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NIH RECOVER: A Multi-site Observational Study of Post-Acute Sequelae of SARS-CoV-2 Infection in Adults (Pregnancy Arm)
This study is looking at the long-term implications of COVID-19 infection in pregnant patients. Study participants may be asked to answer sets of questions about ongoing symptoms, give samples such as blood and urine and possibly have some other imaging tests. ... Protocol #22-2323 |
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Giving Standardized Estradiol Therapy in Transgender Women to Research Interactions with HIV Therapy: the GET IT RIgHT Study
A5403 is a phase IIb, 48-week, open-label, non-randomized, 3-group trial, of 90 adult (≥18 years) transgender women and other individuals identifying as female or transfeminine but with male sex assigned at birth (TW) living with HIV on suppressive antiretroviral therapy (ART) and not curr... Protocol #23-1505 Location: Outpatient CTRC, University of Colorado Hospital |
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Evaluation of the feasibility, acceptability, and effectiveness of TelePrEP for at-risk youth in Colorado
This study aims to assess whether PrEP delivery via a telehealth (termed TelePrEP throughout) approach supports persistence and retention on oral PrEP for young people and identify barriers and facilitators of TelePrEP for youth. The proposed research will address the critical need to iden... Protocol #22-0588 Location: Childrens Hospital Colorado |
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Influenza-Specific Immunity and Responses to Inactivated Influenza Vaccine in Infants: Effect of Maternal Vaccination During Pregnancy
This study aims to learn more about how babies' immune systems react to the influenza vaccine and if there is any difference between babies whose mothers receive the influenza vaccine, or not, before the baby is born. Study visits will take place during prenatal care and delivery as well a... Protocol #20-1074 Location: Childrens Hospital Colorado, University of Colorado Hospital |
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Effect Of Neonatal BCG Administration On Innate And Adaptive Immune Responses To Infection With Rotavirus Live Attenuated Vaccine Strain In HIV-Exposed And Unexposed Infants
Women in this study will consent in the third trimester and have cord blood collected at the time of delivery. The infant will have four visits at Children's Hospital Colorado.... Protocol #20-0593 Location: Childrens Hospital Colorado, Highlands Ranch Hospital, University of Colorado Hospital |
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A5418 A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Monkeypox Virus Disease
Study of Tecovirimat for Human Monkeypox Virus (STOMP)
Phase 3, randomized, placebo-controlled, double-blind trial of tecovirimat for the treatment of human monkeypox virus (HMPXV) disease. The study will also include a cohort of people who will receive open-label tecovirimat including people with protocol-defined severe HMPXV, pregnant and br... Protocol #22-1761 Location: Childrens Hospital Colorado |
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A Phase 2b/3 Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-1654 in Healthy Pre-Term and Full-Term Infants
The ASSERVO study is testing a potential medicine for infants to see if it may help prevent lower respiratory infections caused by RSV. Study participation includes 1 dose of the medicine or placebo, approximately 3 blood draws, e-diary entries, and nasal swabs collected during any respir... Protocol #21-3387 Location: Childrens Hospital Colorado |
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PHACS Health Outcomes around Pregnancy and Exposure to HIV/ARVs (HOPE)
The study is designed to evaluate the health outcomes of women living with HIV over time. Women who elect to participate in this study complete a combination of online surveys, clinical assessments, and interviews, with a blood draw and other samples collected at the time a person enrolls ... Protocol #21-3844 Location: Childrens Hospital Colorado, University of Colorado Hospital |
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A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Monkeypox Virus Disease
Eligible and consented participants for the randomized arms (N=530) will be randomized 2:1 to receive either tecovirimat or placebo; participants with severe disease, significant skin conditions, participants with severe immune suppression will receive open-label tecovirimat. Participants ... Protocol #22-0797 Location: Adult Infectious Disease Clinical Trials Center, Outpatient CTRC, University of Colorado Hospital |
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A Multicenter, Adaptive, Randomized, Controlled Trial Platform To Evaluate Safety and Efficacy of Strategies and Treatments for Hospitalized Patients with Respiratory Infections - Appendix E-2: Immune Modulation Strategy Trial
Protocol #23-0870 Location: Outpatient CTRC, University of Colorado Hospital |
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A Phase 2, Randomized, Double-blind, Placebo-controlled, 2-part Study To Evaluate EDP-938 Regimens In Subjects Aged 28 Days To 36 Months Infected With Respiratory Syncytial Virus (RSV)
Study subjects will take an oral medication/placebo. Study activities include blood draws, nasal swabs, ECGs, and e-diary entries... Protocol #23-1409 Location: Childrens Hospital Colorado |