Background: People who get infected with COVID-19 have an unpredictable risk to worsen and die. This makes it hard to decide who can quarantine at home and who should be treated at a hospital. Researchers think the risk may be related to how a person s B and T cells respond to the virus. B and T cells are the major components of a person s immune response. B and T cells responding to the virus with a favorable pattern may lead to recovery, and this favorable pattern may be helpful to establish. If people in a vaccine trial get this same favorable pattern when responding to a vaccine, this may be a useful early signal that the vaccine will be successful. Objective: To examine how immune cells respond to COVID-19 infection. Eligibility: Adults ages 18 and older who have a confirmed or suspected COVID-19 infection or had COVID-19 in the past. Also, healthy donors with no suspected COVID-19 infection Design: Participants will be screened with medical record review. Participants will be tested with a research assay to determine who was infected with COVID-19 and who was not. This test will be used to understand research results, not to advise patients. Participants with active infection must be isolated, usually in a hospital. Other participants may give blood samples at NIH or at their local doctor s office or lab. Participants may give blood samples up to three times a week for a total of ten times, and may also give blood samples after starting a vaccine trial. Participants will be contacted by phone or email every 2 months for up to 2 years.

Type: Observational

Start Date: Apr 2020

open study

The goal of this study is to evaluate the performance of the COVID/Flu Detect™ Rapid Self-Test when used in a home-like setting by lay users. The COVID/Flu Detect™ Rapid Self-Test is an investigational device intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens in nasal swab samples. Participants who are aged two (2) years and older and have symptoms of respiratory illness consistent with SARS-CoV-2 and influenza infection may be enrolled. Participants will use the COVID/Flu Detect™ Rapid Self-Test to self-collect, self-test, and interpret the results. Participants will have a nasal swab sample collected by a healthcare provider for comparator testing by PCR tests for SARS-CoV-2, influenza A, and influenza B. Researchers will compare the results of the COVID/Flu Detect™ Rapid Self-Test obtained by the participants to results from the PCR comparator tests to evaluate performance.

Type: Observational

Start Date: Dec 2024

open study

The goal of this clinical trial is to learn if probiotics can improve symptoms and quality of life in participants with Long COVID. The main questions it aims to answer are: 1. Do probiotics reduce the number and severity of symptoms in those with Long COVID? 2. Do probiotics improve physical and mental health quality of life in those with Long COVID? 3. Do probiotics improve return to work and daily activities in those with Long COVID? Researchers will compare probiotics to a placebo (a look-alike substance that contains no probiotics) to see if probiotics works to treat Long COVID. Participants will take the study medication (placebo or probiotic) for 4 months. They will then cross-over (take the other medication) for an additional 4 months. Participants will complete a survey at baseline, 4 months, and 8 months.

Type: Interventional

Start Date: Feb 2025

open study

The goal of this pilot study is to assess the feasibility of adapting and delivering the existing home-based epilepsy self-management intervention, HOBSCOTCH, for people with Post Acute Covid Syndrome (PACS). The main questions it aims to answer are: Can the current HOBSCOTCH program be adapted for people with PACS? Will people with PACS experience improved quality of life similar to that found in people with epilepsy after participating in the HOBSCOTCH program? Participants will be asked to: - attend nine, one-hour virtual (online and/or by telephone) HOBSCOTCH-PACS sessions with a one-on-one certified HOBSCOTCH-PACS coach - complete a brief clinical questionnaire about their diagnosis of PACS - complete seven questionnaires before and after the HOBSCOTCH-PACS sessions about their quality of life, memory and thinking processes (objective and subjective cognition), about their physical and mental health and about autonomic symptoms associated with their diagnosis of PACS - keep a short daily diary (using a smart phone app or on paper) about their PACS symptoms and use of the self-management strategies taught in the HOBSCOTCH-PACS program - complete two brief surveys to assess satisfaction with their experience after the entire HOBSCOTCH-PACS program

Type: Interventional

Start Date: May 2024

open study

The main goal of this study is to characterize presentation, clinical course, and long-term outcomes of myocarditis temporally associated with administration of mRNA-1273 (SPIKEVAX) COVID-19 vaccine.

Type: Observational

Start Date: Apr 2022

open study

Treatments are needed to improve outcomes among patients hospitalized for COVID-19, including direct-acting antiviral (DAA) agents to mitigate the pathology driven by ongoing viral replication. This trial will evaluate S-217622 (ensitrelvir), an anti-SARS-CoV2 3C-like protease inhibitor (PI) developed by Shionogi &; Co. Ltd. The study design is a randomized, placebo-controlled, multi-center international clinical trial that will evaluate the clinical efficacy of ensitrelvir when given in addition to standard of care (SOC) for inpatients with COVID-19. The SOC will be determined by local established guidelines and may include additional DAA (e.g., remdesivir) and immunomodulatory treatment strategies. Certain SOC treatments will be pre-specified prior to randomization.

