PK and Safety of Remdesivir for Treatment of COVID-19 in Pregnant and Non-Pregnant Women in the US

NCT ID: NCT04582266

Last Updated: 2023-06-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 54 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-31
• Study Completion Date: 2022-04-13

Brief Summary

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.

Detailed Description

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.

Conditions

COVID-19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Arm 1

Pregnant women hospitalized and receiving RDV for treatment of COVID-19.

Remdesivir

Intervention Type: DRUG

RDV was not provided as part of the study. Participants were administered RDV intravenously once daily for up to 10 days per clinical care.

Arm 2

Non-pregnant women of childbearing potential hospitalized and receiving RDV for treatment of COVID-19.

Remdesivir

Intervention Type: DRUG

RDV was not provided as part of the study. Participants were administered RDV intravenously once daily for up to 10 days per clinical care.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

• 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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Mirochnick, MD

Role: STUDY_CHAIR

Department of Pediatrics, Boston University Chobanian and Avedisian School of Medicine

Diana Clarke, PharmD

Role: STUDY_CHAIR

Pediatric Infectious Diseases, Boston Medical Center

Brookie Best, PharmD, MAS

Role: STUDY_CHAIR

University of California, San Diego

Locations

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

Stony Brook University Medical Center (Site #: 5040)

Stony Brook, New York, United States

Bronx-Lebanon Hospital Center (Site #: 5114)

The Bronx, New York, United States

Texas Children's Hospital (Site #: 5128)

Houston, Texas, United States

Countries

United States

References

Brooks KM, Baltrusaitis K, Clarke DF, Nachman S, Jao J, Purswani MU, Agwu A, Beneri C, Deville JG, Powis KM, Stek AM, Eke AC, Shapiro DE, Capparelli E, Greene E, George K, Yin DE, Jean-Philippe P, Chakhtoura N, Bone F, Bacon K, Johnston B, Reding C, Kersey K, Humeniuk R, Best BM, Mirochnick M, Momper JD; IMPAACT 2032 Study Team. Pharmacokinetics and Safety of Remdesivir in Pregnant and Nonpregnant Women With COVID-19: Results From IMPAACT 2032. J Infect Dis. 2024 Oct 16;230(4):878-888. doi: 10.1093/infdis/jiae298.

Reference Type: DERIVED

PMID: 38839047 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://rsc.niaid.nih.gov/clinical-research-sites/daids-adverse-event-grading-tables

DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, dated July 2017

http://rsc.niaid.nih.gov/clinical-research-sites/manual-expedited-reporting-adverse-events-daids

Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010

Other Identifiers

DAIDS Study ID 38746

Identifier Type: OTHER

Identifier Source: secondary_id

IMPAACT 2032

Identifier Type: -

Identifier Source: org_study_id