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Study aim: Evaluation the effect of one new trial drug on the clinical and paraclinical symptoms in hospitalized patients with COVID-19 Design: A randomized controlled, double blind clinical trial with a parallel-group design; consisted of 120 patients, in which participants will be randomly allocated into trial groups using www.randomization.com Settings and conduct: This study is a randomized controlled two blinded trial that will be conducted on COVID-19 patients who referred to Ali Asghar Hospital of Shiraz in two groups (intervention and control groups). The patients, researcher, monitoring committee, and statistical analyst will be blind to the received active drug or placebo. Participants will be allocated into trial groups randomly using randomization site. Patients will receive a drops containers of new trial drug or placebo by giving 6 sublingual drops every 3hours for 14days. Random allocation sequences will be generated by the non-involved person in the research. Both groups will receive routine treatments. Participants/Inclusion and exclusion criteria: Inclusion criteria: Patients aged 15 years and older with COVID-19 who had hospitalized; Having a definite disease; Having a signed informed consent form to participate in the study; Non-inclusion:not participation in another clinical trial simultaneously. Intervention groups: In the intervention group, participants will receive six drops containing 433±5 mg sublingual new trial drug every 3 hours for 14 days. The control group will receive a placebo, resembled ِherbal medicine with the same prescription. Both groups will receive routine treatments. Main outcome variables: Respiratory Rate (RR); Oxygen saturation (SpO2); Serum white blood cell count; serum CRP level; ٍُESR; the number of hospitalization days; Mortality
IRCTID: IRCT20200509047373N2
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