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):
Erythrosedimentation (values in mm/h). Measurement time: Every 72 hours for a maximum of 15 days.
Key secondary outcomes:
Prognosis biomarkers.
1. C-Reactive Protein (Positive or Negative, or values in mg/mL). Measurement time: Every 72 hours for a maximum of 15 days.
2. Neutrophils (values in cel/mL). Measurement time: Every 72 hours for a maximum of 15 days.
3. Lymphocytes (values in cel/ mL). Measurement time: Every 72 hours for a maximum of 15 days.
4. Neutrophil lymphocyte index (according to neutrophil-lymphocyte ratio). Measurement time: Every 72 hours for a maximum of 15 days.
5. D-dimer (values in mcg / mL). Measurement time: Every 72 hours for a maximum of 15 days.
6. Platelets (values in cel/ mL). Measurement time:Every 72 hours for a maximum of 15 days.
7. Blood glucose (values in mmol / L). Measurement time: Every 72 hours for a maximum of 15 days.
8. Temperature (values in celsius grade). Measurement time: Every 72 hours for a maximum of 15 days.
9. Visceromegaly (Present or Absent). Measurement time: Every 72 hours for a maximum of 15 days.
Therapeutic variables
10. Severity of the patient's clinical picture (Mild, Moderate, Severe). Measurement time: daily for a maximum of 15 days.
11. Presence of clinical signs / symptoms of COVID-19 (Yes, No). Measurement time: daily for a maximum of 15 days.
12. Hospital service where the patient enters and passes through (Respiratory isolation room, Intensive Surveillance Unit, Intensive Care Unit). Measurement time: at the beginning and at the hospital discharge
13. Negative RT-PCR (Positive or Negative). Measurement time: Days 0, 5, 7, 9, 11 and at hospital discharge
14. Hospital stay (Time, in days, from admission until to discharge). Measurement time: At hospital discharge
15. Status of the patient (death or alive). Measurement time: At hospital discharge
16. Presence of sequelae (Yes, No): Measurement time: At one month of hospital discharge
17. Adverse Events (AE) (Occurrence of some AE in the subject (yes / no); Description of the AE (name of the AE); Duration of the AE (hours, days, weeks); AE intensity (mild, moderate, severe); Causation relationship (certain, probable, Possible, Unlikely, Unrelated, Not assessable); AE intensity (Serious / serious, Not serious / not serious); Attitude regarding the study treatment (no changes, dose modification, temporary or definitive interruption of the study treatment); Treatment need (required and which, did not require); Result of AE (recovered, improved, persists, sequelae, leads to death)). Measurement time: Daily for a maximum of 15 days