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
Key dates
- Initial CTIS Submission Date
- 23-04-2025
- First CTIS Authorization Date
- 11-08-2025
Trial design
Randomised, remdesivir — solution for infusion (remdesivir); intravenous route; max daily dose 200 mg; max total dose 400 mg; max treatment period 3 days. matching placebos used: placebo to remdesivir - saline and placebo to ibuzatrelvir.-controlled Phase III trial in Sweden, Netherlands, Spain and others.
- Randomised
- Yes
- Comparator
- Remdesivir — solution for infusion (REMDESIVIR); intravenous route; max daily dose 200 mg; max total dose 400 mg; max treatment period 3 days. Matching placebos used: Placebo to Remdesivir - Saline and Placebo to Ibuzatrelvir.
- Target Sample Size
- 206
- Trial Duration For Participant
- 38
Eligibility
Recruits 206 Vulnerable populations are not selected (isVulnerablePopulationSelected: false). Participants must be adults (18 years or older, or minimum age of consent per local regulations). Subject information and informed consent forms are provided (multiple L1/L2 consent documents listed by country), and optional consent documents for retained research samples and pregnant partner forms are available..
- Pregnancy Exclusion
- Females who are pregnant, breastfeeding, or who are planning to become pregnant within the timeframe of the study.
- Vulnerable Population
- Vulnerable populations are not selected (isVulnerablePopulationSelected: false). Participants must be adults (18 years or older, or minimum age of consent per local regulations). Subject information and informed consent forms are provided (multiple L1/L2 consent documents listed by country), and optional consent documents for retained research samples and pregnant partner forms are available.
Inclusion criteria
- {"criterion_text":"- 18 years of age or older (or the minimum age of consent in accordance with local regulations) at screening who are non-hospitalized or hospitalized for observation or with the intent of administering the study intervention. Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants.\n- Confirmed SARS-CoV-2 infection as determined by RAT (or other locally approved test as noted in Section 8.2.4) in nasal specimen collected within 2 days prior to randomization. Initial onset of symptoms attributable to COVID-19 within 5 days prior to the day of randomization and at least 1 of the specified symptoms attributable to COVID-19 present on the day of randomization (see Section 10.10 for criteria). Randomization must occur no later than the fifth day, where the onset of symptoms is the first day.\n- Severely immunocompromised due to: Solid organ or islet cell transplant recipient who is receiving immunosuppressive therapy; Active hematologic malignancy (eg, chronic lymphocytic leukemia, non- Hodgkin lymphoma, multiple myeloma, acute leukemia); Receipt of CAR-T-cell therapy or HCT either within 2 years of transplantation or who are receiving immunosuppressive therapy; Currently receiving or recently received B-cell depleting therapies (eg, rituximab), where the immunosuppressive effect is still ongoing"}
Exclusion criteria
- {"criterion_text":"- Severe COVID-19, or current need for supplemental oxygen for treatment of COVID-19 (for definition of “severe COVID-19” refer to Section 6.9.4.).\n- Current or previous administration of an investigational product (drug or vaccine) within 30 days (or as determined by local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Authorized or products with conditional approval are not considered investigational.\n- Prior participation in this trial or any clinical trial of ibuzatrelvir.\n- Females who are pregnant, breastfeeding, or who are planning to become pregnant within the timeframe of the study.\n- 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.\n- Receiving dialysis or have current kidney failure (ie, eGFR consistenly <15 mL/min/1.73 m2) using the serum creatinine-based CKD-EPI formula.\n- 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.\n- History of hypersensitivity or other contraindication to any of the components of the study interventions, as determined by the investigator\n- Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.\n- Life expectancy less than 30 days at study entry due to an underlying condition, in the judgement of the investigator.\n- 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.