imotuzumab in the treatment of patients with acute respiratory difficulty syndrome (ARDS)

Phase 1

Not yet recruiting

• Conditions: Acute respiratory distress syndrome (ARDS); Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

• Registration Number: RPCEC00000418
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-03
• Study Completion: 2024-01-31
• Results First Posted: 2024-02-28
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

1. Mild or moderate ARDS, with subpulmonary or extrapulmonary phenotype.
2. Any gender and skin color
3. Age equal to or greater than 19 years
4. Patients with signed informed consent

Exclusion Criteria

1 Pregnancy or breastfeeding.
2. History of known HIV, hepatitis B or C infection (referred by the patient or their representative).
3 Known allergy or hypersensitivity to any component of the formulation under study.
4. Minimal probability of survival and a life expectancy of less than 3-5 days as defined by an APACHE II score of = 35 at enrollment.
5 Be receiving another investigational product.

Study & Design

• Study Type: Interventional
• Study Design: Not specified