Jusvinza in Severe Patients with Acquired Community Pneumonia

Phase 2

Not yet recruiting

• Conditions: Severe Pneumonia; Lung Diseases; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

• Registration Number: RPCEC00000411
• Lead Sponsor: Center for Genetic Engineering and Biotechnology (CGIB), the Havana

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-14
• Study Completion: 2023-03-03
• Results First Posted: 2023-05-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Patients with Age = 18
2. Willingness of the patient through the signing of the informed consent.
3. Patients with diagnosis of SACP (Severe Acquired Community Pneumonia).

Exclusion Criteria

1. Patient with Septic Shock.
2. Patient with Severe Acute Respiratory Distress Syndrome.
3. Hospitalized patient with a diagnosis of CAPg of more than 48 hours of evolution.
4. Patient with prior treatment with JAK inhibitor, tocilizumab or other anti-IL6R or IL-6 inhibitor, IL-1 (Anakinra), Nimotuzumab and Itolizumab.
5. Patients with significant deterioration of their underlying chronic disease that compromise imminent survival: diseases such as unresectable tumors, hematological diseases, Alzheimer's disease or AIDS, terminal chronic respiratory diseases requiring permanent oxygenation, prolonged bed rest due to cerebrovascular diseases.
6. Obese patients (Body Mass Index > 30 kg/m2).
7. Patient with Chronic Kidney Disease undergoing hemodialysis.
8. Hypersensitivity to the product or any of its components.
9. Patients with steroid use at immunosuppressive doses greater than 20 mg daily of Prednisone or equivalent.
10. Psychiatric patients.
11. History of SACP 30 days prior to inclusion.
12. Pregnancy or lactation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with improve the respiratory function, measure to the score of respiratory ?SOFA scale (It will be measured through the respiratory ?SOFA scale score. Improved respiratory function: Will be evaluate the response of treatment using the respiratory ?SOFA scale in term of: a) Resolution of the respiratory function as from to diminish the score in 1 or more point. and b) No resolution of the respiratory function as from to the no chance in the score or increase of score or worsenning to severe respiratory distress). Measurement time: It will be measured daily during the treatment of the patient in the Serious Patient Care Unit.