The ARCTIC Trial: Aerosolized Inhaled Adenosine Treatment in Patients With Acute Respiratory Distress Syndrome (ARDS) Caused by COVID-19

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Treatments: Adenosine

Criteria

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.