The ARCTIC Trial: Aerosolized Inhaled Adenosine Treatment in Patients With Acute Respiratory Distress Syndrome (ARDS) Caused by COVID-19
- Registration Number
- NCT04588441
- Lead Sponsor
- University of Florida
- Brief Summary
This is a phase II study to test adenosine efficacy for down-regulation of the overwhelming inflammation of COVID-19 in the lungs as reflected by clinical recovery of lung function; resolution of clinically relevant markers of lung function, and resolution of systemic markers of inflammation and coagulation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Adult (≥ 18 years old) male and female patients with diagnosed COVID-19 respiratory infection, verified by culture/swab RNA. Impending ARDS respiratory collapse with progressive increasing oxygen requirements, and in line with sub-study as defined below.
- Patients intubated within the prior 24 hours.
- Hemodynamically stable (not requiring vasopressors or catecholamine agents to support systemic blood pressure; no existing shock defined as BP < 100 mmHg systolic).
- In-place continuous arterial line for blood sampling.
Exclusion Criteria
- Younger than 18 years old.
- Prisoners
- Pregnant women.
- Unable to obtain next of kin consent.
- End-stage cardiac disease with COVID-19.
- Non COVID-related causes of ARDS/respiratory failure, septic shock, or post trauma shock, respiratory failure after blood transfusion or surgery.
- Unstable asthma or history of frequent/poorly controlled asthmatic attacks.
- Not expected to live more than 6 months due to underlying condition such as cancer.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Adenosine Adenosine Treatment consists of 9 mg adenosine in 5ml normal saline (NS) administered over 5-10 min via an Aerogen™ nebulizer
- Primary Outcome Measures
Name Time Method Improved COVID-19 symptoms Day 50 Improved COVID-19 symptoms measured by alive v. mortality, not hospitalized, or free of respiratory failure.
- Secondary Outcome Measures
Name Time Method