The objectives of this study were to describe the pharmacokinetic (PK) properties and safety of remdesivir (RDV) administered intravenously as part of clinical care among hospitalized pregnant and non-pregnant women of childbearing potential with coronavirus disease of 2019 (COVID-19). RDV was provided and managed by the participant's treating physician and was not provided as part of this study.
IMPAACT 2032 was a Phase IV prospective, open label, non-randomized opportunistic study to
evaluate the PK and safety of RDV when administered to pregnant and non-pregnant women of
childbearing potential for treatment of COVID-19. Participants were pregnant and non-pregnant
women hospitalized for COVID-19 who received daily RDV infusions, typically for 5 days but in
some cases for up to 10 days, as part of their clinical care. RDV was provided and managed by
the participants' treating physician and was not provided as a part of this study.
This study was comprised of two population-based arms: Arm 1 included pregnant women of any
gestational age (GA) and Arm 2 included non-pregnant women of childbearing potential, who
were between 18 and 45 years of age. The target sample size was 20 PK-evaluable participants
per arm. Study sites were located in the United States.
Study procedures for this study were limited to data collection and blood specimens for PK.
Except for PK sampling, study procedures were largely done via medical chart abstraction or
remote contact/telemedicine visit. Collection of clinical and laboratory data started at 48
hours before the first infusion and continued through 4 weeks after the last infusion. In
addition, data were collected at the time of delivery for participants in Arm 1, and limited
data were also collected from the birth and newborn exam records of their infants. All
participants were followed for safety through 4 weeks after the last infusion; Arm 1
participants who were still pregnant at that time had an additional follow-up at the time of
delivery. If there was a gap in time between 4 weeks after the last infusion and delivery, no
data were collected during that interval.
No formal statistical comparisons were made between Arm 1 and Arm 2 for primary and secondary
objectives. Therefore, all analyses for primary and secondary outcome measures represent
single arm evaluations.
Drug: Remdesivir
RDV was not provided as part of the study. Participants were administered RDV intravenously once daily for up to 10 days per clinical care.
Inclusion Criteria: Arm 1 (Pregnant Women)
- Of legal age or otherwise able to provide independent informed consent or is unable to
provide informed consent (e.g., impaired capacity) and a Legally Authorized
Representative (LAR) is willing and able to provide written informed consent on behalf
of the participant
- At study entry, viable intra-uterine pregnancy of any gestational age, based on
medical records.
- At study entry, hospitalized AND has confirmed or suspected COVID-19, based on medical
records.
- At study entry, receiving or expected to receive RDV for COVID-19 clinical care, as
prescribed by the clinical care provider and documented in medical records.
Inclusion Criteria - Arm 2 (Non-Pregnant Women)
- Of legal age or otherwise able to provide independent informed consent or is unable to
provide informed consent (e.g., impaired capacity) and a Legally Authorized
Representative (LAR) is willing and able to provide written informed consent on behalf
of the participant
- At study entry, between 18 and 45 years of age, based on medical records and
participant report.
- Assigned female at birth and at study entry not taking cross-sex hormone therapy.
- At study entry, not suspected to be pregnant, based on participant report and/or
investigator or designee determination.
- At study entry, hospitalized AND has confirmed or suspected COVID-19, based on medical
records.
- At study entry, receiving or expected to receive RDV for COVID-19 clinical care, as
prescribed by the clinical care provider and documented in medical records.
Exclusion Criteria:
- At study entry, has started or received the 4th RDV infusion.
- At study entry, evidence of post-menopausal status (medical or surgical), based on
medical records and/or participant report.
- At study entry, any contraindications to RDV treatment for COVID-19, based on
investigator or designee determination.
- Received or administered any disallowed medications within 48 hours prior to study
entry.
- At study entry, has any other condition, that, in the opinion of the site investigator
or designee, would make participation in the study unsafe, complicate interpretation
of study outcome data, or otherwise interfere with achieving study objectives.
David Geffen School of Medicine at UCLA (Site #: 5112)
Los Angeles, California, United States
Childrens Hospital (U. Colorado, Denver) NICHD CRS (Site #: 5052)
Denver, Colorado, United States
Pediatric Perinatal HIV Clinical Trials Unit (Site #: 5127)
Miami, Florida, United States
Emory University School of Medicine (Site #: 5030)
Atlanta, Georgia, United States
Rush University Cook County Hospital NICHD CRS (Site #: 5083)
Chicago, Illinois, United States
Lurie Children's Hospital of Chicago (LCH) CRS (Site #: 4001)
Chicago, Illinois, United States
Johns Hopkins University NICHD CRS (Site #: 5092)
Baltimore, Maryland, United States
Bronx-Lebanon Hospital Center (Site #: 5114)
Bronx, New York, United States
Stony Brook University Medical Center (Site #: 5040)
Stony Brook, New York, United States
Texas Children's Hospital (Site #: 5128)
Houston, Texas, United States