RECRUITING

A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease

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Conditions

COVID-19 SARS-CoV-2 InfectionPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesCOVID-19Viral Protease InhibitorsProtease InhibitorsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionAntiviral AgentsAnti-Infective Agentsibuzatrelvir

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe in adults and adolescents with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible participants will be randomly assigned (by chance) to receive ibuzatrelvir or matching placebo orally for 5 days. Co-administration of locally available standard of care is allowed. The total duration of the study is around 6 months.

Official Title

AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, DOUBLE-BLIND, 2-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED IBUZATRELVIR COMPARED WITH PLACEBO IN NON-HOSPITALIZED SYMPTOMATIC ADULT AND ADOLESCENT PARTICIPANTS WITH COVID-19 WHO ARE AT HIGH RISK OF PROGRESSING TO SEVERE ILLNESS

Quick Facts

Study Start:2024-12-08
Study Completion:2027-04-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06679140

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 12 to \<18 years of age, weighing at least 40 kg, or ≥18 years of age of any weight at screening.
  2. 2. Presence of risk factors for progression to severe COVID-19 at the time of screening based on age:
  3. 1. 12 to 49 years of age with at least two risk factors, where one must be moderate immunocompromise;
  4. 2. 50 to 64 years of age with at least two risk factors;
  5. 3. 65 to 74 years of age with at least one risk factor;
  6. 4. For participants 75 years of age or older, there are no requirements related to risk factors.
  7. 3. Confirmed SARS-CoV-2 infection as determined by RAT in nasal specimen collected within 1 day prior to randomization. Initial onset of symptoms attributable to COVID-19 within 5 days prior to randomization and at least 1 of the specified symptoms attributable to COVID-19 present on the day of randomization. Randomization must occur no later than the 5th day, where the onset of symptoms is the first day.
  8. 4. Participants must be unable or unwilling to take nirmatrelvir/ritonavir.
  1. 1. Current need or anticipated need for hospitalization within 24 hours, due to signs of severe COVID-19 illness (eg, SpO2 \<94% on room air, respiratory rate \>30 breaths/minute, or lung infiltrates \>50%) or due to other medical conditions requiring hospitalization in the opinion of the site investigator.
  2. 2. Receiving dialysis or have known severe renal impairment \[ie, eGFR \<30 mL/min/1.73 m2 for adults or CrCl \<30 mL/min for adolescents\] within 6 months of the screening visit, using the serum creatinine-based CKD-EPI formula or the Cockroft Gault, respectively.
  3. 3. Active liver disease with AST or ALT \>3 ULN, Total bilirubin ≥2 × ULN (for Gilbert's syndrome, direct bilirubin \>ULN is exclusionary) within the past 3 months, or liver function impairment with Class C per Child Pugh classification.
  4. 4. Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
  5. 5. Ongoing Long COVID or Post Acute Sequelae of COVID-19 diagnosis.
  6. 6. Severely immunocompromised.
  7. 7. Any comorbidity requiring hospitalization and/or surgery within 7 days prior to study entry, or that is considered life threatening within 30 days prior to study entry, as determined by the investigator.
  8. 8. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  9. 9. Current use of any prohibited concomitant medication(s).
  10. 10. Has received any other antiviral for the treatment of COVID-19, including remdesivir, nirmatrelvir/ritonavir, molnupiravir, or COVID-19 mAbs within 30 days or 5 half-lives \[whichever is longer\] prior to screening, or received convalescent COVID-19 plasma within 12 months.
  11. 11. Received any dose of a COVID-19 vaccine within 4 months of randomization or expected to receive one through Day 34.
  12. 12. Previous administration of an investigational product (drug or vaccine) within 30 days or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).
  13. 13. Prior participation in this clinical trial or any other clinical trial of ibuzatrelvir.
  14. 14. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Contacts and Locations

Study Contact

Pfizer CT.gov Call Center
CONTACT
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Principal Investigator

Pfizer CT.gov Call Center
STUDY_DIRECTOR
Pfizer

Study Locations (Sites)

Herco Medical and Research Center Inc
Coral Gables, Florida, 33134
United States
Kendall South Medical Center
Miami, Florida, 33185
United States
Mercury Street Medical Group, PLLC
Butte, Montana, 59701
United States
Alliance for Multispecialty Research, LLC
Nashville, Tennessee, 37203
United States
The Crofoot Research Center
Houston, Texas, 77098
United States

Collaborators and Investigators

Sponsor: Pfizer

  • Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-08
Study Completion Date2027-04-17

Study Record Updates

Study Start Date2024-12-08
Study Completion Date2027-04-17

Terms related to this study

Keywords Provided by Researchers

  • Pneumonia, Viral
  • Pneumonia
  • Respiratory Tract Infections
  • Infections
  • Virus Diseases
  • Coronavirus Infections
  • Coronaviridae Infections
  • Nidovirales Infections
  • RNA Virus Infections
  • Lung Diseases
  • Respiratory Tract Diseases
  • COVID-19
  • Viral Protease Inhibitors
  • Protease Inhibitors
  • Enzyme Inhibitors
  • Molecular Mechanisms of Pharmacological Action
  • Antiviral Agents
  • Anti-Infective Agents
  • ibuzatrelvir

Additional Relevant MeSH Terms

  • COVID-19 SARS-CoV-2 Infection