This study is a Phase 3 trial designed to check the safety and immune response to a new Omicron JN.1 COVID-19 vaccine. Study researchers will give a single dose of this vaccine, called NVX-CoV2705, to approximately 120 participants. This includes adults aged 65 and older, and individuals aged 12 to 64 who have existing health conditions that put them at high risk for severe COVID-19. All participants must have received a previous COVID-19 vaccine at least 90 days before joining this study. Study researchers will be closely monitoring participants for their immune response for 28 days and collecting safety data for 180 days after vaccination.

Type: Interventional

Start Date: Oct 2025

open study

The primary objective of the study is to determine the relative efficacy of the investigational oral severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccine tablet VXA-CoV2-3.3 compared to a currently recommended vaccine for the prevention of symptomatic Coronavirus Disease 2019 (COVID-19). In order to represent a more recently circulating SARS-CoV-2 variant, the main study endpoints will now evaluate the VXA-CoV2-3.3 (KP.2 strain) vaccine, and not the VXA-CoV2-3.1 (XBB.1.5 strain) vaccine.

Type: Interventional

Start Date: Oct 2024

open study

This two-year study will evaluate the feasibility and safety of an exercise + cognitive training program to improve neurological symptoms of long-COVID. This is a two-phased trial: 1) an exercise phase and 2) a cognitive training phase. The exercise phase will be an aquatic based exercise program. A combination exercise + memory training programs designed for persons with cognitive impairment have significantly improved memory more than other single intervention groups (exercise only, cognitive training only) and given the success of combination training programs with healthy adults, it is important to adapt these programs for persons with neurological symptoms of long-COVID.

Type: Interventional

Start Date: Dec 2024

open study

Researchers are doing this study to find out if a high fermented food diet is tolerable, and if it will help improve quality of life after surviving a critical illness, including severe COVID-19, by promoting gut health recovery and decreasing gut inflammation.

Type: Interventional

Start Date: Feb 2024

open study

This clinical trial aims to test the effects of fluvoxamine as a treatment for Long COVID. Fluvoxamine is an FDA approved SSRI for Obsessive Compulsive Disorder (OCD), that has already had success in preventing hospitalization in patients with COVID-19 (STOP COVID and TOGETHER trials). This trial is testing whether fluoxamine helps to improve symptoms and the negative impacts of long COVID in residents of Missouri and Illinois.

Type: Interventional

Start Date: May 2023

open study

Performance of the LumiraDx SARS-CoV-2 Ag ULTRA assay will be assessed by comparison to a reference method

Type: Observational

Start Date: Jun 2022

open study

This two-year project will adapt and conduct a trial examining the ability of two recruitment strategies, chain-referral and credible messenger, to reach those who use opioids and other substances in order to increase their uptake of onsite point of care COVID-19 testing that will be delivered in two community based organizations (CBOs): Alliance for Positive Change and Argus Health Inc. In Phase 1, Adapt two implementation strategies to support COVID-19 testing uptake and sustainability, adapting elements of existing efficacious social network-based interventions via a CBPR approach. In Phase 2, we will examine and compare the efficacy of two sets of implementation strategies on (i) reach, (ii) testing uptake, (iii) service delivery (i.e. quarantine, medical care, contact tracing) and (iv) sustainability for individuals who use opioids and other drugs. In Phase 3, Elucidate and compare the system/organizational-, staff-, and individual-level factors that influence implementation (i.e. fidelity, acceptability, feasibility, sustainability) of the strategies to develop a plan for dissemination and scale-up in other CBOs who serve opioid and other substance using individuals in NYC.

Type: Interventional

Start Date: Apr 2021

open study

Evaluation of the agreement between fingerstick samples, venous blood, serum and plasma samples when using the LumiraDx SARS-CoV-2 Ab Test against the reference method, using standard qualitative comparison techniques.

Type: Observational

Start Date: Jul 2020

open study

Performance of the LumiraDx SARS-CoV-2 Ag assay will be assessed by comparison to a reference method.

Type: Observational

Start Date: Jun 2020

open study

The study is a randomized, double-blind, placebo-controlled, dose escalation, multi-center clinical trial (RCT) of SPI-1005 in adult subjects with positive PCR test for novel SARS-CoV-2 (nCoV2) and severe symptoms of COVID-19 disease.

Type: Interventional

Start Date: Aug 2021

open study

This study is a Phase 1 / 2 trial to determine the safety and efficacy of CYNK-001, an immunotherapy containing Natural Killer (NK) cells derived from human placental CD34+ cells and culture-expanded, in patients with moderate COVID-19 disease.

