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: 19 August 2024

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

Primary Outcome Measures

Name	Time	Method
Adverse Events (AE). Measurement time: daily until discharge.<br>- Occurrence of some AE in the subject (yes/no).<br>- Description of the AE (Name of the adverse event).<br>- Duration of the EA (Difference of dates between the beginning and the end of the event)<br>- Intensity of the AE (Mild, Moderate, Severe)<br>- AE severity (Serious/serious, Not serious/not serious)<br>- Attitude regarding study treatment (no changes, dose modification, temporary or permanent interruption of study treatment)<br>- Result of the EA (recovered, improved, persists or sequelae)<br>-Causal relationship (1.Very Likely, 2.Likely, 3.Possible, 4.Improbable, 5.Not related, 6.Not evaluable)

Secondary Outcome Measures

Name	Time	Method
Pulmonary function. Measurement time: daily until discharge<br>• Rate of patients who improve the PO2/FiO2 ratio.<br>• Duration time of mechanical ventilation or time until weaning (Date difference between start and end of ventilation).<br>• Chest X-ray or Ultrasound according to the criteria established in intensive care. The same follow-up imaging method will be used.<br>• Ventilation-free days up to 28 days (Difference of days between start and finish without ventilation).<br>• Recovery rate (alive) at ICU discharge.<br>• Overall recovery rate (28 days)<br>• Inflammation Markers: NLR, IL6, C-reactive protein: Measurement time: day 0, and every 48 hours after the use of the drug. <br>• Clinical Laboratory Exams: Hemoglobin (Hb), Total Leukocytes, Neutrophils, Lymphocytes, Platelets, Erythrocyte sedimentation rate, C-Reactive Protein, Triglycerides, Ferritin, Creatinine, LDH (Lactate dehydrogenase), Amino-aspartate Transferase, Glutamic Pyruvic Transferase, coagulogram including PAI-1 .<br>