Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as nirmatrelvir
PF-07321332 · 6 trials · 2 indications
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.
Cmax was the maximum observed plasma concentration and was directly observed from data. Concentration values below the lower limit of quantification (LLQ) were set to zero. Geometric mean analysis was on the log scale. Zero values were not included in geometric mean and geometric coefficient of variation calculation. The geometric coefficient of variation was expressed in percentage.
AUClast was area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration. The geometric coefficient of variation was expressed in percentage.
AUCinf was defined as area under the plasma concentration-time curve from time zero to infinity. The geometric coefficient of variation was expressed in percentage.
| 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 |
| Cohort 1 | EXPERIMENTAL | Healthy Volunteer |
| Cohort 2 | EXPERIMENTAL | Hepatic Impairment |
| 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...
Nirmatrelvir/ritonavir is an investigational small molecule being studied for COVID-19, hepatic impairment, and bioavailability in healthy participants. It is developed by Pfizer, Inc. (PFE) and is currently in Phase 1 clinical development.
Nirmatrelvir/ritonavir is developed by Pfizer, Inc., which trades under the ticker PFE. The drug is in Phase 1 clinical development for conditions including COVID-19 and hepatic impairment.
Nirmatrelvir/ritonavir is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials are ongoing or completed to evaluate its safety and effects.
Nirmatrelvir/ritonavir has been studied in several Phase 1 trials, including NCT04962022, NCT04962230, NCT05064800, and NCT05441215. These trials assess drug-drug interactions and effects in healthy participants, including lactating women.
Yes, nirmatrelvir/ritonavir is also known as nirmatrelvir. The drug is a combination product that includes nirmatrelvir and ritonavir, and it is being developed by Pfizer, Inc. for COVID-19 and other conditions.