873 matching studies

Sponsor Condition of Interest
Longitudinal Energy Expenditure and Metabolic Effects in Patients With COVID-19 (LEEP-COVID)
Duke University COVID-19
This current proposal evaluates the Longitudinal Energy Expenditure and Metabolic Effects in Patients with COVID-19 (LEEP-COVID) to understand, guide and optimize our metabolic and nutritional care of these high risk patients. As no data exist for the metabolic effects of... expand

This current proposal evaluates the Longitudinal Energy Expenditure and Metabolic Effects in Patients with COVID-19 (LEEP-COVID) to understand, guide and optimize our metabolic and nutritional care of these high risk patients. As no data exist for the metabolic effects of COVID-19 patients, this data is urgently needed and essential to assist in the care of COVID-19 patients worldwide. We are uniquely positioned at Duke to perform this research, as we are the only US center with 2 of the FDA-approved devices in existence currently capable of collecting this vital data to guide the care of COVID-19 patients worldwide.

Type: Observational

Start Date: Apr 2020

open study

COVID-19 Risk Stratification
Brigham and Women's Hospital Coronavirus Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere
We seek to derive and validate a clinically useful risk score for patients with Coronavirus Disease 2019 to aide clinicians in the safe discharge of patients. expand

We seek to derive and validate a clinically useful risk score for patients with Coronavirus Disease 2019 to aide clinicians in the safe discharge of patients.

Type: Observational

Start Date: Mar 2020

open study

COVID-19 Mortality Prediction Model
Dascena COVID-19 Pneumonia Mechanical Ventilation
The objective of this study is to develop and evaluate an algorithm which accurately predicts mortality in COVID-19, pneumonia and mechanically ventilated ICU patients. expand

The objective of this study is to develop and evaluate an algorithm which accurately predicts mortality in COVID-19, pneumonia and mechanically ventilated ICU patients.

Type: Observational

Start Date: Apr 2020

open study

A Prospective "Universal" Observational Database for COVID-19
Hackensack Meridian Health COVID-19
The Hackensack Meridian Health Universal Observational COVID-19, a descriptive observational database, is a multi-center initiative collecting data throughout the Hackensack Meridian Health Network (HMH). HMH utilizes the EPIC system at most of the facilities, which will serve... expand

The Hackensack Meridian Health Universal Observational COVID-19, a descriptive observational database, is a multi-center initiative collecting data throughout the Hackensack Meridian Health Network (HMH). HMH utilizes the EPIC system at most of the facilities, which will serve as the primary data source. The database will be designed within the REDCap system. A de-identified dataset will be sent to COTA for primary statistical analysis as requested by the research teams.

Type: Observational [Patient Registry]

Start Date: Mar 2020

open study

ANTIBODY BASED TESTS FOR SARSCoV-2 COVID-19) - Evaluation of Patients and Healthcare Providers in the...
Texas Cardiac Arrhythmia Research Foundation Covid19
This study will be conducted as a registry to identify asymptomatic or symptomatic persons to determine whether they carry SARS-CoV-2 antibodies. expand

This study will be conducted as a registry to identify asymptomatic or symptomatic persons to determine whether they carry SARS-CoV-2 antibodies.

Type: Observational [Patient Registry]

Start Date: Mar 2020

open study

COVID-19 Recovered Volunteer Research Participant Pool Registry
University of California, Los Angeles Recovered From COVID-19
This is a prospective observational registry of COVID-19 recovered patients who are no longer symptomatic. This Registry is intended to serve as a pool of individuals that can participate in studies associated with serological testing, characterization of immunity and immune... expand

This is a prospective observational registry of COVID-19 recovered patients who are no longer symptomatic. This Registry is intended to serve as a pool of individuals that can participate in studies associated with serological testing, characterization of immunity and immune response, vaccine development, and convalescent plasma donors.

