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Clinical trial of trans sodium crocetinate against COVID-19

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20081019001369N7
Enrollment
30
Registered
2020-09-27
Start date
2020-10-22
Completion date
Unknown
Last updated
2020-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19. COVID-19 Disease

Interventions

Intervention 1: Intervention group: In addition to the standard treatment regimen for COVID-19, the trans sodium crocetinate spray with a nebulizer as an oral spray twice a day will be given for 1 wee

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

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

Exclusion criteria: Allergic reactions to saffron Pregnancy and breast-feeding, Multi organ dysfunction disease

Design outcomes

Primary

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

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHossein Hosseinzadeh

Mashhad University of Medical Sciences

hosseinzadehh@mums.ac.ir+98 51 3180 1193

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026