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

Safety evaluation and preliminary effect of the monoclonal antibody Nimotuzumab in the treatment of patients with acute respiratory distress syndrome (ARDS)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000418

Enrollment

Registered

2023-03-03

Start date

2023-03-13

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute respiratory distress syndrome (ARDS)

Interventions

Group I (Experimental) MAb Nimotuzumab, 200 mg the first dose followed by 100 mg doses separated by 72 hours, up to a total of 5 maximum. It will be administered intravenously. This group also receive

Anticuerpos Monoclonales Humanizados

Anticuerpos Monoclonales

Administración Intravenosa

Nimotuzumab

Eligibility

Sex/Gender

All

Age

19 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

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

Measure

Time frame

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

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Secondary

Measure	Time frame
Pulmonary function. Measurement time: daily until discharge • Rate of patients who improve the PO2/FiO2 ratio. • Duration time of mechanical ventilation or time until weaning (Date difference between start and end of ventilation). • Chest X-ray or Ultrasound according to the criteria established in intensive care. The same follow-up imaging method will be used. • Ventilation-free days up to 28 days (Difference of days between start and finish without ventilation). • Recovery rate (alive) at ICU discharge. • Overall recovery rate (28 days) • Inflammation Markers: NLR, IL6, C-reactive protein: Measurement time: day 0, and every 48 hours after the use of the drug. • 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 .	—

Measure

Time frame

Pulmonary function. Measurement time: daily until discharge • Rate of patients who improve the PO2/FiO2 ratio. • Duration time of mechanical ventilation or time until weaning (Date difference between start and end of ventilation). • Chest X-ray or Ultrasound according to the criteria established in intensive care. The same follow-up imaging method will be used. • Ventilation-free days up to 28 days (Difference of days between start and finish without ventilation). • Recovery rate (alive) at ICU discharge. • Overall recovery rate (28 days) • Inflammation Markers: NLR, IL6, C-reactive protein: Measurement time: day 0, and every 48 hours after the use of the drug. • 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 .

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Countries

Cuba

Contacts

Public ContactMayra Suzarte

Center of Molecular Immunology

mayra@cim.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 25, 2026