N/A
Completed N=54
PK and Safety of Remdesivir for Treatment of COVID-19 in Pregnant and Non-Pregnant Women in the US
Source: ClinicalTrials.gov NCT04582266 ↗Enrolled (actual)
54
Serious AEs
20.8%
Results posted
Jun 2023
Primary outcomePrimary: PK Outcome: Geometric Mean Area Under the Plasma Concentration-time Curve (AUC) of Remdesivir (RDV) in Arm 1 — 1246.57 h*ng/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PK Outcome: Geometric Mean Area Under the Plasma Concentration-time Curve (AUC) of Remdesivir (RDV) in Arm 1 |
1246.57 | — |
| PRIMARY PK Outcome: Geometric Mean Half-life (t1/2) of Remdesivir (RDV) in Arm 1 |
1.01 | — |
| PRIMARY PK Outcome: Geometric Mean Trough Concentration (Ctrough) of GS-441524 in Arm 1 |
51.6 | — |
| PRIMARY Safety Outcome: Proportion of Participants With Maternal Renal Adverse Event (AE) of Any Grade in Arm 1 |
— | — |
| PRIMARY Safety Outcome: Proportion of Participants With Maternal Hepatic Adverse Event (AE) of Any Grade in Arm 1 |
0.04 | — |
| PRIMARY Safety Outcome: Proportion of Participants With Maternal Hematologic Adverse Event (AE) of Any Grade in Arm 1 |
0.30 | — |
| PRIMARY Safety Outcome: Proportion of Participants With Maternal Grade 3 or Higher Adverse Event (AE) in Arm 1 |
0.68 | — |
| PRIMARY Safety Outcome: Proportion of Participants With Serious Adverse Event (AE) in Arm 1 |
0.33 | — |
| PRIMARY Safety Outcome: Proportion of Participants With Maternal Grade 3 or Higher Adverse Event (AE) Assessed as Related to Remdesivir (RDV) by the Clinical Management Committee (CMC) in Arm 1 |
0.00 | — |
| PRIMARY Safety Outcome: Proportion of Participants With Pregnancy Loss in Arm 1 |
0.06 | — |
| PRIMARY Safety Outcome: Proportion of Participants With Congenital Anomalies in Arm 1 |
0.00 | — |
| PRIMARY Safety Outcome: Proportion of Participants With Preterm Birth, Defined as < 37 Weeks in Arm 1 |
0.25 | — |
| PRIMARY Safety Outcome: Proportion of Participants With Preterm Birth, Defined as < 34 Weeks in Arm 1 |
0.00 | — |
| PRIMARY Safety Outcome: Proportion of Participants With Small for Gestational Age, Defined as < 10th Percentile in Arm 1 |
0.13 | — |
| PRIMARY Safety Outcome: Mean Newborn Birth Weight in Arm 1 |
3.039 | — |
| PRIMARY Safety Outcome: Mean Newborn Length in Arm 1 |
44.1 | — |
| PRIMARY Safety Outcome: Mean Newborn Head Circumference in Arm 1 |
29.9 | — |
| SECONDARY PK Outcome: Geometric Mean Area Under the Plasma Concentration-time Curve (AUC) of Remdesivir (RDV) in Arm 2 |
1302.75 | — |
| SECONDARY PK Outcome: Geometric Mean Half-life (t1/2) of Remdesivir (RDV) in Arm 2 |
1.09 | — |
| SECONDARY PK Outcome: Geometric Mean Trough Concentration (Ctrough) of GS-441524 in Arm 2 |
57.1 | — |
| SECONDARY Safety Outcome: Proportion of Participants With Renal Adverse Event (AE) of Any Grade in Arm 2 |
0.04 | — |
| SECONDARY Safety Outcome: Proportion of Participants With Hepatic Adverse Event (AE) of Any Grade in Arm 2 |
0.04 | — |
| SECONDARY Safety Outcome: Proportion of Participants With Hematologic Adverse Event (AE) of Any Grade in Arm 2 |
0.26 | — |
| SECONDARY Safety Outcome: Proportion of Participants With Grade 3 or Higher Adverse Event (AE) in Arm 2 |
0.54 | — |
| SECONDARY Safety Outcome: Proportion of Participants With Serious Adverse Event (AE) in Arm 2 |
0.17 | — |
| SECONDARY Safety Outcome: Proportion of Participants With Grade 3 or Higher Adverse Event (AE) Assessed as Related to Remdesivir (RDV) by the Clinical Management Committee (CMC) in Arm 2 |
0.04 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04582266). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.