Preliminary evidence suggests that cognitive impairment is a common outcome experienced by individuals surviving Covid-19 (1-5). Cognitive impairment following Covid-19 which leads to critical illness is not surprising and perhaps even expected. However, significant cognitive deficits appear to be common even among individuals testing positive for Covid-19 who were never hospitalized. Questions exist regarding the mechanisms of the aforementioned cognitive impairment. The association between COVID-19 and brain dysfunction is not surprising since SARS-CoV has been found in the brain and because Coronaviridaes (CoVs) have been associated with central nervous system (CNS) diseases such as acute viral encephalopathy, acute disseminated encephalomyelitis, and multiple sclerosis (6-11).The possible brain entry routes for CoVs include either direct intranasal access to the brain via olfactory nerves or indirect access by crossing the blood-brain barrier (BBB) via hematogenous or lymphatic spread (9).

Type: Interventional

Start Date: Aug 2021

open study

Background: Most people who get COVID-19 seem to recover with no long-term effects. However, some people who recover from acute COVID-19 infections report lingering symptoms. This is called long COVID. Many people with long COVID report symptoms related to the nervous system; these can include problems with fatigue, speech, and memory. Objective: To test motor memory in people with long COVID, compared to healthy volunteers. Eligibility: People aged 18 to 90 years who are also enrolled in study protocol 000089. Healthy adults are also needed. Design: Participants will be screened by telephone. They will confirm they are able to type without discomfort using their nondominant hand. They will confirm they have access to a computer connected to the internet. All study tasks will be done online. Participants will complete 2 tasks in 2 days. Participants will be sent a link to a website. The website will give them instructions. They will place the fingers of their nondominant hand over 4 numbers on the keyboard and type a sequence (eg, 4-1-3-2-4). They will type this sequence as often as they can in 10 seconds. Then they will rest for 10 seconds before repeating the task. They will repeat this pattern for 15 minutes. After they finish the typing task, participants will take a 10-minute questionnaire. They will answer questions about their experiences with COVID-19 and memory issues; they will say which hand they use for tasks such as brushing their teeth or throwing a ball. Participants will get a notice to repeat the typing task 22 hours after they finish the first one. They should complete the second task within 28 hours....

Type: Observational

Start Date: Nov 2021

open study

REGENECYTE (HPC, Cord Blood, hUCB) for treatment in patients with post-COVID.

Type: Interventional

Start Date: May 2023

open study

Potential benefits of a nitrate-rich juice supplement to improve skeletal muscle function and associated physical capacity will be studied in patients with Long COVID. Consenting patients with Long-COVID will be randomized to receive Beet-It nitrate beverage group versus a nitrate-depleted placebo beverage. Both groups will receive physical therapy at the long COVID Clinic at VAPHS with therapeutic goals to improve strength, balance, inspiratory, and aerobic capabilities. Physical therapy will last for 2 weeks and include 2 or 3 sessions with a physical therapist a week depending on each individual's exercise tolerance. These sessions can take place on-site or at home (or a hybrid combination) All participants will undergo functional assessments and tissue assessments before and after the 14-day study intervention.

Type: Interventional

Start Date: Dec 2023

open study

The study staff will conduct a hybrid type 1 effectiveness implementation 2-arm trail with 360 Black young adults from Alabama, Georgia, and North Carolina. Participants will be randomized to receive the standard of care (control) or the TT-C intervention arm, each with a balance of 180 participants. Primary effectiveness outcome is COVID-19 vaccine uptake define as receipt of any vaccine (primary series or secondary booster). Secondary effectiveness outcomes are vaccine hesitancy, confidence, and knowledge, attitudes, and beliefs. The study staff will also conduct qualitative interviews with a group of purposively selected AA-YA participants (est. n=12-16) and site staff (est. n=6-8) to assess barriers and facilitators to implementation. The hypothesis is that the intervention arm will be more effective than the control arm at increasing vaccine uptake.

Type: Interventional

Start Date: Mar 2023

open study

A randomized double-blind, placebo controlled clinical trial of the safety, tolerability, and antiviral activity of angiotensin-converting enzyme 2 (ACE2) chewing gum over a 3-day period in non-hospitalized subjects with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection.

