National Institute of Allergy and Infectious Diseases (NIAID)
Who can join
Eligibility, female only, with COVID-19. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
PK Outcome: Geometric Mean Area Under the Plasma Concentration-time Curve (AUC) of Remdesivir (RDV) in Arm 1Primary· At 3rd, 4th, or 5th infusion. Collection timepoints included: pre-dose, end of infusion (EOI), EOI + 0.75 hours, EOI + 1.5 hours, EOI + 3 hours, EOI + 5 hours, EOI + 7 hours, EOI + 23 hours.
AUC calculated using non-compartmental methods with linear up-log down trapezoidal rule (Phoenix WinNonlin v 8.3, Certara®). Intensive PK sampling occurred once, on the day of the 3rd, 4th, or 5th infusion.
Group
Value
95% CI
Arm 1
1246.57
915.71 – 1696.99
PK Outcome: Geometric Mean Half-life (t1/2) of Remdesivir (RDV) in Arm 1Primary· At 3rd, 4th, or 5th infusion. Collection timepoints included: pre-dose, end of infusion (EOI), EOI + 0.75 hours, EOI + 1.5 hours, EOI + 3 hours, EOI + 5 hours, EOI + 7 hours, EOI + 23 hours.
t1/2 calculated using non-compartmental methods with linear up-log down trapezoidal rule (Phoenix WinNonlin v 8.3, Certara®). Intensive PK sampling occurred once, on the day of the 3rd, 4th, or 5th infusion.
Group
Value
95% CI
Arm 1
1.01
0.87 – 1.17
PK Outcome: Geometric Mean Trough Concentration (Ctrough) of GS-441524 in Arm 1Primary· At 3rd, 4th, or 5th infusion. Collection timepoints included: pre-dose, end of infusion (EOI), EOI + 0.75 hours, EOI + 1.5 hours, EOI + 3 hours, EOI + 5 hours, EOI + 7 hours, EOI + 23 hours.
GS-441524 is a metabolite of remdesivir (RDV). Ctrough calculated using non-compartmental methods with linear up-log down trapezoidal rule (Phoenix WinNonlin v 8.3, Certara®). Intensive PK sampling occurred once, on the day of the 3rd, 4th, or 5th infusion.
Group
Value
95% CI
Arm 1
51.6
44.7 – 59.6
Safety Outcome: Proportion of Participants With Maternal Renal Adverse Event (AE) of Any Grade in Arm 1Primary· First infusion through 7 Days post-last infusion
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. We present the proportion of participants with at least one maternal renal AE through 7 days post last infusion, bounded by an exact 95% confidence interval (CI). Renal AEs were defined using the MedDRA system organ class term "Renal and urinary disorders" and high level grouping term "Renal and urinary tract investigations and urinalyses". The number of RDV infusions varied by participant.
Group
Value
95% CI
Arm 1
0
0 – 0.15
Safety Outcome: Proportion of Participants With Maternal Hepatic Adverse Event (AE) of Any Grade in Arm 1Primary· First infusion through 7 Days post-last infusion
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. We present the proportion of participants with at least one maternal hepatic AE through 7 days post last infusion, bounded by an exact 95% confidence interval (CI). Hepatic AEs were defined using the MedDRA system organ class term "Hepatobiliary disorders" and high level grouping term "Hepatobiliary investigations". The number of RDV infusions varied by participant.
Group
Value
95% CI
Arm 1
0.04
0.00 – 0.22
Safety Outcome: Proportion of Participants With Maternal Hematologic Adverse Event (AE) of Any Grade in Arm 1Primary· First infusion through 7 Days post-last infusion
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. We present the proportion of participants with at least one maternal hematologic AE through 7 days post last infusion, bounded by an exact 95% confidence interval (CI). Hematologic AEs were defined using the MedDRA system organ class term "Blood and lymphatic system disorders" and high level grouping term "Haematology investigations (incl blood groups)". The number of RDV infusions varied by participant.
Group
Value
95% CI
Arm 1
0.30
0.13 – 0.53
Safety Outcome: Proportion of Participants With Maternal Grade 3 or Higher Adverse Event (AE) in Arm 1Primary· First infusion through 4 Weeks post-last infusion and Delivery
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an AE severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one maternal grade
Group
Value
95% CI
Arm 1
0.68
0.45 – 0.86
Safety Outcome: Proportion of Participants With Serious Adverse Event (AE) in Arm 1Primary· First infusion through 4 Weeks post-last infusion and Delivery
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. We present the proportion of participants with at least one maternal serious AE through 4 weeks post last infusion and delivery, bounded by an exact 95% confidence interval (CI). The number of RDV infusions varied by participant.
Group
Value
95% CI
Arm 1
0.33
0.13 – 0.59
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 1Primary· First infusion through 4 Weeks post-last infusion and Delivery
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an AE severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one maternal grade
Group
Value
95% CI
Arm 1
0.00
0.00 – 0.21
Safety Outcome: Proportion of Participants With Pregnancy Loss in Arm 1Primary· Delivery
We present the proportion of participants who had a pregnancy loss at delivery, bounded by an exact 95% confidence interval (CI).
Group
Value
95% CI
Arm 1
0.06
0.00 – 0.29
Safety Outcome: Proportion of Participants With Congenital Anomalies in Arm 1Primary· Delivery
We present the proportion of participants who had a live infant born with congenital anomalies at delivery, bounded by an exact 95% confidence interval (CI).
Group
Value
95% CI
Arm 1
0.00
0.00 – 0.21
Safety Outcome: Proportion of Participants With Preterm Birth, Defined as < 37 Weeks in Arm 1Primary· Delivery
We present the proportion of participants who had a live preterm birth defined as \< 37 weeks, bounded by an exact 95% confidence interval (CI).
Group
Value
95% CI
Arm 1
0.25
0.07 – 0.52
Adverse events — posted to ClinicalTrials.gov
Time frame: Enrolled women in Arm 1 were followed for 4 weeks after the last RDV infusion and at delivery. Enrolled women in Arm 2 were followed for 4 weeks after the last RDV infusion..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06817889 — Remdesivir for the Treatment of Upper Respiratory Tract Infection Due to RSV in Immunocompromised Individuals
· Phase 2
· recruiting
NCT05911906 — An Open-label, Clinical Feasibility Study of the Efficacy of Remdesivir for Long-COVID.
· Phase 4
· completed
NCT06860282 — A Study of CX2101A Enteric-Coated Tablets in Healthy Chinese Adult Subjects
· Phase 1
· completed
NCT05502081 — Clinical Study to Compare Efficacy and Safety of Casirivimab and Imdevimab Combination, Remdesivir and Favipravir in Hos
· Phase 4
· completed
NCT05780541 — PF-07304814 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)
· Phase 3
· terminated
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID)
Last refreshed: 9 June 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04582266.