Mild to moderate COVID-19 patients at high risk of progression to severe COVID-19 and / or hospitalization MedDRA version: 23.1 Level: PT Classification code 10084460 Term: COVID-19 treatment System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: casirivimab/imdevimab
Product Name: Casirivimab/imdevimab
Product Code: [ronapreve]
Pharmaceutical Form: Concentrate for solution for injection/infusion
Current Sponsor code: -
Concentrati
Sponsors
AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Positive SARS-CoV-2 diagnostic (on pharyngeal swab of deep airways material) for all variants, except for beta and gamma. Positive patients will be considered eligible even when the information on variants is not timely available because of technical or organizational issues. 2. Age =18 years of age at the time of randomization 3. Are not hospitalized at the time of randomization 4. Have one or more mild or moderate COVID-19 symptoms according to NIH classification, which onset within 37.5 °C) ¿ Cough ¿ Sore throat ¿ Malaise ¿ Headache ¿ Muscle pain ¿ Gastrointestinal symptoms ¿ Shortness of breath with exertion 5. Meet at least one of the following criteria, which define patients at high risk for progressing to severe COVID-19 and/or hospitalization: ¿ Body Mass Index (BMI) >30 ¿ Chronic kidney disease ¿ Diabetes ¿ Primary or secondary Immunodeficiency ¿ =55 years of age and at least of the following criteria: o cardiovascular disease, OR o hypertension, OR o chronic obstructive pulmonary disease/other chronic respiratory disease. ¿ =65 years of age 6. Signed informed consent Are the trial subjects under 18? no 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 552 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 552
Exclusion criteria
Exclusion criteria: 1. Positive SARS-CoV-2 diagnostic (on pharyngeal swab of deep airways material) for variants beta and gamma 2. Have severe COVID-19 requiring hospital admission or access to the emergency room. Severe COVID-19 is defined as one of the following clinical features: SpO2 = 93% on room air at sea level or PaO2/FiO2 < 300, respiratory rate =30 per minute, heart rate =125 per minute 3. Require oxygen therapy due to COVID-19, or require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity. 4. Require mechanical ventilation or anticipated impending need for mechanical ventilation 5. Have received any dose of vaccine antiSARS-CoV-2 within < 15 days 6. Have known allergies to any of the components used in the formulation of the interventions 7. Have hemodynamic instability requiring use of pressors within 24 hours of randomization 8. Have 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 co-morbidity 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. Are pregnant or breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Aim of this study is to compare efficacy and safety of Casirivimab and Imdevimab or Bamlanivimab and Etesevimab or Sotrovimab in mild to moderate COVID-19 home patients;Secondary Objective: -;Primary end point(s): Primary Efficacy Endpoint: Clinical worsening, defined as the progression of the disease to a more severe state, such as hospitalization or death, whichever comes first, through day 29. The follow up will start the day in which the treatment is administered. Primary Safety Endpoint: Early safety, defined as the occurrence of any adverse event within 24 hours from the beginning of treatment administration, such as any symptoms that can be related to drug hypersensitivity, which include: anaphylaxis, fever, chills, nausea, headache, bronchospasm, hypotension, angioedema, throat irritation, rash (including urticaria), pruritus, myalgia, dizziness or any other symptom, according to the clinical judgment of the attending physician.;Timepoint(s) of evaluation of this end point: Primary Efficacy Endpoint: Occurrence of at least one of the events in the 29 days following treatment. Primary Safety Endpoint: Occurrence of any adverse event within 24 hours of starting treatment administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Safety Endpoint: Late safety, defined as the occurrence of any adverse event occurring after 24 hours and through day 29 from the beginning of the intervention.; Secondary Efficacy Endpoint: The occurrence of: a) death, defined as all-cause mortality; b) any hospital admission; c) any access to the emergency department, up to 6 weeks from the beginning of treatment administration.;Timepoint(s) of evaluation of this end point: Occurrence of any adverse event occurring after 24 hours and up to day 29 from the start of surgery.; 6 weeks from the start of treatment administration. | — |
Countries
Italy
Contacts
Public ContactClinical Trial Quality Team
Azienda Ospedaliero-Universitaria di Modena
Outcome results
None listed