Type: Observational [Patient Registry]

Start Date: Apr 2020

open study

Intermediate-size Expanded Access Program (EAP), Mesenchymal Stromal Cells (MSC) for Acute Respiratory...
Mesoblast International Sàrl Moderate to Severe Acute Respiratory Distress Syndrome Associated With COVID-19
The objectives of this intermediate-size expanded access protocol are to assess the safety and efficacy of remestemcel-L in participants with ARDS due to coronavirus infection 2019 (COVID-19). expand

The objectives of this intermediate-size expanded access protocol are to assess the safety and efficacy of remestemcel-L in participants with ARDS due to coronavirus infection 2019 (COVID-19).

Type: Expanded Access

open study

Antithrombotic Therapy to Ameliorate Complications of COVID-19 ( ATTACC )
University of Manitoba COVID-19 Pneumonia
Endothelial injury as a consequence of SARS-CoV-2 infection leads to a dysregulated host inflammatory response and activation of coagulation pathways. Macro- and micro-vascular thrombosis may contribute to morbidity, organ failure, and death. Therapeutic anticoagulation with... expand

Endothelial injury as a consequence of SARS-CoV-2 infection leads to a dysregulated host inflammatory response and activation of coagulation pathways. Macro- and micro-vascular thrombosis may contribute to morbidity, organ failure, and death. Therapeutic anticoagulation with heparin may improve clinical outcomes in patients with COVID-19 through anti-thrombotic, anti-inflammatory, and anti-viral activities of heparins. This pragmatic, Bayesian adaptive randomized controlled trial will determine whether therapeutic anticoagulation with heparin (subcutaneous low molecular weight heparin or intravenous unfractionated heparin) versus usual care reduces the need for intubation or death in hospitalized patients with COVID-19 not initially requiring invasive mechanical ventilation. The trial uses an adaptive design which was chosen to overcome limitations in available data to inform a priori estimation of event rates and possible effect sizes. The adaptive design also includes response-adaptive randomization based on baseline D-dimer level, probing for differential efficacy across subgroups defined based on initial D-dimer level. This Bayesian adaptive randomized trial will stop at a conclusion 1) when the posterior probability that the proportional odds ratio is greater than 1.0 reaches 99% (definition of benefit); 2) when the posterior probability that the proportional odds ratio is greater than 1.2 is less than 10% (definition of futility) or; 3) when the posterior probability that the proportional odds ratio is less than 1.0 is greater than 90% (definition of harm). The trial will enroll a maximum of 3,000 patients, although in many simulations the trial may require fewer patients. The trial is strategically aligned with the international REMAP-CAP/COVID platform trial to accelerate evidence generation.

Type: Interventional

Start Date: May 2020

open study

Hydroxychloroquine Post Exposure Prophylaxis for Coronavirus Disease (COVID-19)
Columbia University COVID-19 Corona Virus Infection
The purpose of this study is to test the hypothesis that post-exposure prophylaxis with hydroxychloroquine will reduce the symptomatic secondary attack rate among household contacts of known or suspected COVID-19 patients. expand

The purpose of this study is to test the hypothesis that post-exposure prophylaxis with hydroxychloroquine will reduce the symptomatic secondary attack rate among household contacts of known or suspected COVID-19 patients.

Type: Interventional

Start Date: Mar 2020

open study

Hydroxychloroquine vs. Azithromycin for Outpatients in Utah With COVID-19
Intermountain Health Care, Inc. COVID-19
This study will compare two drugs (hydroxychloroquine and azithromycin) to see if hydroxychloroquine is better than azithromycin in treating outpatients with suspected or confirmed COVID-19. expand

This study will compare two drugs (hydroxychloroquine and azithromycin) to see if hydroxychloroquine is better than azithromycin in treating outpatients with suspected or confirmed COVID-19.

