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

Phase 3

Conditions: COVID-19.
U07.1
Covid-19

Registration Number: IRCT20080901001165N64

Lead Sponsor: Ministry of Defense, Department of Health

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 180

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eed 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 Outcome Measures

Name	Time	Method
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.