Type: Interventional

Start Date: Sep 2020

open study

The goal of this clinical trial is to test a compounded dimethyl sulfoxide (DMSO)-based dual-route therapy for adults with refractory subjective tinnitus linked to long-COVID (post-acute sequelae of SARS-CoV-2) or post-COVID-19 vaccine injury. Participants have bothersome tinnitus that has not improved with at least two prior standard treatments. All participants will receive two study treatments for 30 days: a DMSO-based ear canal liquid and a DMSO-based transdermal cream applied to the skin around the ears and upper neck. The ear drops are used every 4 days, and the cream is applied once daily at bedtime. Both formulations are prepared by a licensed compounding pharmacy. The main question is whether at least half of the participants achieve a 50% or greater reduction in their Tinnitus Handicap Inventory (THI) score from baseline to Day 30. Researchers will also look at changes in tinnitus loudness and annoyance, sleep and concentration, other symptoms such as vertigo, insomnia, headache, and fatigue, and any side effects. After an initial in-person ear, nose, and throat (ENT) evaluation, all study visits are conducted by telemedicine. Participants complete electronic questionnaires through a secure, HIPAA-compliant system over 12 months of follow-up.

Type: Interventional

Start Date: May 2026

open study

This study uses total-body [¹⁸F]F-AraG PET/CT imaging to investigate immune activation and vascular changes in individuals with post-acute sequelae of SARS-CoV-2 infection (PASC), also known as Long COVID. Participants will undergo dynamic PET/CT imaging along with blood biomarker assessments and symptom evaluations. The study aims to characterize sites of immunological perturbation, correlate PET imaging findings with peripheral blood markers, and evaluate longitudinal changes in tissue-based immune activity in relation to symptom patterns over time. Data from this study will improve understanding of tissue-level immune dysregulation in PASC and support future clinical tools for assessing and managing this condition.

Type: Interventional

Start Date: Dec 2025

open study

Growing evidence indicates that many people who have chronic post-acute sequelae of SARS-CoV-2 infection (PASC) will experience ongoing neurological and musculoskeletal impairment that can affect gait and balance. Identifying the factors contributing to these impairments and how they influence functional mobility is the first step towards creating effective evaluation and treatment protocols. In this study the investigators will examine cognition, vision, proprioception, muscle strength, gait and balance in persons with and without PASC to understand how PASC may impact functional mobility through a cognitive-sensorimotor lens. Gait and balance will be studied in environments that stress cognitive and sensory abilities. Study outcomes will be critical for the development of evidence-based Veteran Health Administration diagnostic and standard-of-care protocols to address gait and balance dysfunction in Veterans with PASC for restoring their functional mobility and independence.

Type: Observational

Start Date: Apr 2026

open study

Despite the availability of vaccines, there remains a need to identify specific immune responses that correlate with protection against SARS-CoV-2 infection. Additionally, the operational capability of retail pharmacy infrastructure to collect longitudinal data and biological samples needs to be assessed. This study aims to fill these gaps by determining correlates of protection (CoP), assessing the infrastructure's capability, and examining demographic and geographic differences in participation.

Type: Observational [Patient Registry]

Start Date: Oct 2024

open study

This is a Phase 1 non-randomized, open-label, multiple dose, parallel-group study of ALG-097558 in subjects with moderate hepatic impairment and subjects without hepatic impairment, matched for age, body weight and, to the extent possible, for gender. The primary purpose of this study is to characterize the effect of hepatic impairment on the plasma pharmacokinetics of ALG-097558 following administration of multiple, twice daily (Q12H) oral (PO) doses.

Type: Interventional

Start Date: Jan 2025

open study

This is a prospective, randomized, open-label clinical trial to evaluate the safety of COVID-19 vaccination and other routine childhood vaccines given simultaneously at Visit 1, as compared to sequential vaccination of COVID-19 vaccine and other vaccines at separate visits (Visits 1 and 2). Parent(s) or legal authorized representative(s) (LAR) will assess fever and other solicited systemic adverse events on the day of vaccination (Day 1) and the next 6 days (through Day 7) following Visit 1 and Visit 2 using either a web-based data collection system or a paper memory aid. Serious adverse events and adverse events of special interest will be captured during the entire study period. Parental/LAR perceptions about their child's vaccine schedule will be assessed on Day 7 following Visit 2.

Type: Interventional

Start Date: Oct 2023

open study

Frailty is associated with higher rates of morbidity, mortality, and failure to rescue after major surgical procedures. Sarcopenia is degenerative loss of skeletal muscle mass and strength. It is a key component of physical frailty and is associated with poorer post-surgical outcomes due to decreased patient strength and vitality.

Type: Observational

Start Date: Apr 2022

open study

This phase II trial compares the effect of the GEO-CM04S1 vaccine with the current standard of care vaccine in preventing COVID-19 infections in patients with chronic lymphocytic leukemia (CLL). The GEO-CM04S1 vaccine uses a modified vaccinia virus (MVA) backbone that may be more effective at boosting COVID-19 immunity in patients with poor immune responses. MVA strongly induces T cell expansion (infection fighting blood cells) even in the background of a suppressed immune system, which is the case in the targeted CLL patient population. Using the GEO-CM04S1 vaccine may be more effective at preventing COVID-19 infection in patients diagnosed with CLL.

