Back to resultsThe ARCTIC Trial: Aerosolized Inhaled Adenosine Treatment in Patients With Acute Respiratory Distress Syndrome (ARDS) Caused by COVID-19
Primary Purpose
Acute Respiratory Distress
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Adenosine
Sponsored by
About this trial
This is an interventional treatment trial for Acute Respiratory Distress focused on measuring COVID-19, ARDS, Adenosine
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Adenosine
Arm Description
Treatment consists of 9 mg adenosine in 5ml normal saline (NS) administered over 5-10 min via an Aerogen™ nebulizer
Outcomes
Primary Outcome Measures
Improved COVID-19 symptoms
Improved COVID-19 symptoms measured by alive v. mortality, not hospitalized, or free of respiratory failure.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04588441
Brief Title
The ARCTIC Trial: Aerosolized Inhaled Adenosine Treatment in Patients With Acute Respiratory Distress Syndrome (ARDS) Caused by COVID-19
Official Title
Aerosolized Inhaled Adenosine Treatment in Patients With Acute Respiratory Distress Syndrome (ARDS) Caused by COVID-19 (The ARCTIC Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress
Keywords
COVID-19, ARDS, Adenosine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Testing will be applied to patients with deteriorating pulmonary function and who are newly intubated (within 24 hours) with rising oxygen requirements.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adenosine
Arm Type
Experimental
Arm Description
Treatment consists of 9 mg adenosine in 5ml normal saline (NS) administered over 5-10 min via an Aerogen™ nebulizer
Intervention Type
Drug
Intervention Name(s)
Adenosine
Other Intervention Name(s)
Aerogen
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improved COVID-19 symptoms
Description
Improved COVID-19 symptoms measured by alive v. mortality, not hospitalized, or free of respiratory failure.
Time Frame
Day 50
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Gunnett
Phone
(352) 273-8911
Email
agunnett@anest.ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Spiess
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The ARCTIC Trial: Aerosolized Inhaled Adenosine Treatment in Patients With Acute Respiratory Distress Syndrome (ARDS) Caused by COVID-19
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