Actively Recruiting
A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised
Led by Pfizer · Updated on 2026-05-05
300
Participants Needed
54
Research Sites
94 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 3, randomized, actively controlled, double-blinded, double-dummy, superiority study to evaluate the efficacy and safety of ibuzatrelvir alone and in combination with remdesivir IV compared to remdesivir IV alone for the treatment of symptomatic COVID-19 in severely immunocompromised adult participants who are non-hospitalized or are hospitalized for observation or study intervention administration but do not require supplemental oxygen for COVID-19.
CONDITIONS
Official Title
A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older who are non-hospitalized or hospitalized for observation or intervention
- Confirmed SARS-CoV-2 infection by approved test within 2 days prior to randomization
- Onset of COVID-19 symptoms within 5 days before randomization and currently experiencing at least one symptom
- Severely immunocompromised due to solid organ or islet cell transplant with immunosuppressive therapy
- Active blood cancers such as chronic lymphocytic leukemia, non-Hodgkin lymphoma, multiple myeloma, or acute leukemia
- Received CAR-T-cell therapy or hematopoietic cell transplantation within 2 years or currently on immunosuppressive therapy
- Currently receiving or recently received B-cell depleting therapies with ongoing immunosuppressive effect
You will not qualify if you...
- Severe COVID-19 or need for supplemental oxygen for COVID-19 treatment
- Receiving dialysis or have kidney failure with eGFR consistently less than 15 mL/min/1.73 m2
- Active liver disease
- Known allergy or contraindication to study drugs
- Suspected or confirmed active systemic infection other than COVID-19
- Life expectancy under 30 days due to other conditions
- Medical or psychiatric conditions increasing risk or judged inappropriate by investigator
- Received any other antiviral for current COVID-19 infection
- Use of prohibited medications or inability to use required medications
- Previous investigational product use within 30 days or 5 half-lives before study drug
- Previous participation in this trial or any ibuzatrelvir clinical trial
- Females who are pregnant, breastfeeding, or planning pregnancy during the study
- Investigator site staff or family members involved in the study conduct
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 54 locations
1
UC Davis CTSC Clinical Research Center
Sacramento, California, United States, 95817
Actively Recruiting
2
University of California Davis Health
Sacramento, California, United States, 95817
Actively Recruiting
3
UCHealth Anschutz Inpatient Pavilion - Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
4
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
5
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Actively Recruiting
6
D&H Cancer Research Center LLC
Margate, Florida, United States, 33063
Actively Recruiting
7
Velocity Clinical Research, Savannah
Savannah, Georgia, United States, 31406
Actively Recruiting
8
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
9
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Actively Recruiting
10
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
11
Clinical Trials Center
Boston, Massachusetts, United States, 02115
Actively Recruiting
12
Clinical Trials Hub
Boston, Massachusetts, United States, 02115
Actively Recruiting
13
Skylight Health Research, - Burlington
Burlington, Massachusetts, United States, 01803
Actively Recruiting
14
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States, 01655
Actively Recruiting
15
Revive Research Institute, Inc.
Farmington Hills, Michigan, United States, 48334
Actively Recruiting
16
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
17
TRC
Pittsburgh, Pennsylvania, United States, 15213
Not Yet Recruiting
18
UPMC Division of Infectious Disease Clinic
Pittsburgh, Pennsylvania, United States, 15213
Not Yet Recruiting
19
UPMC Presbyterian IDS
Pittsburgh, Pennsylvania, United States, 15213
Not Yet Recruiting
20
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Not Yet Recruiting
21
UPMC Shadyside IDS
Pittsburgh, Pennsylvania, United States, 15232
Not Yet Recruiting
22
Baylor University Medical Center
Dallas, Texas, United States, 75246
Not Yet Recruiting
23
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
24
Memorial Hermann Hospital
Houston, Texas, United States, 77030
Actively Recruiting
25
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
26
Swedish Ambulatory Infusion Center- First Hill
Seattle, Washington, United States, 98104
Actively Recruiting
27
Swedish Cancer Institute Treatment Center
Seattle, Washington, United States, 98104
Actively Recruiting
28
AZ Sint-Jan Brugge-Oostende AV
Bruges, West-vlaanderen, Belgium, 8000
Actively Recruiting
29
School of Medicine Federal University of Minas Gerais
Belo Horizonte, Minas Gerais, Brazil, 30130-100
Actively Recruiting
30
Centro Médico São Francisco
Curitiba, Paraná, Brazil, 80810-050
Actively Recruiting
31
CECIP - Centro de Estudos do Interior Paulista
Jaú, São Paulo, Brazil, 17201130
Not Yet Recruiting
32
Instituto Nacional de Infectologia Evandro Chagas
Rio de Janeiro, Brazil, 21040-360
Not Yet Recruiting
33
Rigshospitalet
Copenhagen, Capital Region, Denmark, 2100
Actively Recruiting
34
Aalborg Universitetshospital, Syd
Aalborg, North Denmark, Denmark, 9000
Actively Recruiting
35
Hopital Claude Huriez - CHU de Lille
Lille, NORD, France, 59037
Actively Recruiting
36
Hôpital Bichat - Claude-Bernard
Paris, France, 75018
Actively Recruiting
37
TUM Klinikum
München, Bavaria, Germany, 81675
Actively Recruiting
38
Alexandra General Hospital of Athens
Athens, Attikí, Greece, 115 28
Actively Recruiting
39
General Hospital of Athens "Laiko"
Athens, Attikí, Greece, 11527
Actively Recruiting
40
Fujita Health University Hospital
Toyoake, Aichi-ken, Japan, 470-1192
Actively Recruiting
41
Rinku General Medical Center
Izumisano, Osaka, Japan, 598-8577
Actively Recruiting
42
Tachikawa Hospital
Tachikawa, Tokyo, Japan, 190-8531
Actively Recruiting
43
National Hospital Organization Kyushu Medical Center
Fukuoka, Japan, 810-8563
Actively Recruiting
44
Saga University Hospital
Saga, Japan, 849-8501
Actively Recruiting
45
Canas Medical Center
Ponce, Puerto Rico, 00728
Not Yet Recruiting
46
Narodny ustav detskych chorob
Bratislava, Bratislava Region, Slovakia, 833 40
Actively Recruiting
47
Narodny onkologicky ustav
Bratislava, Slovakia, 833 10
Actively Recruiting
48
Chonnam National University Hospital
Gwangju, Kwangju-kwangyǒkshi, South Korea, 61469
Actively Recruiting
49
Hospital Universitario Reina Sofia
Córdoba, Andalusia, Spain, 14004
Actively Recruiting
50
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], Spain, 08035
Actively Recruiting
51
Hospital General Universitario Dr. Balmis
Alicante, Spain, 03010
Actively Recruiting
52
Hospital Universitario Virgen de Valme
Seville, Spain, 41014
Actively Recruiting
53
Far Eastern Memorial Hospital
New Taipei City, NEW Taipei, Taiwan, 220
Actively Recruiting
54
Sakarya Training and Research Hospital
Sakarya, Turkey (Türkiye), 54100
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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