1,065 matching studies

Sponsor Condition of Interest
A Study of Brexanolone for Acute Respiratory Distress Syndrome Due to COVID-19
Sage Therapeutics Acute Respiratory Distress Syndrome COVID-19
The purpose of this study is to evaluate the efficacy and safety of brexanolone in participants on ventilator support for acute respiratory distress syndrome (ARDS) due to COVID-19. expand

The purpose of this study is to evaluate the efficacy and safety of brexanolone in participants on ventilator support for acute respiratory distress syndrome (ARDS) due to COVID-19.

Type: Interventional

Start Date: Dec 2020

open study

Mental Health Impact of COVID-19 Pandemic on NIMH Research Participants and Volunteers
National Institute of Mental Health (NIMH) Healthy Volunteer Mood Disorder Anxiety Disorder Preexisting Medical Condition
Background: The COVID-19 outbreak has caused many changes to people s normal social patterns. The respiratory illness has been the major focus of public health efforts. But most experts also agree that government and public health mandates to slow the spread of the illness,... expand

Background: The COVID-19 outbreak has caused many changes to people s normal social patterns. The respiratory illness has been the major focus of public health efforts. But most experts also agree that government and public health mandates to slow the spread of the illness, such as social distancing, have a significant effect on people s mental health. Environmental stressors, such as constraints on activities, social contact, and access to resources, take a toll. Researchers want to learn how stressors related to COVID-19 affect mental health over time. Objective: To learn the relationship between stressors related to COVID-19 and self-rated measures of mental health symptoms and distress among a range of people. Eligibility: English-speaking adults ages 18 and older Design: This study will be conducted online. Participants will give their first and last name and email address. They will indicate if they have ever been in an NIH research study. They will get a username and password. Every 2 weeks for up to 6 months, participants will complete online study surveys. They will get email reminders. Some surveys will be repeated. At the end of the study, they will complete a set of end-of-study surveys. The surveys will ask about the following: Age, sex, race, and other sociodemographic data Mental and medical illness history and treatment Family medical history Mobility, self-care, and life activities Behaviors related to alcohol and substance use disorder Mental illness symptoms Psychological distress Stressors caused by the COVID-19 pandemic. Participants will get links to mental health resources, such as hotlines. They will also get guidance on steps to take to seek care or support. Study website: nimhcovidstudy.ctss.nih.gov

Type: Observational

Start Date: Apr 2020

open study

The Safety and Efficacy of FB2001 in Healthy Subjects and Patients With COVID-19 Infection
Frontier Biotechnologies Inc. Covid19
This is an adaptive, Phase I/II study in 2 parts: Part 1 is to evaluate the Maximum Tolerable Dose (MTD) , tolerance, safety and pharmacokinetics of FB2001 in healthey subjects, Part 2 is to evaluate the safety, pharmacokinetics and efficacy of FB2001 in patients with moderate to... expand

This is an adaptive, Phase I/II study in 2 parts: Part 1 is to evaluate the Maximum Tolerable Dose (MTD) , tolerance, safety and pharmacokinetics of FB2001 in healthey subjects, Part 2 is to evaluate the safety, pharmacokinetics and efficacy of FB2001 in patients with moderate to severe COVID-19 disease. Part 1 of this study is a randomized, double-blinded, placebo-controlled, sentinel design, dose escalation study with single ascending dose (SAD), followed by a multiple ascending dose (MAD) . Thirty-Two (32) male and female healthy volunteers will be enrolled for Part 1 of the study.

Type: Interventional

Start Date: Mar 2021

open study

Studying Students at Risk for COVID-19
University of Michigan Covid19
The purpose of this study is to determine whether continuous heart rate obtained from wearable devices and self-reported data from surveys and symptom logs alongside saliva samples can be used to help students self-monitor for infection and eventually be able to create a predictive... expand

The purpose of this study is to determine whether continuous heart rate obtained from wearable devices and self-reported data from surveys and symptom logs alongside saliva samples can be used to help students self-monitor for infection and eventually be able to create a predictive model to detect infection or illness early.

