Background: The SARS-CoV-2 virus has caused a pandemic infection called COVID-19. It is a global threat to people, communities, and health systems. Researchers are concerned about the mental health effects of the pandemic. They want to learn more about how it is affecting people s alcohol use and problems, and how it may continue to affect them over time. Objective: To study the impact of the COVID-19 pandemic on alcohol use and consequences in individuals across the spectrum of alcohol use and those with alcohol use disorder. Eligibility: Participants who have been screened under the NIAAA Screening, Assessment and Management Protocol (14-AA-0181) Design: Participants will complete a baseline survey by phone. It will ask about alcohol use, alcohol dependence, and stress. It covers 2 time periods: the 12 months before the pandemic started and the time since it started. Participants will get an ID code and a link to an online survey. They will complete the online survey within a week of the phone survey. Participants will complete a series of online surveys over 24 months. For the first year, surveys will be completed weekly for the first 4 weeks, then biweekly for the next 8 weeks, and then every 1-2 months for the rest of the year. For the second year, surveys will be completed every 6 months. Surveys will cover the following topics: - Alcohol use and its consequences - Other substance use - Stress - Impact of the COVID-19 pandemic - Pain - Physical health - Sleep - Quality of life. Because the course of the pandemic may change, the frequency of the surveys may change. Participation lasts 2 years.

Type: Observational

Start Date: Jun 2020

open study

The research objective is to assess the safety and potential efficacy of spleen ultrasound stimulation as an intervention for Long COVID in a pilot study. Specific Aims include: - Measure Long COVID disease activity before, during and after an 8-week course of spleen-directed daily ultrasound stimulation. - Measure molecular correlates of Long COVID disease activity before, during and after an 8-week course of spleen-directed daily ultrasound stimulation. - Track adverse events throughout the study to assess safety of the ultrasound intervention.

Type: Interventional

Start Date: Jan 2024

open study

The COVID-19 pandemic severely impacted the medical system both directly but also through incomplete recovery from the virus in the form of post-acute sequelae of COVID-19 (PASC). PASC affects at least 9.6 million individuals as of May 2022 and continues to affect many more. PASC is a multisystem disorder often presenting with mental fog, dyspnea on exertion, and fatigue among other symptoms. The etiology of PASC is uncertain but theories include direct cytotoxicity, dysregulated immune responses, endotheliitis associated with microthrombi, eNOS uncoupling, and myocardial fibrosis with impaired ventricular compliance. To date, there are no established treatments. Exercise has the potential as a therapeutic option to improve VO2peak and improve each of the aforementioned underlying etiologies. The investigators plan to examine the effect of High-Intensity Interval Training (HIIT) and Moderate intensity exercise training (MOD) on the symptoms and exercise tolerance of patients with PASC. The investigators approach will consist of a randomized, blinded, 2-arm, parallel-group design. Enrolled subjects will be randomly assigned to one of two groups in a 1:1 allocation ratio. All groups will undergo a 4-week intervention of 3 days of HIIT per week and 2 days of MOD per week or control of light stretching and controlled breathing. Subjects will be assessed before and after the 4-week intervention to examine the extent to which 4 weeks of the HIIT and MOD combination improves VO2peak and left ventricular diastolic function, global longitudinal strain (GLS), and global circumferential strain (GCS). Further, the investigators will explore changes in markers such as heart rate, heart rhythm, blood pressure, quality of life, exercise tolerance, and PASC symptoms as well as blood/serum markers.

Type: Interventional

Start Date: Sep 2023

open study

The OLE study aims to investigate the safety, efficacy, pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity of efgartigimod in participants with post-COVID-19 postural orthostatic.

Type: Interventional

Start Date: Jun 2023

open study

COVID-19 can trigger a dysregulated immune response, and previous studies have shown that immune modulation can improve outcomes in hospitalized patients. This trial is designed to determine whether intensification of immune modulation early in the course of the disease (while patients are on low flow oxygen) with abatacept (active arm) combined with standard of care (SOC) improves recovery as compared with placebo + SOC (placebo arm). For both groups, intensification of immunomodulation will be provided as part of SOC in case of signs of disease progression (patient requires high flow nasal oxygen (HFNO) or more support) and/or if the patient has rapidly increasing oxygen requirement.

Type: Interventional

Start Date: Jul 2023

open study

This research is being done to collect preliminary data on the potential of computerized "brain-training" exercises for treating Long COVID symptoms in older adults. The investigators hypothesize that computerized brain-training will be an acceptable and feasible intervention for treating Long COVID symptoms in older adults. The investigators also expect to provide initial evidence that computerized brain-training has potential for improving thinking, mood, and other aspects of everyday functioning in older adults with Long COVID.

