Clinical trial of trans sodium crocetinate against COVID-19

Phase 2

• Conditions: COVID-19.; COVID-19 Disease; U07.1

• Registration Number: IRCT20081019001369N7
• Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 October 2020

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of patients mortality. Timepoint: during 7 days hospitalization. Method of measurement: counting the number.

Secondary Outcome Measures

Name	Time	Method
Days under ventilation. Timepoint: during 7 days hospitalization. Method of measurement: time.;Hospitalization days in ICU. Timepoint: during 7 days hospitalization. Method of measurement: time.;Getting multi organ dysfunction. Timepoint: During 7 days hospitalization. Method of measurement: Clinical and laboratory evaluation.;Improving PF ration. Timepoint: daily during 7 days hospitalization. Method of measurement: ratio calculated from PaO2/FiO2.;Improving Sofa (The sequential organ failure assessment ) score. Timepoint: the first day and during 7 days hospitalization. Method of measurement: According to clinical and laboratory evaluation.