Type: Observational

Start Date: Sep 2020

open study

Self-Help for Stress Related to COVID-19
Penn State University Stress
This is a study on internet-based self-help for stress related to the COVID-19 pandemic. College and university students who score in the moderate or higher range on a stress measure during the COVID-19 pandemic will be invited to participate in this study. Participants will... expand

This is a study on internet-based self-help for stress related to the COVID-19 pandemic. College and university students who score in the moderate or higher range on a stress measure during the COVID-19 pandemic will be invited to participate in this study. Participants will be randomly assigned to receive access to an internet-based self-help program for stress resilience and coping with the COVID-19 pandemic or care as usual. Stress and psychosocial symptoms will be assessed via questionnaire at baseline (pre-randomization), one month post-randomization, and three months post-randomization.

Type: Interventional

Start Date: Nov 2020

open study

Telestroke at Comprehensive Stroke Center During the COVID-19 Pandemic
University of Minnesota Stroke, Acute
TELEstroke to CAre for STroke Patients at a Comprehensive Stroke Center (TELECAST-CSC) during the COVID-19 pandemic is a prospective cohort study evaluating guideline-based acute ischemic stroke care at a comprehensive stroke center during the COVID-19 global pandemic. TELECAST-CSC... expand

TELEstroke to CAre for STroke Patients at a Comprehensive Stroke Center (TELECAST-CSC) during the COVID-19 pandemic is a prospective cohort study evaluating guideline-based acute ischemic stroke care at a comprehensive stroke center during the COVID-19 global pandemic. TELECAST-CSC compares two cohorts: the "in-person phase" (December 1, 2019-March 15, 2020), when all inpatient stroke team care was delivered conventionally in-person and the "telestroke phase" (March 16, 2020-June 29, 2020) when all inpatient stroke team care was delivered exclusively via telestroke as part of our healthcare system's pandemic response. We studied the following primarily clinical endpoints: diagnostic stroke evaluation, secondary stroke prevention, health screening and evaluation, stroke education, and stroke recurrence rates.

Type: Observational

Start Date: Dec 2019

open study

Increasing COVID-19, Influenza, and Pneumonia Vaccine Uptake
Charles Drew University of Medicine and Science Covid19 Influenza Pneumonia Vaccine Refusal
This proposed study seeks to community knowledge and understand the experience of underserved communities in the exploration of reducing health disparities and increasing vaccine uptake and acceptability COVID-19, influenza, and pneumonia for AA and Latinx populations. Unique in... expand

This proposed study seeks to community knowledge and understand the experience of underserved communities in the exploration of reducing health disparities and increasing vaccine uptake and acceptability COVID-19, influenza, and pneumonia for AA and Latinx populations. Unique in its design, it has the following characteristics: 1) multifaceted, 2) culturally tailored, 3) community-based, and 4) mixed methods in which the outcomes of interest will be measured before and after the intervention with 18-month interval. Furthermore, we seek to enhance our partnerships and collaborations with churches in South Los Angeles by supporting efforts to encourage COVID-19, influenza, and pneumonia vaccination uptake among underserved minorities in one of the most challenged and hard-to-reach population areas in the nation.

Type: Interventional

Start Date: Oct 2021

open study

Wearable Diagnostic for Detection of COVID-19 Infection
ClinOne, Inc. COVID-19
The goals of this study are 1) to validate the use of a wearable diagnostic capability and software as a medical device (SaMD) algorithm for the pre or early-symptomatic detection of COVID-19 infection, 2) assess the wearable device on the subjects, and 3) ensure data are... expand

The goals of this study are 1) to validate the use of a wearable diagnostic capability and software as a medical device (SaMD) algorithm for the pre or early-symptomatic detection of COVID-19 infection, 2) assess the wearable device on the subjects, and 3) ensure data are collected, securely stored, and easily read and interpreted by non-laboratory personnel.

Type: Observational

Start Date: Dec 2020

open study

Famotidine vs Placebo for the Treatment of Non-Hospitalized Adults With COVID-19
Northwell Health Covid-19
The overall objective of this study is to evaluate the clinical efficacy of oral famotidine in symptomatic non-hospitalized patients with confirmed COVID-19. This study is expected to enroll up to 84 patients with mild to moderate symptoms divided into each of the two study... expand

The overall objective of this study is to evaluate the clinical efficacy of oral famotidine in symptomatic non-hospitalized patients with confirmed COVID-19. This study is expected to enroll up to 84 patients with mild to moderate symptoms divided into each of the two study arms. Clinical outcomes of the two treatment arms will be compared. This study will be conducted virtually/remotely.

