This observational study aims to evaluate the diagnostic performance of an investigational Influenza A/B and COVID-19 test in patients presenting with signs and symptoms of respiratory infection. The main questions it aims to answer are: 1. What is the sensitivity and specificity of the investigational test compared with an FDA-cleared reference method for detection of Influenza A, Influenza B, and SARS-CoV-2 antigen. 2. What is the overall positive and negative percent agreement between the investigational test and the reference method? Participants will: 1. Provide a respiratory specimen (e.g., nasal or nasopharyngeal swab) for testing with the investigational device. 2. Provide an additional specimen for testing with the FDA-cleared reference method.

Type: Observational

Start Date: Nov 2024

open study

Background: Coronavirus 2019 (COVID-19, or SARS-CoV-2) is a serious public health problem, and genetics may play a role in how serious the illness becomes in certain people. Genes are the instructions that our body uses to grow and develop. Variations in our genes can cause medical conditions and may be the reason why some people get sicker than others. Objective: This study aims to learn more about the genetic contributions to the severity of COVID-19. We hope to use this information to develop therapies that reduce the severity of COVID-19 symptoms in some people. Eligibility: Anyone located in the United States who has tested positive for SARS-CoV-2 infection may be eligible to join (including NIH staff). Design: Participants will complete a questionnaire about their health history and COVID-19 symptoms. Participants will give a blood or saliva sample. It will be about 2 tablespoons of blood, or we will send a saliva collection kit. Researchers will use this blood or saliva sample to study the participant s DNA. The data about participants genes will be stored in a large database. The database will be shared with other qualified researchers who are trying to learn about COVID-19. Participants names and other personal details will not be shared. Instead, the data will be labeled with a code. Participants may be contacted by study team members for up to a year after they join the study.

Type: Observational

Start Date: May 2020

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

The main purpose of this study is to test an investigational drug known as VYD2311, which is being developed to lower the risk of getting COVID-19. VYD2311 is a monoclonal antibody that attaches to the virus that causes COVID-19 and helps block it from entering your cells. It is being tested in adults and adolescents at least 12 years old. Participants in this study will be given a "study drug" that will be either VYD2311 or placebo. The study drug will be given as a shot into the muscle in the participant's upper thigh or upper arm once a month with a total of 3 shots during the study. This study will help researchers see how well VYD2311 works to prevent COVID-19 during the 90 days after the first shot. The study will also look at the safety and tolerability of VYD2311, how the study drug is processed by the body (pharmacokinetics), how the immune system reacts to the study drug (immunogenicity), and how well VYD2311 can block the virus from infecting cells (neutralization). To do these tests, your blood will be drawn at certain times during the study.

Type: Interventional

Start Date: Jan 2026

open study

List of the Hypothesis: Primary hypothesis: A flexible acupuncture and Chinese herbal medicine protocol will be feasible, acceptable, and useful for the treatment of long COVID. Secondary hypothesis: Long COVID patients receiving acupuncture treatment or acupuncture treatment and Chinese herbal supplements over an 8-week period will see improvements in their symptoms, function, and quality of life measurements. Specific Aims of This Research (Purpose of the study): To study the feasibility, acceptability and utility of an acupuncture and Chinese herbal supplement treatment protocol for patients with long COVID and preliminarily assess the effects of treatment. Currently Available Research on This Subject: Studies indicate that acupuncture can effectively treat symptoms that are similar to those often seen in long COVID patients. Additionally, recent studies and clinical evidence suggest that there is substantial potential for acupuncture in the treatment of long COVID. Acupuncture may be beneficial because it can address many symptoms simultaneously with a single intervention, whereas symptom clusters can be difficult to manage with pharmaceuticals due to the need for multiple pharmaceutical agents. Summary of the research protocol/methodology: Five patients will receive acupuncture treatment, and five patients will receive acupuncture and Chinese herbal medicine. Each participant will receive 16 acupuncture treatments over the course of eight weeks (i.e., twice per week). Each treatment session will last for 30 minutes. Follow-up will occur at 12 weeks (i.e., four weeks after the final treatment session). Significance of this research to the health and welfare of general public: There is currently not a single, specific treatment for long COVID. If acupuncture treatment alone and/or acupuncture and Chinese herbal medicine combined are feasible, acceptable, and efficacious in the improvement of long COVID symptoms, it will offer patients additional treatment options, which may help some patients to avoid pharmaceutical treatment side effects or polypharmacy challenges.

