Clinical trial • Phase III • Infectious Disease

IBUZATRELVIR for COVID-19

Phase III trial of IBUZATRELVIR for COVID-19.

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
COVID-19
Trial Stage
Phase III
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
12-02-2025
First CTIS Authorization Date
03-06-2025

Trial design

Randomised, pf-07817883 (ibuzatrelvir) oral film-coated tablet vs placebo to ibuzatrelvir film-coated tablet; dosing details not specified in the available json (maximum treatment period indicated as 5 days in product metadata).-controlled Phase III trial across 62 sites in Belgium, Bulgaria, Denmark and others.

Randomised
Yes
Comparator
PF-07817883 (ibuzatrelvir) oral film-coated tablet vs Placebo to Ibuzatrelvir film-coated tablet; dosing details not specified in the available JSON (maximum treatment period indicated as 5 days in product metadata).
Target Sample Size
1789
Trial Duration For Participant
168

Eligibility

Recruits 1789 paediatric patients.

Vulnerable Population
Adolescents aged 12 to <18 years are included (isVulnerablePopulationSelected = true). Subject information and informed consent form documents are present in the public documents list (e.g. L1_1_Main ICD, L2_1_ICD RRS, L3_1_PPRIF and country-specific ICDs). The JSON does not provide explicit text describing assent or parent/guardian consent procedures.

Inclusion criteria

  • {"criterion_text":"- 1. 12 to <18 years of age, weighing at least 40 kg, or ≥18 years of age of any weight at screening."}
  • {"criterion_text":"- 2.\tPresence of risk factors for progression to severe COVID-19 at the time of screening based on age."}
  • {"criterion_text":"- 3. Confirmed SARS-CoV-2 infection as determined by RAT in nasal or NP specimen collected within 1 day prior to randomization."}
  • {"criterion_text":"- 4. Participants must be unable or unwilling to take nirmatrelvir/ritonavir treatment."}

Exclusion criteria

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

Endpoints

Primary endpoints

  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"Composite proportion measured through Day 28 counting participants with COVID-19-related ED visits involving supplemental oxygen, receipt of COVID-19 antiviral or IV treatment (eg hydration, antibiotics, corticosteroids), all-cause hospitalization, or all-cause death."}

Secondary endpoints

  • {"endpoint_text":"- Time (days) to sustained resolution of all targeted COVID-19 symptoms through Day 28.","definition_or_measurement_approach":"Time in days to sustained resolution of targeted COVID-19 symptoms, assessed through Day 28."}
  • {"endpoint_text":"- Proportion of participants with CRPE from Day 1 to Week 24","definition_or_measurement_approach":"Proportion of participants experiencing pre-specified cardiovascular, renal and pulmonary events (CRPE) from Day 1 up to Week 24."}
  • {"endpoint_text":"- Proportion of participants with PACE from Day 29 to Week 24","definition_or_measurement_approach":"Proportion of participants with post-acute COVID-19 events (PACE) assessed from Day 29 through Week 24."}
  • {"endpoint_text":"- Proportion of participants with Long COVID/PASC symptoms at Week 24, based on the Long COVID/PASC PRO.","definition_or_measurement_approach":"Proportion with Long COVID/PASC symptoms at Week 24 measured by the Long COVID/PASC patient-reported outcome instrument."}

Recruitment

Registry Or Advocacy Recruitment
Yes
Digital Remote Recruitment
True - documented digital methods include social media, site websites, digital media boards, email invitations, global/outside-US website landing pages, and e-boks invitations (Denmark).
Planned Sample Size
1789
Recruitment Window Months
21
Consent Approach
Subject information and informed consent forms are provided (multiple 'L1', 'L2', 'L3' documents and country-specific ICDs are listed). Documents exist in multiple languages (EN and country variants such as BG, ES, DE, SK, FR, NL, CZ, FI appear in document titles). The JSON does not include explicit in-text details of who signs consent/assent, though adolescent inclusion (12 to <18 years) is specified and consent/assent materials are present among the documents.

Methods

  • RAT kit distribution and patient letter (documents titled IFU RAT Kit Leaflet, RAT Kit Bag, COVID-19 RAT Patient Letter).
  • Recruitment via social media and site websites (documents titled 'Recruitment via social media and site website' / digital media boards / OUS Website / Global Website Landing Page).
  • Study brochures, posters, community awareness cards and magnets (country-specific Study Brochure/Study Poster/Community awareness items listed for multiple countries).
  • Email and other digital invitations (documents titled 'Advocacy Study Awareness Email', 'Study Invitation Letter', 'Recruitment Invitation letter', 'Participant Invitation letter via e-boks' for Denmark).
  • Retention materials and regional image libraries (documents titled 'Retention items', 'Regional Image Library').
  • Site-based recruitment (site contact and local hospital/clinic sites listed across countries).

