Trial Outcomes & Findings for Treat COVID-19 Patients With Regadenoson (NCT NCT04606069)

Last Updated: 2025-03-20

Results Overview

Respiratory failure is defined based on resource utilization requiring at least 1 of the following modalities: 1. Endotracheal intubation and mechanical ventilation 2. Oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \>20L/min with fraction of delivered oxygen ≥0.5) 3. Noninvasive positive pressure ventilation or CPAP 4. Whether patient is on ECMO

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

5 participants

Primary outcome timeframe

30 Days

Results posted on

2025-03-20

Participant Flow

Enrollment began in Spring of 2021 at the University of Maryland Medical Center. Study staff screened the medical records of COVID 19 positive patients and reviewed to determine study eligibility. Hospitalized COVID-19 patients were approached according to the unit policy (video chat etc).

Participant milestones

Participant milestones
Measure	Regadenoson Regadenoson will be given intravenously as 5 ug/kg loading dose (up to 400 mg/patient) 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 The same volume of saline will be given intravenously for 30 mins followed by a continuous infusion for 6 hours.
Overall Study STARTED	5	0
Overall Study COMPLETED	5	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treat COVID-19 Patients With Regadenoson

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 30 Days

Population: Following the DSMB recommendations, our site was told to enroll 5 participants in the RA group to assess safety. The enrollment was paused for a safety review of the data from the 5 participants. After a review of the preliminary data, we were approved to resume enrollment per the randomization schema. However, at the time of approval peak COVID rates had declined and despite substantial screening efforts, no eligible participants were enrolled. Therefore, the control arm is zero.

Outcome measures

Outcome measures
Measure	Active Arm n=5 Participants Regadenoson will be given intravenously as 5 ug/kg loading dose (up to 400 mg/patient) 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.	Control Arm The same volume of saline will be given intravenously for 30 mins followed by a continuous infusion for 6 hours.
Proportion of Patients Alive and Free of Respiratory Failure Through the 30-day Trial.	100 Percentage of of patients alive and free	—

SECONDARY outcome

Timeframe: Baseline, 30mins into infusion, 4 hours into drug infusion and 24 hours post drug infusion

Population: Cytokine levels were normalized to baseline just prior to RA infusion.

We will collect blood samples of the Regadenoson and Placebo treated patients at baseline, 30mins into infusion, 4 hours into drug infusion and 24 hours post drug infusion. It may also include the daily blood collected on normal standard care base. The inflammatory cytokines, including IL-1 beta, IL-6, IL-4, IL-8, IL-10, IL-12, IL-17, TNF-α, and IFN-γ will be measured using the Luminex™ 100 Multi-analyte System at The UM SOM Cytokine Core Laboratory. The levels of of cytokines will be measure in picogram/milliliter (pg/ml).

