Background: The COVID-19 global pandemic killed more than 6 million people worldwide. Several vaccines have been developed against the virus that causes this disease. These vaccines are effective at preventing severe symptoms and death from COVID-19. Some people with chronic liver disease, especially those with an advanced condition called cirrhosis, do not respond to many vaccines as well as healthy people do. The goal of this natural history study is to find out how well people with chronic liver disease respond to the COVID-19 vaccines. Objective: To learn how chronic liver disease affects the body s immune response to vaccination against COVID-19. Eligibility: People aged 18 years or older with chronic liver disease. They must also be enrolled in protocol 91-DK-0214 or 18-DK-0091. Design: Participants will have 3 visits, each spaced 6 months apart. Each visit will last 2 hours. Participants will have their vital signs recorded. These include age, sex, race, height, and weight. They will give their medical history. At each visit, participants will have blood drawn through a needle inserted into a vein in the arm. The sample drawn at each visit will be from 1 to 8 tablespoons. At each visit, participants will fill out a questionnaire. They will answer questions about whether they have been vaccinated against COVID-19; whether they have had COVID-19; and whether they have been exposed to someone who had COVID-19. The questionnaire will take 10 to 15 minutes. Researchers will also look at results of past blood tests from other research studies.

Type: Observational

Start Date: Mar 2023

open study

Background: SARS-CoV-2 is the virus that causes COVID-19. Some people who recover from COVID-19 have long-term symptoms that affect the brain. These include headaches; loss of taste and smell; sleep problems; thinking problems; depression; and anxiety. Researchers want to know if a tracer (a substance that is injected into a person s body before an imaging scan) can help identify inflammation in people with these brain disorders. Objective: To see if a radioactive tracer ([11C]PS13) can highlight brain inflammation in those who had COVID-19 but still have symptoms that affect the brain. Eligibility: Adults aged 18 to 70 years with post COVID-19 brain disorders who are enrolled in protocol 000089 or 000711. Healthy volunteers are also needed. Design: Participants will have up to 5 clinic visits. Participants will be screened. They will have blood tests and a test of their heart function. They will have imaging scans: Magnetic resonance imaging (MRI): They will lie on a table that slides into a metal tube. Pictures will be taken of the brain. Positron emission tomography (PET): A needle attached to a thin tube will be inserted into a vein in the arm. The tracer will be injected through the tube. Another needle attached to a thin tube will be inserted into the wrist or inside of the elbow of the other arm to draw blood. They will lie still on a bed while a machine captures images of their brain. The scan will last about 2 hours. Study involvement is 11 to 14 weeks....

Type: Interventional

Start Date: Apr 2025

open study

Background: Vaccines against SARS-CoV-2, the virus that causes COVID-19, have been highly effective against preventing severe disease. But the protective effects of these vaccines appear to wane over time. Researchers want to learn why. Objective: To learn more about how the immune system responds to vaccines against infections like SARS-CoV-2. Eligibility: Healthy adults ages 18 or older who are scheduled to receive either a new vaccine or a booster shot against SARS-COV-2 or another emerging infection. Design: Participants will be screened with a medical history and blood and urine tests. Participants will have up to 8 study visits in 1 year. Each visit should last less than 2 hours. At each visit, participants will give blood samples. Some blood samples will be used for genetic testing. They will also give updates on their health. After the first study visit, participants will receive either a first vaccination or a booster shot. They must get the vaccine in their community or workplace. They will not get the vaccine at NIH. This study currently focuses on SARS-CoV-2, but it will expand to other infectious diseases as they emerge and become the target of new vaccines. ...

Type: Observational

Start Date: Oct 2021

open study

The purpose of this study is to determine if immune responses differ when the mRNA COVID-19 vaccine is given through different delivery methods, including a needle-free injection system, or via intramuscular injection using needle and syringe

Type: Interventional

Start Date: May 2025

open study

This is an open-label phase 1/2, dose-escalation study. Participants will receive a single intramuscular (IM) dose of IMNN-101 on Day 0 in the deltoid muscle and will be followed through 12 months post-vaccination (through Study Day 365).

