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

Acute Respiratory Distress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04588441
• Other study ID #: IRB202002127
• Secondary ID: OCR39505
• Status: Withdrawn
• Phase: Phase 2
• Start date: December 2023
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 105 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress
• COVID-19
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Outcome

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