No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
300 (estimated)
Sponsor
Pfizer · Industry
Who this trial is looking for
This trial is looking for adults who are severely immunocompromised and have COVID-19. Participants will receive either ibuzatrelvir alone or with another medication to see how well it works against the virus.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years of age or older
I have mild to moderate COVID-19
I have confirmed SARS-CoV-2 infection
I started having COVID-19 symptoms within the last 5 days
I am severely immunocompromised due to a qualifying condition
You may not be able to join if
I have severe or critical COVID-19
I am currently receiving dialysis
I have active liver disease
I have a history of serious allergic reactions to study treatments
I have a concurrent active infection other than COVID-19
My doctor thinks I have less than 30 days to live
I have received any other antiviral for my COVID-19
I am pregnant or breastfeeding
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 at baseline with mild-to-moderate CO…
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 at baseline with mild-to-moderate COVID-19.
Trial Locations
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Facility
City
State
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Status
Eligibility Criteria
Inclusion Criteria:
1. 18 years of age or older at screening who are non-hospitalized or hospitalized with mild to moderate COVID-19
2. Confirmed SARS-CoV-2 infection as determined by RAT (or other locally approved test) collected within 2 days prior to randomization. Initial onset of symptoms attr…
Inclusion Criteria:
1. 18 years of age or older at screening who are non-hospitalized or hospitalized with mild to moderate COVID-19
2. Confirmed SARS-CoV-2 infection as determined by RAT (or other locally approved test) 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.
3. 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:
1. Severe or critical COVID-19, or current need for supplemental oxygen.
2. Receiving dialysis or have current kidney failure (ie, eGFR consistently \<15 mL/min)
3. Active liver disease
4. History of hypersensitivity or other contraindication to any of the components of the study interventions, as determined by the investigator
5. Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
6. Life expectancy less than 30 days at study entry due to an underlying condition, in the judgement of the investigator.
7. 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.
8. Has received any other antiviral for the treatment of the current COVID-19 infection
9. Current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).
10. 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.
11. Prior participation in this trial or any clinical trial of ibuzatrelvir.
12. Females who are pregnant, breastfeeding, or who are planning to become pregnant within the timeframe of the study.
13. 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.
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