Phase III clinical trial with monoclonal antibodies versus standard of care for the treatment of early-stage COVID-19

Phase 1

• Conditions: Patients with mild to moderate SARS-COV-2 infection.; MedDRA version: 20.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-004035-88-IT
• Lead Sponsor: FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-26
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 400

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified