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Antiviral

Arm 1 for Coronavirus

N/A
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up delivery
Awards & highlights

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.

Eligible Conditions
  • Coronavirus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~delivery
This trial's timeline: 3 weeks for screening, Varies for treatment, and delivery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PK Outcome: Geometric Mean Area Under the Plasma Concentration-time Curve (AUC) of Remdesivir (RDV) in Arm 1
PK Outcome: Geometric Mean Half-life (t1/2) of Remdesivir (RDV) in Arm 1
PK Outcome: Geometric Mean Trough Concentration (Ctrough) of GS-441524 in Arm 1
+14 more
Secondary outcome measures
PK Outcome: Geometric Mean Area Under the Plasma Concentration-time Curve (AUC) of Remdesivir (RDV) in Arm 2
PK Outcome: Geometric Mean Half-life (t1/2) of Remdesivir (RDV) in Arm 2
PK Outcome: Geometric Mean Trough Concentration (Ctrough) of GS-441524 in Arm 2
+6 more
Other outcome measures
PK Outcome: Ratio of Cord Blood/Maternal Plasma GS-441524 Concentrations
PK Outcome: Ratio of Cord Blood/Maternal Plasma Remdisivir (RDV) Concentrations

Side effects data

From 2020 Phase 3 trial • 1062 Patients • NCT04280705
10%
Glomerular filtration rate decreased
9%
Haemoglobin decreased
8%
Lymphocyte count decreased
8%
Anaemia
7%
Respiratory failure
7%
Pyrexia
7%
Blood glucose increased
6%
Hyperglycaemia
6%
Blood creatinine increased
3%
Aspartate aminotransferase increased
2%
Cardiac arrest
2%
Septic shock
2%
Acute respiratory failure
2%
Lymphopenia
1%
Respiratory distress
1%
Acute respiratory distress syndrome
1%
Hypotension
1%
Shock
1%
Atrial fibrillation
1%
Multiple organ dysfunction syndrome
1%
Intestinal ischaemia
1%
Cerebrovascular accident
1%
Hypoxia
1%
Pneumonia aspiration
1%
Acute kidney injury
1%
Pneumothorax
1%
Pulmonary embolism
1%
Dyspnoea
1%
Endotracheal intubation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Remdesivir

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2Experimental Treatment1 Intervention
Non-pregnant women of childbearing potential hospitalized and receiving RDV for treatment of COVID-19.
Group II: Arm 1Experimental Treatment1 Intervention
Pregnant women hospitalized and receiving RDV for treatment of COVID-19.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Remdesivir
2020
Completed Phase 3
~21440

Find a Location

Who is running the clinical trial?

Gilead SciencesIndustry Sponsor
1,098 Previous Clinical Trials
860,415 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,302 Previous Clinical Trials
5,501,388 Total Patients Enrolled
Mark Mirochnick, MDStudy ChairDepartment of Pediatrics, Boston University Chobanian and Avedisian School of Medicine
4 Previous Clinical Trials
2,072 Total Patients Enrolled
~12 spots leftby Sep 2025
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