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

Not yet recruiting
Acute Respiratory Distress

Drug: Adenosine

Adenosine will be given like an inhaled asthma medication two times daily for one week (7 days). Treatment consists of 9 mg adenosine in 5ml normal saline (NS) administered over 5-10 min via an Aerogen™ nebulizer.
Other Name: Aerogen

Eligibility 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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 105 Years
Contacts

Amy Gunnett
(352) 273-8911
agunnett@anest.ufl.edu

Bruce Spiess, Principal Investigator
University of Florida

University of Florida
NCT Number
Keywords
Covid-19
ARDS
Adenosine
MeSH Terms
COVID-19
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Adenosine