A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study in Adults to Determine the Safety, Efficacy, and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19To estimate the efficacy, safety, tolerability and reactogenicity of 2 IM doses of AZD1222 compared to placebo for the prevention of COVID-19 in adults ≥ 18 years of age Protocol #: 20-9990 Locations: Greeley Campus; Medical Center of the Rockies; Poudre Valley Hospital |
ODYSSEY: A randomized, double-blind, placebo-controlled study to investigate the efficacy of tradipitant in treating inflammatory lung injury and improving clinical outcomes associated with severe COVID-19 infectionThe tradipitant therapy is being studied to explore if the administration prevents or treats the cytokine storm and acute respiratory distress syndrome leading to respiratory failure and high mortality in affected patients with COVID-19. Protocol #: 20-6506 Locations: Memorial Hospital Central; Memorial Hospital North |
Prone Positioning on Admission for Hospitalized COVID-19 Pneumonia ProtocolProtocol #: 20-6034 Location: Medical Center of the Rockies |
ODYSSEY: A randomized, double-blind, placebo-controlled study to investigate the efficacy of in treating inflammatory lung injury and improving clinical outcomes associated with severe COVID-19 infectionProtocol #: 20-6037 Locations: Greeley Campus; Long's Peak Hospital; Medical Center of the Rockies; Poudre Valley Hospital |
The Use of Ultrasound in Establishing COVID-19 Infection as Part of a Trauma EvaluationThis study is to learn more about the effectiveness of EFAST evaluation of the chest to trauma patients to identify the effect of the lungs from COVID-19 infections. This study is to evaluate the effectiveness of Expanded Focused Assessment with Sonography in Trauma (EFAST) in identifying high risk trauma patients with active COVID-19 pulmonary infections. Protocol #: 20-0751 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
NEONATAL ENTEROVIRUS AND HUMAN PARECHOVIRUS VIRAL SEPSIS: NATURAL HISTORY AND PREDICTORS OF MORBIDITY AND MORTALITYProtocol #: 20-0889 Location: Childrens Hospital Colorado |
AN ADAPTIVE PHASE 2/3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY ASSESSING EFFICACY AND SAFETY OF SARILUMAB FOR HOSPITALIZED PATIENTS WITH COVID-19Protocol #: 20-0615 Location: University of Colorado Hospital |
Explorations into the mechanism for INSTI-associated weight gain: a focus on energy balanceProtocol #: 19-2960 Location: University of Colorado Hospital |
GS-US-200-4334: A Phase 2 Randomized, Open Label, Active Controlled Study Evaluating the Safety and Efficacy of Long-acting Capsid Inhibitor GS-6207 in Combination with Other Antiretroviral Agents in People Living with HIVThis study will test an experimental drug named GS-6207 (long acting capsid inhibitor) in combination with other HIV medications for the treatment of human immunodeficiency virus (HIV) infection. An experimental drug means that it is not yet approved for the treatment of HIV-1 Infection by the United States Food and Drug Administration (FDA) and your country’s regulatory agency. Other HIV medications included in this study are B/F/TAF (Biktarvy?) and, F/TAF (Descovy?), which are currently approved by the U.S. FDA for the treatment of HIV infection and TAF (VEMLIDY?) and Bictegravir (BIC) which are part of the medication Biktarvy but are not currently approved as a single agent HIV medication by the U.S. FDA. This is a randomized, open label study. Open-label means you and your study doctor will know what study drugs you will be taking. Randomized means the study treatment you take will be chosen by chance (like flipping a coin) to receive one of four study treatments. The randomization for this study is in a 2:2:2:1 ratio. You will have 6 out of 7 chances to receive GS-6207 in combination with other HIV medications and a 1 out of 7 chance to receive B/F/TAF. Protocol #: 19-2810 Location: University of Colorado Hospital |
A5371: A Single-Arm, Open-Label, Pilot Study of Semaglutide for Non-Alcoholic Fatty Liver Disease (NAFLD), a Metabolic Syndrome with Insulin Resistance, Increased Hepatic Lipids, and Increased Cardiovascular Disease Risk (The SLIM LIVER Study)About 30-40% of people living with HIV have a condition called NAFLD, or non-alcoholic fatty liver disease. NAFLD is caused by high levels of stored fat in the liver. Most people with NAFLD also have other complications like high cholesterol, obesity, increased belly fat or type 2 diabetes. These complications can lead to cardiovascular disease (any disease of the heart or blood vessels that can lead to a stroke or heart attack). In fact, most of the health problems that are associated with NAFLD are related to these conditions of the heart or metabolism. Without treatment, NAFLD can advance to more serious liver disease. By using a drug that can lower the level of stored fat in the liver, people living with HIV may be able to treat NAFLD and reduce their risk of cardiovascular disease and other complications. Protocol #: 19-2824 Location: University of Colorado Hospital |