Type: Interventional

Start Date: Aug 2023

open study

The purpose of this study is to learn about the safety and effects of the vaccine (called COMIRNATY) for the potential prevention of COVID-19. This study is seeking participants who: 1. Are age <21 years. 2. Have presentation to participating medical center with evaluation in Emergency Room and/or hospitalization. 3. Received any dose(s) of COMIRNATY within 21 days of symptom onset. 4. Meet criteria of Centers for Disease Control and Prevention case definition of probable or confirmed myocarditis/pericarditis 5. Are capable of giving signed informed consent/assent (by parents/legal guardians of minors and/or patients), which includes compliance with the requirements and restrictions listed in the Informed Consent/Assent Document and in this protocol OR meets criteria for waiver of consent. This study will examine the potential long-term effects associated with myocarditis/pericarditis following vaccination with COMIRNATY. The association of myocarditis/pericarditis in participants who received the study vaccine (COMIRNATY) compared with those associated with COVID-19 will also be examined. This will help us determine if COMIRNATY is safe and effective, and if there is a myocarditis/pericarditis association that should be noted. Participants will take part in this study for up to 5 years. During this time, they will receive complete cardiac imaging tests, and have follow up visits per guidance stated in the study protocol.

Type: Interventional

Start Date: Nov 2022

open study

Collection of SARS-COV-2 Secretions and Serum for Countermeasure Development (aka ClinSeqSer) is an observational study to understand natural history of SARS-COV-2 infections among special populations and characterise post-covid morbidity through immune response, virus genome sequencing, cytokine response, and virus shedding. Given the descriptions of infection course of patients over the outbreak of 2003 (SARS-Cov01) and since January 2019 in China and Europe, and now worldwide: 1. Acutely infected patients shed virus that could be of major interest to characterize (viral quantification, characterization of virus shedding -of infective and of non-infective virus) the former reflecting/predictive of severity of disease and the latter reflecting extent/source of contagiosity. 2. Convalescent infected patients develop a specific anti-virus antibody response that is (likely) protective and therefore suits the preliminary requirement for the potential benefits of the convalescent patient plasma therapeutic infusion approach. In addition, long term effects of COVID-19 commonly known as long-haulers remains clinically unclear. Thousands of patients have now been diagnosed with COVID-19 in Louisiana (444,000 cases, 10,122 deaths, 2.2% mortality in Louisiana (LA), as of March 2021), and numerous patients are now also complaining of post-acute sequelae of SARS-CoV-2 (PASC). The investigators want to further clarify questions surrounding rational confinement duration and therapeutic approach by collecting plasma of convalescent patients to identify optimal antibody titer by ELISA, specificity of naturally occurring inflammatory (protein/antibody and RNA) response, and possibly test in vitro antibody neutralization activity.

Type: Observational

Start Date: Mar 2020

open study

Establish a biorepository, clinical data registry, and radiographic image database from individuals who were COVID positive at one time and are being seen for outpatient follow-up or a separate study visit.

Type: Observational [Patient Registry]

Start Date: Feb 2021

open study

This is a single center, single arm exploratory imaging study involving up to two intravenous microdoses of [18F]F-AraG (the second tracer dose is optional) followed by whole-body PET-CT imaging in participants with convalescent COVID-19. Up to 80 participants will be enrolled over an accrual period of approximately 48 months.

Type: Interventional

Start Date: Apr 2021

open study

People have had to make a lot of changes to their lives due to the COVID-19 health crisis. Most experts agree that social distancing and other safety measures have taken a toll on people s mental health. Amish and Mennonite communities often have large families. They may have limited access to health care. Their lifestyle is based on interaction and group events rather than technology. So people in Amish and Mennonite communities may experience the pandemic in their own special ways. Objective: To describe the relationship between stress related to the pandemic and self-rated measures of mental health symptoms and distress among Amish and Mennonite people with bipolar disorder and related conditions, and their family members. Eligibility: Adults ages 18 and older who are taking part in the NIMH AMBiGen study (80-M-0083). Design: Participants will be mailed 4 surveys. One survey will ask about depression symptoms. One survey will ask about mania symptoms. One survey will assess a broad range of psychological problems. One survey will assess the impact of COVID-19 on their mental health. They will fill out the surveys 4 times over 24 months. The surveys will not include participants names, just codes. This will help protect privacy. Data collected in 80-M-0083 will be used. This includes data about participants genes, medical conditions, and assessments. Participants will get an 800 number they can call to speak to the research team. They can also write to the team if they prefer. Participants who wish will get referrals for mental health services. Participation will last up to 24 months. There will be an option for recontact in the future.

Type: Observational

Start Date: Dec 2020

open study

This study is being conducted in two parts, A and B. Part A is a randomized, double-blind, parallel arm study to evaluate the safety and efficacy of LYT-100 compared to placebo in adults with post-acute COVID-19 respiratory complications. Part B is an Open Label Extension (OLE) study for patients who complete Part A.

Type: Interventional

Start Date: Dec 2020

open study