CLINICAL TRIALS PROFILE FOR NIRMATRELVIR
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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. |
| NCT05341609 ↗ | Efficacy and Safety of JT001 (VV116) Compared With Paxlovid | Recruiting | Vigonvita Life Sciences | Phase 3 | The purpose of this study is to evaluate the efficacy and safety of JT001 (VV116) Compared With Paxlovid for the Treatment of Coronavirus Disease 2019 (COVID-19) in Participants With Mild to Moderate COVID-19. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
Clinical Trial Conditions for nirmatrelvir
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Clinical Trial Sponsors for nirmatrelvir
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