Type: Interventional

Start Date: Dec 2022

open study

The primary objective of this study is to determine the vaccine effectiveness of 2 doses of Pfizer-BioNTech BNT162b2 vaccine against COVID-19-associated hospitalization. There will be a large retrospective database study using two parallel study designs: a test-negative case-control design and a retrospective cohort design. VE estimates by various strata and strain type will be conducted.

Type: Observational

Start Date: May 2021

open study

The purpose of this study is to test whether Fisetin, a senolytic drug, can assist in preventing an increase in the disease's progression and alleviate complications of coronavirus due to an excessive inflammatory reaction.

Type: Interventional

Start Date: Apr 2022

open study

This protocol tests the safety and efficacy of a novel universal vaccine concept called "allo-priming" which is designed to protect elderly adults from progression of any type of viral infection, including possible protection against progression of the current outbreak of COVID-19 infection, and any future variants, strains, mutations of the causative SARS-CoV-2 virus as well as protection from any future currently unknown newly emergent novel viruses.

Type: Interventional

Start Date: Jul 2021

open study

Background: The immune response is how the body recognizes and defends itself against foreign and harmful substances. Researchers want to compare the immune responses between young and older healthy adults after they receive vaccine doses for COVID-19. This research may help to determine whether age impacts cell response to COVID-19 vaccines. Objective: To study the immune response of people who receive Pizer or Moderna COVID-19 vaccines. Eligibility: People aged 18 and older who have not had COVID-19 and who either plan to receive the first dose of a COVID-19 vaccine within the next month or have received at least the first of 2 doses of the vaccine within the last 6 months. Design: Participants will be screened by telephone. Participants will not get the COVID-19 vaccine in this study. They must get it through a vaccine location. Participants who have not yet been vaccinated will have 7 visits. The first 4 visits will occur in the first month before and after each vaccination. The last 3 visits will occur 6 months, 1 year, and 2 years after completed vaccination. Participants who have received at least 1 of 2 doses of the COVID-19 vaccine within the last 6 months will have 3 visits. The first visit will occur within 6 months of receiving the first vaccine dose. The last 2 visits will occur 1 year and 2 years after the first vaccine dose. At visits, participant will review their medical history. Their height, weight, and/or vital signs will be measured. They will give blood samples after fasting. They may give urine samples. They may have a nasal swab test for COVID-19.

Type: Observational

Start Date: Apr 2021

open study

Background: The higher death rate from COVID-19 in the older population is associated with low CD8 T cell counts in the blood. Researchers want to learn the status of CD8 T cells specific to SARS-CoV-2 and their changes with aging and in COVID-19. This may help to identify why COVID-19 is particularly lethal in the elderly and help to create an effective vaccine against SARS-CoV-2 in the elderly. Objective: To identify SARS-CoV-2 specific CD8 T cells in humans, and to determine their quantity and quality in people who have recovered from COVID-19. Eligibility: Maryland residents age 18 and older who have tested positive for and recovered from COVID-19. Design: Participants will be screened by phone. They must be able to provide a copy of their positive COVID-19 test result. Participants will visit the NIA/Clinical Research Unit. The visit will take about 1 hour. Laboratory tests showing a positive COVID-19 result will be verified. Participants vital signs will be checked. This will include blood pressure, temperature, pulse, and respiration. Height and weight will be measured. Participants will have a medical history and medicine review. They will complete a COVID-19 questionnaire. Participants will have blood drawn. They will give a urine sample. Participants will give a saliva sample. They will rinse their mouth with water. After about 3 minutes, they will let saliva pool in the base of their mouth and then spit into a sterile container. Participants may be asked if they would be willing to return for optional visits at about 4 months and 1 year later. They will repeat the same laboratory sampling performed at the first visit. ...