\n- Has received any other antiviral for the treatment of the current COVID-19 infection, including remdesivir, nirmatrelvir/ritonavir, molnupiravir, or mAb treatment (within 30 days or 5 half-lives [whichever is longer] prior to screening), or received convalescent COVID-19 plasma within 12 months. Use of mAb therapy for prevention (eg, pemivibart) of COVID-19 is prohibited within 3 months prior to screening.\n- Current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s). Refer to Section 6.9."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Proportion of participants with the composite endpoint of: •\tCOVID-19-related emergency department (ED) visits with administration of supplemental oxygen, COVID-19 antiviral, or intravenous (IV) treatment (eg, hydration, antibiotics, or corticosteroids); COVID-19-related hospitalization; or all-cause mortality by Day 38, or • Evidence of recurrent or persistent SARS-CoV-2 infection, [CCI]","definition_or_measurement_approach":"Composite proportion measured through Day 38. Components include COVID-19-related ED visits with administration of supplemental oxygen, COVID-19 antivirals, or IV treatment (e.g., hydration, antibiotics, or corticosteroids); COVID-19-related hospitalization; all-cause mortality by Day 38; or evidence of recurrent/persistent SARS-CoV-2 infection."}
Secondary endpoints
- {"endpoint_text":"- Time to sustained alleviation of all targeted COVID-19 symptoms through Day 38.\n- Proportion of participants with no [CCI]\n- Proportion of participants with evidence of recurrent or persistent SARS-CoV-2 infection, [CCI]\n- Proportion of participants with COVID-19-related ED visits with administration of supplemental oxygen, COVID-19 antiviral, or IV treatment (eg, hydration, antibiotics, or corticosteroids), COVID-19-related hospitalization, or all-cause mortality through Day 38.\n- Change from baseline in SARS-CoV-2 RNA level in NP or nasal swabs over time.\n- Proportion of participants with SARS-CoV-2 NP or nasal RNA< LLOQ at each time point through Day 38.\n- Proportion of participants with viral rebound in SARS-CoV-2 RNA level in NP or nasal swabs through Day 38 visit (in both virologic responders and regardless of virologic response).\n- Time to sustained NP or nasal swab SARS-CoV-2 RNA< LLOQ through Day 38.\n- Incidence of treatment-emergent adverse events (TEAEs).\n- Incidence of serious adverse events (SAEs) and adverse events (AEs) leading to discontinuations.","definition_or_measurement_approach":"Endpoints measured at specified timepoints through Day 38. Virologic measures use NP or nasal swabs (RNA levels, LLOQ, viral rebound). Clinical endpoints include time-to-event analyses (time to sustained alleviation), proportions for events (ED visits, hospitalization, mortality), and incidence counts for TEAEs/SAEs/discontinuations."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 206
- Recruitment Window Months
- 18
- Consent Approach
- Informed consent is provided by the participant (eligible participants are adults: 18 years or older, or minimum age of consent per local regulations). Subject information and informed consent forms (L1/L2 documents) are available and provided per country (many country/language-specific ICD/ICF documents listed: SE_SV, NL_NL, ES_ES, FR_FR, DE_DE, SK_SK, DK_DA, etc.). Optional consent forms for retained research samples and pregnant-partner release forms are also listed.
Methods
- Website landing pages / OUS website (country-specific website landing pages listed in recruitment documents: e.g. 'Website Landing Page', 'OUS Website').
- Study posters, brochures, study invitation letters, community awareness cards and magnets, media boards—local site outreach materials (multiple country-specific packs: SE, NL, ES, SK, DK, GR, FR, BE, DE listed).
- RAT (rapid antigen test) kit distribution with RAT kit bag, IFU leaflets and COVID-19 RAT patient letters (documents: RAT Kit Bag, IFU RAT Kit Leaflet, Panbio COVID-19 Antigen Self Test) to support remote testing-based eligibility.
- Local site outreach packages and site-specific recruitment processes (site outreach packages and recruitment process documents listed for multiple sites/countries).
- Social media and digital recruitment channels (site-specific social media and website recruitment documents e.g. 'Recruitment social media and website' for Denmark and others).
