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

NCT04588441 | Withdrawn Phase 2 FDA Drug

• 2 other identifiers: IRB202002127OCR39505
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

COVID-19; ARDS; Adenosine

Outcome Measures

Primary Outcomes (1)

• Improved COVID-19 symptoms

  Improved COVID-19 symptoms measured by alive v. mortality, not hospitalized, or free of respiratory failure.

  Day 50

Study Arms (1)

Adenosine

EXPERIMENTAL

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

Drug: Adenosine

Interventions

Adenosine 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.

Also known as: Aerogen

Adenosine

Eligibility Criteria

• Age: 18 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

MeSH Terms

Conditions

Acute Lung Injury; COVID-19

Interventions

Adenosine

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Intervention Hierarchy (Ancestors)

Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Bruce Spiess

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 19, 2020
• Study Start: December 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share