Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05261139 | EPIC-Peds: A Study to Learn About the Study Medicine Called PF-07321332 (Nirmatrelvir)/Ritonavir in Patients Under 18 Years of Age With COVID-19 That Are Not Hospitalized But Are at Risk for Severe Disease | PHASE3 | RECRUITING | 160 | — | — | Mar 7, 2022 | Jul 30, 2026 | Jul 17, 2025 | 73 | United States, Bulgaria +5 |
| NCT05567952 | A Study to Learn About a Repeat 5-Day Treatment With the Study Medicines (Called Nirmatrelvir/Ritonavir) in People 12 Years Old or Older With Return of COVID-19 Symptoms and SARS-CoV-2 Positivity After Finishing Treatment With Nirmatrelvir/Ritonavir | PHASE2 | COMPLETED | 436 | — | — | Oct 19, 2022 | Feb 9, 2024 | Oct 8, 2024 | 84 | United States, Canada +3 |
| NCT05438602 | A Study to Learn About the Study Medicines (Nirmatrelvir Plus Ritonavir) in People Aged 12 Years or Older With COVID-19 and a Compromised Immune System | PHASE2 | COMPLETED | 158 | — | — | Aug 3, 2022 | Nov 13, 2023 | Sep 23, 2024 | 84 | United States, Australia +7 |
| NCT05047601 | A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection | PHASE2 | COMPLETED | 2,954 | — | — | Sep 9, 2021 | Apr 12, 2022 | May 6, 2023 | 170 | United States, Argentina +15 |
| NCT04960202 | EPIC-HR: Study of Oral PF-07321332/Ritonavir Compared With Placebo in Nonhospitalized High Risk Adults With COVID-19 | PHASE2 | COMPLETED | 2,091 | — | — | Jul 16, 2021 | Apr 25, 2022 | Jul 10, 2025 | 201 | United States, Argentina +18 |
Baseline was defined as the latest measurement between Day -1 and Day 1, but post-dose samples that were collected within 1 hour post start of dosing were also treated as baseline. Samples with result "\< lower limit of quantification (LLOQ)" were imputed as 1.7 log10 copies/milliliter (mL), and samples with result "Not Detected" were imputed as 0.0 log10 copies/mL.
NP swab was collected by healthcare professional (HCP) from participants and were sent to the central laboratory for viral RNA level testing real-time reverse transcriptase-polymerase chain reaction(RT-PCR). Sustained was defined as NP swab SARS-CoV-2 RNA level not \>=2.0 log10 per milliliter (copies/mL) at any study visit (through Day 44) following the first study visit where the participant's NP swab SARS-CoV-2 RNA level \<LLOQ (\<2.0 log10 copies/mL).
Percentage of participants who developed symptomatic Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) or Rapid Antigen Test (RAT) confirmed SARS-Cov-2 infection were reported in this outcome measure. Index case was defined as participants with symptomatic COVID-19.
Percentage of participants with COVID-19 related hospitalization or death from any cause during the first 28 days of the study was estimated using the Kaplan-Meier (KM) method. Using KM method, survival probability for each time interval was calculated as the number of participants surviving divided by the number of participants at risk. Participants who had the event, dropped out, or moved out were not counted as "at risk" i.e., participants who were lost were considered "censored" and were not counted in the denominator.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 nirmatrelvir/ritonavir | EXPERIMENTAL | nirmatrelvir/ritonavir will be given by tablets or powder by mouth twice a day for 5 days (10 doses total). Weight ≥40 kg 1. ≥12 to \<18 years 2. ≥6 to \<12 years |
| Cohort 2 nirmatrelvir/ritonavir | EXPERIMENTAL | nirmatrelvir/ritonavir will be given as powder by mouth twice a day for 5 days (10 doses total) Weight ≥20 to \<40 kg, ≥6 to \<18 years |
| Cohort 3 nirmatrelvir/ritonavir | EXPERIMENTAL | nirmatrelvir/ritonavir ≥2 to \<6 years |
| Cohort 4 nirmatrelvir/ritonavir | EXPERIMENTAL | nirmatrelvir/ritonavir ≥1 month (≥28 days) to \<2 years |
| Cohort 5 nirmatrelvir/ritonavir | EXPERIMENTAL | nirmatrelvir/ritonavir \<1 month (\<28 days) old |
| nirmatrelvir plus ritonavir for 5 days | EXPERIMENTAL | Nirmatrelvir (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 5 days |
| placebo plus ritonavir for 5 days | OTHER | placebo (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 5 days |
| Nirmatrelvir plus ritonavir for 10 days | EXPERIMENTAL | Nirmatrelvir (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 10 days followed by placebo for nirmatrelvir (2 tablets) plus placebo for ritonavir (1 capsule) every 12 hours for 5 days |
| Nirmatrelvir plus ritonavir for 15 days | EXPERIMENTAL | Nirmatrelvir (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 15 days. |
| PF-07321332/ritonavir (5 days) | EXPERIMENTAL | Participants will receive PF-07321332/ritonavir every 12 hours from Day 1 through Day 5 followed by Placebo every 12 hours from Day 6 through Day 10 |
| PF-07321332/ritonavir (10-Day) | EXPERIMENTAL | Participants will receive PF-07321332/ritonavir every 12 hours from Day 1 through Day 10. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo every 12 hours from Day 1 through Day 10. |
| PF-07321332/ritonavir | EXPERIMENTAL | Orally administered PF-07321332+ritonavir |
| Name | Type | Description |
|---|---|---|
| nirmatrelvir | DRUG | PF-07321332 |
| ritonavir | DRUG | ritonavir |
| placebo for nirmatrelvir | DRUG | Participants will receive 2 tablets of placebo for nirmatrelvir every 12 hours. A placebo does not have any medicine in it but looks just like the medicine being studied. |
| Placebo for ritonavir | DRUG | Participants will receive 1 capsule of placebo for ritonavir every 12 hours. A placebo does not have any medicine in it but looks just like the medicine being studied. |
| PF-07321332 | DRUG | PF-07321332 |
| Placebo for PF-07321332 | DRUG | Placebo |
| Placebo | DRUG | Placebo (tablet or capsule) |
Inclusion criteria: * Male and female, age 0 to \< 18 years, able to swallow for some participants * Confirmed SARS-CoV-2 infection within 72 hours prior to enrollment * Initial onset of COVID-19 signs/symptoms within 5 days prior to the day of enrollment and at least 1 of the specified COVID-19 si...