Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as PF-07817883
ibuzatrelvir · 5 trials · 4 indications
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
The difference in proportions of patients requiring 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 between ibuzatrelvir and placebo, among patients who were treated ≤5 days after COVID-19 symptom onset and who were not receiving background SoC treatment for their COVID-19 infection at baseline.
Change from baseline in SARS-CoV-2 RNA level at Day 5 was analyzed using Mixed Effects Repeated Measures (MMRM) model with fixed effects including treatment, visit, visit by treatment interaction, and baseline viral load. Covariates included days from baseline since symptom onset (\<=3 versus \[vs.\] \>3 days), vaccination status (complete or partial vs. unvaccinated), baseline anti-N serology status and age at screening (years). Participants were excluded from the analysis if baseline viral load was less than 4\*log10 copies/milliliter, missing, or not detected.
Plasma PF-07817883 PK parameters
Plasma PF-07817883 PK parameters
Plasma PF-07817883 parameters
| Arm | Type | Description |
|---|---|---|
| Ibuzatrelvir + Remdesivir | EXPERIMENTAL | Participants will receive ibuzatrelvir orally twice a day + IV remdesivir |
| Ibuzatrelvir | EXPERIMENTAL | Participants will receive ibuzatrelvir orally twice a day + IV placebo for remdesivir |
| Remdesivir | EXPERIMENTAL | Participants will receive placebo for ibuzatrelvir orally twice a day + IV remdesivir |
| placebo | PLACEBO_COMPARATOR | placebo administered orally every 12 hours (twice daily) for 5 days. |
| Arm 1: low dose | EXPERIMENTAL | - |
| Arm 2: medium dose | EXPERIMENTAL | - |
| Arm 3: high dose | EXPERIMENTAL | - |
| Arm 4: Placebo | PLACEBO_COMPARATOR | - |
| Cohort 1 | EXPERIMENTAL | No renal impairment |
| Cohort 2 | EXPERIMENTAL | Severe renal impairment |
| Cohort 3 | EXPERIMENTAL | Moderate renal impairment |
| Cohort 4 | EXPERIMENTAL | Severe hepatic impairment |
| Name | Type | Description |
|---|---|---|
| ibuzatrelvir | DRUG | tablet |
| remdesivir | DRUG | injection, for intravenous use |
| placebo for ibuzatrelvir | DRUG | tablet |
| placebo for remdesivir | DRUG | injection, for intravenous use |
| placebo | DRUG | placebo tablets |
| PF-07817883 | DRUG | Arm 1: low dose Arm 2: medium dose Arm 3: high dose |
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...
Ibuzatrelvir is an investigational antiviral medicine being studied for the treatment of COVID-19, the disease caused by SARS-CoV-2 infection. Pfizer is evaluating it in adults and adolescents who are not hospitalized but are at risk of severe disease, and in adults with COVID-19 who are severely immunocompromised.
Ibuzatrelvir is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sponsor of the clinical trials evaluating the drug in patients with COVID-19.
Ibuzatrelvir is in Phase 3 clinical development. It is an investigational small molecule and has not been approved by the FDA. Two Phase 3 trials are currently recruiting participants, and no completed trials of ibuzatrelvir have been reported.
Ibuzatrelvir is being studied in two recruiting Phase 3 trials. NCT06679140 enrolls about 2,330 adults and adolescents with COVID-19 who are not hospitalized but are at risk for severe disease. NCT07013474 enrolls about 300 adults with COVID-19 who are severely immunocompromised.
Both ibuzatrelvir trials are randomized, double-blind, and controlled, meaning participants are assigned by chance to receive ibuzatrelvir or a comparator, and neither participants nor investigators know the assignment. NCT06679140 includes sites across North America, South America, Europe, Asia, and South Africa, while NCT07013474 spans the United States, Europe, Asia, Mexico, and Puerto Rico.