Summary

Eligibility
for females (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCLA UCSD
Dates
study started
estimated completion
Principal Investigator
by Brookie Best, PharmD, MAS (ucsd)
Photo of Brookie Best
Brookie Best

Description

Summary

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.

Official Title

Pharmacokinetics and Safety of Remdesivir for Treatment of COVID-19 in Pregnant and Non-Pregnant Women in the United States

Details

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.

Keywords

COVID-19 COVID-19, Pregnancy Remdesivir

Eligibility

You can join if…

Open to females

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.

You CAN'T join if...

  • 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.

Locations

  • David Geffen School of Medicine at UCLA (CRS 5112)
    Los Angeles California 90095 United States
  • University California, San Diego (CRS 4601)
    San Diego California 92103 United States

Lead Scientist at UC Health

  • Brookie Best, PharmD, MAS (ucsd)
    Dr. Brookie Best is a Professor of Clinical Pharmacy and Pediatrics and the Associate Dean for Pharmacy Education at the University of California (UC), San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences (SSPPS) and the Department of Pediatrics, School of Medicine (SOM).

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
ID
NCT04582266
Study Type
Observational
Last Updated