Type: Interventional

Start Date: Jan 2021

open study

Nebulized Heparin for the Treatment of COVID-19
Frederick Health Covid19 Pneumonia, Viral
Randomized, placebo controlled study to determine if nebulized heparin may reduce the need for mechanical ventilation in hospitalized patients with the novel coronavirus, also known as COVID-19. This will be a part of a larger meta-trial. expand

Randomized, placebo controlled study to determine if nebulized heparin may reduce the need for mechanical ventilation in hospitalized patients with the novel coronavirus, also known as COVID-19. This will be a part of a larger meta-trial.

Type: Interventional

Start Date: Feb 2021

open study

Risk Stratification and Early Alerting Regarding COVID-19 Hospitalization
Current Health Covid19
The purpose of this research is to remotely monitor individuals who have tested positive for COVID-19 to learn more about progression and recovery from the disease. Individuals who test positive for COVID-19 will wear the Current Health wearable device continuously and answer a... expand

The purpose of this research is to remotely monitor individuals who have tested positive for COVID-19 to learn more about progression and recovery from the disease. Individuals who test positive for COVID-19 will wear the Current Health wearable device continuously and answer a brief series of questions on Current Health tablet daily for up to 30 days. The health data will be used to develop predictive models of hospitalization risk.

Type: Observational

Start Date: Feb 2021

open study

KIDney Injury in Times of COVID-19 (KIDCOV)
University of California, San Francisco SARS-CoV Infection Covid19 Corona Virus Infection Acute Kidney Injury Kidney Injury
There is an unmet need to evaluate the impact of sub-clinical/mild COVID19 disease in the outpatient setting on prevalent and incident renal injury, as this data is currently unavailable. To capture the diversity of race/ethnic risk and COVID19 related municipal shelter-in-place... expand

There is an unmet need to evaluate the impact of sub-clinical/mild COVID19 disease in the outpatient setting on prevalent and incident renal injury, as this data is currently unavailable. To capture the diversity of race/ethnic risk and COVID19 related municipal shelter-in-place guidance, the investigators will enroll COVID19-negative and COVID19-positive samples balanced by race/ethnicity from 3 different states, California, Michigan, and Illinois. Study endpoints will be assayed from urine samples mailed to the study team at 2, 6, and 12 months after their date of PCR test, with no requirement for these individuals to leave their homes to participate.

Type: Observational [Patient Registry]

Start Date: Mar 2021

open study

Estimating Prevalence of COVID-19 Infection and SARS-CoV-2 Antibodies in MS Patients
NYU Langone Health Multiple Sclerosis Covid19
This non-interventional, biospecimen collection study is designed to help us better understand whether MS patients have impaired immune defenses to COVID-19 infection. The potential influence of immune modulating medications for MS will be considered through these exploratory... expand

This non-interventional, biospecimen collection study is designed to help us better understand whether MS patients have impaired immune defenses to COVID-19 infection. The potential influence of immune modulating medications for MS will be considered through these exploratory studies. This study is also designed to provide context for interpretation of anti-SARS CoV2 serologies in MS patients during convalescence from COVID-19 infection.

Type: Observational

Start Date: Jan 2021

open study

Comparison of Viral Particle Dispersion Following Administration of an MDI or Nebulizer in Subjects With...
Theravance Biopharma COVID-19
A randomized, 2-period crossover, single-center, open-label study for viral sample collection. After initiation of inhaled therapy with nebulizer or MDI, cascade impactors and surface samplers will be used to assess viral loads in rooms of subjects with COVID-19. expand

A randomized, 2-period crossover, single-center, open-label study for viral sample collection. After initiation of inhaled therapy with nebulizer or MDI, cascade impactors and surface samplers will be used to assess viral loads in rooms of subjects with COVID-19.

Type: Observational

Start Date: Feb 2021

open study

Understanding Immunity to the COVID-19 Vaccines
Stanford University COVID-19 Immunity Vaccine
The purpose of this study is to test over time immunity to the COVID-19 vaccines. Adults who are receiving COVID-19 vaccines will be invited to participate. expand

The purpose of this study is to test over time immunity to the COVID-19 vaccines. Adults who are receiving COVID-19 vaccines will be invited to participate.