Type: Interventional

Start Date: Apr 2023

open study

The overall goal of this project is to advance the understanding of underlying mechanisms impacting performance fatigability and perceived fatigability in Veterans with post-COVID-19 fatigue and explore the safety and feasibility of a home-based "minimal-dose" resistance exercise program in this population. The central hypothesis is that declines in force capacity, skeletal muscle oxygen extraction, and affective responses to physical activity offer potential mechanisms through which fatigability is increased in Veterans with post-COVID-19 fatigue. Moreover, home-based resistance exercise delivered remotely may provide a safe and feasibility treatment option for targeting neuromuscular and neurobehavioral factors influencing fatigability severity in this population.

Type: Interventional

Start Date: Jul 2023

open study

Long COVID patients experience high symptom burden for many months after initial infection of the COVID-19 virus. This study will investigate a mobile intervention Merging Yoga and Self-Management Skills (MY-Skills Mobile) as a complementary therapy for fatigue, pain, mood and quality of life in long COVID patients at the UCHealth Center for Integrative Medicine. The study aim is to assess the feasibility and acceptability of MY-Skills Mobile and research procedures including planned assessments.

Type: Interventional

Start Date: Feb 2023

open study

Primary objective: - To evaluate the efficacy of oral reparixin versus standard care alone in limiting disease progression in adult patients hospitalised for infectious pneumonia acquired in the community (CAP), including COVID-19. Secondary objectives: - To determine the effect of reparixin on several disease severity/progression measures including recovery, ventilatory free days and mortality. Safety objectives: - To evaluate the safety of oral reparixin versus placebo in the specific clinical setting.

Type: Interventional

Start Date: Apr 2022

open study

Healthcare providers (HCP) serving the El Paso U.S.-Mexico Border Region will be recruited to compare educational and professional skills interventions focused on the human papillomavirus (HPV). Our hypothesis is that improving provider knowledge and communication strategies about HPV and its vaccine will reduce hesitancy and increase uptake and completion among the populations they serve.

Type: Interventional

Start Date: Dec 2023

open study

The main goal of this study is to improve dysexecutive symptoms (e.g., sustained attention, processing speed) in patients exhibiting post-acute sequelae of COVID-19 (PASC) through home-based transcranial direct current stimulation (tDCS), a noninvasive method that uses low intensity electric currents delivered to the brain through stimulation electrodes on the scalp.

Type: Interventional

Start Date: Jun 2022

open study

This is a multi-center, randomized, double-blind, placebo-controlled clinical trial to evaluate a 21-herb formula named modified Qing Fei Pai Du Tang (mQFPD) to treat COVID-19-positive outpatients with mild-to-moderate symptoms assigned to self-quarantined and home management. This the study aims to establish the safety and feasibility of the use of mQFPD vs placebo in 66 total subjects. Subsequent trials will evaluate other therapeutics as well as the efficacy of mQFPD in a larger study population.

Type: Interventional

Start Date: Jul 2021

open study

The next phase of the COVID-19 pandemic is likely to see a surge in an associated chronic cardiopulmonary disease that will challenge health systems. Recovered patients are presenting with persistent dyspnea at the Duke Pulmonary Post-COVID clinic. Evidence is now mounting that recovered patients have significant residual pulmonary disease, while myocardial injury has also been increasingly reported. To optimally care for these patients, Duke Pulmonary study team must comprehensively assess and monitor the changes in cardiopulmonary function and relate the changes to physiologic and quality of life outcomes. The study team will deploy cutting-edge MRI to fully characterize cardiopulmonary function in enrolled 30 subjects (accrual 23 subjects) at time point 60-120 days post recovery and 6-9 months later. Cardiac MRI will assess the myocardial status and right ventricular function, while hyperpolarized 129Xe MRI will provide a 3D assessment of pulmonary ventilation, interstitial barrier integrity, and pulmonary vascular hemodynamics. The overall objective outlined in this study is to demonstrate the feasibility and value of comprehensive longitudinal imaging characterization of cardiopulmonary structure and function in patients recovered from Covid-19.

