COVID-19Phase 1/2NCT04606069
Treat COVID-19 Patients With Regadenoson
A Phase 1/2 study testing Regadenoson in people with COVID-19 and Lung Inflammation, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Lung Inflammation
- What is being tested?
- Regadenoson
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2021to 24 Apr 2023
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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) <300, or lung infiltrates >50%
- Written informed consent must be obtained before any study procedure is performed.
Who cannot join
- 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)
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Medical Center
Baltimore, Maryland, 21201
About this study
Official title: Clinical Trial on the Safety and Efficacy of Regadenoson for Moderate to Severe COVID-19 Adult Patients
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.
Read the detailed description
The investigators reason that Regadenoson treatment will reduce COVID-19-induced lung injury by inhibiting hyperinflammation. Our overarching goal is to demonstrate that Regadenoson treatment increases survival by reducing hyperinflammation and pulmonary function. The investigators will test the hypothesis that Regadenoson elicits clinical improvement and enhances survival compared to placebo control patients with COVID-19. The investigators hypothesize that the survival benefit of Regadenoson will be additive or synergistic with the anti-viral drug, Remdesivir. Remdesivir and Dexamethasone are currently standard of care and would remain so.
Specific Aim 1: will determine the initial high dose followed by low dose continuous infusion that is safe and feasible in moderate to severe COVID-19 patients. Even if the dosages that the investigators will use in moderate to severe COVID-19 patients has been proved to be safe in myocardial perfusion imaging patients, sickle cells disease and lung transplantation patients, it is still unclear whether it is safe in COVID-19 patients. Therefore, our primary endpoint for this Aim will be safety. For the first 6 patients, the investigators will be looking at any drug related side effects and toxicity of Regadenoson as the investigators did in lung transplantation trial.
Specific Aim 2: will determine the potential efficacy of Regadenoson infusion in moderate to severe COVID-19 patients. If Regadenoson infusion is safe and feasible in the moderate to severe COVID-19 patients in Aim 1, the investigators will test its efficacy in 34 moderate to severe COVID-19 patients in a randomized controlled trial of regadenoson versus placebo control. The primary endpoints of this specific aim are: 1) Proportion of patients alive and free of respiratory failure through the 30 day trial. Respiratory failure is defined based on resource utilization requiring at least 1 of the following modalities, 2) Endotracheal intubation and mechanical ventilation, 3) 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), 4) Noninvasive positive pressure ventilation or CPAP, 5) ECMO.
Specific Aim 3: will explore the mechanisms of the effects of Regadenoson infusion in moderate to severe COVID-19 patients. If Regadenoson is proved to be effective on treating moderate to severe COVID-19 patients in Aim 2, the investigators will continue the study in this Aim. The investigators will measure 1) the plasma levels of Regadenoson in the collected blood samples (these will be done only on the first 6 patients as the investigators need specific time points and want to limit non routine blood draws); 2) the levels of pro-inflammatory cytokines (TNF-α, IL-1, IL-6, IL-12, IL-8, INF-γ, etc) and anti-inflammatory cytokines ( IL-4 and IL-10), and 3) the levels of matrix metalloproteinase-9 (MM-9) and tissue inhibitor of metalloproteinase-1 (TIMP-1) in blood samples which will be collected from COVID-19 patients at prior baseline lab draws and also next day am routine labs. For the first 6-patients the investigators will ask for 2- additional study lab draws, one at the conclusion of the 30-min infusion and one at 4-hours into the 6-hours slow continuous infusion. The investigators may limit this to 3 if there are no dose limiting toxicities. The investigators are asking for up to 6 in the safety aim 1 in case one of the 3 has a dose limiting toxicity the investigators would then provide to 6 total. 5 of 6 would need to be without dose limiting toxicity to continue with the additional 34 patients.
- Conditions
- COVID-19, Lung Inflammation
- Being tested
- Regadenoson, Placebo Control
- Medical subject headings
- COVID-19, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegadenosonDrug
Also called LEXISCAN,
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
Also called Saline
The same volume of saline will be given intravenously for 6 and half hours.
| Study group | Role | What they receive |
|---|---|---|
| Active Arm | Experimental | 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. Receives: Drug: Regadenoson |
| Control Arm | Placebo comparator | The same volume of saline will be given intravenously for 30 mins followed by a continuous infusion for 6 hours. Receives: Other: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Alive and Free of Respiratory Failure Through the 30-day Trial.
Respiratory failure is defined based on resource utilization requiring at least 1 of the following modalities:
- Endotracheal intubation and mechanical ventilation
- 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)
- Noninvasive positive pressure ventilation or CPAP
- Whether patient is on ECMO
Measured: 30 Days
Secondary outcomes (1)
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug 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).
