CIMAvax-EGF®-post-COVID19 convalescent with respiratory disorders-adults-Phase II (CORVAXCIM)

Phase 2

• Conditions: Respiratory disorders in convalescent patients from SARS-CoV-2 infection; COVID-19; SARS-CoV2; Coronavirus Infections; SARS Virus; Coronaviridae Infections; Betacoronavirus; Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases

• Registration Number: RPCEC00000375
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-18
• Study Completion: 2023-04-30
• Results First Posted: 2023-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

1. Willingness of the patient by signing the informed consent.
2. Subject of any sex and age greater than or equal to 18 years.
3. Subjects for whom at least 14 days have elapsed from discharge from the post-COVID-19 patient care service or referral of the specialized consultation.
4. Patients with respiratory clinical manifestations and deterioration of respiratory function due to spirometric or radiological functional pattern.
5. Subject that in the pre-inclusion checkup they have: hemoglobin = 9 g/L, leukocytes = 3.4x109 L, absolute neutrophil count = 1.5 x 109 L.
6. Liver and kidney function tests in normal ranges.

Exclusion Criteria

1. Patients with pre-existing lung disorders (including pulmonary fibrosis, COPD, severe asthma, lung cancer, etc).
2. Patients with confirmed severe or life-limiting chronic disease, or a history of angioedema prior to COVID-19 infection.
3. Pregnancy or lactation period.
4. Subjects of childbearing age who are not using an adequate method of contraception prior to their inclusion in the study.
5. Subject that they are receiving another product under investigation.
6. Known hypersensitivity to any of the components of the formulation under study.
7. Obvious mental incapacity to issue consent and act accordingly with the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response to treatment (It will measure through the variation of forced vital capacity (FVC) in the categories favorable or unfavorable. It will be considered Favorable response when FVC does not vary or is reduced by less than 10% in patients with pulmonary fibrosis and does not vary or is reduced by less than 5% in patients with another respiratory disorder with respect to the initial measurement. Unfavorable response: when FVC is reduced more than 10% with respect to the initial measurement in patients with pulmonary fibrosis, and more than 5% in patients with another respiratory disorder). Measurement time: days 63 and 182.