This study will assess the acceptability, feasibility, and impact of game-based computer-delivered cognitive training on cognitive function in persons with cognitive symptoms that persist after recovery from acute coronavirus-19 (COVID) infection.

Type: Interventional

Start Date: Apr 2022

open study

This is a combined retrospective and prospective, longitudinal, observational meta-cohort of individuals age 0-25 years who will enter the cohort with and without SARS-CoV-2 infection at varying stages before and after infection. Individuals with and without SARS-CoV-2 infection and with or without PASC symptoms will be followed to identify risk factors and occurrence of PASC. This study will be conducted in the United States and participants will be recruited through inpatient, outpatient, and community-based settings. Study data including age, demographics, social determinants of health, medical history, vaccination history, details of acute SARS-CoV-2 infection, overall health and physical function, and PASC symptoms will be reported by participants or collected from the electronic health record using a case report form at specified intervals. Biologic specimens will be collected at specified intervals, with some tests performed in local clinical laboratories and others performed by centralized research centers or banked in the Biospecimen Repository. Advanced clinical examinations and radiologic examinations will be performed at local study sites with cross-site standardization.

Type: Observational

Start Date: Mar 2022

open study

The purpose of this study is to test if visualizing the heart with cardiac MRI/echo will be important in the understanding cardiac function and prediction of cardiopulmonary symptoms, physical effort tolerance, and outcomes in COVID-19 survivors. If successful, the research will allow us to identify the causes of lasting cardiopulmonary symptoms and begin developing cardiac and lung directed therapies accordingly.

Type: Observational

Start Date: Jul 2021

open study

The main goal of Part A of this study is to assess the safety, reactogenicity, and immunogenicity of the study vaccine candidates. The main goal of Part B of this study is to assess the safety, reactogenicity, and immunogenicity of the mRNA-1283.529 booster vaccine candidate.

Type: Interventional

Start Date: Dec 2021

open study

This study is being done to determine the highest tolerated dose of an investigational cell therapy called DVX201 in patients hospitalized with COVID-19. DVX201 is an allogeneic NK (natural killer) cell therapy. NK cells are a normal part of your immune system that have the ability to identify and kill cells in the body that are infected by viruses such as COVID-19. There is evidence that both NK cell exhaustion and low numbers of NK cell in the blood occur in COVID-19 patients, and this may contribute to worsening of the infection. Therefore, infusion of healthy functional NK cells (like DVX201) may help overcome COVID-19 infection and prevent progression of the disease. This study is being done to look at the safety and tolerability of DVX201 in patients with COVID-19 and to gather information on how COVID-19 responds to treatment with DVX201.

Type: Interventional

Start Date: Aug 2021

open study

A 2-part, multicenter, Phase 2/3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of upamostat in adult patients with COVID-19 disease who do not require inpatient care.

Type: Interventional

Start Date: Feb 2021

open study

This open label clinical trial is to evaluate two different doses of dexamethasone on the health outcome using World Health Organization ordinal scale at day 28 in hospitalized patients with COVID-19.

Type: Interventional

Start Date: Jan 2021

open study

This study seeks to determine the the impact of COVID-19 on the incidence, characteristics, management and outcome of patients admitted to U.S. hospitals with non-COVID-19 related sepsis.

Type: Observational

Start Date: Aug 2020

open study

Researchers are creating real-time epidemiology registry to evaluate the efficacy of COVID-19 subject risk assessment scores based on recording of symptoms, biomarkers, chronic illness and mental health assessments with digital technology using wearables and mobile app tools. Researchers aim to study in Phase 1, epidemiological variations in COVID-19 presentation in both PCR positive and negative subjects in the registry. Assessment of variables, predictive modeling of variables that impact severity of COVID-19 positive and negative subjects and assessment of predictors for post COVID-19 complications. In Phase 2, 2700 subjects with COVID-19 positive test will be studied in the intervention group comparing ECL-19 vs placebo with primary end point of hospital admission assessment. Treatment strategy for PCR positive COVID-19 subjects in the registry who are in Stage I of the disease process with ECL-19 drug compared to placebo in reducing hospital admissions

Type: Observational [Patient Registry]

Start Date: Dec 2020

open study

This study is designed to evaluate three dose levels of Anti-SARS-CoV-2 Immunoglobulin Intravenous (Human) (COVID-HIGIV) for safety and pharmacokinetics (PK) in healthy adults. Twenty-eight healthy adult subjects will be enrolled into the study to receive a single dose of COVID-HIGIV or placebo with 84 days of safety and PK follow-up post-administration.

Type: Interventional

Start Date: Dec 2020

open study

In the current study, the investigators will revise our existing 10-session group RRT treatment manual to specifically address the challenges in building social support and enhancing both momentary and sustained reward during the COVID-19 pandemic (Preliminary Aim 1). In months 2-18, the investigators will conduct a small pilot RCT that will randomize individuals to receive either 10-sessions of RRT (n=30) or supportive therapy (n=30), both delivered as group-treatments via videoconferencing software. The specific aims of the current study are to confirm the feasibility and acceptability of RRT for EDs (Primary Aim 1), evaluate the ability of RRT to engage critical targets including reward to day-to-day life activities, reward to palatable foods, social isolation, and loneliness (Primary Aim 2), and provide preliminary estimates of efficacy in reducing ED symptoms at both post-treatment and a 3-month follow-up (Primary Aim 3). the investigators will also evaluate the impact of RRT on secondary outcome variables including depression, substance use, and quality of life (Secondary Aim 1).

Type: Interventional

Start Date: Dec 2020

open study

The main purpose of this phase-1b, multicenter, randomized double-blind, placebo-controlled, trial is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of bempegaldesleukin (BEMPEG; NKTR-214) in combination with standard of care (SOC) in adult patients with mild COVID-19 (coronavirus disease 2019). The trial will also define the recommended phase 2 dose (RP2D) of bempegaldesleukin in patients with mild COVID-19.