Measured: Baseline, 30mins into infusion, 4 hours into drug infusion and 24 hours post drug infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start6 May 2021
- Primary completion24 Apr 2023
- Study completion24 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Lau, University of Maryland, Baltimore
- Investigators
- Christine L Lau, MD, MBA, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606069
- Sponsor's protocol ID
- HP-00091372
- Status last verified
- Feb 2025
- First submitted
- 26 Oct 2020
- Last updated
- 20 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lau CL, Beller JP, Boys JA, Zhao Y, Phillips J, Cosner M, Conaway MR, Petroni G, Charles EJ, Mehaffey JH, Mannem HC, Kron IL, Krupnick AS, Linden J. Adenosine A2A receptor agonist (regadenoson) in human lung transplantation. J Heart Lung Transplant. 2020 Jun;39(6):563-570. doi: 10.1016/j.healun.2020.02.003. Epub 2020 Feb 13.
PubMed 32503727Field JJ, Majerus E, Gordeuk VR, Gowhari M, Hoppe C, Heeney MM, Achebe M, George A, Chu H, Sheehan B, Puligandla M, Neuberg D, Lin G, Linden J, Nathan DG. Randomized phase 2 trial of regadenoson for treatment of acute vaso-occlusive crises in sickle cell disease. Blood Adv. 2017 Aug 28;1(20):1645-1649. doi: 10.1182/bloodadvances.2017009613. eCollection 2017 Sep 12.
PubMed 29296811Zhao Y, Xiao A, diPierro CG, Carpenter JE, Abdel-Fattah R, Redpath GT, Lopes MB, Hussaini IM. An extensive invasive intracranial human glioblastoma xenograft model: role of high level matrix metalloproteinase 9. Am J Pathol. 2010 Jun;176(6):3032-49. doi: 10.2353/ajpath.2010.090571. Epub 2010 Apr 22.
PubMed 20413683Zhao Y, Sharma AK, LaPar DJ, Kron IL, Ailawadi G, Liu Y, Jones DR, Laubach VE, Lau CL. Depletion of tissue plasminogen activator attenuates lung ischemia-reperfusion injury via inhibition of neutrophil extravasation. Am J Physiol Lung Cell Mol Physiol. 2011 May;300(5):L718-29. doi: 10.1152/ajplung.00227.2010. Epub 2011 Mar 4.
PubMed 21378024
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial on the Safety and Efficacy of Regadenoson for Moderate to Severe COVID-19 Adult Patients
- ClinicalTrials.gov ID
- NCT04606069
- Acronym / sponsor ID
- HP-00091372
- Conditions
- COVID-19, Lung Inflammation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 6 May 2021 (actual)
- Primary completion
- 24 Apr 2023 (actual)
- Study completion
- 24 Apr 2023 (actual)
- First posted
- 28 Oct 2020 (actual)
- Results
- Posted 20 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators reason that Regadenoson treatment will reduce COVID-19-induced lung injury by inhibiting hyperinflammation. Our overarching goal is to demonstrate that Regadenoson treatment increases survival by reducing hyperinflammation and pulmonary function. The investigators will test the hypothesis that Regadenoson elicits clinical improvement and enhances survival compared to placebo control patients with COVID-19. The investigators hypothesize that the survival benefit of Regadenoson will be additive or synergistic with the anti-viral drug, Remdesivir. Remdesivir and Dexamethasone are currently standard of care and would remain so.
Specific Aim 1: will determine the initial high dose followed by low dose continuous infusion that is safe and feasible in moderate to severe COVID-19 patients. Even if the dosages that the investigators will use in moderate to severe COVID-19 patients has been proved to be safe in myocardial perfusion imaging patients, sickle cells disease and lung transplantation patients, it is still unclear whether it is safe in COVID-19 patients. Therefore, our primary endpoint for this Aim will be safety. For the first 6 patients, the investigators will be looking at any drug related side effects and toxicity of Regadenoson as the investigators did in lung transplantation trial.
Specific Aim 2: will determine the potential efficacy of Regadenoson infusion in moderate to severe COVID-19 patients. If Regadenoson infusion is safe and feasible in the moderate to severe COVID-19 patients in Aim 1, the investigators will test its efficacy in 34 moderate to severe COVID-19 patients in a randomized controlled trial of regadenoson versus placebo control. The primary endpoints of this specific aim are: 1) Proportion of patients alive and free of respiratory failure through the 30 day trial. Respiratory failure is defined based on resource utilization requiring at least 1 of the following modalities, 2) Endotracheal intubation and mechanical ventilation, 3) 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), 4) Noninvasive positive pressure ventilation or CPAP, 5) ECMO.