Type: Interventional

Start Date: Feb 2025

open study

This telephone-based survey included adults of Hispanic/Latino background residing in New Hampshire (NH). Information on food security and access, food environment, and health status and behaviors was collected through validated questionnaires. This project addresses the need for assessment of barriers to nutrition and health during COVID-19 in this population.

Type: Observational

Start Date: Oct 2021

open study

Individuals susceptible to SARS-CoV-2 and the illness it causes (COVID-19) are comprised of heterogeneous populations with a large risk spectrum for more severe disease. Pre-existing risk factors for a more severe course include respiratory and cardiovascular disease, morbid obesity, diabetes, underlying kidney or liver disease, and immunocompromised status. Whether children and young adults with inflammatory bowel disease (IBD) or juvenile idiopathic arthritis (JIA) receiving immunomodulating biologic and other therapies which are known to increase risk of viral infection are at increased risk of complications from COVID-19 or post-infectious co-morbidities, including the recently described multi inflammatory syndrome (MISC), is entirely unclear. This research focuses on the heretofore uncharacterized immune response to SARS-CoV-2 infection in children and young adults with IBD or JIA who are receiving maintenance immunosuppressive biologic therapies. Given the large Connecticut based infusion program, in a region of the United States with a recent large outbreak of COVID-19, the investigators have a unique opportunity to address a glaring knowledge gap in this unique pediatric, adolescent, and young adult population. The investigators will longitudinally determine antibody development and durability to SARS-CoV-2 in approximately 450-500 children and young adults with IBD or JIA receiving biologic therapy using a highly sensitive and specific quantitative assay utilizing novel technology. This period will include a return to school or work for many with likely resurgent infections, as well as the possible introduction of anti-SARS CoV-2 vaccines. The specific aim is to study the acute and convalescent antibody responses to SARS-CoV-2 infection in a cohort of children and young adults receiving infusions of biologic therapies for IBD and JIA.

Type: Observational

Start Date: May 2020

open study

Study to support the mental and physical well-being of US health care workers during the COVID-19 pandemic and ensure high-quality care for patients through Stress First Aid.

Type: Interventional

Start Date: Mar 2021

open study

The purpose of this randomized, double blinded, placebo controlled study is to assess the efficacy and safety of tofacitinib in hospitalized adult (18-99 years old) patients with SARS-CoV-2 and pneumonia who require supplemental oxygen and have serologic markers of inflammation but do not need mechanical ventilation.

Type: Interventional

Start Date: Oct 2020

open study

The viral Covid-19 outbreak is now considered a pandemic according to the World Health Organisation (WHO). A free monitoring app 'COVID-19 Symptom Tracker' has been developed to record and monitor the symptoms of the COVID-19 coronavirus infection; tracking in real time how the disease progresses. The app also records how measures aimed at controlling the pandemic including self-isolation and distancing are affecting the mental health and well-being of participants. The data from the study will reveal important information about the symptoms and progress of COVID-19 infection in different people, and why some go on to develop more severe or fatal disease while others have only mild symptoms do not.

Type: Observational

Start Date: Mar 2020

open study

This multilevel, multidisciplinary, theoretically based, culturally sensitive, community-engaged intervention sets out to mitigate uptake barriers and non-adherence to vaccination schedules as recommended by the CDC and increase influenza, meningitis, pneumonia, VZV, and COVID-19 vaccine rates among under-resourced African American and Latino public housing residents in South Los Angeles.

Type: Interventional

Start Date: Jul 2024

open study

The purpose of this study is to measure, monitor, and analyze long term effects of SARS-CoV-2. The main purpose is to assess the post-hospitalization outcomes of patients who were diagnosed with SAR-CoV-2 by comparing to patients who were hospitalized with an acute neurological disease.

Type: Observational

Start Date: Jan 2022

open study

This is a study to evaluate the immunogenicity, safety, and reactogenicity of mRNA-1273.211, mRNA-1273, mRNA-1273.617.2, mRNA-1273.213, mRNA-1273.529, mRNA-1273.214, mRNA-1273.222, mRNA-1273.815, and mRNA-1273.231 administered as booster doses.

