This research study seeks to establish the effectiveness of a combination of an inhaled corticosteroid and a beta agonist compared to placebo for the prevention of acute respiratory failure (ARF) in hospitalized patients with pneumonia and hypoxemia.

Type: Interventional

Start Date: Jun 2020

open study

Background: COVID-19 is a worldwide pandemic and currently there is no effective therapy or vaccine. SARS-CoV-2, the virus that causes the COVID-19 respiratory infection, appears to be very contagious however all the modes of transmission are unclear. Transmission may occur in up to 25 percent of cases when there are no symptoms (asymptomatic). Before there are any symptoms, droplet spray during speaking may increase transmission from person to person; most of the spray is saliva. Researchers at the NIH would like to test saliva for the virus before symptoms are reported. Additionally, they would like to examine the importance of using masks to prevent transmission. They hope to better understand how COVID-19 is spread among people and how it can be prevented. For this study they would like to collect samples from the nose (nasopharyngeal swab), mouth (spit sample), eye (conjunctival fluid) and blood to test for the virus and if it is contagious. Objectives: To determine if the SARS-CoV-2 virus is present in saliva in asymptomatic individuals who are COVID-19 positive. To determine if using masks can prevent transmission. Eligibility: People ages 18 and older without symptoms or with mild symptoms (e.g., low grade fever, mild malaise, minor sore throat, runny nose, or sneezing) who have been in close contact (e.g. live in the same house) with someone who has tested positive for COVID-19 or people who have tested positive for COVID-19 and have mild (e.g., low grade fever, mild malaise, minor sore throat, runny nose, or sneezing) or no symptoms. Design and Procedures: For screening, interested participants will contact a study team member. The interested participant will be asked to provide documentation of COVID-19 positive status, their symptoms, or their contact to a COVID-19 positive person. Participants will be asked to come to the NIH drive-up COVID-19 testing site or NIH Clinical Center (Bethesda, MD) for 2 or more visits in 15 days for the following procedures: nasal swab for COVID-19 and viral load, verbal symptom assessment, saliva collection, and speaking exercise to capture oral fluid. During this time, participants will also be asked to participate in phone calls with the study staff and to complete questionnaires electronically. Participants will have weekly telephone calls to discuss their symptoms and 2-5 drive-up visits to the NIH within 28 days. If visits are scheduled at the Clinical Center, participants will have the option to participate in providing blood sample(s), a conjunctival swab and 1-2 salivary gland biopsies. If a participant has tested positive, they may be asked to return to the NIH after they have recovered from COVID-19 for additional sampling. The following procedures are part of this research: - Speaking exercise - participants will be asked to read a short script with and without wearing a mask. The droplets they produce while they speak will be collected. - Saliva collection - participants will spit into a cup and have saliva collected from different areas of the mouth. They should not eat 90 minutes before this but drinking water or juice is acceptable. They may have their tongue painted with a sour liquid to increase their saliva. - Nasal swab- participants will have a swab rubbed inside their nose. - Nasopharyngeal swab - participants that are close contacts of COVID-19 positive individual(s) and need a COVID-19 test, will have a swab inserted through the nose to rub the back of their throat. - Questionnaires - participants will complete questionnaires about their symptoms electronically at home. The following procedures are optional for participants to agree to participate in and will be performed in the Clinical Center: - Blood sample(s) - participants will have blood collection via venipuncture. - Conjunctival swab - participants will have the inner lower eyelid wiped with swab. - Minor salivary gland biopsy - participants will have tiny glands in mouth removed. Procedure will be done in the hospital. Participants will be paid up to a total of $300 for the study, based on the number of visits to NIH and the types of procedures performed. Payment will be: $50 on Day 1, Day 15 and at the recovery visit. Participants who agree to the optional conjunctival swab and/or biopsy will be paid $50 for each conjunctival swab (up to 1) and/or $50 for each salivary biopsy (up to 2). If at any time the participants start to have moderate or severe respiratory symptoms, their participation in the study will end and they should seek care with their local provider.

