Investigating the Efficacy and Safety ICATIBANT For The Treatment of Patients with SARS-CoV-2 (COVID-19) Infectio

Phase 1

• Conditions: Pneumonia caused by COVID-19; MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0Level: PTClassification code 10070255Term: Coronavirus test positiveSystem Organ Class: 10022891 - Investigations; MedDRA version: 23.0Level: LLTClassification code 10084381Term: Coronavirus pneumoniaSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-002166-13-ES
• Lead Sponsor: Dr. Ramón Lleonart Bellfill / Dr. Xavier Corbella Virós

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-22
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1-adult patients (18 years or older), both sexes
2-Sars-CoV-2 infection confirmed by PCR less than 4 days before randomization
3-hospitalized with a diagnosis of SARS-CoV-2 pneumonia
4-radiographic evidence of pulmonary infiltrates
5-grade 4 or 5 on the ordinal scale for the evaluation of the patient's clinical condition
6-pO2/FiO2 <380
7-men and women of childbearing age who have heterosexual relations must be
agreement to use the safe method(s) of contraception
8-obtaining the informed consent of the patient or the legal representative.
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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

1-imminent death (life expectancy less than 72h)
2-known hypersensitivity or known adverse reactions to the study drug, or its
metabolites or excipients of the formulation
3-invasive mechanical ventilation
4-participation in any other clinical trial
5- ALT or AST > 5 x ULN
6-creatinine clearance <50 mL/min using the Cockcroft-Gault formula for
participants '18 years old [Cockcroft 1976]
7-patients with recent acute coronary syndrome (<1 month)
8-patients with a history of stroke
9-positive pregnancy test
10-pregnant or lactating woman

Study & Design

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