Geography

Total Number Of Sites
62
Total Number Of Participants
1789

Belgium

Earliest CTIS Part Ii Submission Date
06-05-2025
Latest Decision Or Authorization Date
24-03-2026
Processing Time Days
322
Number Of Sites
2
Number Of Participants
10

Sites

Site Name
Pneumocare
Contact Person Name
Jean-Benoit Martinot
Contact Person Email
martinot.j@respisom.be
Site Name
Anima
Contact Person Name
Erik Buntix
Contact Person Email
erik.buntinx@anima-alken.be

Bulgaria

Earliest CTIS Part Ii Submission Date
20-05-2025
Latest Decision Or Authorization Date
26-03-2026
Processing Time Days
310
Number Of Sites
13
Number Of Participants
207

Sites

Site Name
Mnogoprofilna Bolnica Za Aktivno Lechenie Samokov EOOD
Department Name
Internal Disease Department
Contact Person Name
Roza Mitreva
Contact Person Email
Rozza_m@abv.bg
Site Name
Specialized Hospital For Active Treatment Of Pulmonary Diseases Troyan EOOD
Department Name
Department of Pneumology
Contact Person Name
Krasimir Kovashki
Contact Person Email
kkovashki@yahoo.com
Site Name
Medical Center Hera EOOD
Contact Person Name
Kiril Palaveev
Contact Person Email
kiril.palaveev@heraclinics.com
Site Name
Rahila Angelova Mbal AD
Department Name
First Internal Department
Contact Person Name
Boyko Boyanov
Contact Person Email
Boiko.boianov@abv.bg
Site Name
Diagnostic Consultative Center 1 Lom EOOD
Contact Person Name
Chavdar Antonov
Contact Person Email
chavdar.antonov@fidelissmo.com
Site Name
Dcc 1 Sevlievo EOOD
Contact Person Name
Mladen Penchev
Contact Person Email
mlpenchev@gmail.com
Site Name
Medical Center Pulmo-2018 EOOD
Contact Person Name
Veselin Kalfov
Contact Person Email
kalfov@abv.bg
Site Name
Military Medical Academy
Department Name
Clinic of Infectious Diseases
Contact Person Name
Raynichka Mihaylova-Garnizova
Contact Person Email
doctor.mihaylova@mail.bg
Site Name
Medical Center Dianamed 2001 EOOD
Contact Person Name
Angelina Dimitrova
Contact Person Email
dr.andimitrova@abv.bg
Site Name
Asclepius Medical Center OOD
Contact Person Name
Elena GYUZELEVA
Contact Person Email
Dr.gyuzeleva@gmail.com
Site Name
Diagnostic Consultative Center Sveti Georgi EOOD
Contact Person Name
Vanya Dobreva
Contact Person Email
vanydobreva@gmail.com
Site Name
Medical Center St. Ivan Rilski Chudotvorets 2010 EOOD
Contact Person Name
Marin Marinov
Contact Person Email
r_m_marinov@abv.bg
Site Name
Ambulatory For Individual Primary Medical Aid Dr. Pavlina Petrova Poli ET
Contact Person Name
Pavlina Petrova
Contact Person Email
poli_doc@abv.bg

Denmark

Earliest CTIS Part Ii Submission Date
23-05-2025
Latest Decision Or Authorization Date
07-04-2026
Processing Time Days
319
Number Of Sites
5
Number Of Participants
33

Sites

Site Name
Region Midtjylland
Department Name
Godstrup Hospital - Department of Infectious Diseases & Internal Medicine
Contact Person Name
Steffen Leth
Contact Person Email
stefleth@rm.dk
Site Name
Region Sjaelland
Department Name
Department of Infectious Diseases
Contact Person Name
Lothar Wiese
Contact Person Email
low@regionsjaelland.dk
Site Name
Aalborg University Hospital
Department Name
Department of Infectious Diseases
Contact Person Name
Henrik Nielsen
Contact Person Email
henrik.nielsen@rn.dk
Site Name
Hillerod Hospital
Department Name
Department of Pulmonary- and Infectious Diseases
Contact Person Name
Birgitte Lindegaard Madsen
Site Name
University Hospital Rigshospitalet
Department Name
Department of Infectious Diseases
Contact Person Name
Inger Mathiesen