Type: Interventional

Start Date: Apr 2020

open study

COVID-19 Pandemic Response Network
Duke University COVID-19 SARS-CoV-2 Coronavirus Influenza -Like Illness Lower Resp Tract Infection
Coronavirus Disease 19 (COVID-19) represents an unprecedented challenge to the operations and population health management efforts of health care systems around the world. The "Pandemic Research Network (PRN): Duke Community Health Watch" study leverages technology, clinical... expand

Coronavirus Disease 19 (COVID-19) represents an unprecedented challenge to the operations and population health management efforts of health care systems around the world. The "Pandemic Research Network (PRN): Duke Community Health Watch" study leverages technology, clinical research, epidemiology, telemedicine, and population health management capabilities to understand how to safely COVID-19. The target population is individuals in the Duke Health region as well as individuals beyond the Duke Health region who have flu-like symptoms, a viral test order for COVID-19, confirmed COVID-19, or concern for exposure to COVID-19. A subgroup of particular interest within the target population is health care workers (HCW) and families of HCW. Community members will enroll in the study electronically and for 28 days will be reminded via email or SMS to submit signs and symptoms related to COVID-19. Participants who report symptoms will be provided information about COVID-19 testing (if needed) and established mechanisms to seek care within Duke Health. Instructions for telemedicine and in-person visits, which is available publicly at https://www.dukehealth.org/covid-19-update, will be presented to participants. Participants who are unable to report symptoms independently may be contacted via telephone by Population Health Management Office (PHMO) or Clinical Events Classification (CEC) team members. Data collected through the "Pandemic Response Network (PRN): Duke Community Health Watch" study will be used for three objectives. - First, to characterize the epidemiological features of COVID-19. Specifically, we will have a high-risk subgroup of HCW and families of HCW that we enroll. - Second, to develop models that predict deterioration and the need for inpatient care, intensive care, and mechanical ventilation. - Third, to develop forecast models to estimate the volume of inpatient and outpatient resources needed to manage a COVID-19 population. The primary risk to study participants is loss of protected health information. To address this concern, all data will be stored in Duke's REDCap instance and the Duke Protected Analytics Compute Environment (PACE).

Type: Observational

Start Date: Apr 2020

open study

SQuISH-COVID: A Pilot Study
Cytovale, Inc. Sepsis COVID-19
This is a single-site prospective study to evaluate the diagnostic performance of the investigational SeptiScan System for patients presenting to the Emergency Department with signs or suspicion of COVID-19 or other infectious respiratory diseases. expand

This is a single-site prospective study to evaluate the diagnostic performance of the investigational SeptiScan System for patients presenting to the Emergency Department with signs or suspicion of COVID-19 or other infectious respiratory diseases.

Type: Observational

Start Date: Apr 2020

open study

At-Home COVID-19 Antibody Test Usability Assessment & Behavior Change Study
ProofPilot COVID19 COVID-19 Coronavirus
Radish Health and ProofPilot in coordination with Sanesco are running this study to help establish whether the Premier Biotech COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma Authorized for distribution under emergency use authorization - though not yet FDA... expand

Radish Health and ProofPilot in coordination with Sanesco are running this study to help establish whether the Premier Biotech COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma Authorized for distribution under emergency use authorization - though not yet FDA reviewed) can be conducted effectively at home to detect COVID-19 antibodies among individuals who have tested positive, or suspect they have previous contracted from COVID-19 and recovered. The study also aims to examine how the results of those tests change social-distancing behaviors and general anxiety over 8 weeks post-test.

Type: Interventional

Start Date: Apr 2020

open study

Open Label Non-comparative Trial of the Combination of Hydroxychloroquine and Azithromycin in the Treatment...
University of New Mexico COVID-19
This research is designed as an open-label,non-comparative prospective trial. expand

This research is designed as an open-label,non-comparative prospective trial.

Type: Interventional

Start Date: Mar 2020

open study

The PATCH Trial (Prevention And Treatment of COVID-19 With Hydroxychloroquine)
Ravi Amaravadi, MD COVID-19
The PATCH trial (Prevention And Treatment of COVID-19 with Hydroxychloroquine) is funded investigator-initiated trial that includes 3 cohorts. Cohort 1: a double-blind placebo controlled trial of high dose HCQ as a treatment for home bound COVID-19 positive patients; Cohort... expand

The PATCH trial (Prevention And Treatment of COVID-19 with Hydroxychloroquine) is funded investigator-initiated trial that includes 3 cohorts. Cohort 1: a double-blind placebo controlled trial of high dose HCQ as a treatment for home bound COVID-19 positive patients; Cohort 2: a randomized study testing different doses of HCQ in hospitalized patients; Cohort 3: a double blind placebo controlled trial of low dose HCQ as a preventative medicine in health care workers.