Type: Interventional

Start Date: Jun 2024

open study

The goal of this project is to understand the household level transmission dynamics and factors that predict transmission of SARS-COV-2 between pediatric and adults in the household. The novel coronavirus SARS-CoV-2 has spread all around the world and testing has posed a challenge globally. Not much is known about who does and does not acquire SARS-CoV2. It is also unknown who will show symptoms or progress severe disease or death from COVID-19. Children tend to have milder symptoms or none at all. Therefore, few children have ever been tested, so it is unknown if they get the infection as much as anyone else. Health care providers are highly exposed, and they do not get tested unless they show severe symptoms. If groups like children and health workers are infected, they can unknowingly spread SARS-CoV-2, unless they practice behaviors like self-isolation very strictly. The investigators aim to measure the prevalence of SARS-CoV-2 in children and health care workers at a large urban health center. The investigators will also measure how many people in the household of the positive children and health care workers also get SARS-CoV-2 infection. Lastly, the investigators will see what other risk factors affect who acquires SARSCoV-2 from inside or outside of the household clusters.

Type: Observational

Start Date: Aug 2021

open study

The goal of this study is to assess the best COVID-19 vaccine uptake strategy among students, staff and household members that have not been vaccinated. There is a multitude of recommendations present that highlight different vaccination strategy; however, it is still unclear which strategy is best to increase COVID-19 vaccination rates. We will compare the effectiveness and acceptance of two different communication strategies among unvaccinated students, staff, and their household members.

Type: Interventional

Start Date: Jul 2022

open study

This study entitled Community-Centered Interventions for Improved Vaccine Uptake for COVID-19 (CIVIC): Getting to Yes, Michigan!, is designed to increase vaccine uptake among populations that experience COVID-19 related disparities. The investigators will focus on the four counties within Michigan where a disproportionate burden of COVID-19 is within African Americans and Latinx communities, i.e., Wayne, Genesee, Kent and Washtenaw Counties. Using a community-based participatory research (CBPR) approach, CIVIC will leverage: its long term relationships with the communities involved, an established CBPR Steering Committee developed and the knowledge gained as a Community Engagement Alliance (CEAL) grant recipient, the resources and networks of the University of Michigan CTSA (MICHR), and the expertise of our academic partners to identify and understand factors that contribute to COVID-19 vaccine hesitancy in African Americans and Latinx communities in Michigan. The investigators will develop and test interventions based on community-centered approaches to achieve a primary goal of increased vaccine uptake. The investigators will achieve this goal with the following aims: 1. Increase understanding of the barriers and drivers of vaccine uptake and hesitancy; 2. Increase vaccine uptake and decrease vaccine hesitancy through the implementation and evaluation of a multi-component intervention; and maintain, enhance, and evaluate the effectiveness of the CIVIC partnership to equitably engage all partners.

Type: Interventional

Start Date: Jul 2022

open study

This study will enroll individuals who have: - Completed primary series of mRNA COVID-19 vaccine, and - An antibody response ≤ 2500 U/mL measured at least 30 days after the last dose of vaccine. This group of patients is at high risk for severe COVID-19 disease due to pharmacologic immunosuppression and a high prevalence of non-transplant risk factors such as obesity and diabetes.

Type: Interventional

Start Date: Dec 2021

open study

The purpose of this study is to evaluate pulmonary function of patients recovering from mild, moderate, and severe COVID-19 disease using hyperpolarized 129Xe MRI.

Type: Interventional

Start Date: Feb 2021

open study

The Professional Peer Resilience Initiative (PPRI) study is an observational study aimed at understanding how symptoms of traumatic stress and resilience evolve over time in the University of Minnesota (UMN) healthcare workforce during the coronavirus disease 2019 (COVID-19) pandemic. The study is being conducted concurrently with a UMN peer support program called the MinnRAP program and will remotely administer quality of life and mental health surveys to healthcare workers before they start the MinnRAP program and throughout their participation in the program.

