Status:
COMPLETED
Non-inferiority Trial on Treatments in Early COVID-19
Lead Sponsor:
Azienda Ospedaliera Universitaria Integrata Verona
Collaborating Sponsors:
Agenzia Italiana del Farmaco
Azienda Sanitaria-Universitaria Integrata di Udine
Conditions:
COVID-19
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
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) o...
Eligibility Criteria
Inclusion
- Age ≥ 50 years
- Informed consent by the subject or legally authorized representative
- Laboratory-confirmed SARS-CoV-2 infection, as determined by PCR or other commercial or public health assay in any specimen, no more than 4 days prior to the study drug administration
- Peripheral oxygen saturation ≥ 94% on room air and not requiring supplemental oxygen
- Onset of symptom is no more than 4 days prior to the study drug administration. Onset time of symptom is defined as the time when the patient experienced the presence of at least one of the following (but not limited to) SARS-CoV-2 infection-associated symptom (FDA, September 2020): nasal obstruction or congestion, cough, fever \> 37.3 °C, sore throat, body pain or muscle pain, headache, loss of taste or smell, nausea or vomiting, diarrhoea
Exclusion
- Previously or currently hospitalized or requiring hospitalization
- Respiratory distress with respiratory rate ≥ 25 breaths/min
- Heart rate ≥ 125 beats per minute
- Peripheral oxygen saturation ≤ 93% on room air at sea level
- Known allergies to any of the components used in the formulation of the interventions
- Severe renal impairment (eGFR \<30 mL/min)
- Severe hepatic impairment (Child-Pugh Class C)
- Co-administration with drugs highly dependent on CYP3A for clearance and for which elevated concentrations are associated with serious and/or life-threatening reactions
- Co-administration with potent CYP3A inducers
- Hemodynamic instability requiring use of pressors within 24 hours of randomization
- Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that could potentially lead to hospitalization in within 30 days
- Any co-morbidity requiring surgery within 7 days or that is considered life-threatening within 90 days
- History of a positive SARS-CoV-2 test prior to the one serving as eligibility for this study
- Other investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing
- Previous treatment with a SARS-CoV-2 specific monoclonal antibody
- History of convalescent COVID-19 plasma treatment
- Participation, within the last 30 days, in a clinical study involving an investigational intervention
- Pregnancy or breast feeding
- Investigator site personnel directly affiliated with this study
- Sexually active women of childbearing potential or sexually active men who are unwilling to practice effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose
- Inability to participate to the study follow-up
Key Trial Info
Start Date :
March 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 29 2023
Estimated Enrollment :
536 Patients enrolled
Trial Details
Trial ID
NCT05321394
Start Date
March 7 2022
End Date
October 29 2023
Last Update
November 7 2023
Active Locations (19)
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1
RCCS Policlinico di S. Orsola
Bologna, Italy
2
PO SS Trinità di Cagliari
Cagliari, Italy
3
Azienda Ospedaliera Cannizzaro
Catania, Italy
4
Azienda Ospedaliera Universitaria Policlinico Vittorio Emanuele
Catania, Italy