Acute Respiratory Distress Syndrome due to COVID-19. Acute respiratory distress syndrome
Conditions
Interventions
Intervention 1: Intervention group: Phase one: 12 patients with COVID-19 in two groups of 6 with ARDS (each group includes intervention groups of 3). Phase Two: 60 patients with COVID-19-ARDS in two g
Sponsors
Tarmim Ava Baran Knowledge Based Company
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactRashin Mohseni
Tehran University of Medical Sciences
Outcome results
None listed