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

June 16, 2023 updated by: University of Florida

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 105 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adenosine
Treatment consists of 9 mg adenosine in 5ml normal saline (NS) administered over 5-10 min via an Aerogen™ nebulizer
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.
Other Names:
  • Aerogen

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Bruce Spiess, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

October 13, 2020

First Submitted That Met QC Criteria

October 13, 2020

First Posted (Actual)

October 19, 2020

Study Record Updates

Last Update Posted (Estimated)

June 19, 2023

Last Update Submitted That Met QC Criteria

June 16, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB202002127
  • OCR39505 (Other Identifier: UF OnCore)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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