CLINICAL TRIALS PROFILE FOR NIRMATRELVIR

Clinical Trials for nirmatrelvir

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT05261139 ↗	EPIC-Peds: Study of Oral PF-07321332 (Nirmatrelvir)/Ritonavir in Nonhospitalized COVID-19 Pediatric Patients at Risk for Severe Disease	Not yet recruiting	Pfizer	Phase 3	The purpose of the study is to evaluate the safety, pharmacokinetics, and efficacy of nirmatrelvir/ritonavir for the treatment of nonhospitalized, symptomatic pediatric participants with coronavirus disease 2019 (COVID-19) who are at risk of progression to severe disease.
NCT05321394 ↗	Non-inferiority Trial on Treatments in Early COVID-19	Recruiting	Agenzia Italiana del Farmaco	Phase 3	The study aims at assessing the non-inferiority of tixagevimab plus cilgavimab and nirmatrelvir plus ritornavir vs. sotrovimab (reference standard due to the wider evidence gathered on its efficacy) on COVID-19 progression in a real-life setting of outpatients aged at least 50 years at an early stage of the disease. The progression of COVID-19 disease (hospitalization, need for supplementary oxygen therapy at home, death) within 14 days of randomisation is the composite outcome variable on which the calculation of the sample size is based. Based on available data regarding the reduction in the number of hospitalisations and medical visits with the use of sotrovimab at an early-stage of COVID-19, a disease progression of 1% has been estimated in the reference arm. 3% delta margin was considered clinically relevant, taking into account both the estimates of disease progression in the study population in absence of early treatment (7%, based on national data) and the efficacy of the reference standard. Therefore, 1095 participants will be randomly assigned in an equal ratio between the reference standard and each of the other two experimental arms (1:1:1). Randomization will be computer-generated in permuted blocks with a stratification based on site.
NCT05321394 ↗	Non-inferiority Trial on Treatments in Early COVID-19	Recruiting	Azienda Sanitaria-Universitaria Integrata di Udine	Phase 3	The study aims at assessing the non-inferiority of tixagevimab plus cilgavimab and nirmatrelvir plus ritornavir vs. sotrovimab (reference standard due to the wider evidence gathered on its efficacy) on COVID-19 progression in a real-life setting of outpatients aged at least 50 years at an early stage of the disease. The progression of COVID-19 disease (hospitalization, need for supplementary oxygen therapy at home, death) within 14 days of randomisation is the composite outcome variable on which the calculation of the sample size is based. Based on available data regarding the reduction in the number of hospitalisations and medical visits with the use of sotrovimab at an early-stage of COVID-19, a disease progression of 1% has been estimated in the reference arm. 3% delta margin was considered clinically relevant, taking into account both the estimates of disease progression in the study population in absence of early treatment (7%, based on national data) and the efficacy of the reference standard. Therefore, 1095 participants will be randomly assigned in an equal ratio between the reference standard and each of the other two experimental arms (1:1:1). Randomization will be computer-generated in permuted blocks with a stratification based on site.
NCT05321394 ↗	Non-inferiority Trial on Treatments in Early COVID-19	Recruiting	Azienda Ospedaliera Universitaria Integrata Verona	Phase 3	The study aims at assessing the non-inferiority of tixagevimab plus cilgavimab and nirmatrelvir plus ritornavir vs. sotrovimab (reference standard due to the wider evidence gathered on its efficacy) on COVID-19 progression in a real-life setting of outpatients aged at least 50 years at an early stage of the disease. The progression of COVID-19 disease (hospitalization, need for supplementary oxygen therapy at home, death) within 14 days of randomisation is the composite outcome variable on which the calculation of the sample size is based. Based on available data regarding the reduction in the number of hospitalisations and medical visits with the use of sotrovimab at an early-stage of COVID-19, a disease progression of 1% has been estimated in the reference arm. 3% delta margin was considered clinically relevant, taking into account both the estimates of disease progression in the study population in absence of early treatment (7%, based on national data) and the efficacy of the reference standard. Therefore, 1095 participants will be randomly assigned in an equal ratio between the reference standard and each of the other two experimental arms (1:1:1). Randomization will be computer-generated in permuted blocks with a stratification based on site.

Clinical Trial Conditions for nirmatrelvir

Condition Name

Condition Name
Intervention	Trials
COVID-19	13
Long COVID	3
Healthy Participants	2
Post COVID-19 Condition, Unspecified	2

Condition MeSH

Condition MeSH
Intervention	Trials
COVID-19	15
Severe Acute Respiratory Syndrome	1
Post-Acute COVID-19 Syndrome	1
Coronavirus Infections	1

Clinical Trial Locations for nirmatrelvir

Trials by Country

Trials by Country
Location	Trials
United States	5
China	3
Italy	1
Russian Federation	1
Belgium	1

Trials by US State

Trials by US State
Location	Trials
North Carolina	1
Connecticut	1
Texas	1
South Carolina	1
Mississippi	1

Clinical Trial Progress for nirmatrelvir

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	5
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Not yet recruiting	16
Recruiting	4
Completed	2

Clinical Trial Sponsors for nirmatrelvir

Sponsor Name

Sponsor Name
Sponsor	Trials
Pfizer	12
Shandong Provincial Hospital	1
University Hospital, Geneva	1

Sponsor Type

Sponsor Type
Sponsor	Trials
Other	21
Industry	15