Type: Observational

Start Date: Mar 2021

open study

Hyperpolarized 129Xe MRI of Survivors of COVID-19
University of Kansas Medical Center Covid19
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. expand

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

A Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273 Vaccine in Adolescents...
ModernaTX, Inc. SARS-CoV-2
The mRNA-1273 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to primarily evaluate the safety and reactogenicity of a single dose level of mRNA-1273 vaccine... expand

The mRNA-1273 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to primarily evaluate the safety and reactogenicity of a single dose level of mRNA-1273 vaccine administered in 2 doses 28 days apart to an adolescent population.

Type: Interventional

Start Date: Dec 2020

open study

Study to Assess Adverse Events and How Intravenous (IV) ABBV-47D11 Moves Through the Body of Adult Participants...
AbbVie CoronaVirus Disease-2019 (COVID-19)
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Lung failure is the main cause of death related to COVID-19 infection. The main objective of this study is to evaluate the safety and tolerability... expand

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Lung failure is the main cause of death related to COVID-19 infection. The main objective of this study is to evaluate the safety and tolerability of ABBV-47D11 in participants hospitalized with COVID-19 infection. In addition, this study will evaluate the pharmacokinetics (how the body handles the study drug) and anti-viral activity of the study drug. ABBV-47D11 is an investigational anti-SARS-CoV-2 monoclonal antibody being developed for the treatment of COVID-19. Participants will receive either placebo or ABBV-47D11. There is a 1 in 4 chance that participants will be assigned to placebo. Around 24 adult participants hospitalized for a diagnosis of COVID-19 will be enrolled in approximately 10 to 30 sites globally. Participants will receive single intravenous (into the veins) infusion of ABBV-47D11 or placebo of Day 1. There may be higher treatment burden for participants in this trial compared to their standard of care. The effect of the treatment will be checked by medical assessments, blood tests, nasal swabs and presence of side effects.

Type: Interventional

Start Date: Dec 2020

open study

Blood Purification With Seraph 100 Microbind Affinity Blood Filter for Treatment of Severe COVID19 Observational...
Henry M. Jackson Foundation for the Advancement of Military Medicine Covid19
This is a multi-center, observational study that will enroll 1) patients with severe COVID-19 who have agreed to undergo therapy with Seraph® 100 under the existing EUA; 2) patients (medical record data) that have been previously treated with the Seraph® 100 after the date... expand

This is a multi-center, observational study that will enroll 1) patients with severe COVID-19 who have agreed to undergo therapy with Seraph® 100 under the existing EUA; 2) patients (medical record data) that have been previously treated with the Seraph® 100 after the date of the EUA approval (17 April 2020), but before the date that the study is approved at the study site, and 3) a convenience sample of patients (medical record data) in a historical control group who were admitted to the ICU at participating sites with severe COVID-19 infection, meeting the EUA treatment criteria, but not treated with Seraph® 100 up to the time the PURIFY-OBS protocol is approved at the site

Type: Observational

Start Date: Dec 2020

open study

Self-Collected Saliva Samples Without Viral Transport Media for COVID-19 Testing Via RT-PCR
David Grant U.S. Air Force Medical Center SARS-CoV Infection Polymerase Chain Reaction Laboratory Testing
This is a study that will attempt to validate the process for detecting SARS-CoV-2 (COVID19) on a non-FDA-approved technology using self-collected saliva as the specimen. Investigators will compare self-collected saliva samples and healthcare-worker collected nasopharyngeal... expand

This is a study that will attempt to validate the process for detecting SARS-CoV-2 (COVID19) on a non-FDA-approved technology using self-collected saliva as the specimen. Investigators will compare self-collected saliva samples and healthcare-worker collected nasopharyngeal samples (Nasal swabs) to see if the self-collected saliva samples are similar in terms of diagnostic accuracy. Investigators will be performing this testing at the site where patients regularly go for COVID19 testing. There will be minimal risk of harm as consenting patients will only have to provide a small amount of saliva into a tube.

