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 |
In-Utero Vascular Accidents in Neonates from COVID-19 Infected MothersThis study plans to learn more about how COVID-19 infection during pregnancy may have direct effects on the developing baby 30 days after birth. Protocol #: 20-1399 Locations: Childrens Hospital Colorado; University of Colorado 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 |
Explorations into the mechanism for INSTI-associated weight gain: a focus on energy balanceProtocol #: 19-2960 Location: University of Colorado Hospital |
A5379: B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-BA5379 is a study looking at hepatitis B vaccination in adults living with HIV. Hepatitis B is a serious viral infection that affects the liver and is transmitted through blood and body fluids. The study will involve individuals who have received a previous hepatitis B vaccination but the vaccine did not respond well and individuals who have never received the vaccination. The study will take place both in the US and internationally. The study will compare how well an individual responds to the vaccine in different groups based on the type of vaccine and number of doses. Protocol #: 19-2935 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 |
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 |