Type: Interventional

Start Date: Sep 2025

open study

This proposal aims to understand the neurobiological mechanisms of fatigue in individuals with Post-Acute Sequelae of SARS-CoV-2 Infection (PASC). This knowledge will eventually provide candidate mechanisms to target with pharmacological intervention and inform rehabilitative care for those individuals suffering from symptoms of fatigue in PASC.

Type: Interventional

Start Date: Jul 2025

open study

The purpose of this study is to evaluate the efficacy and safety of mRNA-1283 and mRNA-1273 (variant formulations) in adults 50 to 64 years of age without high risk factors for severe COVID-19.

Type: Interventional

Start Date: Nov 2025

open study

The goal of this study is to determine whether a medicine called tirzepatide, also called Zepbound, can reduce symptoms of Long COVID. A randomized control trial will allow us to measure the effect of the treatment by having half of the participants take the medication and half take a placebo that has no medication. Participants will take the medication (or placebo) they are given and complete study surveys for 12 months. All of the study tasks are done remotely from the comfort of a participants home.

Type: Interventional

Start Date: Oct 2025

open study

Plain Language Summary: This study is a clinical trial to see if ketamine can help treat symptoms of Long COVID, especially fatigue and problems with thinking clearly (often called "brain fog"). Long COVID is a condition that affects people even after they have recovered from COVID-19, causing ongoing health issues like tiredness, memory problems, and difficulty concentrating. Right now, there are very few treatments available for these symptoms, and many people are looking for new options to feel better. What is the study trying to find out? Does ketamine help reduce fatigue and improve thinking skills in people with Long COVID? Does ketamine improve overall quality of life and mental health for people with Long COVID? Is ketamine safe and well-tolerated for people with Long COVID? How does ketamine affect the body's biological processes, like inflammation and brain function? How will the study work? The study will include 20 adults between 18 and 65 years old who have Long COVID symptoms like fatigue or brain fog. Participants will first meet with researchers to answer health questions, take surveys about their symptoms, and do tests to check their thinking skills. All participants will also have a brain scan (MRI) and give a blood sample to look at markers of inflammation. Participants will then receive four ketamine treatments over two weeks at a specialized clinic. The ketamine will be given as an injection, with the dose slightly increasing during the treatment period. After six weeks, participants will return for follow-up tests to see if their symptoms have improved. This includes repeating the surveys, thinking tests, MRI and blood test. Why ketamine? Ketamine is a medicine originally used for anesthesia but has also been found to help with depression and other mental health issues. Researchers think it might help with Long COVID symptoms because it can reduce inflammation in the brain and improve how the brain functions. People with Long COVID often have signs of inflammation and changes in brain chemicals, which ketamine might help balance. What are the potential benefits? Participants might experience less fatigue and clearer thinking after ketamine treatment. They could also feel better overall in terms of mood and quality of life. Since ketamine can work quickly, some people may notice improvements shortly after starting the treatment. What are the risks? Ketamine can cause side effects like feeling dizzy, anxious, or having an unusual sense of reality (sometimes called dissociation). It may also cause temporary increases in blood pressure or heart rate. All treatments will be carefully monitored by healthcare professionals to ensure safety. Who can participate? Adults aged 18-65 with Long COVID who have significant fatigue or thinking problems can join. People will not be able to participate if they have certain health conditions like severe heart disease, uncontrolled high blood pressure, or a history of severe mental health disorders. Why is this study important? Long COVID affects millions of people, and many are struggling to find treatments that work. This study is one of the first to explore ketamine as a potential treatment for Long COVID symptoms. If ketamine helps, it could lead to more research and eventually new treatment options for people living with Long COVID.

Type: Interventional

Start Date: Apr 2025

open study

The purpose of this study is to learn about how the flu and COVID vaccines act when given alone or when mixed together. This study is seeking healthy participants aged 18 or older. All participants in this study will receive only 1 shot to their arm, either a flu or COVID vaccine, alone or mixed. Participants will take part in this study for about 6 months, and participants will need to visit the clinical study site at least 4 times.

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 purpose of this study is to understand: - the symptoms of COVID-19 or influenza- health-related outcomes of people with COVID-19 or influenza (influenza only included in updated study analyses) - the potential effects of COVID-19 vaccines in people with COVID-19 This study will enroll participants who are: - 18 years or older - reported to have symptoms with tests that have confirmed illness. The tests can be taken at any of CVS pharmacy COVID-19 or influenza test sites. The study will collect vaccine history information from participants who are ready to take part in the study. Participant will be emailed a form with questions about their health related to COVID-19 or influenza during multiple follow-ups over a 6-month period.

Type: Observational

Start Date: Jan 2022

open study

The primary purpose of this study is to determine whether the drug sirolimus reduces the likelihood of developing of pulmonary fibrosis in patients who are hospitalized with COVID-19 pneumonia.

