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

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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04588441

Enrollment

Registered

2020-10-19

Start date

2023-12-31

Completion date

2025-12-31

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress

Keywords

COVID-19, ARDS, Adenosine

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.

Interventions

DRUGAdenosine

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Testing will be applied to patients with deteriorating pulmonary function and who are newly intubated (within 24 hours) with rising oxygen requirements.

Eligibility

Sex/Gender

ALL

Age

18 Years to 105 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Improved COVID-19 symptoms	Day 50	Improved COVID-19 symptoms measured by alive v. mortality, not hospitalized, or free of respiratory failure.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026