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STATUS Terminated

Study of Obeldesivir in Children and Adolescents With COVID-19

LAST UPDATED

March 26, 2024

Clinicaltrials.gov ID

NCT05996744

CTIS ID

2023-503282-27

OVERVIEW

A Phase 2/3 Single-Arm, Open-label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Obeldesivir in Pediatric Participants With COVID-19

PROTOCOL SUMMARY

The goal of this clinical study is to learn more about the safety and tolerability of obeldesivir (ODV) in children and adolescents with coronavirus disease 2019 (COVID-19). The primary objectives are to evaluate the plasma pharmacokinetics (PK), safety and tolerability of ODV in pediatric participants with COVID-19.

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Participation Requirements

Calendar

Age

0 - 18 Years

Condition

Sex

All

Healthy Icon

Healthy Volunteers

No

Study Details

Medical Condition

COVID-19

Gender

N/A

Date

December 2023 - February 2024

Study Type

Interventional

Study Phase

Phase 2, Phase 3

Product

Obeldesivir

Eligibility Information

Inclusion

Inclusion Criteria

  • Individual or legal guardian willing and able to provide written informed consent prior to performing study procedures. Individuals will provide assent, if possible, in accordance with local requirements and investigator's discretion.
  • Aged < 18 years who meet one of the following weight criteria and gestational age (GA) criteria where applicable:
  • Cohort 1: ≥ 6 years to < 18 years and weight ≥ 40 kg
  • Cohort 2: ≥ 6 years to < 18 years and weight ≥ 20 kg to < 40 kg
  • Cohort 3: ≥ 2 years to < 18 years and weight ≥ 12 kg to < 20 kg
  • Cohort 4: ≥ 28 days to < 18 years and weight ≥ 3 kg to < 12 kg
  • Cohort 5: ≥ 14 days to < 28 days of age, GA ≥ 37 weeks and weight ≥ 2.5 kg
  • Cohort 6: 0 days to < 14 days of age, GA ≥ 37 weeks and birth weight ≥ 2.5 kg
  • Cohort 7: 0 days to < 56 days of age, GA < 37 weeks and birth weight ≥ 1.5 kg
  • Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) or an alternative molecular diagnostic assay ≤ 5 days before screening.
  • Initial onset of coronavirus disease 2019 (COVID-19) signs/symptoms ≤ 5 days before screening with ≥ 1 sign/symptom such as fever, cough, fatigue, shortness of breath, sore throat, headache, myalgia/arthralgia present at screening.
  • Presence of ≥ 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness due to COVID-19.
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Exclusion

Exclusion Criteria

  • Anticipated access to and use of authorized or approved COVID-19 therapies during the current COVID-19 illness < 5 days after screening (therapies including but not limited to nirmatrelvir/ritonavir, molnupiravir, intravenous RDV, monoclonal antibodies).
  • Vaccination for SARS-CoV-2 or self-reported history of SARS-CoV-2 infection < 4 months prior to screening.
  • Received any approved, authorized, or investigational direct acting antiviral drug against SARS-CoV-2 for the treatment of COVID-19 < 28 days or < 5 half-lives, whichever is longer, before enrollment.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Locations

Locations (18)
Other

Trinity Clinical Research, LLC

Centreville, Alabama, United States, 35042

Other

Advanced Research Center, Inc.

Anaheim, California, United States, 92805

Other

Stanford University Medical Center

Palo Alto, California, United States, 94304

Other

UF Health- Shands Hospital

Gainesville, Florida, United States, 32610

Other

Encore Medical Research LLC

Hollywood, Florida, United States, 33021

Other

Accel Research Sites Network - Nona Pediatric Center

Orlando, Florida, United States, 32829

Other

Avanza Medical Research Center

Pensacola, Florida, United States, 32503

Other

Santos Research Center

Tampa, Florida, United States, 33603

Other

Pas Research

Tampa, Florida, United States, 33613

Other

Velocity Clinical Research, Norfolk

Norfolk, Nebraska, United States, 68701

Other

Velocity Clinical Research, Omaha

Omaha, Nebraska, United States, 68134

Other

Pas Research

Las Vegas, Nevada, United States, 89128

Other

Velocity Clinical Research -Albuquerque

Albuquerque, New Mexico, United States, 87107

Other

Child Health Care Associates

East Syracuse, New York, United States, 13057

Other

Velocity Clinical Research, Charleston

Charleston, South Carolina, United States, 29414

Other

PanAmerican Clinical Research, LLC

Brownsville, Texas, United States, 78520

Other

Texas Children's Hospital

Houston, Texas, United States, 77030

Other

The University of Texas Medical School at Houston

Houston, Texas, United States, 77030