Type: Interventional

Start Date: Nov 2020

open study

Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate COVID-19

Type: Interventional

Start Date: Aug 2020

open study

The purpose of this study is to understand the impact of COVID-19 on patients with cancer through a survey.

Type: Observational

Start Date: Apr 2020

open study

The purpose of this study is to assess the extent to which LDL report increased adherence with COVID 19 mitigation practices 1 month post intervention.

Type: Interventional

Start Date: Nov 2023

open study

The purpose of this study is to investigate if receiving doses of arginine (a protein in the body) will improve mitochondria function in children with COVID-19. The study will be performed in Children's Healthcare of Atlanta, Egleston campus. Patients will be randomized to receive one of three doses of arginine three times a day for five days or at discharge whichever comes first.

Type: Interventional

Start Date: Jan 2024

open study

This study looks at the safety and effectiveness of MP0420 in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either MP0420 plus current standard of care (SOC), or with placebo plus current SOC. This is ACTIV-3/TICO Treatment Trial H5.

Type: Interventional

Start Date: Jun 2021

open study

The goal of this clinical trial is to understand how the introduction of an app-based intervention changes knowledge, attitudes, and practices on COVID-19 self-testing.

Type: Interventional

Start Date: Apr 2023

open study

Prevention of COVID-19 caused by SARS-CoV-2.

Type: Interventional

Start Date: Aug 2022

open study

Post-Acute COVID-19 Syndrome (PACS), colloquially known as Long COVID, is a prevalent phenomenon that affects thousands of Veterans in VA care. VA patients suffering from Long COVID not only experience lingering physical symptoms following COVID-19 infection, but have increased mental health problems including sleep disorders, anxiety disorders, trauma and stress-related disorders as well as increased use of opioid and non-opioid pain medications, antidepressants, and sedatives to treat these conditions. Developing recovery-oriented care, "a process of change through which individuals improve their health and wellness, live a self-directed life, and strive to reach their full potential" is a VA priority, however available Long COVID treatments primarily target symptom relief and are not designed to promote the recovery and rehabilitation of Veterans in a mental health context. Long COVID Coping and Recovery (LCCR) is a promising manualized, recovery-focused psychotherapeutic group intervention which aims to improve psychological adjustment to Long COVID symptoms, promote resilience, and facilitate coping, based on established psychotherapeutic techniques such as skills training, acceptance-based and identity-based principles. The investigators will assess rates of recruitment, intervention engagement, and session attendance (feasibility), Veteran satisfaction (acceptability), treatment adherence (fidelity) and preliminarily explore response to Long COVID Coping and Recovery (LCCR). Findings will be used to make a final adaptation of the treatment materials and to develop a research protocol for a large scale RCT of LCCR for Veterans with Long COVID. This study will pilot test a well-specified, group-based intervention tailored to the unique needs of Veterans with Long COVID. The results of the proposed study will provide data to 1) identify adaptations needed to optimize LCCR for Veterans with Long COVID; 2) identify possible benefits of LCCR; 3) inform development of a large scale RCT of LCCR for Veterans with Long COVID.

Type: Interventional

Start Date: Oct 2022

open study

The GW Medical Faculty Associates recently launched a remote monitoring program for patients diagnosed with COVID-19. Patients are provided with a home pulse oximeter and thermometer. Participants complete daily surveys about their symptoms and vital signs and are escalated to receive phone calls and video visits if responses are abnormal. Investigators would like to complete a study of the program to understand: 1. Operational parameters of program performance, such as how many patients were enrolled and how many patients completed monitoring 2. Clinical course of patients, including their reported symptoms over time and clinical endpoints such as hospitalization or ICU admission 3. Patient satisfaction with program

Type: Observational

Start Date: Sep 2020

open study

The purpose of this study is to assess the safety and reactogenicity of Ad26.COV2.S administered intramuscularly (IM) as a 1-dose schedule at the standard dose level in adult participants during the second and/or third trimester of pregnancy and (potentially) post-partum; to assess the humoral immune response in peripheral blood of adult participants to Ad26.COV2.S administered IM as a 1-dose schedule during the second and/or third trimester of pregnancy, 28 days after vaccination.

Type: Interventional

Start Date: Aug 2021

open study

The purpose of the AcRIS study is to obtain data to characterize the relationship between symptoms and voice features for (reverse transcription polymerase chain reaction (RT-PCR) confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza virus, or Respiratory Syncytial Virus (RSV) positive participants with acute viral respiratory illness. This data will be used as the basis to build voice and symptom algorithm(s) for detection and monitoring of these illnesses. This would benefit vaccine development across several key disease areas, including SARS-CoV-2, influenza virus and RSV. The study also models concepts of more efficient "flexible" clinical trials involving not only voice capture, but also web-based participant recruitment, enhanced participant engagement, and remote sample collection that could make future clinical studies more efficient. The clinical data obtained in this observational study could provide the documentation of the technology's performance needed to enable its deployment in future interventional studies.

Type: Observational

Start Date: Apr 2021

open study

The primary objective is to assess and validate the ability of the Beckman Coulter Access COVID-19 IgG and IgM assays to detect immunity in COVID-19 patients in the Henry Ford Hospital Health System.

Type: Observational

Start Date: Aug 2020

open study

To evaluate the safety and efficacy of intravenous administration of bone marrow derived extracellular vesicles, ExoFlo, versus placebo as treatment for moderate-to-severe Acute Respiratory Distress Syndrome (ARDS) in patients with severe COVID-19.

Type: Interventional

Start Date: Sep 2020

open study