A Phase 2/3 Randomized, Double-blind, Palivizumab-controlled Study to Evaluate the Safety of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in High-risk Children (MEDLEY)MEDLEY is a clinical study to research an investigational medicine for babies at high risk for respiratory syncytial virus (RSV) disease. The study is looking to see how safe the investigational medication is and if it works as well as a medication already approved to protect against RSV. The study will include about 1500 babies globally. If you decide to take part, your baby may be in the MEDLEY Study for up to 2 years and may have up to 17 scheduled study visits. Your baby will be monitored throughout the study for respiratory illnesses. Protocol #: 19-1403 Location: Childrens Hospital Colorado |
A Pilot Study in the Treatment of Refractory Adenovirus (ADV) Infection with Related Donor ADV Cytotoxic T-Lymphocytes (ADV-CTLs)in Children, Adolescents and Young Adult Recipients - NYMC 579Protocol #: 19-0858 Location: Childrens Hospital Colorado |
IMPAACT 2019: Phase I/II Study of the Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less than 12 Years of Age, Version 1.0Protocol #: 18-2714 Location: Childrens Hospital Colorado |
A5357: A Study of Long-Acting Cabotegravir Plus VRC01LS to Maintain Viral Suppression in Adults Living with HIV-1Protocol #: 18-2315 Location: University of Colorado Hospital |
An Open-label Study to Assess the Intrapulmonary Concentrations of Cefiderocol at Steady State in Hospitalized Subjects with Bacterial Pneumonia on Treatment with Standard of Care Antibiotics and Requiring Mechanical VentilationThe study is being performed in patients with bacterial pneumonia, an infection in the lung[s] to determine how safe the experimental drug, cefiderocol, is and the amount of cefiderocol that is in blood and lung secretion over time (also known as pharmacokinetics or PK). All participants in this study will receive the study drug. Protocol #: 18-1706 Location: University of Colorado Hospital |
A5359: A Phase III Study to Evaluate Long-Acting Antiretroviral Therapy in Non-adherent HIV-Infected Individuals. Version 1.0 07/05/2018Protocol #: 18-1493 Location: University of Colorado Hospital |
A Phase 3 Prospective, Randomized, Double-blinded, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of Rebiotix RBX2660 (microbiota suspension) for the Prevention of Recurrent Clostridium difficile InfectionPrimary Objective: To confirm the efficacy of RBX2660 as compared to a Placebo in preventing recurrent episodes of CDI through 8 weeks. Secondary Objective: To evaluate the sustained clinical response rate of RBX2660 as compared to Placebo after blinded treatment. Protocol #: 18-1344 Location: University of Colorado Hospital |
Implementing a pharmacist-led protocol to survey and follow-up people living with HIV taking Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) single tablet regimen after being switched from two tablet regimen of Dolutegravir plus Emtricitabine/Tenofovir Alafenamide (DTG + FTC/TAF): patients' satisfaction and adherenceProtocol #: 18-0715 Location: University of Colorado Hospital |
A5366: Selective Estrogen Receptor Modulators to Enhance the Efficacy of Viral Reactivation with Histone Deacetylase InhibitorsProtocol #: 17-2431 Location: University of Colorado Hospital |
Mitochondria in HIV and Aging (MITO+)The general hypothesis of the proposed pilot study is that older, HIV-infected individuals with a prolonged antiretroviral therapy (ART) treatment history experience an even greater burden of mitochondrial dysfunction, and resulting symptoms of muscle fatigue, physical function impairment, and impaired exercise tolerance compared to HIV-uninfected controls of a similar age and body mass index (BMI). Protocol #: 17-2161 Location: University of Colorado Hospital |
The relationship between the gut microbiome composition and pulmonary immune function in HIV infectionProtocol #: 17-1512 Location: University of Colorado Hospital |
Anal Cancer/HSIL Outcomes Research (ANCHOR) StudyProtocol #: 15-1466 Locations: Denver Health Medical Center; University of Colorado Hospital |