NCT05545319

A Study to Learn About the Medicine Called Nirmatrelvir Used in Combination With Ritonavir in People With Weakened Immune Systems or at Increased Risk for Poor Outcomes Who Are Hospitalized Due to Severe COVID-19

AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 2, DOUBLE-BLIND, 2-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED NIRMATRELVIR/RITONAVIR COMPARED WITH PLACEBO/RITONAVIR FOR THE TREATMENT OF SEVERE COVID-19 IN HOSPITALIZED PARTICIPANTS WHO ARE IMMUNOCOMPROMISED OR AT INCREASED RISK FOR SEVERE COVID-19 OUTCOMES

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

A Study to Learn About the Medicine Called Nirmatrelvir Used in Combination With Ritonavir in People with Weakened Immune Systems or at Increased Risk for Poor Outcomes who are Hospitalized Due to Severe COVID-19

Conditions

• Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
• Coronavirus Disease 2019 (COVID-19)
• Immunocompromised
• Hospitalization
• Child, Hospitalized

Interventions

Type	Name	Description
DRUG	Nirmatrelvir	Participants will receive 2 tablets of nirmatrelvir (or 1 tablet for participants with eGFR or eCrCl ≥30 to \<60 mL/min) every 12 hours
DRUG	Ritonavir	Participants will receive 1 capsule of ritonavir every 12 hours
DRUG	Placebo for nirmatrelvir	Participants will receive 2 tablets of placebo for nirmatrelvir (or 1 tablet for participants with eGFR or eCrCl ≥30 to \<60 mL/min) every 12 hours. A placebo does not have any medicine in it but looks just like the medicine being studied.

Timeline

• Start date: 2022-12-13
• Primary completion: 2023-09-21
• Completion: 2024-01-06
• First posted: 2022-09-19
• Last updated: 2023-03-01

Locations

11 sites across 2 countries: United States, Bulgaria

Regulatory

• FDA-regulated drug study