C4671026-A PHASE 2/3, INTERVENTIONAL SAFETY, PHARMACOKINETICS, AND EFFICACY, OPEN-LABEL, MULTI-CENTER, SINGLE-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED PF-07321332 (NIRMATRELVIR)/RITONAVIR IN NONHOSPITALIZED SYMPTOMATIC PEDIATRIC PARTICIPANTS WITH COVID-19 WHO ARE AT RISK OF PROGRESSION TO SEVERE DISEASE

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509773-23-00

Acronym

C4671026

Enrollment

Registered

2024-05-14

Start date

2023-07-13

Completion date

Unknown

Last updated

2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS-CoV-2 Infection

Brief summary

Plasma nirmatrelvir PK parameters including Cmax, AUC0-tau, t1/2, and Ctrough., Incidence of TEAEs, SAEs, AEs leading to discontinuations, and vital sign measurements

Detailed description

SARS-CoV-2 viral RNA measured via RT-PCR in nasopharyngeal or nasal swabs over time, Proportion of participants with COVID-19 related hospitalization or death from any cause through Day 28, Acceptability and palatability assessments of nirmatrelvir/ritonavir (filmcoated tablets and oral powder)

Interventions

DRUGRitonavir

DRUGNIRMATRELVIR

DRUGnirmatrelvir / ritonavir

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Plasma nirmatrelvir PK parameters including Cmax, AUC0-tau, t1/2, and Ctrough., Incidence of TEAEs, SAEs, AEs leading to discontinuations, and vital sign measurements	—

Secondary

Measure	Time frame
SARS-CoV-2 viral RNA measured via RT-PCR in nasopharyngeal or nasal swabs over time, Proportion of participants with COVID-19 related hospitalization or death from any cause through Day 28, Acceptability and palatability assessments of nirmatrelvir/ritonavir (filmcoated tablets and oral powder)	—

Countries

Bulgaria, Hungary

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026