Phase 2
N=5
Treat COVID-19 Patients With Regadenoson
COVID-19 · Lung Inflammation
Bottom Line
View on ClinicalTrials.gov: NCT04606069 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Proportion of Patients Alive and Free of Respiratory Failure Through the 30-day Trial. — 100 Percentage of of patients alive and free
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Regadenoson (Drug); Placebo Control (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Maryland, Baltimore
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Alive and Free of Respiratory Failure Through the 30-day Trial. |
100 | — |
| SECONDARY Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. |
1.53; 1.32; 0.98; 1.02; 0.76; 0.80 | — |
Summary
More than 17 million people have been infected and more than 677K lives have been lost since the COVID-19 pandemic. Unfortunately, there is neither an effective treatment nor is there a vaccination for this deadly virus. The moderate to severe COVID-19 patients suffer acute lung injury and need oxygen therapy, and even ventilators, to help them breathe. When a person gets a viral infection, certain body cells (inflammatory/immune cells) get activated and release a wide range of small molecules, also known as cytokines, to help combat the virus. But it is possible for the body to overreact to the virus and release an overabundance of cytokines, forming what is known as a "cytokine storm". When a cytokine storm is formed, these cytokines cause more damage to their own cells than to the invading COVID-19 that they're trying to fight. Recently, doctors and research scientists are becoming increasingly convinced that, in some cases, this is likely what is happening in the moderate to severe COVID-19 patients. The cytokine storm may be contributing to respiratory failure, which is the leading cause of mortality for severe COVID-19 patients. Therefore, being able to control the formation of cytokine storms will also help alleviate the symptoms and aid in the recovery of severe COVID-19 patients.
Eligibility Criteria
Inclusion Criteria
- Age: adults 18 years and older
- Laboratory-confirmed COVID-19+ by RT-PCR
- Moderate to Severe COVID-19 patients according to FDA's COVID-19 treatment guideline on Management of Persons with COVID-19: Moderate illness is defined as individuals who have evidence of lower respiratory disease by clinical assessment or imaging and a saturation of oxygen (SpO2) >93% on room air at sea level. Severe Illness is defined as individuals who have respiratory frequency >30 breaths per minute, SpO2 ≤ 93% on room air at sea level, ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) 50%
- Written informed consent must be obtained before any study procedure is performed.
Exclusion Criteria
- Pregnant or breastfeeding women
- Symptoms or signs of acute myocardial ischemia
- Sinoatrial (SA) and Atrioventricular (AV) Nodal Block/dysfunction
- Symptoms or signs of Atrial Fibrillation/Atrial Flutter
- History of Hypotension
- History of severe hypertension not adequately controlled with anti-hypertensive medications (Systolic blood pressure ≥ 200 mmHg and/or Diastolic blood pressure ≥ 110 mmHg)
- Severe renal impairment defined as glomerular filtration rate (GFR) < 30 ml/min
- History of clinically overt stroke within the past 3 years
- History of seizure disorder
- Pre-existing asthma or chronic obstructive pulmonary disease
- Chronic anti-coagulation or anti-platelet therapy that would preclude surgery (prophylactic aspirin is acceptable)
- 12.Treatment within 30 days with Hydroxychloroquine (HCQ) or Azithromycin
- Treatment with Janus Kinase inhibitors
- Treatment with theophylline or aminophylline within 12 hours of study dosing
- Treatment with Persantine and/or Aggrenox within 5 days
- Other clinical conditions that in the opinion of the investigator would make the subject unsuitable for the study
Data sourced from ClinicalTrials.gov (NCT04606069). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.