Type: Observational

Start Date: Apr 2020

open study

The primary objective of this effort will be to optimize and operationalize innovative passive surveillance systems and in parallel, the effort will identify, evaluate, and transition groundbreaking new technologies in diagnostics for operationalization. To meet the objective and execute the deliverables for this program of effort, the A&M Breathalyzer PROTECT Kiosk will be tested, modified and validated at Brooke Army Medical Center (BAMC). The collaborative efforts between the PI, Dr. Michael Morris at BAMC and Co-Investigator Dr. Tony Yuan at USU- Center for Biotechnology (4D Bio3) will assess the passive detection technology and provide a capability survey of use-case scenarios for different operational settings. Goals: 1. Optimization and operationalize the A&M Breathalyzer PROTECT Kiosk, portable mass spectrometer (MS) Detector for Deployment in Military Operational Medicine Environments. The Breathalyzer will be deployed to BAMC to test its detection capabilities of COVID-19 among symptomatic and asymptomatic COVID-19 carrier vs. those not infected compared to gold standard RT-PCR. 2. Evaluate the passive sensing, breath capture system, built within the A&M Breathalyzer PROTECT Kiosk. The conversion of the active breath capture system, currently requires a straw that the subject breaths into, where then a series of sensors built in the Breathalyzer would automatically sample the exhaled breath within proximity for recent COVID-19 exposure. This task would conclude with a set of sensors and sensor inputs that would be analyzed by the Atomic AI platform built in the device. Field testing at BAMC is planned to determine the level of detection and discrimination for sensor combinations to SARS-CoV2 components and biomarkers detected. This testing would update the Atomic AI algorithm, within the device, to understand the accuracy of positive detection and the resulting sensitivities.

Type: Observational

Start Date: Dec 2023

open study

Persistent viral infection with viral reservoirs and detection of circulating spike protein after the initial acute illness is one potential pathogenic mechanism for Long COVID. This mechanism may be susceptible to antiviral therapy that blocks viral replication, which has the potential to alleviate long COVID symptoms. This trial will study the safety and efficacy of Ensitrelvir (S-217622), an antiviral, to treat individuals with Long COVID in an adult population.

Type: Interventional

Start Date: Apr 2024

open study

The goal of this clinical trial is to test an COVID-19 vaccination information video in adults with sickle cell disease. The main questions it aims to answer are why are some adults with sickle cell disease hesitant to receive COVID-19 vaccination and whether a COVID-19 vaccination information video tailored for people with sickle cell disease will reduce vaccine hesitancy. Participants will complete a brief survey before and after watching a short video with information on vaccine safety, efficacy, and the greater impact of COVID-19 infection on people with sickle cell disease.

Type: Interventional

Start Date: Sep 2023

open study

The project is to facilitate pandemic recovery by promoting emotional wellness among Asian Californians. The intervention includes a 6-week program in which participants may choose to receive text only or text + Lay Health Worker outreach targeting 600 self-identified Asian Americans residing in California who speak/read English, Chinese, Korean, Hmong, or Vietnamese.

Type: Interventional

Start Date: Mar 2024

open study

This study is being done to see if collecting saliva samples with a "lollipop" collection method works as well as nasopharyngeal samples for COVID-19 polymerase chain reaction (PCR) testing. 225 COVID-positive participants aged 4 years and above admitted to a hospital in the Madison, Wisconsin metropolitan area will be enrolled over a 6 month period.

Type: Interventional

Start Date: Apr 2023

open study

This is a prospective multicenter study conducted to evaluate the performance of the LumiraDx SARS-CoV-2 Ag Ultra test in detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and LumiraDx SARS-CoV-2 & Flu A/B test in differential detection of SARS-CoV-2, Influenza A (Flu A) and Influenza B (Flu B) at point of care sites. Subjects presenting with symptoms suggestive of coronavirus disease 2019 (COVID-19) and/or Influenza at the time of the study visit will be enrolled and asked to donate swab sample(s) for testing in the device(s) under evaluation.

