A study with immunotherapy for Moderate COVID-19

Phase 1

• Conditions: COVID-19; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001854-23-IT
• Lead Sponsor: SOCIETA' ITALIANA MALATTIE INFETTIVE E TROPICALI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-26
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1400

Inclusion Criteria

• Adults aged >= 18 years able to provide a valid informed consent to the study
• Documented COVID-19 according to local requirements, with pneumonia at imaging (Chest-X ray or CT)
• High inflammation, one of the following:
¿ CRP > 6 times UNL
¿ D-dimer > 1500 ng/ml
• PaO2/FiO2 250-400 mmHg
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 800
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 600

Exclusion Criteria

• Orotracheal intubation or ECMO support
• Active solid / hematologic cancer (including invasive non-melanoma skin cancer)
• Hypersensitivity or contra-indications to one of the investigational agents (including history of deep vein thrombosis / pulmonary thromboembolism or diverticulitis)
• Other active concurrent viral, fungal or bacterial infections (including active tuberculosis, HIV and HCV/HBV infections)
• Pregnancy/breastfeeding
• Incapability to provide a valid informed consent (including age < 18 years old)
• Heart failure with NYHA >= 2 or any acute cardiac or vascular event requiring therapy in the previous 12 months
• Chronic renal failure (baseline GFR < 45 ml/min*1.73m2)
• Liver cirrhosis moderate / severe (Child-Pugh B or C)
• Chronic respiratory failure requiring O2 therapy or ventilation therapy at home
• Blood neutrophils <500/mcL, platelet <50000/mcL, Hb levels <80 g/
• ALT/AST > 5 times UNL
• Use of any biologic agent or small molecule inhibitor and other investigational drugs in the previous 3 months (or 5 half-lives)
• Use of other immunosuppressive agents in the last 3 months
• Any other condition judged by the local investigator as a contra-indication to eligibility

Study & Design

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