Effectiveness of enriched garlic extract in patients with COVID-19

INTERVENTION: Intervention 1: Intervention group: Based on the patient's clinical status, and treatment criteria, the following antiviral and anti‐inflammatory drugs may be prescribed to the patient: Interferon beta‐1a with a dose of 44 micrograms by subcutaneous injection every other day in the amount of 5 to 7 doses of Favipiravir with a dose: the first day of 1800 mg every 12 hours and from the following days 800 mg every 12 hours for 10 days up to a maximum of 14 days. Persistent oxygen demand despite supportive therapy and SpO2 between 90‐93%, corticosteroids can be given in low doses: Dexamethasone 8 mg intravenously daily for up to 10 days. Or oral prednisolone tablets 0.5mg / kg for a maximum of 10 days. Remdesivir IV: 200 mg as a single dose on day 1, followed by 100 mg once daily. Total duration is 5 days. To the above drug treatment, one Gallecina® capsule (containing processed garlic extract) prepared by Sami Saz Pharmaceutical Company is added every 8 hours for 6 days. Intervention 2: Control group: Based on the patient's clinical status, and treatment criteria, the following antiviral and anti‐inflammatory drugs may be prescribed to the patient: Interferon beta‐1a with a dose of 44 micrograms by subcutaneous injection every other day in the amount of 5 to 7 doses of Favipiravir with a dose: the first day of 1800 mg every 12 hours and from the following days 800 mg every 12 hours for 10 days up to a maximum of 14 days. Persistent oxygen demand despite supportive therapy and SpO2 between 90‐93%, corticosteroids can be given in low doses: Dexamethasone 8 mg intravenously daily for up to 10 days. Or oral prednisolone tablets 0.5mg / kg for a maximum of 10 days. Remdesivir IV: 200 mg as a single dose on day 1, followed by 100 mg once daily. Total duration is 5 days. To the CONDITION: B34.2 Covid‐19. ; Coronavirus infection, unspecified SECONDARY OUTCOME: Incidence of adverse effects: Acute respiratory failure, hypotension, viral pneumonia, acute renal failure, anemia, decreased hemoglobin, decreased GFR, increased creatinine, hyper or hypoglycemia, increased LFT. Timepoint: End of the study. Method of measurement: Incidence of the adverse effect. INCLUSION CRITERIA: Hospitalized patients with definite diagnosis of SARS‐CoV‐2 infection based on PCR or detection of pulmonary involvement on CT scan. Hospitalized patients aged 18 to 65 years old PRIMARY OUTCOME: Change in measured quantitative CRP. Timepoint: Before the intervention and the end of the study. Method of measurement: blood test. Improved lung CT scan. Timepoint: Before the intervention and the end of the study. Method of measurement: CT Scan. Mortality rate. Timepoint: End of the study. Method of measurement: Number of patients who died. Number of patients with changes in oxygen delivery status. The categories are as follows: 1. hospitalized, not requiring supplemental oxygen and no longer requiring ongoing medical care (used if hospitalization was extended for infection‐control reasons); 2. hospitalized, not requiring supplemental oxygen but requiring ongoing medical care (Covid‐19–related or other medical conditions); 3. hospitalized, requiring any supplemental oxygen; 4. hospitalized, requiring noninvasive ventilation or use of high‐flow oxygen devices; 5, hospitalized, receiving invasive mechanical ventilation. Timepoint: End of the study. Method of measurement: Number of days. The time to recovery, defined as the from the time of randomization and start of treatment to the first day of recovery: not hospitalized, hospitalized with not requiring supplemental oxygen and/or no longer requiring ongoing medical care (used if hospitalization was extended for infection‐control reasons). Timepoint: From the time of randomization. Method of measurement: Number of days. Time to improve cough (in hours): From the time of randomization and start of treatment, to be improved cough. The criteria for normalization is: Cough ‐ mild or absent on a patient‐reported scale of severe, moderate, mild, absent. Timepoint: every 6 hour. Method of measurement: Cough rate. Time to improve shortness of breath (in hours): From the time of randomization and start of treatment, to be normalized respiratory rate. The criteria for normalization is: Respiratory rate ‐ =24/minute on room air. Timepoint: every 6 hour. Method of measurement: Respiratory rate. Time to normalize fever (in hours): From the time of randomization and start of treatment, to be normalized fever. The criteria for normalization is: Fever ‐ =36.9°C or ‐axilla, =37.2 °C oral. Timepoint: every 6 hour. Method of measurement: Body temperature. Time to normalize oxygen saturation (in hours): From the time of randomization and start of treatment, to be normalized oxygen saturation. The criteria for normalization is: Oxygen saturation ‐ >94% on room air. Timepoint: every 6 hour. Method of measurement: O2 saturation measurement.