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Evaluation of efficacy and safety of Glurunic acid (G2013) in patients with COVID-19

Evaluation of efficacy and safety of Glurunic acid (G2013) in patients with COVID-19

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20080901001165N64
Enrollment
180
Registered
2021-05-21
Start date
2021-05-31
Completion date
Unknown
Last updated
2021-05-26

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

Conditions

COVID-19. Covid-19

Interventions

Intervention 1: Intervention group: Guluronic acid (G2013) capsule 500 mg, 2 capsules every 12 hours, after meal, for 4 weeks
in addition to routine treatment according to the latest national guideline. Intervention 2: Control group: routine treatment according to the latest national guideline.

Sponsors

Ministry of Defense, Department of Health
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Confirmed diagnosis of COVID-19, with either lung CT-Scan result, which is typical for COVID-19 pulmonary involvement,or RT-PCR confirmation. The patient/Legal guardian has written consciously and freely consent to participate in the study; In the first 48 hours after his/her inclusion into this study, there is no possibility of discharge from the patient's hospital; Moderate to severe COVID pneumonia

Exclusion criteria

Exclusion criteria: Pregnancy Lactation The patient is present at another clinical trial at the same time. Severe renal impairment Severe hepatic impairment Severe cardiac impairment Uncontrolled diabetes Active infection Active cancer Coagulopathy Primary immunodeficiency syndrome Allergy to Glurunic acid

Design outcomes

Primary

MeasureTime frame
Need to receive ICU service rate (occurrence of shock, resistant hypoxemia despite receiving oxygen via reservoir oxygen mask, GCS score drops below 12). Timepoint: Daily. Method of measurement: Clinical assessment.

Secondary

MeasureTime frame
Mortality rate. Timepoint: 30 days after including the study. Method of measurement: Clinical assessment.;Length of hospitalization. Timepoint: The first day and the end of hospitalization. Method of measurement: The hospital record review.;Laboratory changes. Timepoint: Daily until discharge. Method of measurement: Blood sample, laboratory analysis.;Fever. Timepoint: Daily until discharge. Method of measurement: Clinical assessment.;Respiratory distress. Timepoint: Daily until discharge. Method of measurement: Clinical assessment.;Oxygen saturation without receiving oxygen supplement. Timepoint: Daily until discharge. Method of measurement: Pulse-oxymetery device.;Side effects. Timepoint: Daily during hospitalization, weekly after discharge. Method of measurement: During hospitalization by clinical evaluation, after discharge by telephone follow-up.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactArmita Mahdavi Goorabi

Shahid Dr. Chamran hospital

name@domain.com+98 21 2293 7031

Outcome results

None listed

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