Finland

Earliest CTIS Part Ii Submission Date
09-05-2025
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
350
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
FVR Suomen rokotetutkimus Oy (Oulu)
Contact Person Name
Satu Kokko
Contact Person Email
satu.kokko@fvr.fi
Site Name
FVR Suomen rokotetutkimus Oy (Helsinki)
Contact Person Name
Ulla Elina Otava
Contact Person Email
ulla.otava@fvr.fi
Site Name
Helsinki University Hospital - Meilahti Vaccine Research Center
Department Name
Meilahti Vaccine Research Center MeVac
Contact Person Name
Hanna Välimaa
Contact Person Email
hanna.valimaa@hus.fi
Site Name
FVR Suomen rokotetutkimus Oy (Tampere)
Contact Person Name
Ulla Elina Otava
Contact Person Email
ulla.otava@fvr.fi

Germany

Earliest CTIS Part Ii Submission Date
22-05-2025
Latest Decision Or Authorization Date
20-03-2026
Processing Time Days
302
Number Of Sites
12
Number Of Participants
110

Sites

Site Name
Novopraxis Berlin GbR
Department Name
Medizinische Klinik
Contact Person Name
Sven Schellberg
Contact Person Email
schellberg@novopraxis.berlin
Site Name
Medical Center - University Of Freiburg
Department Name
Abteilung Infektiologie
Contact Person Name
Siegbert Richard Rieg
Site Name
Rostock University Medical Center
Department Name
Abteilung für Tropenmedizin, Infektionskrankheiten und Sektion Nephrologie
Contact Person Name
Micha Loebermann
Site Name
zibp Zentrum fuer Infektiologie Berlin Prenzlauer Berg GmbH
Contact Person Name
Axel Baumgarten
Contact Person Email
baumgarten@zibp.de
Site Name
IKF Pneumologie GmbH & Co. KG, Institut für klinische Forschung Pneumologie
Contact Person Name
Marc Oliver Kornmann
Contact Person Email
kornmann@ikf-pneumologie.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Department of Internal Medicine, Section Infectiology
Contact Person Name
Julian Schulze zur Wiesch
Contact Person Email
j.schulze-zur-wiesch@uke.de
Site Name
LMU Klinikum Muenchen AöR
Department Name
Med. Klinik und Poliklinik IV
Contact Person Name
Ulrich Seybold
Site Name
Studien Rahman & Detho GmbH
Contact Person Name
Anja Ploss
Contact Person Email
sz.apl@praxis-rd.de
Site Name
Universitaetsklinikum Augsburg
Department Name
III. Medizinische Klinik
Contact Person Name
André Fuchs
Contact Person Email
andre.fuchs@uk-augsburg.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Department of Infectious Diseases and Critical Care Medicine
Contact Person Name
Florian Kurth
Contact Person Email
florian.kurth@charite.de
Site Name
Studienpraxis Heimeranplatz
Contact Person Name
Angelika Sieber
Contact Person Email
sieber.angelika@gmx.de
Site Name
Praxis am Ebertplatz
Contact Person Name
Christoph Wyen
Contact Person Email
wyen@praxis-ebertplatz.de

Spain

Earliest CTIS Part Ii Submission Date
29-05-2025
Latest Decision Or Authorization Date
23-03-2026
Processing Time Days
298
Number Of Sites
10
Number Of Participants
60

Sites

Site Name
Hospital General Universitario Dr. Balmis
Department Name
Infectious Disease
Contact Person Name
Esperanza Merino de Lucas
Contact Person Email
merino_luc@gva.es
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Servicio de Enfermedades Infecciosas
Contact Person Name
Maria Dolores Sousa Regueiro
Contact Person Email
dsoureg@sergas.es
Site Name
Hospital Universitario Infanta Leonor
Department Name
Internal Medicine
Contact Person Name
Jorge Valencia La Rosa
Contact Person Email
jorge_vlr@yahoo.es
Site Name
Hospital Alvaro Cunqueiro
Department Name
Infectious Diseases
Contact Person Name
Maria Teresa Perez Rodriguez
Site Name
Hospital Universitari Vall D Hebron
Department Name
Infectious Diseases
Contact Person Name
Oscar Len Abad
Contact Person Email
oscarmanuel.len@vallhebron.cat
Site Name
Hospital Germans Trias I Pujol
Department Name
Infectious Diseases
Contact Person Name
Roger Paredes Deiros
Contact Person Email
rparedes@lluita.org
Site Name
Hospital Universitario Reina Sofia
Department Name
Infectious Diseases
Contact Person Name
Angela Cano Yuste
Site Name
Hospital Vithas Xanit Internacional
Department Name
Infectious Disease
Contact Person Name
Alejandro Martin Quiros
Contact Person Email
a.martinquiros@gmail.com
Site Name
Hospital Universitario Virgen De Valme
Department Name
Unidad de Enfermedades Infecciosas y Microbiologia
Contact Person Name
Nicolas Merchante Gutierrez
Contact Person Email
nicolasmerchante@gmail.com
Site Name
Hospital Universitario La Paz
Department Name
Infectious Diseases
Contact Person Name
Elena Munoz de Val
Contact Person Email
elena.munoz.dv@gmail.com