Type: Interventional

Start Date: Apr 2020

open study

Estrogen Patch for COVID-19 Symptoms
Sharon Nachman COVID
The purpose of this study is to find out if estrogen, a female sex hormone, given as a patch placed on skin of COVID19 positive or presumptive positive patients for 7 days can reduce the severity of COVID19 symptoms compared to regular care. This study has two study groups.... expand

The purpose of this study is to find out if estrogen, a female sex hormone, given as a patch placed on skin of COVID19 positive or presumptive positive patients for 7 days can reduce the severity of COVID19 symptoms compared to regular care. This study has two study groups. One group will receive the study drug, a single-use Climara 25cm2 estrogen patch. The other group will receive standard of care. Participants will be asked questions about their symptoms for up 6 times in up to 45 days.

Type: Interventional

Start Date: Apr 2020

open study

Pragmatic Factorial Trial of Hydroxychloroquine, Azithromycin, or Both for Treatment of Severe SARS-CoV-2...
Duke University SARS-CoV-2
This is a pragmatic, randomized, open-label, incomplete factorial with nested randomization clinical trial evaluating the efficacy and safety of two potential treatments for hospitalized patients with confirmed SARS-CoV-2 infection. Participants who are hospitalized and have... expand

This is a pragmatic, randomized, open-label, incomplete factorial with nested randomization clinical trial evaluating the efficacy and safety of two potential treatments for hospitalized patients with confirmed SARS-CoV-2 infection. Participants who are hospitalized and have a positive nucleic acid amplification test for SARS-CoV-2 will undergo an initial randomization in a 1:1 ratio to one of the following regimens: Arm 1: Standard of care alone Arm 2: Standard of care plus hydroxychloroquine Participants who meet eligibility criteria to receive azithromycin will undergo a second randomization in a 1:1 ratio to receive additional concurrent therapy. This will effectively result in four treatment groups: 1. Standard of care alone 2. Standard of care plus hydroxychloroquine 3. Standard of care plus azithromycin 4. Standard of care plus hydroxychloroquine plus azithromycin

Type: Interventional

Start Date: Apr 2020

open study

Gargling and Nasal Rinses to Reduce Oro- and Nasopharyngeal Viral Load in Patients With COVID-19
NYU Langone Health COVID-19
For this study, 48 patients who have been diagnosed with COVID-19 will be randomly assigned to four study groups: control, saline, chlorhexidine gluconate, and povidone-iodine. Each patient will be asked to gargle with a solution of either saline, chlorhexidine gluconate, or... expand

For this study, 48 patients who have been diagnosed with COVID-19 will be randomly assigned to four study groups: control, saline, chlorhexidine gluconate, and povidone-iodine. Each patient will be asked to gargle with a solution of either saline, chlorhexidine gluconate, or povidone-iodine or nothing (control group) as well as spray the same solution in their nose four times daily. Patients will then be tested for COVID-19 once daily in the evening for 7 days and viral loads will be measured.

Type: Interventional

Start Date: Apr 2020

open study

Adaptive COVID-19 Treatment Trial 2 (ACTT-2)
National Institute of Allergy and Infectious Diseases (NIAID) COVID-19
ACTT-2 will evaluate the combination of baricitinib and remdesivir compared to remdesivir alone. Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29. For discharged subjects,... expand

ACTT-2 will evaluate the combination of baricitinib and remdesivir compared to remdesivir alone. Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29. For discharged subjects, it is preferred that the Day 15 and 29 visits are in person to obtain safety laboratory tests and oropharyngeal (OP) swab and blood (serum only) samples for secondary research as well as clinical outcome data. However, infection control or other restrictions may limit the ability of the subject to return to the clinic. In this case, these visits may be conducted by phone, and only clinical data will be obtained. The Day 22 visit does not have laboratory tests or collection of samples and is conducted by phone. The primary outcome is time to recovery by Day 29.