Type: Interventional

Start Date: May 2021

open study

More than 17 million people have been infected and more than 677K lives have been lost since the COVID-19 pandemic. Unfortunately, there is neither an effective treatment nor is there a vaccination for this deadly virus. The moderate to severe COVID-19 patients suffer acute lung injury and need oxygen therapy, and even ventilators, to help them breathe. When a person gets a viral infection, certain body cells (inflammatory/immune cells) get activated and release a wide range of small molecules, also known as cytokines, to help combat the virus. But it is possible for the body to overreact to the virus and release an overabundance of cytokines, forming what is known as a "cytokine storm". When a cytokine storm is formed, these cytokines cause more damage to their own cells than to the invading COVID-19 that they're trying to fight. Recently, doctors and research scientists are becoming increasingly convinced that, in some cases, this is likely what is happening in the moderate to severe COVID-19 patients. The cytokine storm may be contributing to respiratory failure, which is the leading cause of mortality for severe COVID-19 patients. Therefore, being able to control the formation of cytokine storms will also help alleviate the symptoms and aid in the recovery of severe COVID-19 patients.

Type: Interventional

Start Date: May 2021

open study

Novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) OR COVID-19 related Addition: The aim of this addition activity is to track the impact of the COVID-19 epidemic on participants with diabetes and chronic kidney disease (CKD). Investigators have modified the original HBKC Study protocol to expand data currently collected from study participants to include data in the following domains linked to the COVID-19 epidemic: symptoms of COVID-19 disease, access to healthcare, and impact on health related behaviors (such as medication adherence, physical activity, dietary behaviors, smoking, and alcohol use).

Type: Observational

Start Date: Jan 2021

open study

Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has caused a global pandemic and is associated with significant morbidity and mortality. The mortality rate for COVID-19 patients admitted to an intensive care unit (ICU) who require mechanical intubation is approximately 75%. While the pathophysiology of severe COVID-19 has yet to be fully understood, it is possible that a combination of high viral loads and an overactive dysregulated inflammatory response may contribute. Therefore, the clearance of SARS-CoV-2 virus and cytokines could provide a more opportunistic environment for the innate immune system to clear the virus and establish lasting immunity. The Seraph®-100 Microbind® Affinity Blood Filter (Seraph®-100) is an extracorporeal broad-spectrum sorbent hemoperfusion filter for removing virus and cytokines from the blood. The FDA authorized an Emergency Use Authorization (EUA) for treatment of severe COVID-19 with the Seraph®-100. As part of the EUA, this registry study will collect de-identified data to assess safety and efficacy on the use of Seraph®-100 Microbind® Affinity Blood Filter in the treatment of COVID-19 patients.

Type: Observational [Patient Registry]

Start Date: Jun 2020

open study

Olfactory dysfunction (OD) is a defining symptom of COVID-19 infection. As the number of total, confirmed novel coronavirus SARS-CoV-2 (COVID-19) cases exceeds 45 million in the United States, it is estimated that up to 85% of infected patients will experience at least some olfactory dysfunction. Therefore, we propose a Pilot single-site clinical trial to explore the efficacy of MBSR for Covid-19-related smell distortion (parosmia)

Type: Interventional

Start Date: Sep 2023

open study

This study seeks to evaluate communication strategies for better encouraging understanding and uptake of salivary SARS-CoV-2 antibody testing among individuals residing in rural Northern Michigan. This iteration will consider individuals recruited from rural Northern Michigan and assess individuals' willingness to participate in home-based saliva sample collections.

Type: Interventional

Start Date: May 2023

open study

This study will examine the effectiveness of a 6-week behavioral intervention for patients who are recently diagnosed with COVID-19. Patients and their households will be randomized to one of two groups (Standard of Care vs. Enhanced Standard of Care). Patients in the Standard-of-Care group will receive established clinical care and follow-up. Patients in the Enhanced Standard-of-Care group will receive standard-of-care plus tailored, real-time text messaging and virtual counseling delivered by promotores/as. The investigators hypothesize that households in the Enhanced Standard-of-Care group will have fewer (any new) household COVID-19 infectivity rates compared to households in the standard-of-care group post-intervention.

