COVID-19 Clinical Trial
Official title:
Clinical Trial on the Safety and Efficacy of Regadenoson for Moderate to Severe COVID-19 Adult Patients
Verified date | August 2023 |
Source | University of Maryland, Baltimore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 5 |
Est. completion date | April 24, 2023 |
Est. primary completion date | April 24, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) <300, or lung infiltrates >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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Maryland Medical Center | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
University of Maryland, Baltimore |
United States,
Field 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. Erratum In: Blood Adv. 2017 Oct 19;1(23 ):2058. — View Citation
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. — View Citation
Zhao 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. — View Citation
Zhao 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
30 Days | |
Secondary | 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 the baseline, 30mins, 4 hours during drug infusion and 12 hour post drug infusion. It may also including 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-a, and IFN-? 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). | 30 days | |
Secondary | Change of the levels of MMP-2 and MMP-9 prior, during and post drug infusion. | The same blood samples used in outcomes 2 will be used to measure the levels of matrix metalloproteinase-2 (MMP-2) and MMP-9 using gelatin zymography as described in our previous publications (Zhao et al, 2010 & 2011). The enzyme levels will be quantified using The Image Lab 5.1 software. The unit will be nanogram/ml (ng/ml). | 30 days |
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