Type: Observational

Start Date: Feb 2023

open study

The primary objective of this project is to evaluate the role of patient navigation in promoting timely follow-up of abnormal breast imaging findings in patient populations that have been most severely impacted by the novel coronavirus (COVID-19) pandemic. This project aims to assess the impact of patient navigation as an intervention tool in patient populations that are most at risk for delayed follow-up. The investigators hypothesize that patient navigation services may be an effective way to mitigate the impact of the pandemic by decreasing the risk of a delayed breast cancer diagnosis and promoting timely diagnostic follow-up.

Type: Interventional

Start Date: Jul 2022

open study

This is an open label, phase I dose-escalation study to evaluate the safety of coronavirus-specific T cell (CST) therapy for prevention of SARS-CoV-2 infection in immunocompromised patients following hematopoietic stem cell transplantation (HSCT). Participants will receive donor-derived CSTs for prevention of SARS-CoV-2 infection after HSCT (≥28 days and <4 months after HSCT). In this dose escalation trial, three doses (1x107/m2, 2x107/m2, and 4x107/m2) will be tested for safety, with study arms for adult (≥18 years of age and <80 years) HSCT recipients (Arm A) and pediatric (≥12 years of age and <18 years) HSCT recipients (Arm B), and defined dose escalations in each study arm. The study agent will be assessed for safety (stopping rules defined) and antiviral activity.

Type: Interventional

Start Date: Oct 2021

open study

This disparities-focused study seeks to evaluate communication strategies for better encouraging understanding and uptake of salivary SARS-CoV-2 antibody testing among African Americans residing in Flint, Michigan. This iteration will consider individuals recruited from the Flint Registry and assess willingness to participate in a drive-up saliva sample collection taking place at a central location in Flint, Michigan.

Type: Interventional

Start Date: Aug 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 purpose of this study is to evaluate the sensitivity and specificity of several marketed commercial or prototype test kits for antibody to SARS-CoV-2. The focus will be on rapid-format, point-of-care antibody test kits that detect both IgM and IgG antibodies to recombinant viral proteins. Note: No voluntary enrolment into this study will be conducted; all testing is to be conducted anonymously.

Type: Observational

Start Date: Apr 2020

open study

Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Pre- and Post Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers and Others at Increased Risk of SARS-CoV-2 Infection

Type: Interventional

Start Date: May 2020

open study

Dime La VerDAD is an innovative social media capacity-building program that empowers promotores de salud to debunk vaccine misinformation through the use of personal narratives on social media. The core of the implementation strategy consists of augmenting training and self-efficacy for natural community champions, "promotores de salud" from the Hispanic community as trusted messengers to debunk vaccination misinformation. The study will leverage existing community relationships in Chicago and a first of its kind misinformation curriculum to debunk misinformation in communities served by participating promotores de salud. Dime La VerDAD (Verify, Debunk, and Disseminate) is an innovative social media capacity-building program based on theoretical frameworks related to health communication that empowers promotores de salud to debunk vaccine misinformation through the use of personal narratives on social media. This mixed methods study will use a rigorous stepped wedge design to 1) deliver a scalable program of science communicators using an adapted curriculum grounded in infodemiology, 2) evaluate how debunking misinformation is perceived on social media, and 3) discern how use of personal narratives to enhance science communication can lead to changes in opinions and behavior (vaccination rates) about COVID and influenza vaccines among Chicago's predominantly Hispanic communities.

Type: Interventional

Start Date: May 2023

open study

The purpose of this observational research study is to better understand immune responses to vaccines against viruses (influenza or SARS-CoV2). The goal is to determine any differences in immune responses to vaccines in uninjured people and in people living with spinal cord injuries, who are typically at increased risk of infections.

Type: Observational

Start Date: Mar 2023

open study

Investigators are evaluating whether an intervention consisting of box-fans with MERV 16 filters ("filtration fans") and recommendations for improving ventilation in the home can reduce secondary spread of Covid19 from an index case to susceptible contacts within the home.

