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 | Biotech Hunter

Timeline

Start Date

December 13, 2022

Primary Completion Date

September 21, 2023

Study Completion Date

January 6, 2024

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)Coronavirus Disease 2019 (COVID-19)ImmunocompromisedHospitalizationChild, Hospitalized

Interventions

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.

Trial Locations (11)

2300

"Specialized Hospital for Active Treatment of Lung Diseases - Pernik EOOD", Pernik

3320

Multiprofile Hospital for Active Treatment Sv. Ivan Rilski - Kozloduy EOOD, Kozloduy

3600

Multiprofile Hospital for Active Treatment - Sveti Nikolay Chudotvoretz, Lom

4003

"Multiprofile Hospital for Active Treatment - Medical Complex Sveti Ivan Rilski EOOD", Plovdiv

5800

"University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski EAD", Pleven

5804

MHAT - Heart and Brain, Pleven

6003

"UMHAT Prof. Dr. Stoyan KirkovichAD", Stara Zagora

6304

Multiprofile Hospital for Active Treatment - Haskovo AD, Haskovo

6305

Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases - Haskovo EOOD, Haskovo

10037

Harlem Hospital Center, New York

13326

Bassett Medical Center, Cooperstown