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

NCT ID: NCT04588441

Last Updated: 2024-05-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-31
• Study Completion Date: 2025-12-31

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.

Conditions

Acute Respiratory Distress

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adenosine

Treatment consists of 9 mg adenosine in 5ml normal saline (NS) administered over 5-10 min via an Aerogen™ nebulizer

Group Type: EXPERIMENTAL

Adenosine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 105 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruce Spiess

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Other Identifiers

OCR39505

Identifier Type: OTHER

Identifier Source: secondary_id

IRB202002127

Identifier Type: -

Identifier Source: org_study_id