Lung lesions COVID-19
Conditions
Interventions
Experimental Group: Mobilization of stem cells with the intramuscular administration of IOR® LEUKOCIM in 4 doses of 10 µg / kg of weight every 12 hours for 2 days as a strategy to stimulate the hemato
Prednisone
Injections, Intramuscular
Administration, Oral
IOR® LEUKOCIM
Sponsors
Institute of Hematology and Immunology “Dr. Jose Manuel Ballester Santovenia”
Ministry of Public Health (MINSAP)
Eligibility
Sex/Gender
All
Age
19 Years to 74 Years
Inclusion criteria
Inclusion criteria: 1. Patient who gives his informed consent. 2. Negative viral load by PCR. 3. Over 18 and under 75. 4. Lung damage evidenced by the criteria of radiological severity in COVID 19 on CT.
Exclusion criteria
Exclusion criteria: 1. Anemia 2. Patients with contraindications to the use of IOR® LEUKOCIM. 3. Patients who have taken amiodarone in the last 3 months, which can cause pulmonary fibrosis. 4. Patients with malignant tumor in the last 5 years. 5. Patients with decompensated heart and kidney disease. 6. Patients with liver disease whose presence of enzyme values 2 times above the upper level of the range of normal values is demonstrated in the blood chemistry. 7. Patients who have ultrasound images that require further study for diagnosis. 8. Pregnant women 9. Patients with severe lung infection who need anti-infective treatment. 10. Patients with proven viral infections or positive serology.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of the lung lesions (They will evaluate by images of the Chest Computed Tomography. In which it is measured through a lung damage assessment scale consisting of: a. No injury (0 points), b. Unilateral lesion with less than three lesions of any type or without expression of lesions in all lung lobes a + b (1 point), c. Unilateral lesion with more than three injuries of any type or involvement of all the lung lobes (2 points), d. Bilateral lung lesions b + b (2 points) b + c (4 points) and c + c (6 points), e. Add one more point if there are lesions in all the lobes between both lungs and f. Add an additional point if there is lung consolidation (bacterial pneumonia or clothing), lymphadenopathy or pleural effusion. The value is between 0 (normal) and 8 (maximum possible involvement). The scale will allow quantifying in percentage the results of the improvement or not of the lung lesions, classifying them as improvement, stabilization or worsening). Measurement time: at baseline and, a month and six months after treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Differences in forced vital capacity measured through the FEV1/FVC (It is expressed as the Increase of more than 10% of FVC by Spirometry according to the ATS / ERS 2019 update). Measurement time: at baseline and, a month and six months after treatment. 2. Differences in forced expiratory volume to the second-FEV1 (It will evaluate through a spirometer which measures the milliliters of expiration in one second and is expressed in hundreds. Measurement time: at baseline and, a month and six months after treatment. 3. Differences in the 6-minute walk test-6MWD (It will measure in meters walked in 6 minutes. Which according to the values predicted on the Borg scale give a classification of excessively light, very light, light, neither light nor heavy, heavy, very heavy and excessively heavy). Measurement time: at baseline and, a month and six months after treatment. 4. Quality of life (It will evaluate by the SF-36 questionnaire which evaluates 9 items, to which a score is given and based on the total points is classified as excellent, Very good, good, fair and poor. Decreased degree of dyspnea or cough a degree on the Medical Research Council (mMRC) modified dyspnea rating scale measured in degrees such as: (0) Dyspnea occurs only with great physical exertion, (1) Dyspnea occurs when walking fast on a flat surface or when climbing a shallow slope, (2) Dyspnea makes it impossible to keep up with other people of the same age walking on a flat surface, or forces you to stop or rest when walking on a flat surface at your own pace, (3) Has to stop to rest when walking ~ 100 m or more after a few minutes of walking on the flat and (4) Dyspnea prevents the patient from leaving home or appears with activities such as dressing or undressing). Measurement time: at baseline and, a month and six months after treatment. 5. Adverse Events-AE (- Occurrence of some AE in the subject (yes / no), - Description of the AE (Name of the adverse event), - Duration of the AE (Difference o | — |
Countries
Cuba
Contacts
Public ContactConsuelo Macias Abraham
Institute of Hematology and Immunology “Dr. Jose Manuel Ballester Santovenia”
Outcome results
None listed