Type: Interventional

Start Date: Jul 2021

open study

A Phase 1 study of agenT-797 to treat moderate to severe acute respiratory syndrome in Coronavirus disease 2019 (COVID-19) participants.

Type: Interventional

Start Date: Sep 2020

open study

This is an observational study of patients with COVID-19 designed to specifically address important clinical questions that remain incompletely answered for coronavirus disease 2019.

Type: Observational

Start Date: Apr 2020

open study

Thousands of healthcare workers have been infected with SARS-CoV-2 and contracted COVID-19 despite their best efforts to prevent contamination. No proven vaccine is available to protect healthcare workers against SARS-CoV-2. This study will enroll 470 healthcare professionals dedicated to care for patients with proven SARS-CoV-2 infection. Subjects will be randomized either in the observational (control) group or in the inhaled nitric oxide group. All personnel will observe measures on strict precaution in accordance with WHO and the CDC regulations.

Type: Interventional

Start Date: Apr 2020

open study

DiaBetter Together is a strengths-based peer support intervention delivered to young adults (age 17-25) by trained Peer Mentors (age 20-35) during the transition between pediatric and adult diabetes care. The aims of this proposed randomized controlled trial are to evaluate the impact of the intervention on glycemic control (primary), time to first adult care visit, adherence, and psychosocial outcomes (secondary) in young adults with T1D after 12 months.

Type: Interventional

Start Date: Dec 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: Mar 2025

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

A Double-blind, Randomized, Controlled, Phase 2a Study to Evaluate the Safety and Tolerability of a Newcastle Disease Virus-based Mucosal Vaccine (NDV-HXP-S-KP.2) Relative to an Approved Systemic mRNA Vaccine in Previously Vaccinated Adults

Type: Interventional

Start Date: Nov 2025

open study

The purpose of this study is to learn about how well the yearly updates to the COVID-19 vaccine work in adults (age 18 years and above) with a healthy immune system (the body's cells, tissues and organs that work together to protect your body) and in children (age 6 months to 17 years). This study will use a collection of insurance claims and state vaccine registry data called HealthVerity. All patient names and other identifying information is removed. This study will include children who: - Are 6 months of age to 17 years of age - Are enrolled for at least 6 months in a row in a health insurance plan that provides data to HealthVerity - Are enrolled for at least 6 months in a row in a prescription drug insurance plan that provides data to HealthVerity - Live in the same US state for 6 months in a row - Live in a US state that requires COVID-19 vaccine reporting and provides all vaccine history data to HealthVerity - Do not have mismatches in sex and/or year of birth between any of the available datasets - Do not have records of having had COVID-19 and/or any COVID-19 vaccine in the 90 days before the start of the study This study will include adults who: - Are 18 years of age and older - Are enrolled for at least 12 months in a row in a health insurance plan that provides data to HealthVerity - Are enrolled for at least 12 months in a row in a prescription drug insurance plan that provides data to HealthVerity - Have lived in the same US state for at least 12 months - Live in a US state that requires COVID-19 reporting and provides all vaccine history data to HealthVerity - Do not have mismatches in sex and/or year of birth between any of the available datasets - Do not have records of having had COVID-19 and/or any COVID-19 vaccine in the 90 days before the start of the study This study will use the data that has already been collected, and no treatment or vaccine will be given in the study. People who match the information above will be followed in the HealthVerity database for up to 6 months following the first day that a new COVID-19 vaccine is available. This information will be reviewed to see if any of the following happen: - they had a COVID-19 vaccine - they're diagnosed with COVID-19 in a doctor's office - they visit the emergency department for COVID-19 - they visit urgent care for COVID-19 - they are hospitalized for COVID-19 The experiences of people who received a COVID-19 vaccine will be compared to the experiences of people who did not receive the vaccine. This will help to understand how well the Pfizer-BioNTech COVID-19 vaccine works at stopping COVID-19.

Type: Observational

Start Date: Apr 2025

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

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

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

This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans. This protocol is a prospective, multi-center, multi-arm, double-blind, randomized, controlled platform trial with different interventions organized as appendices to the protocol. Each appendix (or sub-study) evaluates potential mechanisms of action, efficacy, and safety of antivirals and other therapeutics in individuals with PASC, according to the platform protocol objectives. The hypothesis is that persistent viral infection, viral reactivation, and/or overactive/chronic immune response and inflammation are underlying contributors to PASC and that antiviral and other applicable therapies may result in viral clearance or decreased inflammation and improvement in PASC symptoms.

Type: Interventional

Start Date: Jul 2023

open study