Type: Interventional

Start Date: Feb 2021

open study

Immune Modulators for Treating COVID-19
Daniel Benjamin Covid19
ACTIV-1 IM is a master protocol designed to evaluate multiple investigational agents for the treatment of moderately or severely ill patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The research objectives are to evaluate each agent with... expand

ACTIV-1 IM is a master protocol designed to evaluate multiple investigational agents for the treatment of moderately or severely ill patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The research objectives are to evaluate each agent with respect to speed of recovery, mortality, illness severity, and hospital resource utilization. Each agent will be evaluated as add-on therapy to the standard of care (SoC) in use at the local clinics, including remdesivir (provided). The SoC may change during the course of the study based on other research findings. Comparisons of the agents among themselves is not a research objective. The study population corresponds to moderately and severely ill patients infected with the coronavirus disease 2019 (COVID-19) virus. Recruitment will target patients already hospitalized for treatment of COVID-19 infection as well as patients being treated for COVID-19 infection in Emergency Departments while waiting to be admitted to the hospital. Patients both in and out of the ICU are included in the study population.

Type: Interventional

Start Date: Oct 2020

open study

Dulce Digital-COVID Aware (DD-CA) Discharge Texting Platform for US/Mexico Border Hispanics With Diabetes...
Scripps Whittier Diabetes Institute Diabetes Mellitus, Type 2 Covid19
The COVID-19 pandemic has triggered extremely high hospitalization rates where mitigation strategies are urgently necessary to aid vulnerable Hispanic and Latino populations who are experiencing health disparities as well as high type 2 diabetes (T2D) prevalence with poor... expand

The COVID-19 pandemic has triggered extremely high hospitalization rates where mitigation strategies are urgently necessary to aid vulnerable Hispanic and Latino populations who are experiencing health disparities as well as high type 2 diabetes (T2D) prevalence with poor clinical outcomes when compared to non-Hispanic populations. The supplemental Dulce Digital-COVID Aware (DD-CA) intervention addresses specific barriers in diverse underserved Hispanic and Latino communities to improve glucose control and lower transmission of COVID-19 during a highly vulnerable period post hospitalization discharge, to reduce hospital readmission rates. This supplement will integrate COVID educational messaging with glucose management messaging within a low-cost, easily adoptable digital texting platform and offer critical information in a culturally and linguistically relevant manner to address specific barriers in diverse underserved communities.

Type: Interventional

Start Date: Feb 2021

open study

Study of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalized Patients
Amgen COVID-19
The primary objective of this study is to evaluate the time to confirmed clinical recovery in participants hospitalized with COVID-19. Candidate agents will be evaluated frequently for efficacy and safety, with candidate agents being added to and/or removed from the study on an... expand

The primary objective of this study is to evaluate the time to confirmed clinical recovery in participants hospitalized with COVID-19. Candidate agents will be evaluated frequently for efficacy and safety, with candidate agents being added to and/or removed from the study on an ongoing basis, depending on the results of their evaluation.

Type: Interventional

Start Date: Nov 2020

open study

GLS-1027 for the Prevention of Severe Pneumonitis Caused by SARS-CoV-2 Infection (COVID-19)
GeneOne Life Science, Inc. Pneumonitis SARS-CoV Infection
This clinical trial will evaluate the safety, tolerability and efficacy of GLS-1027 in the prevention of severe pneumonitis caused by SARS-CoV-2 infection expand

This clinical trial will evaluate the safety, tolerability and efficacy of GLS-1027 in the prevention of severe pneumonitis caused by SARS-CoV-2 infection

Type: Interventional

Start Date: Feb 2021

open study

COVID-19: Pediatric Research Immune Network on SARS-CoV-2 and MIS-C
National Institute of Allergy and Infectious Diseases (NIAID) Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Multisystem Inflammatory Syndrome in Children (MIS-C) Coronavirus Disease 2019 (COVID-19)
The primary objectives of this study are: - To determine the proportion of children with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) related death, rehospitalization or major complications after infection with SARS-CoV-2 and/or Multisystem Inflammatory... expand

The primary objectives of this study are: - To determine the proportion of children with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) related death, rehospitalization or major complications after infection with SARS-CoV-2 and/or Multisystem Inflammatory Syndrome in Children (MIS-C), and - To determine immunologic mechanisms and immune signatures associated with disease spectrum and subsequent clinical course during the year of follow-up.

Type: Observational

Start Date: Nov 2020

open study