Evaluation of trans sodium crocetinate spray against on mild to moderate ARDS induced by COVID-19 patients: A Randomized Open label Clinical Trial

Evaluation of trans sodium crocetinate spray in COVID-19 patients

A randomized and open clinical trial with a parallel group design of 30 inpatients, randomizing with the table of random numbers.

This study will be performed on inpatients. In this study, 30 patients with covid-19 disease were selected and randomly assigned to two groups of 15 individuals. Patients in the standard diet control group will receive standard coronavirus treatment . In addition to the standard diet, patients in the treatment group will be treated with 1 mg/kg of trans sodium crocetinate i.v. for 1 week. Patients are monitored during 7 days hospitalization and daily checked for PF ratio, O2 saturation, vital signs as well as adverse drug reactions. At three days intervals, the function of liver, kidney and CBC will be checked. At the end of treatment, disease intensity parameters will be checked again in both groups.

Inclusion criteria:Patients with clinical diagnosis for Covid-19 disease, Patients with acute respiratory distress syndrome (ARDS), PF ratio (the ratio of arterial oxygen partial pressure to fractional inspired oxygen) <200 , Patients not having kidney, liver and heart dysfunction according to clinical and laboratory findings Exclusion criteria:Allergic reactions to saffron , pregnancy and breast-feeding, multi organ dysfunction disease

The control group receives standard anti-coronavirus drugs . In addition to the common anticorona virus drugs, the treatment group also receives trans sodium crocetinate.

Primary outcomes: frequency of patients mortality Secondary outcomes:days under ventilation, hospitalization days in ICU, Getting multi organ dysfunction, improving PF ratio and sofa score

Randomization in three stages: 1- Random sequence generation: this step simple or limited randomization will be done based on a table of random numbers 2- Allocation concealment: which is done in the form of coded boxes (numbered drug containers) with a random sequence. In this method, a number of boxes with the same shape and size are numbered based on random sequences and contain drugs or placebo that have a completely similar appearance. 3- Execution of random allocation process: A: Identify the person who creates the random sequence B: A person who evaluates and registers researchers in terms of inclusion and exclusion criteria C: The person who assigned the participants to the groups: infectious diseases specialist The main researcher of the project, who creates a random sequence, does not interfere in other stages of randomization, including registration and allocation of participants, and the person involved in creating a random program is separate from other researchers.