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):
Safety:
1. Serious adverse events. Causation relationship (1. Possible, 2. Probable, 3. Definitive). Measurement time: 7 days after treatment.
Exploring the Effect:
2. Antiviral and anti-inflammatory favorable response on the 7th day after the treatment The favorable response is measured if there is an increase in the Ct value, in the RT PCR and a decrease in the neutrophil/lymphocyte ratio; of C-reactive protein and D-Dimer). Measurement time: days 0, 3, 5 and 7 after treatment.
Key secondary outcomes:
Of safety:
1. Clinical Adverse Events-AE (- Type of AE (Serious or Not serious), - Duration of the AE (Difference, in dates, between the start and end of the AE), - AE Intensity (Mild, Moderate, Severe), - Behavior regarding the treatment under study (No changes, Interruption of the treatment under study), - AE result (Recovered, Improved, Persists, Sequelae). Measurement time: 7 days after treatment administration.
2. Percentage of patients with out-of-range values in clinical laboratory variables (hemochemistry).Measurement time: Days 0, 3, 5 and 7.
Of antiviral effect.
3. PCR RT (Qualitative: positive or not, and value of CTs (cycle threshold)). Measurement time: Days 0, 3, 5 and 7.
Inflammatory immune response.
4. Neutrophil / lymphocyte ratio (NLR) (The values at each time and the absolute change of the final value with respect to the initial value will be described). Measurement time: Days 0, 3, 5 and 7.
5. Quantitative C-Reactive Protein (The values at each time and the absolute change of the final value with respect to the initial value will be described. It will be recorded if there was a decrease in the values on day 7 with respect to the baseline value). Measurement time: Days 0, 3, 5 and 7.
6. D-dimer (The values at each time and the absolute change of the final value with respect to the initial value will be described. It will be recorded if there was a decrease on day 7 with respect to the baseline value). Measurement time: Days 0, 3, 5 and 7.
Clinical response:
7. Imaging changes of the CT scan (Favorable: When there is a decrease in SCORE and there are no qualitative complications, whether or not it has. Stationary: When the same conditions are maintained in both variables. Unfavorable: When the SCORE is increased and / or there are qualitative complications). Measurement time: Days 0, 7.
8. Lung X-ray changes (The score on the diagnostic scale will be categorized into normal (0), mild (1-2), moderate (3-6) and severe (> 6).). Measurement time: Days 0, 3, 5 and 7.
9. Improvement of severity criteria (It will be recorded whether or not each one of the severity parameters considered is present: (SpO2 <93%, need for oxygen therapy to maintain SO2> 93%, PaO2 / FiO2 ratio <250 mm Hg, Respiratory rate ≥ 25 inspirations / min, Infiltrates in more than 50% of both lung fields). Each day will be considered if there was improvement to the favorable change in each of them. The evolution of the improvement will be evaluated at each moment with respect to the initial moment). Measurement time: Daily
10. Worsening of the patient's clinical condition (The following variables will be recorded as yes or no to the patient's condition: Need for ventilation during the study period, Increase in RF, decrease in oxygen saturation, worsening of chest X-ray images, shock, disseminated intravascular coagulation, multi-organ failure, death. It is defined as a worsening of the clinical state of the patient if at least one of these described conditions occurs, at some point after the treatment under study.). Measurement time: Daily
11. Need for mechanical ventilation (It Will recorded if patient’s needs, or no, mechanical ventilation). Measurement time: Daily
12. Duration of mechanical ventilation (the start and end date of assisted ventilation will be recorded). Measurement time: at the end of mechanical ventilation
13. Stay in the ICU (the date of admission and discharge from the ICU will be recorded). Measurement time: at the ICU discharge
14. Hospital stay (The date of admission and discharge from the hospital will be recorded). Measurement time: at the hospital discharge.