Geography
- Total Number Of Sites
- 44
- Total Number Of Participants
- 94
Sweden
- Earliest CTIS Part Ii Submission Date
- 26-06-2025
- Latest Decision Or Authorization Date
- 13-04-2026
- Processing Time Days
- 291
- Number Of Sites
- 2
- Number Of Participants
- 9
Sites
- Site Name
- Region Skane Skanes Universitetssjukhus
- Department Name
- VE infektionssjukdomar
- Principal Investigator Name
- John Thegerström
- Principal Investigator Email
- john.thegerstrom@skane.se
- Contact Person Name
- John Thegerström
- Contact Person Email
- john.thegerstrom@skane.se
- Site Name
- Karolinska University Hospital
- Department Name
- Infektion / CAST
- Principal Investigator Name
- Anna Nordlander
- Principal Investigator Email
- anna.nordlander@regionstockholm.se
- Contact Person Name
- Anna Nordlander
- Contact Person Email
- anna.nordlander@regionstockholm.se
Netherlands
- Earliest CTIS Part Ii Submission Date
- 08-08-2025
- Latest Decision Or Authorization Date
- 14-04-2026
- Processing Time Days
- 249
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Radboud universitair medisch centrum Stichting
- Department Name
- Infectious Disease
- Principal Investigator Name
- Frank de Veerdonk
- Principal Investigator Email
- frank.vandeveerdonk@radboudumc.nl
- Contact Person Name
- Frank de Veerdonk
- Contact Person Email
- frank.vandeveerdonk@radboudumc.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Infectious Disease
- Principal Investigator Name
- Bart Rijnders
- Principal Investigator Email
- b.rijnders@erasmusmc.nl
- Contact Person Name
- Bart Rijnders
- Contact Person Email
- b.rijnders@erasmusmc.nl
Spain
- Earliest CTIS Part Ii Submission Date
- 17-07-2025
- Latest Decision Or Authorization Date
- 14-04-2026
- Processing Time Days
- 271
- Number Of Sites
- 10
- Number Of Participants
- 29
Sites
- Site Name
- Hospital Del Mar
- Department Name
- Infectious Diseases
- Principal Investigator Name
- Juan Pablo Horcajada Gallego
- Principal Investigator Email
- JHorcajada@parcdesalutmar.cat
- Contact Person Name
- Juan Pablo Horcajada Gallego
- Contact Person Email
- JHorcajada@parcdesalutmar.cat
- Site Name
- Hospital Universitario La Paz
- Department Name
- Infectious Diseases
- Principal Investigator Name
- Juan Carlos Ramos
- Principal Investigator Email
- ramosramosjc@gmail.com
- Contact Person Name
- Juan Carlos Ramos
- Contact Person Email
- ramosramosjc@gmail.com
- Site Name
- Hospital Universitario Virgen De Valme
- Department Name
- Infectious Diseases
- Principal Investigator Name
- Nicolas Merchante Gutierrez
- Principal Investigator Email
- nicolasmerchante@gmail.com
- Contact Person Name
- Nicolas Merchante Gutierrez
- Contact Person Email
- nicolasmerchante@gmail.com
- Site Name
- Hospital Universitario Reina Sofia
- Department Name
- Infectious Diseases
- Principal Investigator Name
- Angela Cano Yuste
- Principal Investigator Email
- cayuam@hotmail.com
- Contact Person Name
- Angela Cano Yuste
- Contact Person Email
- cayuam@hotmail.com
- Site Name
- Hospital General Universitario Dr. Balmis
- Department Name
- Infectious Diseases
- Principal Investigator Name
- Esperanza Merino de Lucas
- Principal Investigator Email
- merinoluc@gmail.com
- Contact Person Name
- Esperanza Merino de Lucas
- Contact Person Email
- merinoluc@gmail.com
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Infectious Diseases
- Principal Investigator Name
- Pedro Puerta Alcalde
- Principal Investigator Email
- ppuerta@lluita.org
- Contact Person Name
- Pedro Puerta Alcalde
- Contact Person Email
- ppuerta@lluita.org
- Site Name
- Hospital Universitario da A Coruna
- Principal Investigator Name
- María Dolores Sousa Regueiro
- Principal Investigator Email
- dsoureg@sergas.es
- Contact Person Name
- María Dolores Sousa Regueiro
- Contact Person Email
- dsoureg@sergas.es
- Site Name
- Hospital Alvaro Cunqueiro
- Department Name
- Infectious Diseases
- Principal Investigator Name
- Carmen Albo Lopez
- Principal Investigator Email
- carmen.albo.lopez@sergas.es
- Contact Person Name
- Carmen Albo Lopez
- Contact Person Email
- carmen.albo.lopez@sergas.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Infectious Diseases
- Principal Investigator Name
- Oscar Len Abad