Type: Observational

Start Date: Jun 2020

open study

Background: People who get COVID-19 have a wide range of symptoms. They also recover from COVID-19 in different ways. In this study, researchers will use survey data to describe the different ways people experience and recover from COVID-19. They will also use the data to help create future studies to understand why some people do not fully recover. Objective: To learn more about the range and timing of symptoms that people have before, during, and after COVID-19 infection. Eligibility: People ages 18 and older who can give documentation of a positive COVID-19 or antibody test. Design: Participants will be screened with a telephone interview. It will take 15 minutes. They will provide their COVID-19 test results and medical records. Participants will complete a second telephone interview. It will take 30 60 minutes. They will also take online surveys every 3 months for 3 years. The interview and surveys will ask participants about their health before they got COVID-19, what happened while they had COVID-19, and what their recovery has been like. Participants will get log-in data to take the online surveys. Completing all of the surveys the first time may take up to 3 hours. Follow-up surveys will take up to 30 minutes. Participants do not have to complete the surveys in one sitting. They will be able to save their progress and finish the surveys later. Participants may be contacted to take part in other research studies.

Type: Observational

Start Date: Jan 2022

open study

Study VBT00001 is planned to be a Phase 1/2, randomized, modified double-blind, active-controlled, multi-center study to be conducted in approximately 980 adults aged 50 years and older in the United States. The purpose of the study is to assess the safety and immunogenicity of IIV-HD (high-dose inactivated influenza vaccine) + rC19 (adjuvanted recombinant COVID-19 vaccine) vaccine comprised of IIV-HD combined with different recombinant Spike (rS) antigen levels of rC19 compared to IIV-HD alone, rC19 (dose 1) alone, and IIV-HD and rC19 (dose 1) (coadministered in opposite arms). Placebo will be coadministered in the IIV-HD alone, rC19 (dose 1) alone, and IIV-HD + rC19 study groups to control for the number of injections and to maintain observer-blinding. Thus, each participant will receive two injections at enrollment, one in each deltoid muscle. Study details include: - The study duration will be approximately 12 months - Study intervention will be administered via a single intramuscular (IM) injection into the right and left deltoid muscles on D01 - Dose escalation with sequential enrollment (sentinel cohort followed by main cohort for a given dose) - The visit frequency will be D01, D09 (telephone call), D30, D182 (telephone call), and D366 (telephone call) Number of Participants: Approximately 980 participants are expected to be randomized.

Type: Interventional

Start Date: Nov 2024

open study

This is an appendix of master protocol (NCT05595369) designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans. This sub-study is a prospective, multi-center, double-blind, randomized, controlled trial evaluating nirmatrelvir/ritonavir (Paxlovid) in two dosing durations for the treatment of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC). The study is evaluating potential mechanisms of action, efficacy, and safety of antivirals and other therapeutics in individuals with PASC, according to the platform protocol objectives. The hypothesis is that persistent viral infection and/or overactive/chronic immune response and inflammation are underlying contributors to PASC and that antiviral and other applicable therapies may result in viral clearance or decreased inflammation and improvement in PASC symptoms.

Type: Interventional

Start Date: Jul 2023

open study

Adults who do not have major health, kidney, gastrointestinal disease will be randomized to receive oral mitoquinone/mitoquinol mesylate (Mito-MES) versus placebo to prevent the development and progression of COVID-19 after high-risk exposure to a person with confirmed SARS-CoV-2 infection.

Type: Interventional

Start Date: Mar 2024

open study

This study is a 24-30 month behavioral intervention study to assess the impact of enrolling individuals a clinical pharmacist run telehealth education focused on wellness and vaccination. Individuals will be randomized to either a wellness only model focusing on nutrition, diabetes and hypertension or a wellness model with a vaccination education component. All participants will complete individual and group based interventions. Individuals will be recruited from industries with high risk for COVID-19 and other respiratory illness infection, such as health workers, teachers aides and the food industry. We are recruiting individuals who identify as African-American, Hispanic, come from a semi-rural/rural community or have additional social determinants of health that indicate social vulnerability. The primary outcome is COVID-19 vaccine completion. The secondary outcome is influenza vaccine completion.

Type: Interventional

Start Date: Jan 2024

open study

The main purpose of this study is to gather data and assess changes in patient-reported outcomes with the stellate ganglion blocks as treatment for their sympathetically-mediated long COVID symptoms.