Type: Interventional

Start Date: May 2021

open study

The primary objectives of the study are: To assess the safety profile of the study vaccines in each study intervention group. To assess the neutralizing antibody profile after primary series vaccination in SARS-CoV-2-naïve adults. To demonstrate that a booster dose of monovalent or bivalent SARS-CoV-2 vaccine given to adults previously vaccinated with an authorized/approved COVID-19 vaccine induces an immune response that is non-inferior to the response induced by a twodose priming series with the monovalent vaccine, and superior to that observed immediately before booster. The secondary objectives of the study are: To assess the neutralizing and binding antibody profiles after primary series vaccination at pre-defined time points during the study. To assess the neutralizing and binding antibody responses of booster vaccination. To describe the occurrences of laboratory-confirmed symptomatic COVID19 after primary series and booster vaccination. To describe the occurrences of serologically-confirmed SARS-CoV-2 infection after primary series vaccination.

Type: Interventional

Start Date: Feb 2021

open study

The research objective of the UNITE Study is to assess device feasibility of ultrasound application to the spleen to assess its effect on coronavirus disease 2019 (COVID-19) in a pilot study with an off-the-shelf ultrasound GE device originally used for diagnostic applications. Specific Aims: 1. Determine the feasibility of splenic ultrasound with an ultrasound device in affecting physiological markers in COVID-19 infected patients between an ultrasound group versus a control group for the primary analyses; and 2. Evaluate the potential capabilities of splenic ultrasound in affecting additional outcomes in COVID-19 infected patients in the ultrasound group compared to a control group.

Type: Interventional

Start Date: Jan 2021

open study

The purpose of this study is to collect patients' experiences and feedback to better understand and improve mental health care using telehealth services. This is critically important as telehealth appointments, including both phone and video calls, continue to be offered for regular appointments to reduce in-person interaction as a preventive measure to help control the spread of COVID-19.

Type: Observational

Start Date: Dec 2020

open study

The purpose of this study is to evaluate the effectiveness of external evacuation units and mouth rinses during aerosol generating procedures in a dental clinic and to determine the risk level to the dental practitioners during aerosol generating procedures.

Type: Interventional

Start Date: Jul 2021

open study

The purpose of this trial is to understand whether: 1. Metformin vs fluvoxamine vs ivermectin vs metformin+fluvoxamine vs metformin+ivermectin is superior to placebo in non-hospitalized adults with SARS-CoV-2 disease for preventing Covid-19 disease progression. 2. To understand if the active treatment arms are superior to placebo in improving viral load, serologic markers associated with Covid-19, and gut microbiome in non-hospitalized adults with SARS-CoV-2 infection. 3. To understand if any of the active treatment arms prevent long-covid syndrome, PASC (post-acute sequelae of SARS-CoV-2 infection).

Type: Interventional

Start Date: Jan 2021

open study

The novel coronavirus (SARS-CoV-2) has spread all around the world and testing has posed a challenge globally. Health care providers are highly exposed and are an important group to test. On top of these concerns, health care workers are also stressed by the needs on responders in the COVID-19 crisis. The investigators will look at different ways to measure how common COVID-19 is among health care workers, how common is the presence of antibodies by serological tests (also known as serostatus). The investigators will describe health worker mental and emotional well-being and their coping strategies in their institutional settings. Lastly, the investigators will describe how knowing serostatus can affect individuals' mental and emotional well-being and how to cope in the midst of the COVID-19 response. This will help to how to better test and help healthcare workers in the COVID-19 pandemic and prepare for possible future outbreaks.

Type: Observational [Patient Registry]

Start Date: Apr 2020

open study

The purpose of the Phase 2 CSEG101B2201 study is to confirm and to establish appropriate dosing and to evaluate the safety in pediatric participants ages 6 months to <18 years with a history of VOC with or without HU/HC, receiving crizanlizumab for 2 years. The efficacy and safety of crizanlizumab was already demonstrated in adults with sickle cell disease. The approach is to extrapolate from the PK/pharmacodynamics (PD) already established in the adult population. The study is designed as a Phase II, multicenter, open-label study.