Type: Interventional

Start Date: Apr 2022

open study

Background: Information is limited on the experience of children aged 15 to 17 who have or have not been vaccinated against COVID-19. Research has assessed attitudes toward COVID-19 vaccination among adults and parents of teenagers. Few surveys have explored attitudes among teens themselves. Objective: This anonymous cross-sectional survey of a national sample US teens to find out about their experiences and attitudes on getting vaccinated for COVID-19. This study will be conducted in collaboration with a national firm (Qualtrics) responsible for the recruitment and data collection. Eligibility: People aged 15 to 17 years. Participants will come from urban, suburban, and rural areas in the United States. Factors such as race and gender will match US averages. Participants will only include subjects recruited by Qualtrics from their national panel of available respondents, who have agreed to be contacted by Qualtrics with opportunities to participate in surveys. Design: Participants will be contacted by email. The email will include a link to the survey. The emails will be sent only to people who agreed to be contacted about taking surveys. Participants will complete the survey online. It should take only 10 minutes. Questions will include the following: Have participants been vaccinated against COVID-19? Are they in the process of getting vaccinated? Do they want to be vaccinated? Have they had trouble getting vaccinated? If so, what kind of barriers did they face? What reasons have they considered for and against getting vaccinated? What have their personal experiences been with COVID-19? What is their primary source of information about COVID-19? Other questions will ask about: Household size. Employment of people in the household. How many people in the house have been vaccinated. The primary language spoken at home. The natural history survey will be anonymous. Participants will not be asked to give their names....

Type: Observational

Start Date: Sep 2022

open study

San Diego State University (SDSU), a designated Hispanic-serving institution, is partnering with Sweetwater Union High School District, an independent public school district serving 90% ethnic minority and a high proportion of socioeconomically disadvantaged students, and other community partners, to generate evidence for effective and feasible COVID-19 testing for unvaccinated and medically vulnerable middle school students and staff as part of broader COVID mitigation strategies including vaccination to return students back to school safely.

Type: Interventional

Start Date: Oct 2021

open study

The purpose of this study is to demonstrate non-inferiority (NI) in terms of humoral immune responses after 6 dose levels of Ad26.COV2.S.

Type: Interventional

Start Date: Jun 2021

open study

The purpose of this study is to understand how to prevent COVID-19 spread in a school like the Mary Cariola Center (MCC) in Rochester, NY by answering questions like these: how do activities in the school alter chances of infection? Are there people infected with the COVID-19 virus who have no symptoms? How is spread of COVID-19 affected by vaccination rates? Is there any hesitancy to get the vaccine and what are the reasons? This information will be used to help keep the school open and the students and staff safe. Eligible participants are those that work at the Mary Cariola Center (MCC) and interact with the students at MCC who have a high risk of infection from COVID-19. The study lasts for up to 16 months.

Type: Interventional

Start Date: May 2021

open study

The pandemic caused by the novel coronavirus, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), has resulted in substantial global morbidity and mortality including in Oklahoma and caused unprecedented interruptions in nearly all aspects of our lives. The population of the state of Oklahoma is at particular risk to SARS-CoV-2 due to its large rural population, strained healthcare system, and poor overall health. The Community-Engaged Approaches to Testing in Community and Healthcare Settings for Underserved Populations (CATCH-UP) program will involve both practice-based and community-based approaches to maximize the reach of the Rapid Acceleration of Diagnostics - Underserved Populations (RADx-UP) consortium, broaden the potential perspectives that could be captured, and compare the effectiveness of strategies. The interventions will be pragmatic to allow CATCH-UP to respond to changing attitudes, barriers, and environments as the pandemic progresses as well as expected technology developments to produce more effective viral testing that can provide rapid results to patients. The investigators will assist 50 small primary care practices to implement guidelines-based testing and patient education about Coronavirus Disease 2019 (COVID-19) and risk mitigation strategies. The project's community-based approach is designed to rapidly respond to community testing needs by deploying mobile testing sites that will provide operational support to increase the efficiency and the existing capacity for state-wide testing by Oklahoma's public health authorities. Together, the investigators estimate that the CATCH-UP program will result in at least 105,000 SARS-CoV-2 tests performed during the first year of implementation. A comprehensive, ongoing evaluation will be performed to analyze patient and provider attitudes, barriers and facilitators of viral testing, identified health disparities caused by COVID-19, effectiveness of the intervention in both settings, and to allow robust collaboration with other RADx-UP consortium sites.

Type: Interventional

Start Date: Sep 2020

open study