Type: Observational

Start Date: Sep 2020

open study

Background: SARS-CoV-2 is the virus that causes COVID-19. Some people who recover from COVID-19 have symptoms that last long after the active infection ends. This is called long COVID. Sometimes, long COVID can affect the nerves and cause problems with sleep, thinking, the senses, and movement. Researchers want to find out whether people with long COVID have retained inactive remnants of SARS-CoV-2 in their bodies. Objective: To collect tissue samples to see if people with long COVID have remnants of SARS-CoV-2 in their bodies. Eligibility: People 18 years or older who have recovered from COVID-19, both with and without neurologic symptoms. Design: Participants will have 2 to 4 inpatient or outpatient visits over 4 months. Each visit will last 4 to 5 days. Participants will be screened to make sure it is safe to collect tissue samples from their body. They will have a physical and dental exam. They will have imaging scans and a test of their heart function. They will complete questionnaires about their health. They will give blood, urine, saliva, and stool samples. Their sense of taste and smell will be tested. Tissue samples will be taken from the digestive tract, lungs, colon, skin, muscle, lymph nodes, nasal passages, and mouth. Participants may be numbed or sedated for some of the procedures. Swabs will be used to collect cells from inside the mouth and nose. Participants will undergo lumbar puncture. A thin needle will be inserted into their lower back to draw out a sample of the fluid around their spinal cord. Participants will have follow-up phone calls after each clinic visit.

Type: Observational

Start Date: Jan 2025

open study

This study looks at the safety and effectiveness of Aviptidil in treating COVID-19 in people who have been hospitalized with the infection and who have acute respiratory failure. Participants in the study will be treated with Aviptidil plus current standard of care (SOC), or with placebo plus current SOC.

Type: Interventional

Start Date: Apr 2021

open study

This is a pilot randomized trial of rTMS for symptoms of fatigue and brain fog, and other neuropsychiatric symptoms of Long-COVID (Post-COVID, post-acute sequelae of COVID-19 infection, PASC). Twenty participants diagnosed with Long-COVID and recruited from the UCLA Long-COVID clinic will be randomized to receive active rTMS versus sham stimulation for 15 treatments followed by another 15 open-label rTMS treatments. Investigators will compare the safety and tolerability of rTMS vs Sham and examine within-group changes in symptoms of fatigue, sleep, pain, mood, and subjective and objective cognitive impairment. This project will provide information and pilot data for future larger clinical trials.

Type: Interventional

Start Date: Jan 2025

open study

The Metrix COVID/Flu Test will be evaluated for use in Point-of-Care and Non-Laboratory settings in a home testing environment utilizing the clinical study design described herein. The study will take place in simulated home environments which will be set up within or near active clinical settings (e.g., urgent care facilities). This will be a prospective study conducted at three or more investigational sites located within the United States for the clinical validation of the Metrix COVID/Flu Test for the differential detection of SARS-CoV-2, Influenza A, and Influenza B in AN swab or saliva samples. Additional sites may be added to the study in order to meet minimum subject/sample enrollment requirements and geographic prevalence of respiratory virus infections. One or more investigational sites outside of the US (at which participants are required to be fluent in English) may also be included in the study depending on enrollment needs and geographical/seasonal prevalence of respiratory virus infections. Comparator testing will be performed to determine the infection status of each sample for comparison to results generated by the candidate test. The primary comparator for the study will be an FDA-cleared assay for the detection of SARS-CoV-2, Flu A, and/or Flu B.

Type: Interventional

Start Date: Nov 2023

open study

This study will be conducted as a prospective cohort study, enrolling all eligible women in their first trimester of pregnancy during a baseline visit during week 6-13 of pregnancy at Government Medical College Hospital, Nagpur. The Hospital provides primary, secondary, and tertiary care and the obstetric department delivers about 10,000 babies a year. The hypothesis is that co-infection of other respiratory viruses (ORV), particularly COVID-19 and Influenza increases the risk of adverse pregnancy outcomes in mothers and babies and could address the current standard of care in India to not vaccinate pregnant women during pregnancy, by either encouraging vaccination against both viruses before planning a pregnancy or during pregnancy based on global data supporting the safety of this strategy.

Type: Observational

Start Date: Dec 2023

open study

The COVID-19 pandemic has led to a mis/disinformation ecosystem that promotes divergent views of vaccine efficacy, as well as the legitimacy of science and medicine. Individuals are confronted with vaccine-related information from a multitude of sources, posing a challenge to identifying inaccurate information. COVID-19 vaccine uptake is lower among people with anxiety and depression than in the general population, due in part to higher levels of vaccine hesitancy. The prevalence of anxiety and depressive symptoms among US adults increased significantly during the COVID pandemic and has remained elevated. Interventions capable of mitigating the impact of vaccine hesitancy and mis/disinformation among undervaccinated people with anxiety or depression are therefore an urgent priority. Emerging evidence suggests that reasons for vaccine hesitancy and the impact of conventional vaccination messaging differ between those with and without mental health symptoms. There may also be added challenges overcoming logistical barriers to vaccination for people with anxiety or depressive symptoms. The investigators aim to determine the effectiveness of two different brief digital intervention strategies compared with conventional public health messaging for increasing vaccine uptake in undervaccinated adults with and without anxiety or depressive symptoms. Attitudinal inoculation is a brief, scalable strategy that leverages the power of narrative, values, and emotion to strengthen resistance to mis/disinformation and reduce hesitancy. Though this approach has been shown to decrease COVID-19 vaccine hesitancy among US adults, the extent to which this approach increases COVID-19 vaccination remains unknown. Cognitive-behavioral therapy (CBT) is an evidence-based intervention for anxiety and depression. However, the efficacy of incorporating CBT-informed messaging in a vaccine promotion intervention has not been tested. The investigators hypothesize that both attitudinal inoculation and CBT-style communication will be more effective than conventional public health messaging to increase COVID-19 vaccination. The investigators also hypothesize that the CBT-informed intervention will be more effective than the attitudinal inoculation intervention for increasing COVID-19 vaccination among participants with symptoms of anxiety or depression.