Outcome measures

Outcome measures
Measure	Active Arm n=5 Participants Regadenoson will be given intravenously as 5 ug/kg loading dose (up to 400 mg/patient) 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.	Control Arm The same volume of saline will be given intravenously for 30 mins followed by a continuous infusion for 6 hours.
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. IL-6 - 30 Minutes	1.53 pg/ml Interval 0.69 to 3.37	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. MCP-1 - 30 Minutes	1.32 pg/ml Interval 1.11 to 1.58	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. IL-8 - 30 Minutes	0.98 pg/ml Interval 0.6 to 1.59	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. IL-10 - 30 Minutes	1.02 pg/ml Interval 0.73 to 1.43	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. IFN-G - 30 Minutes	0.90 pg/ml Interval 0.59 to 1.38	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. MIP-1A - 30 Minutes	0.52 pg/ml Interval 0.2 to 1.35	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. IL-12p70 - 30 Minutes	0.76 pg/ml Interval 0.53 to 1.1	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. IL-17 - 30 Minutes	0.49 pg/ml Interval 0.19 to 1.22	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. IL-1B - 30 Minutes	0.49 pg/ml Interval 0.21 to 1.15	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. TNF-A - 30 Minutes	0.45 pg/ml Interval 0.2 to 1.03	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. IL-6 - 4hr	1.23 pg/ml Interval 0.55 to 2.71	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. MCP-1 - 4hr	1.10 pg/ml Interval 0.92 to 1.32	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. IL-8 - 4hr	0.97 pg/ml Interval 0.6 to 1.59	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. IL-10 - 4hr	0.87 pg/ml Interval 0.62 to 1.22	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. IL-12p40 - 4hr	0.81 pg/ml Interval 0.61 to 1.07	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. IL-7 - 4hr	0.78 pg/ml Interval 0.44 to 1.38	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. IP-10 - 4hr	0.76 pg/ml Interval 0.56 to 1.03	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. IFN-G - 4hr	0.73 pg/ml Interval 0.48 to 1.12	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. MIP-1A - 4hr	0.70 pg/ml Interval 0.27 to 1.8	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. IL-12p70 - 4hr	0.70 pg/ml Interval 0.49 to 1.01	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. IL-1B - 4hr	0.50 pg/ml Interval 0.22 to 1.17	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. IL-2 - 4hr	0.47 pg/ml Interval 0.19 to 1.18	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. TNF-A - 4hr	0.47 pg/ml Interval 0.21 to 1.07	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. IL-6 - 24hr	1.53 pg/ml Interval 0.69 to 3.37	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. MCP-1 - 24hr	1.32 pg/ml Interval 1.11 to 1.58	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. IL-8 - 24hr	0.98 pg/ml Interval 0.6 to 1.59	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. IL-10 - 24hr	1.02 pg/ml Interval 0.73 to 1.43	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. IL-12p40 - 24hr	0.76 pg/ml Interval 0.57 to 1.01	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. IL-7 - 24hr	0.80 pg/ml Interval 0.45 to 1.42	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. IP-10 - 24hr	0.77 pg/ml Interval 0.56 to 1.04	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. MIP-1A - 24hr	0.52 pg/ml Interval 0.2 to 1.35	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. IL-12p70 - 24hr	0.76 pg/ml Interval 0.53 to 1.1	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. IL-17 - 24hr	0.49 pg/ml Interval 0.19 to 1.22	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. IL-2 - 24hr	0.45 pg/ml Interval 0.18 to 1.13	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. TNF-A - 24hr	0.45 pg/ml Interval 0.2 to 1.03	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. IL-12p40 - 30 Minutes	0.76 pg/ml Interval 0.57 to 1.01	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. IL-7 - 30 Minutes	0.80 pg/ml Interval 0.45 to 1.42	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. IP-10 - 30 Minutes	0.77 pg/ml Interval 0.56 to 1.04	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. IL-2 - 30 Minutes	0.45 pg/ml Interval 0.18 to 1.13	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. IL-17 - 4hr	0.60 pg/ml Interval 0.24 to 1.51	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. IFN-G - 24hr	0.90 pg/ml Interval 0.59 to 1.38	—
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion. IL-1B - 24hr	0.49 pg/ml Interval 0.21 to 1.15	—

Adverse Events

Regadenoson

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Christine Lau, MD, MBA, Department of Surgery, Surgeon-in-Chief

University of Maryland Medical Center

Phone: 410-328-8407

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Regadenoson n=5 Participants Regadenoson will be given intravenously as 5 ug/kg loading dose (up to 400 mg/patient) 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 The same volume of saline will be given intravenously for 30 mins followed by a continuous infusion for 6 hours.	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	53.2 years STANDARD_DEVIATION 11.4 • n=5 Participants	—	53.2 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	—	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	—	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	—	2 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	—	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	—	5 participants n=5 Participants
BMI	35.5 Kg/m^2 STANDARD_DEVIATION 6.8 • n=5 Participants	—	35.5 Kg/m^2 STANDARD_DEVIATION 6.8 • n=5 Participants
Oxygen Supplementation on Admission 2L NC	3 Participants n=5 Participants	—	3 Participants n=5 Participants
Oxygen Supplementation on Admission 6L NC	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Oxygen Supplementation on Admission HFNC	1 Participants n=5 Participants	—	1 Participants n=5 Participants