Status:
TERMINATED
Non-inferiority Trial on Monoclonal Antibodies in 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
Currently, 3 anti-SARS-CoV-2 monoclonal antibody products have received Emergency Use Authorizations from the Italian Medicines Agency (AIFA) for the treatment of mild to moderate COVID-19 in non hosp...
Detailed Description
Sample size. The parameters for the sample size estimation were derived from the only double-blind, randomised, placebo-controlled trial assessing the clinical efficacy of casirivimab/imdevimab (refer...
Eligibility Criteria
Inclusion
- Age ≥ 50 years
- Informed consent by the subject or legally authorized representative
- Laboratory-confirmed SARS-CoV-2 infection, as determined by antigen or nucleic acid identification in any specimen, within 4 days of eligibility assessment
- Peripheral oxygen saturation ≥ 94% on room air and not requiring supplemental oxygen
- Onset of symptoms within 4 days of eligibility assessment. Onset time of symptoms is defined as the time when the patient experienced the presence of at least one of the following SARS-CoV-2 infection-associated symptoms for the first time \[4\]: cough, nasal congestion, sore throat, feeling hot or feverish, myalgia, fatigue, headache, anosmia/ageusia, nausea, vomiting, and/or 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 trial drugs
- 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 within 30 days
- Any co-morbidity requiring surgery within 7 days or that is considered life-threatening within 90 days
- History of positive SARS-CoV-2 test prior to 4 days of the eligibility assessment
- Previous treatment with a SARS-CoV-2 specific monoclonal antibody
- History of convalescent COVID-19 plasma treatment
- Participation in a clinical study involving an investigational intervention within the last 30 days
- 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 :
December 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 5 2022
Estimated Enrollment :
319 Patients enrolled
Trial Details
Trial ID
NCT05205759
Start Date
December 9 2021
End Date
April 5 2022
Last Update
July 26 2022
Active Locations (20)
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1
IRCCS 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