The ARCTIC Trial: Aerosolized Inhaled Adenosine Treatment in Patients With Acute Respiratory Distress Syndrome (ARDS) Caused by COVID-19
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04588441|
Recruitment Status : Not yet recruiting
First Posted : October 19, 2020
Last Update Posted : August 17, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Acute Respiratory Distress||Drug: Adenosine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention 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)|
|Official Title:||Aerosolized Inhaled Adenosine Treatment in Patients With Acute Respiratory Distress Syndrome (ARDS) Caused by COVID-19 (The ARCTIC Trial)|
|Estimated Study Start Date :||September 2021|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
Treatment consists of 9 mg adenosine in 5ml normal saline (NS) administered over 5-10 min via an Aerogen™ nebulizer
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 Name: Aerogen
- Improved COVID-19 symptoms [ Time Frame: Day 50 ]Improved COVID-19 symptoms measured by alive v. mortality, not hospitalized, or free of respiratory failure.
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|Ages Eligible for Study:||18 Years to 105 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- Younger than 18 years old.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04588441
|Contact: Amy Gunnett||(352) firstname.lastname@example.org|
|Principal Investigator:||Bruce Spiess||University of Florida|
|Responsible Party:||University of Florida|
|Other Study ID Numbers:||
OCR39505 ( Other Identifier: UF OnCore )
|First Posted:||October 19, 2020 Key Record Dates|
|Last Update Posted:||August 17, 2021|
|Last Verified:||August 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|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|
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Purinergic P1 Receptor Agonists