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

University of Florida

Status and phase

Withdrawn

Phase 2

Conditions

Acute Respiratory Distress

Treatments

Drug: Adenosine

Study type

Interventional

Funder types

Other

Identifiers

NCT04588441

IRB202002127

OCR39505 (Other Identifier)

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 105 years old

Volunteers

No Healthy Volunteers

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.