This R01 project titled "Family-focused vs. Drinker-focused Smartphone Interventions to Reduce Drinking-related Consequences of COVID-19" is a Hybrid II RCT/implementation study to modify and test two of our alcohol smartphone interventions to address the fallout from COVID. We propose a three-arm RCT comparing a smartphone control group vs. a drinker-focused intervention vs. a family-focused intervention. All study arms recruit dyads comprising a person who drinks and a family partner.

Type: Interventional

Start Date: Apr 2022

open study

This study investigates the changes in practice by pulmonary procedural programs across the United States as they faced the coronavirus pandemic. Information gathered from this study may help guide pulmonary programs on a wider scale and improve their practice. The study may also help researchers understand where they should focus research efforts to better respond to a pandemic in the future.

Type: Observational

Start Date: Nov 2020

open study

Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19). The global outbreak of COVID-19 is a major public health problem. COVID-19 causes a wide range of symptoms. These symptoms range from mild breathing problems to life-threatening problems or death. Some people have no symptoms. This study aims to learn how acute and late immune responses to COVID-19 lead to different outcomes. The immune system is the body s defense against germs, including viruses, that invade the body. Objective: To characterize the immune responses during and after SARS-CoV-2 infection and determine if there is any relationship to clinical course and outcome. Eligibility: People ages 0 99 who have confirmed or suspected SARS-CoV-2 infection, people who are not infected despite heavy exposure, and relatives of enrolled participants. Design: This is a sample collection protocol to receive send-in biological specimens for exploratory studies, including gene testing. Participants will not be seen at the NIH for study visits. Study staff will talk with participants health care providers to screen them for the study. Participants enrolled into the protocol will send samples and clinical information at least once and more often if the participant has COVID-19. All participants will provide blood samples and possibly stool. We may also ask for left over specimens from any medical procedures completed as part of medical care. The study staff will also request participants health care providers to complete a survey to collect demographic and medical data. Some of this information may need to be provided directly by the participant. Pregnant individuals are invited to participate and may be asked to give cord blood samples after delivery. Study findings that affect participants health may be shared with their health care provider. Depending on findings, participants may be contacted to take part in other NIH studies.

Type: Observational

Start Date: Oct 2020

open study

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

Long COVID is defined by a range of symptoms affecting multiple organs that persist for more than three months following an acute SARS-CoV-2 infection. Approximately 7% of individuals who recover from SARS-Cov-2 infection develop Long COVID. Long COVID Postural Orthostatic Tachycardia Syndrome (LCPOTS) symptoms include fatigue, exercise intolerance, orthostatic intolerance, syncope, and heightened orthostatic tachycardia. Research has found that decreased parasympathetic activity in LCPOTS increases the production of highly immunogenic neoantigens Isolevuglandins (IsoLG-adducts). IsoLG-adducts induce formation of circulating monocyte/T cell complexes(doublets) leading to the persistent and unresolved immune response that continues after the initial infection. The purpose of the this research, is to study the effects of 2-hydroxybenzylamine (2-HOBA), an Iso-LG-adduct scavenger, its effects in immune markers and compare it with Placebo

Type: Interventional

Start Date: Dec 2025

open study

The purpose of this study is to understand how COVID-19 affects people's ability to work and to calculate the costs associated with loss of work. The study compares two groups of participants who are confirmed to have mild-to moderated COVID-19 and who have high chances of the disease becoming severe. The two groups are: People who took the antiviral medication nirmatrelvir-ritonavir (also called Paxlovid) People who were eligible to receive antiviral medication but did not receive any. The participants will be selected from various health databases in the US between June 2021 and December 2022. The main goals are: To look at the characteristics of both groups of participants with COVID-19. To measure how much work these participants missed, including days off and sick leave, and the costs associated with this work loss. To compare work loss and costs between the two groups of participants, considering differences in their clinical and demographic characteristics. The study will evaluate at least 30 days of data from participants after they are confirmed to have COVID-19

Type: Observational

Start Date: Oct 2024

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 trial will test if two repurposed HIV antivirals can reduce symptom burden in adult participants with Long Covid compared to placebo. Viral infection and viral reactivation have been documented in Long Covid. Participants will be randomly allocated to receive antivirals, Truvada (tenofovir disoproxil/emtricitabine, TDF/FTC, Group 1) or Selzentry (Group 2), or a placebo (pill) (Group 3), taken daily for 90 days.

Type: Interventional

Start Date: Oct 2024

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

This Phase 1 clinical trial will evaluate the safety and immunogenicity of an intranasal vaccine candidate, a recombinant, live-attenuated, bovine/human parainfluenza virus vector vaccine expressing the 6-P prefusion-stabilized version of the SARS-CoV-2 spike protein.

Type: Interventional

Start Date: Sep 2023

open study

Racial and ethnic minority children who live in socioeconomically disadvantaged communities are disproportionately impacted by pandemic and climate-induced disasters. Although effective interventions have been designed to treat mental health related symptoms in post-disaster settings, accessible, empirically supported prevention interventions are needed to prevent the onset of mental and behavioral health issues among these children. Building on our preliminary findings, the proposed study examines the efficacy and implementation of a COVID-19 adapted disaster focused prevention intervention, Journey of Hope-C19, in preventing behavioral health and interpersonal problems among racial and ethnic minority children who live in low-resource high poverty communities.

Type: Interventional

Start Date: Nov 2022

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 purpose of this study is to identify the number of individuals with severe CoVID who require ventilator support and who develop serious fungal infections. The study is an observational study, meaning that we are not providing any intervention that does not involve usual standard of care. Our chief goal is to find evidence of fungal infection by using traditional, approved methods of diagnosis, but by applying these methods in the same way and frequency among all study participants. We will be looking especially for evidence of a fungal infection known as Aspergillus, which can causes a serious lung infection called invasive aspergillosis (IA).

Type: Observational

Start Date: Mar 2021

open study

This is study is comprised of three approaches. First, the investigators will conduct a retrospective cohort study to determine factors associated with COVID-19 severity and complications and understand COVID-19 outcomes, including all-cause mortality, post-discharge events, and impacts of rehabilitation services (third aim). The second aim is a mixed-method study and follows COVID-19 patients with repeated surveys to determine patient-reported functional outcomes, health recovery, and rehabilitation needs after COVID-19. The investigators will recruit patients and their informal caregivers for interviews to assess their function and rehabilitation needs.

Type: Observational

Start Date: May 2021

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 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

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

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: 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

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 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