imotuzumab in COVID-19

Phase 1

• Conditions: COVID-19; SARS-CoV2; Coronavirus Infections; SARS Virus; Coronaviridae Infections; Betacoronavirus; Acute Disease; Critical Care

• Registration Number: RPCEC00000369
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-21
• Study Completion: 2021-08-31
• Results First Posted: 2021-09-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.- Any gender and skin color
2.- Age equal to or greater than 19 years
3.- Patients in a severe stage of COVID-19 of the disease defined by any of the following conditions:
- Patients who have SpO2 <94% or patients in need of oxygen therapy to maintain SO2> 93% or
- Patients with a PaO2 / FiO2 ratio <300 mm Hg or
- Patients with a respiratory rate> 30 inspirations / min,
- Patients with infiltrate in more than 50% of both lung fields

Exclusion Criteria

1.- Pregnant or lactating women.
2.-Under 19 years.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety<br>1. Serious Adverse Events-SAE (Percentage of patients who developed SAE according to the CTCAE v5.0 classification). Measurement time: During hospitalized time<br>2. Clinical and laboratory adverse events (The frequency distribution of AD appearance, type of event and body system will be determined. Duration, intensity, result, attitude and causal relationship of the AE will be identified. Measurement time: 0, 24, 48h, 72h, 120h, 168h, 14 days, 21 days y 28 days.<br>Effect:<br>3. Rate of deceased patients in 14 days following the use of the drug. Measurement time: at 14 days<br>4. Rate of patients with disease progression (clinical or radiological worsening in the classification of clinical status). Measurement time: 0, 48h, 72h, 120h, 168h, 14 days, 21 days y 28 days.

Secondary Outcome Measures

Name	Time	Method
1. Pulmonary function (Rate of patients who improve the PO2/FiO2 ratio, Oro-tracheal intubation rate, measured as the rate of patients requiring intubation, Duration of mechanical ventilation or time to deteste, Chest X-ray). Measurement time: 0, 24h, 48h, 72h, 120h, 168h, 14 days, 21 days and 28 days<br>2. Inflammation Markers (NLR, IL6, Interferon gamma, C-reactive protein). Measurement time: Day 0, at 72 hours, 120 and, 168 hours after the use of the drug. <br>3. Clinical Laboratory (Hemoglobin (Hb), Total Leukocytes, Neutrophils, Lymphocytes, Platelets, Erythrosedimentation, Triglycerides, Ferritin, Creatinine, LDH (Lactate dehydrogenase), Amino-aspartate transferase, Pyruvic glutamic transferase, Complete Pyruvic Coagulogram, according the lab units). Measurement time: 0, 24h, 48h, 72h, 120h, 168h, 14 days, 21 days and 28 days<br>