Type: Interventional

Start Date: Apr 2024

open study

This study is a large-scale investigation (Phase 3) into a new booster shot designed specifically for teenagers. The booster targets a particular variant of COVID-19, Omicron XBB.1.5. The main focus is on safety: researchers want to see if this new booster is safe for teenagers who have already received two doses of the Pfizer or Moderna mRNA COVID-19 vaccines. To ensure a fair comparison, the study will use a double-blind approach. This means two groups of teenagers will receive booster shots, but neither the teenagers nor the researchers giving the shots will know beforehand which version of the booster each person gets. The study will also assess how well the body fights the virus after the booster shot.

Type: Interventional

Start Date: Aug 2023

open study

The goal of this clinical study is to test if obeldesivir (GS-5245) is safe and effective for the treatment of coronavirus disease 2019 (COVID-19) in participants who have a standard risk of developing severe illness. This study will also measure how much obeldesivir gets into the blood and how long it takes for the body to get rid of it.

Type: Interventional

Start Date: Feb 2023

open study

The objectives of this project are to (1) assemble a crowdsourced, de-identified radiographic repository; and (2) train and validate existing COVID-NET deep learning diagnostic models.

Type: Observational [Patient Registry]

Start Date: Nov 2020

open study

The overall goal of the study is to investigate the characteristics and potential mechanisms responsible for myocardial injury and dysfunction in patients after COVID-19 vaccination. Cardiac damage will be assessed with cardiac MRI and endomyocardial biopsy (EmBx) histopathology. Myocardial gene expression will be measured in RNA extracted from EmBxs mRNA abundance compared to nonfailing and failing control hearts.

Type: Observational

Start Date: May 2021

open study

This study evaluates immunologic response following COVID-19 vaccination in children, adolescents, and young adults with cancer. Vaccines work by stimulating the body's immune cells to respond against a specific disease. The immune response produces protection from that disease. Effects from cancer and from treatments for cancer can reduce the body's natural disease fighting ability (called immunity). Factors such as vaccine type, timing of vaccine dosing related to treatment for cancer and number of vaccine doses or "boosts" (extra vaccine shots) may strengthen or diminish the body's protective immune response. This study may help researchers learn more about how the body's immune system responds to the COVID-19 vaccine when the vaccination is given during or after cancer treatment.

Type: Observational

Start Date: Apr 2022

open study

This project will address key testing challenges in Utah schools by building on collaborations with public school districts, private schools, charter schools and with Utah Department of Health on coronavirus disease (COVID-19) testing and existing infrastructure. The study team will work closely with schools and the Utah public health system to implement and test a shovel-ready and scalable health information technology approach that delivers automated text messages (TM) to students' parents around COVID-19 testing. In addition, some parents will receive a health navigator (HN) follow-up to ensure that tests are completed. Families will be offered the recently FDA-approved in-home serial testing approach if accessing in-person testing is a challenge. While this project is focused on COVID-19 testing, in the case that the COVID-19 vaccination becomes more relevant or is the priority of the school, the study team is able to tailor the intervention to focus on the vaccine as well. The outcomes in this study utilized parent/student reported data. Staff data were also collected but will not be reflected in primary outcome analyses.

Type: Interventional

Start Date: Jan 2022

open study

This study gathers information about how a cancer patient responds to COVID-19 vaccine during cancer treatment compared to healthy individuals. The information gained may help determine how effective currently available COVID-19 vaccines are in cancer patients receiving chemotherapy and learn more regarding how long an immune response will last compared to healthy individuals.

Type: Observational

Start Date: Mar 2021

open study

This study will assess the safety and efficacy of a single dose of AZD7442(× 2 IM injections) compared to placebo for the prevention of COVID-19.

Type: Interventional

Start Date: Nov 2020

open study