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A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients with Coronavirus Disease 2019 (COVID-19) who are Not Hospitalized but are at Risk for Severe Disease
EU CTIS ID: 2024-517727-39-00
What this study is testing
To compare the efficacy of ibuzatrelvir to placebo in nonhospitalized participants with COVID-19 who are at high risk of progression to severe illness.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. 12 to <18 years of age, weighing at least 40 kg, or ≥18 years of age of any weight at screening.
- 2. Presence of risk factors for progression to severe COVID-19 at the time of screening based on age.
- 3. Confirmed SARS-CoV-2 infection as determined by RAT in nasal or NP specimen collected within 1 day prior to randomization.
- 4. Participants must be unable or unwilling to take nirmatrelvir/ritonavir treatment.
You likely can't join if
- 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.
- 5. Ongoing Long COVID or PASC diagnosis.
- 6. Severely immunocompromised
- 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.
- 9. 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.
- 10. Current use of any prohibited concomitant medication(s).
See the full eligibility criteria
- 1. 12 to <18 years of age, weighing at least 40 kg, or ≥18 years of age of any weight at screening.
- 2. Presence of risk factors for progression to severe COVID-19 at the time of screening based on age.
- 3. Confirmed SARS-CoV-2 infection as determined by RAT in nasal or NP specimen collected within 1 day prior to randomization.
- 4. Participants must be unable or unwilling to take nirmatrelvir/ritonavir treatment.
- 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.
- 5. Ongoing Long COVID or PASC diagnosis.
- 6. Severely immunocompromised
- 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.
- 9. 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.
- 10. Current use of any prohibited concomitant medication(s).
- 8. History of hypersensitivity or other contraindication to any of the components of the study interventions.
- 11. 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.
- 12. Received any dose of a COVID-19 vaccine within 4 months of randomization or expected to receive one through Day 34.
- 13. 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).
- 14. Prior participation in this clinical trial or any other clinical trial of ibuzatrelvir.
- 15. 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.
- 2. Receiving dialysis or have known severe renal impairment (ie, eGFR consistently <30 mL/min/1.73 m2 for adults or CrCl <30 mL/min for adolescents, using the serum creatinine-based CKD-EPI formula or the Cockroft Gault, respectively).
- 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. Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
The study team makes the final eligibility decision.
Where it's taking place
- South Africa
- Argentina
- Taiwan
- China
- Japan
- Korea, Republic of
- Turkey
- United States
- Canada
- Brazil
- Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include South Africa; Argentina; Taiwan; China; Japan; Korea, Republic of and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.