Patients with mild to moderate SARS-COV-2 infection. MedDRA version: 20.0 Level: SOC Classification code 10021881 Term: Infections and infestations System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: SOTROVIMAB
Product Name: SOTROVIMAB
Product Code: [SOTROVIMAB]
Pharmaceutical Form: Solution for infusion
Current Sponsor code: SOTROVIMAB
Concentration unit: mg/ml milligram(s)/millilitre
Sponsors
FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Signed Informed Consent Form 2. Men or non-pregnant women =12 years of age at the time of randomization 3. Agree to the collection of nasopharyngeal swabs 4. Patients currently not hospitalized 5. Have one or more mild or moderate COVID-19 symptoms such as fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath 6. Must have sample collection for first positive SARS-CoV-2 viral infection 7. High risk for severe COVID-19 disease defined as the presence of one or more of the following conditions: age=65 years, BMI=30 kg/m2, chronic kidney disease, chronic lung diseases, including COPD (chronic obstructive pulmonary disease), asthma (moderate-to-severe), interstitial lung disease, cystic fibrosis, and pulmonary hypertension, diabetes, heart conditions (such as heart failure, coronary artery disease, cardiomyopathies or hypertension), immunocompromised state, liver disease, stroke or cerebrovascular disease. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 400
Exclusion criteria
Exclusion criteria: 1. Have SpO2 =92% on room air at sea level or PaO2/FiO2 <300 2. Respiratory rate =30 per minute 3. Heart rate =125 per minute 4. Hospitalized for COVID-19 disease 5. Respiratory failure secondary to COVID-19 disease 6. Have known allergies to any of the components used in the formulation of the interventions 7. Have hemodynamic instability 8. Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention 9. Have any comorbidity requiring surgery within 7 days, or that is considered life-threatening within 29 days 10. Have any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study 11. Have a history of a positive SARS-CoV-2 serology test 12. Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing (Anti-COVID-19 vaccines are allowed) 13. Have received treatment with a SARS-CoV-2 specific monoclonal antibody 14. Have a history of convalescent COVID-19 plasma treatment 15. Have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed 16. Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study 17. Are pregnant or breast feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is: - To assess the efficacy of monoclonal antibodies (Bamlanivimab/Etesevimab, Casirivimab/Imdevimab, Sotrovimab) in patients with COVID-19 by looking at disease progression in terms of hospitalization in intensive care unit, oxygen desaturation =4% and peripheral oxygen saturation =92% during the follow-up period (30 days).;Secondary Objective: The secondary objectives of the study are: - To assess the impact of experimental drugs on safety and tolerability during the 30-day follow-up period, - To assess the impact of experimental drugs on survival during the 30-day follow-up period.;Primary end point(s): The primary endpoint of the study is: - Disease progression defined as: hospitalization in intensive care unit, oxygen desaturation =4% and peripheral oxygen saturation =92% during the follow-up period (30 days).;Timepoint(s) of evaluation of this end point: Timepoint are reported within the endpoint list | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints of the study are: - Incidence and severity of adverse events, with severity determined according to the 5-point severity scale (National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 [NCI CTCAE, v.5.0]) during the follow-up period (30 days). - Proportion of patients admitted to the Emergency Department for COVID-19 disease during the follow-up period. - All-cause mortality due to COVID-19 disease.;Timepoint(s) of evaluation of this end point: Timepoint are reported within the endpoint list | — |
Countries
Italy
Contacts
Public ContactU.O.C PNEUMOLOGIA
FONDAZIONE POLICLINICO UNIOVERSITARIO AGOSTINO GEMELLI UNIVERSITA CATTOLICA DEL SACRO CUORE
Outcome results
None listed