Slovakia

Earliest CTIS Part Ii Submission Date
07-05-2025
Latest Decision Or Authorization Date
19-03-2026
Processing Time Days
316
Number Of Sites
9
Number Of Participants
50

Sites

Site Name
MUDr. Viliam Cibik PhD. s.r.o.
Department Name
Všeobecná ambulancia pre dospelých
Contact Person Name
Viliam Cibik
Contact Person Email
viliam.cibik@gmail.com
Site Name
Artromac N.O.
Department Name
Reumatologická ambulancia
Contact Person Name
Michaele Zarikova
Contact Person Email
m.zarikova@gmail.com
Site Name
SALUBER SK s.r.o.
Department Name
Všeobecná ambulancia pre dospelých
Contact Person Name
Zuzana Vanova Jakovlevova
Contact Person Email
terezkazahr15@gmail.com
Site Name
Vl.Ak s.r.o.
Department Name
Všeobecná ambulancia pre dospelých
Contact Person Name
Patricia Babjaková
Contact Person Email
babjakovapatricia@gmail.com
Site Name
Ml Med s.r.o.
Department Name
Všeobecná ambulancia pre dospelých
Contact Person Name
Michal Banik
Contact Person Email
banik.michal@gmail.com
Site Name
IRS Medicinska cinnost s.r.o.
Department Name
Všeobecná ambulancia pre dospelých
Contact Person Name
Elena Adamkovicova
Contact Person Email
adamkovicova@yahoo.com
Site Name
Amb4you s.r.o.
Department Name
Všeobecná ambulancia pre dospelých
Contact Person Name
Lukas Vanco
Contact Person Email
lukas.vanco@gmail.com
Site Name
PULMO s.r.o.
Department Name
Pneumologicko-ftizeologická ambulancia
Contact Person Name
Luboslava Frajtová
Contact Person Email
lfrajtova@gmail.com
Site Name
Plucna ambulancia Hrebenar s.r.o.
Department Name
Pneumologicko-ftizeologická ambulancia
Contact Person Name
Slavomir Hrebenar
Contact Person Email
Slavomir.hrebenar@gmail.com

Czechia

Earliest CTIS Part Ii Submission Date
10-07-2025
Latest Decision Or Authorization Date
14-05-2026
Processing Time Days
308
Number Of Sites
7
Number Of Participants
61

Sites

Site Name
Lékařský dum v Mezibranské s.r.o.
Contact Person Name
Laura Hantak
Contact Person Email
laura@hantak.cz
Site Name
Doktor Brno s.r.o.
Contact Person Name
Lenka Dybova
Contact Person Email
dybova@doktorbrno.cz
Site Name
Prakticky lekar Horineves s.r.o.
Contact Person Name
Zuzana Simkova
Contact Person Email
lekarhorineves@gmail.com
Site Name
MUDr. Pavel Navrátil ORL ordinace
Contact Person Name
Pavel Navratil
Contact Person Email
ordinace@seznam.cz
Site Name
Ordinace Hradebni s.r.o.
Contact Person Name
Ivo Petrasek
Contact Person Email
ivo.petrasek@mensa.cz
Site Name
Zdravi-fit s.r.o.
Contact Person Name
Jan Kolar
Contact Person Email
kolar.dr@email.cz
Site Name
MUDr. Petra Prvni s.r.o.
Contact Person Name
Petra Prvni
Contact Person Email
prvnipetrastudie@seznam.cz

Sponsor

Primary sponsor

Full Name
Pfizer Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Signant Health Global LLC
Name
Azenta US Inc.
Responsibilities
Biospecimen long term storage
Name
PPD Global Central Labs
Responsibilities
Lab kits production and distribution, sample management
Name
UW Medicine Virology Lab
Name
York Bioanalytical Solutions Limited

Third parties

  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Biospecimen long term storage","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"Lab kits production and distribution, sample management","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"UW Medicine Virology Lab","duties_or_roles":"","organisation_type":"Health care"}
  • {"country":"United Kingdom","full_name":"York Bioanalytical Solutions Limited","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
PF-07817883 Tablet
Active Substance
IBUZATRELVIR
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Investigational Product Name
Placebo to Ibuzatrelvir film-coated tablet
Modality
Other

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