- Principal Investigator Email
- oscar.len@vhir.org
- Contact Person Name
- Oscar Len Abad
- Contact Person Email
- oscar.len@vhir.org
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Infectious Diseases
- Principal Investigator Name
- Joaquin Lopez-Contreras Gonzalez
- Principal Investigator Email
- jlcontreras@santpau.cat
- Contact Person Name
- Joaquin Lopez-Contreras Gonzalez
- Contact Person Email
- jlcontreras@santpau.cat
Slovakia
- Earliest CTIS Part Ii Submission Date
- 30-07-2025
- Latest Decision Or Authorization Date
- 10-04-2026
- Processing Time Days
- 254
- Number Of Sites
- 5
- Number Of Participants
- 9
Sites
- Site Name
- Narodny Ustav Detskych Chorob
- Department Name
- Klinika detskej hematológie a onkológie LF UK a NÚDCH
- Principal Investigator Name
- Alexandra Kolenová
- Principal Investigator Email
- sasa.kolenova@gmail.com
- Contact Person Name
- Alexandra Kolenová
- Contact Person Email
- sasa.kolenova@gmail.com
- Site Name
- F D Roosevelt University General Hospital Of Banska Bystrica
- Department Name
- Oddelenie infektológie, Cesta k nemocnici 1, 974 01 Banska Bystrica
- Principal Investigator Name
- Diana Volosinova
- Principal Investigator Email
- volosinovad@gmail.com
- Contact Person Name
- Diana Volosinova
- Contact Person Email
- volosinovad@gmail.com
- Site Name
- Fakultna Nemocnica Trnava
- Department Name
- Klinika infektológie
- Principal Investigator Name
- Maria Solavova
- Principal Investigator Email
- mariasolavova2@gmail.com
- Contact Person Name
- Maria Solavova
- Contact Person Email
- mariasolavova2@gmail.com
- Site Name
- Narodny Onkologicky Ustav
- Department Name
- Klinika onkohematológie LFUK a NOU
- Principal Investigator Name
- Lubos Drgona
- Principal Investigator Email
- lubos.drgona@nou.sk
- Contact Person Name
- Lubos Drgona
- Contact Person Email
- lubos.drgona@nou.sk
- Site Name
- Nemocnica s poliklinikou Stefana Kukuru Michalovce a.s.
- Department Name
- Oddelenie infektológie
- Principal Investigator Name
- Stefan Zamba
- Principal Investigator Email
- stefan.zamba@pentahospitals.sk
- Contact Person Name
- Stefan Zamba
- Contact Person Email
- stefan.zamba@pentahospitals.sk
Denmark
- Earliest CTIS Part Ii Submission Date
- 11-07-2025
- Latest Decision Or Authorization Date
- 12-04-2026
- Processing Time Days
- 275
- Number Of Sites
- 4
- Number Of Participants
- 9
Sites
- Site Name
- Region Midtjylland
- Department Name
- Department of Infectious Diseases
- Principal Investigator Name
- Nina Breinholt Staerke
- Principal Investigator Email
- ninase@rm.dk
- Contact Person Name
- Nina Breinholt Staerke
- Contact Person Email
- ninase@rm.dk
- Site Name
- Odense University Hospital
- Department Name
- Department of Infectious Diseases
- Principal Investigator Name
- Isik Somuncu Johansen
- Principal Investigator Email
- isik.somuncu.johansen@rsyd.dk
- Contact Person Name
- Isik Somuncu Johansen
- Contact Person Email
- isik.somuncu.johansen@rsyd.dk
- Site Name
- Rigshospitalet
- Department Name
- Klinik for Infektionsmedicin
- Principal Investigator Name
- Marie Helleberg
- Principal Investigator Email
- Marie.helleberg@regionh.dk
- Contact Person Name
- Marie Helleberg
- Contact Person Email
- Marie.helleberg@regionh.dk
- Site Name
- Aalborg University Hospital
- Department Name
- Department of Infectious Diseases
- Principal Investigator Name
- Henrik Nielsen
- Principal Investigator Email
- henrik.nielsen@rn.dk
- Contact Person Name
- Henrik Nielsen
- Contact Person Email
- henrik.nielsen@rn.dk
Greece
- Earliest CTIS Part Ii Submission Date
- 09-05-2025
- Latest Decision Or Authorization Date
- 15-04-2026
- Processing Time Days
- 341
- Number Of Sites
- 8
- Number Of Participants
- 9
Sites
- Site Name
- Hippokration Hospital
- Department Name
- 3rd Pediatrics Department Infectious Diseases Unit
- Principal Investigator Name
- Elias Iosifidis
- Principal Investigator Email
- iosifidish@gmail.com
- Contact Person Name
- Elias Iosifidis
- Contact Person Email
- iosifidish@gmail.com
- Site Name
- Laiko General Hospital Of Athens
- Department Name
- Department of Pathophysiology and Bone Marrow Transplant Unit
- Principal Investigator Name
- Nikolaos Sipsas
- Principal Investigator Email
- nsipsas@med.uoa.gr
- Contact Person Name