Type: Interventional

Start Date: Jan 2023

open study

The goal of this proof-of-concept clinical trial is to determine whether cardiac rehabilitation improves exercise capacity and chronotropic (heart rate) response to exercise among people with Long COVID. The study will include individuals with confirmed SARS-CoV-2 infection, symptoms not present prior to COVID-19 that are persistent for at least 3 months after acute infection ("Long COVID"), and who have reduced exercise capacity less than predicted and reduced heart rate response during cardiopulmonary exercise testing (CPET). In addition to the primary outcome of change in peak VO2, secondary outcomes will include change in symptoms including autonomic symptoms (COMPASS-31), anxiety (GAD-7), depression (PHQ-9), endothelial function with brachial artery flow-mediated dilation, and satisfaction (net-promotor score).

Type: Interventional

Start Date: Dec 2022

open study

The purpose of this study is to evaluate the impact of vagal nerve stimulation on patients with post COVID syndrome who have fatigue and headache.

Type: Interventional

Start Date: Dec 2022

open study

The main goal of this study is to evaluate the safety, reactogenicity, and immunogenicity of study vaccines.

Type: Interventional

Start Date: May 2022

open study

The main purposes of Part A of this study are to evaluate the safety, tolerability, and immunogenicity of mRNA-1345 coadministered with a seasonal influenza vaccine (Afluria® Quadrivalent); to evaluate the impact of coadministered influenza vaccine on the immune response to RSV-A; and to evaluate the impact of coadministered RSV vaccine on the immune response to influenza. The main purposes of Part B of this study are to evaluate the safety, tolerability, and immunogenicity of mRNA-1345 coadministered with mRNA-1273.214; to evaluate the effect of coadministered mRNA-1273.214 on the immune response to RSV-A; and to evaluate the effect of coadministered RSV vaccine on the immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The main purposes of Part C (single arm, open-label) of this study are to evaluate the safety and tolerability of a booster dose (BD) of mRNA-1345 administered at 1 Year following a primary dose; to evaluate the immune response to RSV-A of a BD of mRNA 1345 administered at 1 Year following a primary dose; and to evaluate the immune response to RSV-B of a BD of mRNA-1345 administered at 1 Year following a primary dose.

Type: Interventional

Start Date: Apr 2022

open study

Lung transplant recipients have poor outcomes after COVID-19 infection with mortality. Due to the immunosuppression, they have had poor responses to SARS-CoV-2 vaccine and remain at high risk of poor outcomes. This is a Phase I/II clinical trial to evaluate the safety and immune response from a higher dose mRNA-1273 vaccine among lung transplant recipients who have already received three or four doses of the COVID-19 vaccine.

Type: Interventional

Start Date: Mar 2022

open study

This phase 2 trial studies the immune response to GEO-CM04S1 (previously designated as COH04S1) compared to standard of care (SOC) mRNA SARS-COV-2 vaccine in patients with blood cancer who have received stem cell transplant or cellular therapy. GEO-CM04S1 belongs to a category called modified vaccinia Ankara (MVA) vaccines, created from a new version of MVA, called synthetic MVA. GEO-CM04S1 works by inducing immunity (the ability to recognize and fight against an infection) to SARS-CoV-2. The immune system is stimulated to produce antibodies against SARS-CoV-2 that would block the virus from entering healthy cells. The immune system also grows new disease fighting T cells that can recognize and destroy infected cells. Giving GEO-CM04S1 after cellular therapy may work better in reducing the chances of contracting coronavirus disease 2019 (COVID-19) or developing a severe form of COVID-19 disease in patients with blood cancer compared to SOC mRNA SARS-CoV-2 vaccine.

Type: Interventional

Start Date: Sep 2021

open study

Pregnant women are a vulnerable and high-risk population, as COVID-19 is associated with an increased risk preterm birth, cesarean section, and maternal critical care. This study will examine the factors that impede testing for SARS-CoV-2 (the causative virus among pregnant women), help determine optimal testing strategies by evaluating the necessity of testing for asymptomatic disease in pregnancy, inform prenatal care plans by assessing the full impact of infection, and contribute to a provider's ability to counsel women and create prenatal care plans if they are pregnant or considering pregnancy.

Type: Interventional

Start Date: Mar 2021

open study

This clinical trial will evaluate the safety, tolerability and efficacy of GLS-1027 in the prevention of severe pneumonitis caused by SARS-CoV-2 infection

Type: Interventional

Start Date: May 2021

open study