A Phase III Randomized, Open-label, Multicenter Study to Determine the Safety and Efficacy of different MONoclonal Antibodies (MoAbs) to SARS-CoV-2 for the Early Treatment of COVID-19 in Non-hospitalized Adults

Phase 1

• Conditions: COVID-19 infection; MedDRA version: 23.0Level: PTClassification code 10084268Term: COVID-19System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-004188-28-IT
• Lead Sponsor: ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE LAZZARO SPALLANZANI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-13
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1550

Inclusion Criteria

-Age = 18 years;
-Signed informed consent provided by the patient, or by the patient’s legally authorized representative(s), as applicable;
-Virological diagnosis of SARS-CoV-2 infection (SARS-CoV-2 infection confirmed by RT-PCR test); patients must have sample taken for test confirming viral infection no more than 3 days prior to randomization;
-Having one or more mild or moderate COVID-19 symptoms: fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion for no more than 7 days;
-Men and women of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method (s) of contraception (Appendix C);
oHighly effective contraceptive measures in women include: stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening, Intrauterine device (IUD), Intrauterine hormone-releasing system (IUS), Bilateral tubal ligation, Vasectomized partner and/or Sexual abstinence.
oHighly effective contraceptive measures in men include: study participants with WOCBP partners are required to use condoms unless they are vasectomized or practice sexual abstinence.
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 1000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 550

Exclusion Criteria

-Having one of the following conditions:
oBody mass index (BMI) >30
oChronic kidney disease
oUncontrolled diabetes
oHaving immunosuppressive disease or receiving immunosuppressive treatment
-Being >65 years old and having one of the above mentioned conditions
-Being >55 years old and having one of the following conditions:
oCardiovascular or cerebrovascular disease (including hypertension with concomitant organ damage)
oChronic obstructive pulmonary disease (COPD) or other chronic respiratory diseases
-Pregnancy/lactation;
-Have oxygen saturation (SpO2) less than or equal to (=)93 percent (%) on room air and persisting for more than 7 days;
-Virological diagnosis of SARS-CoV-2 infection (SARS-CoV-2 infection confirmed by PCR test) more than 3 days before;
-Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study;
-Enrolment in another concurrent clinical interventional study within 30 days;
-Existence of any life-threatening co-morbidity or any other medical condition, which, in the opinion of the investigator, makes the patient unsuitable for the study;
-Having known allergy or hypersensitivity to components of study drugs

Study & Design

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