- Nikolaos Sipsas
- Contact Person Email
- nsipsas@med.uoa.gr
- Site Name
- General University Hospital Of Patras
- Department Name
- Hematology Department and Bone Marrow Transplantation Unit/Internal Medicine Department
- Principal Investigator Name
- Alexandros Spyridonidis
- Principal Investigator Email
- aspyridonidis183@gmail.com
- Contact Person Name
- Alexandros Spyridonidis
- Contact Person Email
- aspyridonidis183@gmail.com
- Site Name
- University General Hospital Of Alexandroupoli
- Department Name
- Internal Medicine and Infectious Diseases
- Principal Investigator Name
- Periklis Panagopoulos
- Principal Investigator Email
- ppanago@med.duth.gr
- Contact Person Name
- Periklis Panagopoulos
- Contact Person Email
- ppanago@med.duth.gr
- Site Name
- Evangelismos S.A.
- Department Name
- Department of Hematology-Lymphoma and BMT Unit
- Principal Investigator Name
- Ioannis Baltadakis
- Principal Investigator Email
- ibaltadakis@icloud.com
- Contact Person Name
- Ioannis Baltadakis
- Contact Person Email
- ibaltadakis@icloud.com
- Site Name
- University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
- Department Name
- 4th Department of Internal Medicine
- Principal Investigator Name
- Alexandros Spyridonidis
- Principal Investigator Email
- aspyridonidis183@gmail.com
- Contact Person Name
- Alexandros Spyridonidis
- Contact Person Email
- aspyridonidis183@gmail.com
- Site Name
- University General Hospital Of Heraklion
- Department Name
- Department of Internal Medicine and Infectious Diseases
- Principal Investigator Name
- Diamantis Kofteridis
- Principal Investigator Email
- kofterid@med.uoc.gr
- Contact Person Name
- Diamantis Kofteridis
- Contact Person Email
- kofterid@med.uoc.gr
- Site Name
- Alexandra Hospital
- Department Name
- Internal Medicine and Clinical Therapeutics
- Principal Investigator Name
- Eleni Korompoki
- Principal Investigator Email
- ekoromp@gmail.com
- Contact Person Name
- Eleni Korompoki
- Contact Person Email
- ekoromp@gmail.com
France
- Earliest CTIS Part Ii Submission Date
- 11-07-2025
- Latest Decision Or Authorization Date
- 13-04-2026
- Processing Time Days
- 276
- Number Of Sites
- 5
- Number Of Participants
- 11
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Infectiology, Service des Maladies Infectieuses et Tropicales
- Principal Investigator Name
- Karine Lacombe
- Principal Investigator Email
- karine.lacombe2@aphp.fr
- Contact Person Name
- Karine Lacombe
- Contact Person Email
- karine.lacombe2@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Infectiology, Service des Maladies Infectieuses et Tropicales
- Principal Investigator Name
- Jean-Michel Molina
- Principal Investigator Email
- jean-michel.molina@aphp.fr
- Contact Person Name
- Jean-Michel Molina
- Contact Person Email
- jean-michel.molina@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Dijon
- Department Name
- infectious diseases
- Principal Investigator Name
- Lionel Piroth
- Principal Investigator Email
- lionel.piroth@chu-dijon.fr
- Contact Person Name
- Lionel Piroth
- Contact Person Email
- lionel.piroth@chu-dijon.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Infectiology, Service des Maladies Infectieuses et Tropicales
- Principal Investigator Name
- Emmanuel Faure
- Principal Investigator Email
- emmanuel.faure2@chru-lille.fr
- Contact Person Name
- Emmanuel Faure
- Contact Person Email
- emmanuel.faure2@chru-lille.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- infectious diseases
- Principal Investigator Name
- Nathan Peiffer-Smadja
- Principal Investigator Email
- nathan.peiffer-smadja@aphp.fr
- Contact Person Name
- Nathan Peiffer-Smadja
- Contact Person Email
- nathan.peiffer-smadja@aphp.fr
Belgium
- Earliest CTIS Part Ii Submission Date
- 14-07-2025
- Latest Decision Or Authorization Date
- 15-04-2026
- Processing Time Days
- 275
- Number Of Sites
- 4
- Number Of Participants
- 7
Sites
- Site Name
- Institut Jules Bordet
- Department Name
- Infectious disease
- Principal Investigator Name
- Aspasia Georgala
- Principal Investigator Email
- Aspasia.georgala@hubruxelles.be
- Contact Person Name
- Aspasia Georgala
- Contact Person Email
- Aspasia.georgala@hubruxelles.be
- Site Name
- Az St-Jan Brugge-Oostende A.V.
- Principal Investigator Name
- Alexander Schauwvlieghe
- Principal Investigator Email
- alexander.schauwvlieghe@azsintjan.be
- Contact Person Name
- Alexander Schauwvlieghe
- Contact Person Email
- alexander.schauwvlieghe@azsintjan.be
- Site Name
- UZ Brussel
- Principal Investigator Name
- Sabine Allard
- Principal Investigator Email
- sabine.allard@uzbrussel.be
- Contact Person Name
- Sabine Allard
- Contact Person Email
- sabine.allard@uzbrussel.be
- Site Name
- Hopital Erasme
- Department Name
- Infectious disease
- Principal Investigator Name
- Maya Hites
- Principal Investigator Email
- maya.hites@erasme.ulb.ac.be
- Contact Person Name
- Maya Hites
- Contact Person Email
- maya.hites@erasme.ulb.ac.be
Germany
- Earliest CTIS Part Ii Submission Date
- 18-07-2025
- Latest Decision Or Authorization Date
- 14-04-2026
- Processing Time Days
- 270
- Number Of Sites
- 4
- Number Of Participants
- 7
Sites
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- I. Medizinische Klinik und Poliklinik
- Principal Investigator Name
- Julian Constantin Raimer Schulze zur Wiesch
- Principal Investigator Email
- j.schulze-zur-wiesch@uke.de
- Contact Person Name
- Julian Constantin Raimer Schulze zur Wiesch
- Contact Person Email
- j.schulze-zur-wiesch@uke.de
- Site Name
- Universitaetsklinikum Augsburg
- Principal Investigator Name
- Andre Fuchs
- Principal Investigator Email
- andre.fuchs@uk-augsburg.de
- Contact Person Name
- Andre Fuchs
- Contact Person Email
- andre.fuchs@uk-augsburg.de
- Site Name
- Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
- Department Name
- Internal Medicine II
- Principal Investigator Name
- Christoph Spinner
- Principal Investigator Email
- christoph.spinner@mri.tum.de
- Contact Person Name
- Christoph Spinner
- Contact Person Email
- christoph.spinner@mri.tum.de
- Site Name
- University Hospital Cologne AöR
- Principal Investigator Name
- Jakob Johannes Malin
- Principal Investigator Email
- jakob.malin@uk-koeln.de
- Contact Person Name
- Jakob Johannes Malin
- Contact Person Email
- jakob.malin@uk-koeln.de
Sponsor
Primary sponsor
- Full Name
- Pfizer Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- PPD Global Central Labs
- Responsibilities
- Lab kits production and distribution, sample management
- Name
- Signant Health Global LLC
- Name
- York Bioanalytical Solutions Limited
- Name
- Azenta US Inc.
- Responsibilities
- Biospecimen long term storage
Third parties
- {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"Lab kits production and distribution, sample management","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"York Bioanalytical Solutions Limited","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Biospecimen long term storage","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"UW Medicine Virology Lab","duties_or_roles":"","organisation_type":"Health care"}
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- PF-07817883 Tablet
- Active Substance
- IBUZATRELVIR
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Investigational Product Name
- Remdesivir
- Active Substance
- REMDESIVIR
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Maximum Dose
- Max daily dose 200 mg; max total dose 400 mg; max treatment period 3 days
- Investigational Product Name
- Placebo to Remdesivir - Saline
- Modality
- Other
- Investigational Product Name
- Placebo to Ibuzatrelvir
- Modality
- Other
- Combination Treatment
- Yes
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