CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 5 enrolled
Drug / intervention
Regadenoson +1 moredrug
Likely dose
Regadenoson 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04606069
NCT04606069Phase 2Completed

Clinical Trial on the Safety and Efficacy of Regadenoson for Moderate to Severe COVID-19 Adult Patients

University of Maryland, Baltimore·interventional·Posted Oct 28, 2020·Updated Mar 20, 2025

In Brief

A Phase 2 clinical trial evaluating Regadenoson and Placebo Control for COVID-19 and Lung Inflammation. Completed, enrolled 5 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedOct 28, 2020
Enrollment StartMay 6, 2021
Primary CompletionApr 24, 2023
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 5.7 years ago

Interventions

Regadenosondrug

Regadenoson will be given intravenously as 5 ug/kg (up to 400 mg/patient) loading dose over 30 mins (to avoid unpleasant side effects sometimes associated with the rapid bolus injection of Regadenoson), followed by a continuous slow infusion (1.44micrograms/kg/hour) with the use of a pediatric infusion pump for 6 hours.

Placebo Controlother

The same volume of saline will be given intravenously for 6 and half hours.