Open Actively Recruiting

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

About

Brief 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.

Study Type
Observational

Eligibility

Gender
Female
Healthy Volunteers
Yes
Minimum Age
N/A
Maximum Age
N/A

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.

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Study Stats
Protocol No.
20-002009
Category
Pediatrics
Other
Contact
Michele Carter
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04582266
For detailed technical eligibility, visit ClinicalTrials.gov.