Type: Interventional

Start Date: Oct 2018

open study

Background: The COVID-19 pandemic infected and killed African Americans at higher rates than other Americans. Researchers want to understand why. Objective: This natural history study will look at how genetic, environmental, and social factors may predict or affect COVID-19 in African Americans. Information from this study will be combined with data from the GENE-FORECAST study. Eligibility: African Americans who were previously enrolled in GENE-FORECAST. Design: The study includes a telephone interview and 1 visit to the NIH clinic. Participants may engage in either one or both of these activities. The telephone interview will last 20 minutes. Participants will talk about their experiences during the COVID-19 pandemic. The clinic visit will last up to 4 hours. Participants will have a physical exam. They will have blood and urine tests. They will be tested for COVID-19. A long swab will be inserted into a nostril to get a fluid sample from the back of the nose. They will have noninvasive tests of their blood vessels. One device used is a pen-like probe placed lightly on the wrist. Another is a rubber sleeve placed around a finger while a blood pressure cuff is used on the arm. Participants will have a test to measure the electrical activity in their heart. Stickers attached to wires will be placed on their chest, arms, and legs. Participants will answer more questions about COVID-19. They will talk about their health behavior. They will talk about their family's health and the neighborhood they live in. Other questions will ask how they feel, live, work, and play....

Type: Observational

Start Date: Feb 2023

open study

The value of clinical cardiopulmonary exercise testing (CPET) within healthcare settings has been established in the last decade. CPET methods remain highly relevant in the COVID-19 endemic phase and should be used to assess those recovering from COVID-19 (SARS-CoV-2) infection. This diagnostic tool could play an integral role in disease prognostication and evaluate the integrative response to incremental exercise. Date from such assessments can enable practitioners to characterise cardio-respiratory fitness and identify reasons for physical impairment or abnormal cardio-respiratory function. More than 50% of patients admitted to hospital will experience cardiorespiratory issues and significant morbidity during their recovery and will require significant rehabilitative support. In this context, measurements obtained from an assessment of cardio-respiratory responses to physiological stress could provide insight regarding the integrity of the pulmonary-vascular interface and characterisation of any impairment or abnormal cardio-respiratory function. Current approaches to rehabilitation are being developed on existing knowledge from Severe Acute Respiratory Syndrome (SARS) and Acute Respiratory Distress Syndrome (ARDS) related illness. These provide important insight but do not provide insight into the novel challenges provided by COVID-19.

Type: Observational

Start Date: Mar 2023

open study

This study is a platform protocol 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 protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating various interventions for use in the treatment of autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (POTS), in PASC participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs.

Type: Interventional

Start Date: Mar 2024

open study

The goal of this clinical trial is to evaluate the SMILE app, a Digital Health Platform (DHP), that will deliver a mindfulness intervention, designed to mitigate COVID-19 related stress. Additionally, the SMILE app will remotely collect self-reported psychological and physiological metrics of mental health and autonomic regulation. Study participants are adults who self-identify as African American, Black and/or Latino, and who have clinically significant levels of anxiety. The study aims are: - Aim 1: Establish the effectiveness and durability of an 8-week Mindfulness DHP intervention. The investigators will focus on two constructs important to mental health and hypothesize that: A) Anxiety, self-report stress and quality-of-life measures will significantly improve when comparing: A.1) Pre-to-post intervention, and; A.2) Control vs. intervention groups over 8 weeks and at 1-month follow-up. B) Arousal, autonomic indices of HRV (reflecting parasympathetic activation) will significantly improve, when comparing: B.1) Pre-to-post intervention, and; B.2) Control vs. intervention groups over 8 weeks and at 1-month follow-up. - Aim 2: Establish the sustainability of two Mindfulness DHP interventions utilizing retention, usage (frequency), and participant satisfaction. - Aim 3: Examine associations between COVID-19 related stress, mental health outcomes, and HRV. Examine the extent to which COVID-19 related stress and mental health symptoms are linked to HRV at baseline and how that relationship changes over time. Participants will be assigned to 1 of 3 arms of the study: MTIA intervention, MAPP intervention, or wait-list control. All participants will be mailed a device with the SMILE app installed, and the equipment for recording cardiac data in the home. All participants will complete the baseline psychometrics measures and physiological stress test using the instructions provided on the SMILE app. Those assigned to the MTIA or MAPP intervention groups will then participate in their assigned intervention over the subsequent 8 weeks. During these 8 weeks, psychometric and physiological data will be completed biweekly for all participants. 3 months following the initial baseline, all participants will complete a final psychometric/physiological evaluation.

Type: Interventional

Start Date: May 2024

open study

The goal of this clinical trial is to develop a comprehensive mental health counseling program purposed to address the social determinant of health impacts of the coronavirus disease of2019 (COVID-19). The main questions the investigators aim to answer are: 1) What are the mental and social determinant of health impacts of a COVID-19 diagnosis, and 2) What are the impacts of a counseling program implemented to address those impacts? Participants will participate in individual interviews, attend individual and group counseling, and be provided resources related to their social determinants of health needs.

Type: Interventional

Start Date: Apr 2024

open study