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Study aim:
Evaluation of the efficacy of Gallecina® oral capsules, a hydrogen sulfide prodrug, as an adjuvant therapy in hospitalized patients with COVID-19
Design:
a randomized placebo-controlled triple-blind phase 3 clinical trial on 148 patients with COVID-19
Settings and conduct:
In the drug and placebo group, the capsules will be prescribed for a final period of 6 days. During treatment, SaO2 status will be monitored continuously once a day, and CT scan of the lung and CRP and CBC diff will be recorded at the beginning and end of the study. The patient's clinical signs and vital signs will be evaluated daily.
Participants/Inclusion and exclusion criteria:
Inclusion criteria:
Hospitalized patients aged 18 to 65 years with definite diagnosis of SARS-CoV-2 infection based on PCR or detection of pulmonary involvement on CT scan.
Exclusion criteria:
History of garlic allergy and garlic-derived products
Pregnancy and lactation period
Low patient pressure at the beginning of the study (below 120/80)
Malignancy, Immune deficiency, Alzheimer's, Multiple organ failure, Encephalopathy
Intervention groups:
Consumption of Gallecina® capsules every 8 hours for 6 days
Main outcome variables:
Time to improve clinical condition, time to normalize clinical symptoms, number of patients with change in oxygenation status, improved lung CT scan, change in quantitative CRP, number of deaths.