Respiratory disorders in convalescent patients from SARS-CoV-2 infection COVID-19 SARS-CoV2
Conditions
Interventions
CIMAvax-EGF group (Experimental). The patients will receive 8 administrations of the product. Every administrationwill have a dose of 2.4 mg of the active principle of the therapeutic vaccine CIMAvax-
Immunotherapy, Active
Epidermal Growth Factor
Injections, Intramuscular
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: 1. Occurrence of any AE (Yes, No). Measurement time: 6 months. 2. Adverse event description (Name of the adverse event). Measurement time: 6 months. 3. Duration of the adverse event (Difference between the start date and the stop of the event). Measurement time: 6 months. 4. Intensity of AE (1. Light, 2. Moderate 3. Severe, 5. Very severe 5. Death, according to Common Toxicity Criteria (CTCAE) version 5.0). Measurement time: 6 months. 5. Causality relationship (.Definitive, 2.Very likely, 3.Likely, 4.Possible, 5.Unlikely, 6.Unrelated, 7.Unknown). Measurement time: 6 months. 6. Gravity (Seriousness) of AE (Critical event / No serious. Serious event (seriously) be considered as causing the death of the patient, life-threatening, results in hospitalization or prolongation of existing hospitalization, causes disability / persistent or significant disability, birth defects or congenital anomalies or an important medical event that according to medical judgment, could endanger the health of the patient or may require medical or surgical intervention to prevent the occurrence of any of the previously listed outcomes). Measurement time: 6 months. 7. Attitude towards drug (1. No change 2. Dose reduction 3. Temporary discontinuation of treatment. 4. Definitive Treatment discontinuation). Measurement time: 6 months. 8. Outcome of the AE (1. Reversible effect, 2. Effect 3. Death 4. Irreversible loss of patient monitoring). Measurement time: 6 months. Effect: 1. Maximum expiratory volume-VEM (It is the fraction of the forced vital capacity that can expire in the first second in a forced expiration after a maximum inspiration, observed value in ml). Measurement time: days 0, 63 and 182. 2. Number of lesions (number of lesions that the patient presents at each moment of evaluation, measured by CT). Measurement time: days 0, 63 and 182. 3. Type of lesion (nonspecific pulmonary fibrosis, tarnished virio pattern, reticulo-nodular pattern, or other). Measurement time: days 0, | — |
Countries
Cuba
Contacts
Public ContactSoraida Acosta Brooks
Saturnino Lora´s Hospital
Outcome results
None listed