Type: Interventional

Start Date: Jan 2023

open study

Study of EDP-235 in Non-hospitalized Adults with Mild or Moderate COVID-19.

Type: Interventional

Start Date: Nov 2022

open study

The long-term objective of SCALE-UP II is to increase the reach, uptake, and sustainability of COVID-19 testing among underserved populations. Through RADx-UP Phase I funding (SCALE-UP Utah), the team has established population health management (PHM) interventions that have been used since Feb 2021 to increase the uptake of COVID-19 testing and vaccination among community health center patients. Interventions are based on a PHM approach that uses widely available technology (i.e. cell phones and text messaging). SCALE-UP II will both build on SCALE-UP Utah PHM interventions and investigate novel resource conservation approaches (i.e., Request-Patient Navigation vs. No Patient Navigation and text messaging vs. conversational agent). SCALE-UP II builds on long standing partnerships among the University of Utah Clinical and Translational Science Institute (UofU CTSI), Association for Utah Community Health (AUCH), CHCs, and the Utah Department of Health(UDOH). CTSI and SCALE-UP II investigators are leading several COVID-19 initiatives that drive public health response and state government policies in Utah.

Type: Interventional

Start Date: Dec 2022

open study

The purpose of this study is to describe the long-term health effects of COVID-19 in a population of mostly Black and Latinx individuals and their households who were diagnosed with COVID-19 at Columbia University Irving Medical Center. In New York, the upper Manhattan and south Bronx communities neighboring Columbia University Irving Medical Center (CUIMC) have been two of the most impacted communities of the COVID-19 pandemic. These neighborhoods are predominantly non-Hispanic black or African American and Latinx. This study will invite people who tested positive for COVID-19 and/or were treated at Columbia University Irving Medical Center to: 1) take a survey to ask about current symptoms and any health problems and 2) ask permission to review COVID-related health history including COVID-19 testing results (from the medical record) since infection to learn about health effects after COVID-19 infection; 3) invite anyone in their household to take a survey; and 4) for up to 500 patients who were hospitalized for COVID, give the option of doing a nasal swab to test for SARS-CoV-2 virus and blood test to check for antibody up to 12 months after diagnosis, to compare how results are different 12 months after infection. The goal is to learn about how the severity of person's infection in 2020 influences long term health effects and how others in their household are impacted by COVID-19.

Type: Observational

Start Date: Jul 2021

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 Coronavirus Disease 2019 (COVID-19) pandemic has resulted in catastrophic infections and fatalities across the nation. Many older Veterans with comorbidities are especially vulnerable to complications and poor recovery. This award will investigate the effect of a novel, home-based, supervised, group exercise tele-rehabilitation in Veterans recovered from COVID-19 on cardiopulmonary and physical function.

Type: Interventional

Start Date: Jun 2023

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

This study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of AZD7442 administered intramuscularly (IM) or intravenously (IV) in pediatric participants aged ≥ 29 weeks GA to < 18 years.

Type: Interventional

Start Date: Mar 2022

open study

The novel coronavirus (SARS-CoV-2) infection (COVID-19) has caused a worldwide pandemic. There is still much that is unknown regarding the virus, especially its effects on pregnancy, the fetus, and the neonate. This study seeks to evaluate adverse pregnancy and neonatal outcomes related to COVID-19 infection. The FDA has authorized emergency use authorization for the SARS-CoV-2 messenger ribonucleic acid (mRNA) vaccines from Pfizer and Moderna. Pregnant women were excluded from the Phase III clinical trials of the mRNA vaccines. There are no studies that have evaluated functional antibody responses, antibody reactivity to variant viruses, T cell frequencies or activity, or protection against infection or development of COVID-19. Having a more detailed understanding of how pregnancy and lactation alters the longevity, specificity, and activity of antiviral antibody and T cell-mediated immune responses to COVID-19 mRNA vaccines is essential for the FDA to inform future recommendations and regulation of these vaccines.

Type: Observational

Start Date: Apr 2020

open study