Type: Interventional

Start Date: May 2020

open study

Beat COVID-19 - Observational Trial
Beat COVID LLC COVID-19
JUPITER is an observational study protocol that aims to understand factors that can help prevent/mitigate the spread of COVID-19 and understand factors that help reduce disease progression in patients with COVID-19. We aim to accomplish this by obtaining self-reported historical... expand

JUPITER is an observational study protocol that aims to understand factors that can help prevent/mitigate the spread of COVID-19 and understand factors that help reduce disease progression in patients with COVID-19. We aim to accomplish this by obtaining self-reported historical and longitudinal data from study participants.

Type: Observational

Start Date: Apr 2020

open study

Hyperbaric Oxygen Therapy (HBOT) as a Treatment for COVID-19 (COVID-19) Infection
Ochsner Health System COVID-19
Patients who meet inclusion criteria will be randomized into treatment vs control group. Treatment groups will undergo Hyperbaric Oxygen Therapy (HBOT) and compared to the control group. expand

Patients who meet inclusion criteria will be randomized into treatment vs control group. Treatment groups will undergo Hyperbaric Oxygen Therapy (HBOT) and compared to the control group.

Type: Interventional

Start Date: Apr 2020

open study

Rutgers COVID-19 Cohort Study
Rutgers, The State University of New Jersey Coronavirus SARS-CoV-2
The specific objective is to rapidly establish a prospective cohort to characterize the factors related to viral transmission and disease severity in a large healthcare system in healthcare settings and HCW (healthcare worker) households. Investigators propose to address this... expand

The specific objective is to rapidly establish a prospective cohort to characterize the factors related to viral transmission and disease severity in a large healthcare system in healthcare settings and HCW (healthcare worker) households. Investigators propose to address this hypothesis by recruiting and longitudinally following 500 HCW and 250 age- and sex-matched NHCW (Non-healthcare workers) within a large academic health system, Rutgers Biomedical and Health Sciences (RBHS). By intensively following participants over a six-month period and collecting serial biospecimens (nasopharyngeal/throat swabs, blood, and saliva) and questionnaire data at nine time points, investigators can uniquely characterize Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) transmission and risk factors for Coronavirus Disease 19 (COVID-19) among health care workers and their families

Type: Observational

Start Date: Apr 2020

open study

COPING With COVID-19( CWC-19)
Duke University COVID-19
The purpose of this study is 1) to understand effects of COVID-19 crisis on wellness of pulmonary and critical care faculty and trainees who are at frontline fighting this pandemic 2) Assess the effectiveness of series of weekly web based crisis management coaching from world... expand

The purpose of this study is 1) to understand effects of COVID-19 crisis on wellness of pulmonary and critical care faculty and trainees who are at frontline fighting this pandemic 2) Assess the effectiveness of series of weekly web based crisis management coaching from world renowned experts in coaching and 3) identify future areas of opportunities in physician wellness

Type: Interventional

Start Date: Mar 2020

open study

Healthcare Worker Exposure Response and Outcomes (HERO) Registry Study, COVID-19
Duke University Health Care Worker (HCW) COVID-19
The HERO Registry provides a resource for collecting information on Healthcare Workers (HCWs) currently working in the United States. The overall goal of the Registry is to develop the infrastructure necessary to create and engage a community of HCWs who may be eligible for... expand

The HERO Registry provides a resource for collecting information on Healthcare Workers (HCWs) currently working in the United States. The overall goal of the Registry is to develop the infrastructure necessary to create and engage a community of HCWs who may be eligible for participation in future research studies, including those of COVID-19 prophylaxis and treatment.

Type: Observational [Patient Registry]

Start Date: Apr 2020

open study

Breath Analysis Based Disease Biomarkers of COVID-19 and Other Diseases
Mayo Clinic Liver Diseases Liver Cancer COVID19
The purpose of the study is to develop a clinical test based on breath analysis that can be used for disease diagnosis or prognosis. expand

The purpose of the study is to develop a clinical test based on breath analysis that can be used for disease diagnosis or prognosis.

Type: Observational

Start Date: Sep 2019

open study