Tranilast in COVID19

Phase 2

Conditions: U07.1
COVID19.
COVID-19, virus identified

Registration Number: IRCT20200419047128N1

Lead Sponsor: Ahvaz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 60

Inclusion Criteria

Age =18 years
Laboratory polymerase chain reaction (PCR) confirmed infection with COVID19
Lung involvement confirmed with chest imaging Hospitalized with: Fever Or Cough Less than 8 days since illness onset
Willingness of study participant to accept randomization to any assigned treatment arm
Acceptance of non-participation in another study before the 28th day of the study
arterial blood O2 saturation under 93%
non-pregnant females

Exclusion Criteria

Autoimmune diseases (lupus, MS, etc.)
Hepatic failure
Hepatit B, C,
pregnant and lactating women
use of antioxidants, anti-inflammatory and immunosuppressant drugs
kidney failure
known allergy to Tranilast

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ICU-admitted patients. Timepoint: after treatment. Method of measurement: Record information in a checklist by a trained nurse.;Duration of ICU-admission. Timepoint: after treatment. Method of measurement: Record information in a checklist by a trained nurse.;Deaths. Timepoint: After the intervention until the 28th day. Method of measurement: Record information in a checklist by a trained nurse.;Neutrophil-lymphocyte ratio (NLR). Timepoint: End of day 7. Method of measurement: White blood cell count.;C-reactive protein. Timepoint: End of day 7. Method of measurement: ELISA.

Secondary Outcome Measures

Name	Time	Method
IL1. Timepoint: Before and 7 days after starting treatment. Method of measurement: ELISA (enzyme-linked immunosorbent assay).;IL6. Timepoint: Before and 7 days after starting treatment. Method of measurement: ELISA (enzyme-linked immunosorbent assay).;CBC. Timepoint: Before and 7 days after starting treatment. Method of measurement: Cell Counter.;TNF. Timepoint: Before and 7 days after starting treatment. Method of measurement: ELISA (enzyme-linked immunosorbent assay).;D-dimer. Timepoint: Before and 7 days after starting treatment. Method of measurement: ELISA (enzyme-linked immunosorbent assay).;SGPT. Timepoint: Baseline and days 7. Method of measurement: blood biochimecal test.;SGOT. Timepoint: Baseline and days 7. Method of measurement: blood biochimecal test.;Blood oxygen saturation percentage. Timepoint: Before and ten days after starting treatment. Method of measurement: Pulse oximeter.