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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Pfizer Inc.

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Trial duration

28 Jul 2025 → ongoing

Decision date (initial)

2025-06-04

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-517727-39-00

ClinicalTrials.gov

NCT06679140

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Pharmacokinetic

To compare the efficacy of ibuzatrelvir to placebo in nonhospitalized participants with COVID-19 who are at high risk of progression to severe illness.

Secondary objectives 2

1. To compare the severity of COVID-19 symptoms of ibuzatrelvir to placebo in non-hospitalized participants with COVID-19 who are at high risk of progression to severe illness.
2. To compare the efficacy of ibuzatrelvir to placebo in preventing the onset of prespecified CRPE, PACE, and PASC, or Long COVID, in non-hospitalized participants with COVID-19 who are at high risk of progression to severe illness.

Conditions and MedDRA coding

Covid-19 at high risk of progression to severe illness.

Regulatory references

Scientific advice from competent authorities

European Medicines Agency, Food And Drug Administration

EMA paediatric investigation plan (PIP)

EMEA-000022-PIP91-95

Plan to share IPD

Yes

IPD plan description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

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. 3. Confirmed SARS-CoV-2 infection as determined by RAT in nasal or NP specimen collected within 1 day prior to randomization.
4. 4. Participants must be unable or unwilling to take nirmatrelvir/ritonavir treatment.

Exclusion criteria 15

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. 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.
3. 12. Received any dose of a COVID-19 vaccine within 4 months of randomization or expected to receive one through Day 34.
4. 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).
5. 14. Prior participation in this clinical trial or any other clinical trial of ibuzatrelvir.
6. 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.
7. 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).
8. 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.
9. 4. Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
10. 5. Ongoing Long COVID or PASC diagnosis.
11. 6. Severely immunocompromised
12. 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.
13. 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.
14. 10. Current use of any prohibited concomitant medication(s).
15. 8. History of hypersensitivity or other contraindication to any of the components of the study interventions.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of participants with COVID-19-related emergency department visits with administration of supplemental oxygen, COVID-19 antiviral or IV treatment (eg, hydration, antibiotics, or corticosteroids), all-cause hospitalization, or all-cause death through Day 28.

Secondary endpoints 4

1. Time (days) to sustained resolution of all targeted COVID-19 symptoms through Day 28.
2. Proportion of participants with CRPE from Day 1 to Week 24
3. Proportion of participants with PACE from Day 29 to Week 24
4. Proportion of participants with Long COVID/PASC symptoms at Week 24, based on the Long COVID/PASC PRO.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Pfizer Inc.

Sponsor organisation

Pfizer Inc.

Address

66 Hudson Boulevard East

City

New York

Postcode

10001-2189

Country

United States

Scientific contact point

Organisation

Pfizer Inc.

Contact name

Clinical Medical Lead

Public contact point

Organisation

Pfizer Inc.

Contact name

Clinical Medical Lead

Third parties 5

Locations

8 EU/EEA countries · 62 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 176 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

12 submissions — initial application plus substantial / non-substantial modifications