COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05205759

Evelina Tacconelli

Not reported

2022-01-25

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: 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

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

3

Azienda Ospedaliera Universitaria Integrata Verona

50

100

Italy

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

319

COVID-19 progression

None

Phase 3

[{"arm_notes": "", "treatment_id": 1426, "treatment_name": "Bamlanivimab+etesevimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1859, "treatment_name": "Sotrovimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1864, "treatment_name": "Casirivimab+imdevimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}]