A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised
ConditionCOVID-19 Infection
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPfizer
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years of age or older at screening who are non-hospitalized or hospitalized with mild to moderate COVID-19
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.
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);
Disqualifiers
Severe or critical COVID-19, or current need for supplemental oxygen.
Receiving dialysis or have current kidney failure (ie, eGFR consistently <15 mL/min)
Active liver disease
History of hypersensitivity or other contraindication to any of the components of the study interventions, as determined by the investigator
Trial design
Design model
Parallel
Treatments tested in this trial
ibuzatrelvir
Drugtablet
remdesivir
Druginjection, for intravenous use
placebo for ibuzatrelvir
Drugtablet
placebo for remdesivir
Druginjection, for intravenous use
Treatment groups
300 Participants
are divided into 3 treatment groupsGroup A: Ibuzatrelvir + RemdesivirExperimental treatment 2 interventions
Group B: IbuzatrelvirExperimental treatment 2 interventions
Group C: RemdesivirExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
The difference in the proportion of patients meeting the primary composite endpoint, between ibuzatrelvir and remdesivir vs remdesivir groups in symptomatic adult participants with COVID-19 who are severely immunocompromised
The difference in the proportion of participants with the composite endpoint of a) Progression to severe COVID-19 or all-cause mortality by Day 38, or b) Evidence of recurrent or persistent SARS-CoV-2 infection
Time frame
38 daysSecondary outcomes
1
Time to sustained alleviation of all targeted COVID-19 symptoms
The difference in median time to sustained alleviation of all targeted symptoms. Symptoms will be assessed through a daily electronic diary and include sore throat, cough, fever and diarrhea, among others.
Time frame
38 days2
Proportion of participants with evidence of recurrent or persistent SARS-CoV-2 infection.
The viral load is measured in nasal or nasopharyngeal samples using reverse transcription polymerase chain reaction (RT-PCR)
Time frame
38 days3
Proportion of participants with COVID-19-related ED visits with medical intervention, COVID-19-related hospitalization, or all-cause mortality.
Proportion of participants with COVID-19-related ED visits with medical intervention, COVID-19-related hospitalization, or all-cause mortality.
Time frame
38 days4
Change from baseline in SARS-CoV-2 RNA level in NP or nasal swabs over time
The viral load is measured in nasal or nasopharyngeal samples using reverse transcription polymerase chain reaction (RT-PCR)
Time frame
38 days Source ClinicalTrials.gov