CIMAvax-EGF®-post-COVID19 convalescent with respiratory disorders-adults-Phase II (CORVAXCIM)
- Conditions
- Respiratory disorders in convalescent patients from SARS-CoV-2 infectionCOVID-19SARS-CoV2Coronavirus InfectionsSARS VirusCoronaviridae InfectionsBetacoronavirusPulmonary FibrosisLung DiseasesRespiratory Tract Diseases
- Registration Number
- RPCEC00000375
- Lead Sponsor
- Center of Molecular Immunology (CIM)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 135
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.
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
- Secondary Outcome Measures
Name Time Method