Exosome therapy in ARDS patients

Phase 1

Recruiting

Conditions: Acute Respiratory Distress Syndrome due to COVID-19.
Acute respiratory distress syndrome
U07.1

Registration Number: IRCT20201202049568N3

Lead Sponsor: Tarmim Ava Baran Knowledge Based Company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 72

Inclusion Criteria

Acute respiratory distress Syndrome of moderate to severe type (PaO2/ FiO2 <200mmHg)
Age range between 18 to 65 years
Men and Women
No participation in another clinical trial during this study
Patients who have given themselves and their families a full explanation of the study process and have obtained informed written consent
Chest X-ray showed bilateral infiltration with pulmonary edema
Definitive infection with COVID-19 confirmed by PCR

Exclusion Criteria

Cancer or malignant diseases
Pregnant women or planning to become pregnant
Inflammatory diseases
Symptoms or history of liver or kidney failure
History of lung surgery or Lung transplantation
Having an autoimmune disease
Metabolic disorders (such as diabetes)
Infectious viral infection
Proven blood clotting disorders
Participate in other clinical trials simultaneously
Severe trauma occurred within 14 days before screening
They are undergoing hemodialysis or peritoneal dialysis
Bone marrow transplantation
Have a history of epilepsy, need continuous anticonvulsant therapy

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse reaction (AE) and severe adverse reaction (SAE). Timepoint: At the beginning of the intervention and on days 2, 3, 4, 7 and 14 after the intervention. Method of measurement: Physical examination of pulmonary function test.

Secondary Outcome Measures

Name	Time	Method
Murray lung injury score. Timepoint: Baseline and Days 1, 2, 3, 7, 14, 28, and 60 after intervention. Method of measurement: Clinical checklist. The minimum value is 0 and the maximum is 16. Higher scores mean a worse outcome.;PaO2/FiO2. Timepoint: Baseline and Day 3, Day7, Day14, Day28, Day60. Method of measurement: Oxygen index: the ratio of alveolar oxygen partial pressure to fraction of inspired oxygen.;The number of days the survivor was out of ICU. Timepoint: 60 Days. Method of measurement: The number of days the survivor was out of ICU.;Blood biochemistry (CRP). Timepoint: Baseline, day 5, 10, 20. Method of measurement: C-reactive protein (CRP, mg/mL) concentration in the plasma will be measured.