COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05321394

Evelina Tacconelli

evelina.tacconelli@univr.it

2022-04-11

Recruiting

RCT

Randomized

Parallel

Open 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 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

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

3

Azienda Ospedaliera Universitaria Integrata Verona

50

100

Italy

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

1095

COVID-19 progression

None

Phase 3

[{"arm_notes": "nan", "treatment_id": 2421, "treatment_name": "Nirmatrelvir+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 1465, "treatment_name": "Cilgavimab+tixagevimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 1859, "treatment_name": "Sotrovimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}]