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. |
| NCT05386472 ↗ | A Study to Learn About the Study Medicine (Called Nirmatrelvir/Ritonavir) in Pregnant Women With Mild or Moderate COVID-19. | Not yet recruiting | Pfizer | Phase 1 | The purpose of this clinical trial is to learn about how study medicine (Paxlovid, which contains nirmatrelvir and ritonavir) is changed and eliminated from the body, as well as its safety, and the extent to which side effects can be tolerated for treatment of pregnant women with mild or moderate COVID-19 compared to non-pregnant women with mild or moderate COVID-19. This study is seeking participants who: - are expecting a healthy baby and are in their second or third trimester pregnant and have mild or moderate COVID-19 - are not pregnant and have mild or moderate COVID-19. All participants in this study will take Paxlovid by mouth every 12 hours for 5 days (10 doses total). We will examine the experiences of people receiving the study medicine. This will help us determine if the study medicine is safe. All participants will take part in this study for at least 34 days; pregnant participants will take part until their delivery, so that the study duration may be up to 6 months, depending on their delivery date. During this time, participants will have 7-8 visits and, if pregnant, a visit at delivery. 2-3 visits and the delivery visit will be done in person (at the clinic or at the participant's home). The other 5 visits may be done over the phone, unless an in-person visit is necessary as determined by the investigator. Blood samples will be collected on the first 4-5 study visits (and at other study visits, if necessary). Some blood samples may be taken by participants themselves. |
| NCT05438602 ↗ | A Study to Learn About the Study Medicines (Called Nirmatrelvir/Ritonavir) in People 12 Years Old or Older With COVID-19 Who Are Immunocompromised | Not yet recruiting | Pfizer | Phase 2 | Patients with COVID-19 who are immunocompromised have a higher chance of severe illness. Such patients may benefit from longer treatment durations compared to the standard treatment regimen. The purpose of the clinical trial is to evaluate the efficacy (how well a study treatment works in the clinical trial) and safety when taking the study medicine for either 5, 10, or 15 days. All the study medication will be taken by mouth. The first dose of study medication is taken at the study site and the rest at home. People taking part will be in this study for about 24 weeks. Enrolled participants will need to visit the study site at least 10 times during the study. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
Clinical Trial Conditions for nirmatrelvir
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