Specific Aim 3: will explore the mechanisms of the effects of Regadenoson infusion in moderate to severe COVID-19 patients. If Regadenoson is proved to be effective on treating moderate to severe COVID-19 patients in Aim 2, the investigators will continue the study in this Aim. The investigators will measure 1) the plasma levels of Regadenoson in the collected blood samples (these will be done only on the first 6 patients as the investigators need specific time points and want to limit non routine blood draws); 2) the levels of pro-inflammatory cytokines (TNF-α, IL-1, IL-6, IL-12, IL-8, INF-γ, etc) and anti-inflammatory cytokines ( IL-4 and IL-10), and 3) the levels of matrix metalloproteinase-9 (MM-9) and tissue inhibitor of metalloproteinase-1 (TIMP-1) in blood samples which will be collected from COVID-19 patients at prior baseline lab draws and also next day am routine labs. For the first 6-patients the investigators will ask for 2- additional study lab draws, one at the conclusion of the 30-min infusion and one at 4-hours into the 6-hours slow continuous infusion. The investigators may limit this to 3 if there are no dose limiting toxicities. The investigators are asking for up to 6 in the safety aim 1 in case one of the 3 has a dose limiting toxicity the investigators would then provide to 6 total. 5 of 6 would need to be without dose limiting toxicity to continue with the additional 34 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Arm | Experimental | Drug: RegadenosonRegadenoson 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 | Placebo comparator | Other: Placebo ControlThe same volume of saline will be given intravenously for 30 mins followed by a continuous infusion for 6 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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) <300, or lung infiltrates >50%
- Written informed consent must be obtained before any study procedure is performed.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RegadenosonAlso: LEXISCAN,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. | Drug | Active Arm |
| Placebo ControlAlso: SalineThe same volume of saline will be given intravenously for 6 and half hours. | Other | Control Arm |
Primary outcome
Proportion of Patients Alive and Free of Respiratory Failure Through the 30-day Trial.
Time frame: 30 Days
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
1 secondary outcome
Change of the Levels of the Inflammatory Cytokines Prior, During and Post Drug Infusion.
Time frame: Baseline, 30mins into infusion, 4 hours into drug infusion and 24 hours post drug infusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32503727Lau CL, Beller JP, Boys JA, Zhao Y, Phillips J, Cosner M, Conaway MR, Petroni G, Charles EJ, Mehaffey JH, Mannem HC, Kron IL, Krupnick AS, Linden J. Adenosine A2A receptor agonist (regadenoson) in human lung transplantation. J Heart Lung Transplant. 2020 Jun;39(6):563-570. doi: 10.1016/j.healun.2020.02.003. Epub 2020 Feb 13.
- Background: PubMed 29296811Field JJ, Majerus E, Gordeuk VR, Gowhari M, Hoppe C, Heeney MM, Achebe M, George A, Chu H, Sheehan B, Puligandla M, Neuberg D, Lin G, Linden J, Nathan DG. Randomized phase 2 trial of regadenoson for treatment of acute vaso-occlusive crises in sickle cell disease. Blood Adv. 2017 Aug 28;1(20):1645-1649. doi: 10.1182/bloodadvances.2017009613. eCollection 2017 Sep 12.
- Background: PubMed 20413683Zhao Y, Xiao A, diPierro CG, Carpenter JE, Abdel-Fattah R, Redpath GT, Lopes MB, Hussaini IM. An extensive invasive intracranial human glioblastoma xenograft model: role of high level matrix metalloproteinase 9. Am J Pathol. 2010 Jun;176(6):3032-49. doi: 10.2353/ajpath.2010.090571. Epub 2010 Apr 22.
- Background: PubMed 21378024Zhao Y, Sharma AK, LaPar DJ, Kron IL, Ailawadi G, Liu Y, Jones DR, Laubach VE, Lau CL. Depletion of tissue plasminogen activator attenuates lung ischemia-reperfusion injury via inhibition of neutrophil extravasation. Am J Physiol Lung Cell Mol Physiol. 2011 May;300(5):L718-29. doi: 10.1152/ajplung.00227.2010. Epub 2011 Mar 4.
- Individual participant dataSharing planned: No
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine L Lau, MD, MBA principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Regadenoson in people with COVID-19 and Lung Inflammation, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Alive and Free of Respiratory Failure Through the 30-day Trial. (time frame: 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04606069, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.