Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
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.
Key secondary outcomes:
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 of dates between the start and the end of the event), - time of presentation of the AE (Immediate, Medium, Late), - Severity of the AE (Serious / serious, Not serious / not serious), -Relation of causality (Very Probable, Probable, Possible, Unlikely, Not related, Not evaluable)). Measurement time: at baseline and, a month and six months after treatment.
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