Impact of Tissue Plasminogen Activator (tPA) Treatment for an Atypical Acute Respiratory Distress Syndrome (COVID-19)

• Status: Withdrawn
• Trial end date: 2021-02-15
• Target enrollment: 0
• Participant gender: All

Summary

At the beginning COVID-associated lung injury was considered as typical ARDS, hence respiratory and nonrespiratory treatments were delivered according to general principles for this kind of illness. There is hypothesis that in predisposed individuals, alveolar viral damage is followed by an inflammatory reaction and by microvascular pulmonary thrombosis. The investigators suggest that thrombolytic therapy may be beneficial when compared to standard care in patients with SARS-CoV-2 and severe respiratory failure.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Negovsky Reanimatology Research Institute
• Collaborators: Demikhov Municipal Clinical Hospital 68; Sklifosovsky Institute of Emergency Care
• Treatments: Plasminogen; Tissue Plasminogen Activator

Criteria

Inclusion Criteria:

1. Severe pulmonary coronavirus disease 19 (COVID 19) with suspect for MicroCLOTS (microvascular COVID-19 lung vessels obstructive thromboinflammatory syndrome)

2. P/F ratio <200 mmHg> 70 mmHg

3. a.) Contrast CT scan positive for pulmonary thrombosis, OR b.) Contrast CT scan negative for pulmonary thrombosis:

• D-Dimer > 10 mcg/mL, OR

• 5 < D-dimer < 10 mcg/mL and C Reactive Protein (CRP) > 100 mg/dL

Exclusion Criteria:

• Age < 18

• Pregnancy or breastfeeding

• Known allergy to iodinated contrast dye

• Severe vasoplegic shock: norepinephrine > 300 ng/kg*min

• Glomerular Filtration rate < 30 ml/min

• Active bleeding or absolute contraindication to anticoagulant therapy (Stroke (intracranial hemorrhage, hemorrhagic stroke), including a history of the last 6 months.; cancer of the Central nervous system and other localities with an increased risk of bleeding, vascular aneurysm, traumatic open heart massage, obstetric delivery, General operations, severe uncontrolled hypertension, gastric ulcer and 12-duodenal ulcer (for 3 months. from the moment of exacerbation), arterial or venous malformations, liver failure, liver cirrhosis, portal hypertension, esophageal varicose veins, active hepatitis).