Purpose

The purpose of this study is to describe the pharmacokinetic (PK) properties and safety of remdesivir (GS-5734TM) (RDV) administered to pregnant and non-pregnant women with COVID-19. It is a Phase I, prospective, open label, non-randomized opportunistic PK study in pregnant and non-pregnant women of childbearing potential hospitalized and receiving RDV for treatment of COVID-19. RDV will not be provided as part of the study.

Condition

Eligibility

Eligible Ages
All ages
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

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, not within 6 weeks postpartum, based on participant report, medical records, 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.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Arm 1 Pregnant women hospitalized and receiving RDV for treatment of COVID-19.
  • Drug: Remdesivir
    RDV will not be provided as part of the study. Participants will be 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.
  • Drug: Remdesivir
    RDV will not be provided as part of the study. Participants will be administered RDV intravenously once daily for up to 10 days per clinical care.

Recruiting Locations

Boston Medical Center Ped. HIV Program NICHD CRS (5011)
Boston, Massachusetts 02118
Contact:
Debra McLaud, RN
617-414-5813
demclaud@bmc.org

More Details

Status
Recruiting
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

Study Contact

Elizabeth Greene, MPH
9195447040
egreene@fhi360.org

Detailed Description

This is a Phase I 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. RDV is not provided as part of this study; a requirement for entry is that participants receive RDV as part of their clinical care (i.e., outside of the study). A target of 20 PK evaluable pregnant women will be enrolled into Arm 1; a target of 20 PK evaluable non-pregnant women of childbearing potential will be enrolled into Arm 2. Study sites will be located in the United States. Participants will be pregnant and non-pregnant women hospitalized for COVID-19 and will receive daily RDV infusions, typically for 5 days but in some cases for up to 10 days, as part of their clinical care. RDV will be provided and managed by the participants' treating physician and will not be provided as a part of this study. Participants will undergo intensive PK sampling. For all women, clinical and laboratory evaluations will be abstracted from the medical record. Pregnancy, birth, and infant outcomes will be obtained from pregnant women enrolled in Arm 1. Women will be followed for safety through 4 weeks after the last infusion; Arm 1 women who are still pregnant at that time will also be followed for safety at delivery.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.