Effects of Shilajit (Momiai) on COVID-19 disease

INTERVENTION: Intervention 1: Intervention group: The intervention group will receive two 500mg Shilajit capsules per day for two weeks. Intervention group will also receive medical treatments based on moderate COVID‐19 treatment protocols. Intervention 2: Control group: The control group will receive two placebo capsules per day for two weeks. Control group will also receive medical treatments based on moderate COVID‐19 treatment protocols. CONDITION: COVID‐19. ; COVID‐19, virus identified U07.1 SECONDARY OUTCOME: All‐cause mortality. Timepoint: any time during the study period. Method of measurement: Incidence of death due to any cause during the study period. Hospital admission duration. Timepoint: during the study period. Method of measurement: Days from admission to discharge or decease. Intensive Care Unit admission duration. Timepoint: during the study period. Method of measurement: Days from admission in the Intensive care unit to discharge or decease. Intensive Care Unit admission. Timepoint: During the study period. Method of measurement: Incidence of Intensive Care Unit admission. Time to Intensive Care Unit admission. Timepoint: During the study period. Method of measurement: Days from hospital admission to Intensive Care Unit referral. Time to ventilation. Timepoint: During the study period. Method of measurement: Days from admission to initiation of mechanical ventilation. Ventilation requirement. Timepoint: During the study period. Method of measurement: Incidence of ventilation requirement. INCLUSION CRITERIA: Diagnosis of moderate COVID‐19 disease (based on the World Health Organization laboratory and clinical criteria) Receiving standard and routine medications for moderate COVID‐19 based on management protocols for COVID‐19 age between 18 and 75 years old signing the written informed consent form PRIMARY OUTCOME: Axillary temperature. Timepoint: At the beginning of the study (before intervention initiation) and daily afterwards. Method of measurement: mercury thermometer. Duration of Intensive Care Unit admission. Timepoint: anytime during the study period. Method of measurement: Patient records data/Physician examination. Incidence of respiratory distress. Timepoint: At the beginning of the study (before intervention initiation) and anytime during the study period. Method of measurement: Patient records data/Physician examination. Intensive Care Unit admission. Timepoint: At the beginning of the study (before intervention initiation) and anytime during the study period. Method of measurement: Patient records data/Physician examination. Oxygen saturation:fraction of inspired oxygen ratio (SPO2:FiO2). Timepoint: At the beginning of the study (before intervention initiation) and 7, 14, and 28 days after Shilajit use. Method of measurement: Pulse oxymeter. Respiratory rate. Timepoint: At the beginning of the study (before intervention initiation) and daily afterwards. Method of measurement: Patient records data/Physician examination. Severity of clinical presentations of COVID‐19. Timepoint: At the beginning of the study (before intervention initiation) and 7, 14, and 28 days after Shilajit use. Method of measurement: The criteria proposed by the World Health Organization will be used to determine COVID‐19 severity and to assess the changes in disease severity during the study. Based on the criteria disease severity is defined based on a score between 0 and 8 as follows: (0) no clinical or virologic sign of infection (1) no limitation in activity (2) limitation in activity (3) hospital admission without oxygen therapy (4) hospital admission with oxygen therapy with mask or nasal cannula (5) hospital admission with non‐invasive oxygen therapy or high flow oxygen (6) hospital admission with intubation or mechanical ventilation (7) hospital admission with supported ventilation including extracorporeal membrane oxygenation, vasopressors, or renal replacement therapy (8) death. Time of death. Timepoint: anytime during the study period. Method of measurement: Patient records data/Physician examination. Ventilation need. Timepoint: At the beginning of the study (before intervention initiation) and anytime during the study period. Method of measurement: Patient records data/Physician examination.