979 matching studies

Sponsor Condition of Interest
Mother-infant Bonding During COVID-19
Columbia University Child Development Mother-Infant Interaction COVID-19
The purpose of this study is to compare the mother-infant emotional connection formed during the pandemic in standard care (SC) versus Family Nurture Intervention (FNI) pairs, an evidence-based intervention designed to counteract the adverse effects of maternal-infant disconnection.... expand

The purpose of this study is to compare the mother-infant emotional connection formed during the pandemic in standard care (SC) versus Family Nurture Intervention (FNI) pairs, an evidence-based intervention designed to counteract the adverse effects of maternal-infant disconnection. In prior research on preterm infants in the neonatal intensive care unit (NICU), FNI participants demonstrated increased quality of maternal caregiving behaviors and significant improvements in premature infants' neurodevelopment across multiple domains, including social-relatedness and attention problems. Goals of FNI include assisting mothers in providing appropriate types of stimulation for their babies that are important for social, emotional, and neurobehavioral development as well as reducing stress physiology in both mother and infant. Data gathered in this study will help the investigators learn more about the underlying mechanisms that take place during mother-infant interactions and examine how these play a role in setting the infant up for the best neurodevelopmental trajectory. Intervention will be conducted electronically both in the Well Baby Nursery (WBN) and at home over the following 4 months. Assessments will consist of videos of mother-infant interactions at the time of each intervention session, and pediatrician-led follow-up surveys conducted in the linked Institutional Review Board-approved study.

Type: Interventional

Start Date: Aug 2020

open study

Study of Ensifentrine or Placebo Delivered Via pMDI in Hospitalized Patients With COVID-19
Verona Pharma Inc Coronavirus Infection Covid-19 SARS-CoV-2
This pilot study is being performed to assess the efficacy and safety of inhaled ensifentrine delivered via pMDI compared with a matching placebo in conjunction with standard of care treatments on recovery in patients hospitalized due to COVID-19 infection. expand

This pilot study is being performed to assess the efficacy and safety of inhaled ensifentrine delivered via pMDI compared with a matching placebo in conjunction with standard of care treatments on recovery in patients hospitalized due to COVID-19 infection.

Type: Interventional

Start Date: Sep 2020

open study

Transpulmonary Pressure Measurements in Intubated Children With Covid-19 Respiratory Failure
Mayo Clinic COVID 19
The purpose of this study is to gather information to help doctors understand how Covid-19 affects the lungs in children. expand

The purpose of this study is to gather information to help doctors understand how Covid-19 affects the lungs in children.

Type: Interventional

Start Date: May 2020

open study

Neuromodulation With Percutaneous Electrical Nerve Field Stimulation for Adults With COVID-19
Olive View-UCLA Education & Research Institute COVID-19
COVID-19 is a disease caused by the virus, SARS-CoV-2. Patients with this viral infection are at risk for developing pneumonia and acute respiratory distress syndrome (ARDS). Approximately 20% to 30% of hospitalized patients with COVID-19 and pneumonia require intensive care... expand

COVID-19 is a disease caused by the virus, SARS-CoV-2. Patients with this viral infection are at risk for developing pneumonia and acute respiratory distress syndrome (ARDS). Approximately 20% to 30% of hospitalized patients with COVID-19 and pneumonia require intensive care for respiratory support. Clinically, ARDS presents with severe hypoxemia evolving over several days to a week in combination with bilateral pulmonary infiltrates on chest X-ray. Widespread alveolar epithelial cell and pulmonary capillary endothelial injury can lead to severe impairment in gas exchange. In one report of 1,099 patients hospitalized with COVID-19, ARDS occurred in 15.6% of patients with severe pneumonia. In a smaller case series of 138 hospitalized patients, ARDS occurred in 19.6% of patients and in 61.1% of patients admitted to an intensive care unit (ICU). To date, no effective treatment has been established to treat COVID-19 or to prevent progression of ARDS. It is thought that a heightened immune response with an unbalanced release of inflammatory mediators in the airway is a major cause of morbidity and mortality associated with the disease. It is therefore reasonable to postulate that improved outcomes may be obtained in patients with a balanced immune response with adequate viral control and appropriate counter-regulatory immune responses whereas a poor outcome may be expected in patients with inadequate viral control or a heightened immune response or what is referred to as a "cytokine storm". Thus, modulating the pulmonary immune response without suppressing the immune system would be a viable strategy for patients with COVID-19. The current literature supports the role of neuromodulation, particularly vagal nerve stimulation (VNS), in modulating the immune response. Modulating the pro-inflammatory pathway through VNS has been demonstrated to decrease inflammatory mediators and improve outcomes in several animal models and in humans. Percutaneous electrical nerve field stimulation (PENFS) provides a novel, non-invasive method of VNS through a non-implantable device applied to the external ear. Already, the FDA has cleared this technology for reducing symptoms of opioid withdrawal in patients with opioid use disorder. Symptoms of opioid withdrawal can be decreased by approximately 90% after 1 hour of stimulation. Similarly, the IB-Stim device has been shown to improve symptom in children with abdominal-pain-related functional GI disorders and recently received market approval by the FDA for that indication. Unpublished studies have demonstrated marked decrease in inflammation with PENFS compared to sham stimulation in a model of TNBS colitis. While the efficacy of PENFS in modulating the progression of pulmonary disease in patients with COVID-19 is unknown, several proposed mechanisms for regulation of the immune response through VNS have already been demonstrated. We propose to perform an open label, randomized study to evaluate the efficacy of PENFS for the treatment of respiratory symptoms in patients with COVID-19.

Type: Interventional

Start Date: Jul 2020

open study

Novel Point-of-Care Diagnostic Test for SARS-CoV-2 (COVID-19)
M.D. Anderson Cancer Center COVID-19 Infection
This study investigates a new diagnostic test in detecting SARS-CoV-2, the virus that causes the disease COVID-19. This may help to improve testing for COVID-19. expand

This study investigates a new diagnostic test in detecting SARS-CoV-2, the virus that causes the disease COVID-19. This may help to improve testing for COVID-19.

Type: Interventional

Start Date: Apr 2020

open study

The C3I COVID-19 Project
University of Wisconsin, Madison Covid19 Cancer Nicotine Dependence Pulmonary Disease Cardiovascular Diseases
This cohort study will obtain electronic health record (EHR) de-identified data from 21 health systems affiliated with the Cancer Center Cessation Initiative (C3I) network or health systems with large numbers of COVID-19 patients to explore whether smoking status, cancer history,... expand

This cohort study will obtain electronic health record (EHR) de-identified data from 21 health systems affiliated with the Cancer Center Cessation Initiative (C3I) network or health systems with large numbers of COVID-19 patients to explore whether smoking status, cancer history, and other risk factors among patients diagnosed with COVID-19 are associated with mortality and/or COVID-19 disease severity/complications. Each site will provide de-identified data from their health system EHR on a monthly basis that includes all patients identified as having COVID-19 at some point in the interval from February 1, 2020, through December 31, 2020.

Type: Observational [Patient Registry]

Start Date: Aug 2020

open study

COVID-FISETIN: Pilot in Covid-19 of Fisetin to Alleviate Dysfunction and Inflammation
Mayo Clinic COVID-19
The purpose of this study is to test whether Fisetin, a senolytic drug, can assist in preventing an increase in the disease's progression and alleviate complications of coronavirus due to an excessive inflammatory reaction. expand

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

Type: Interventional

Start Date: Aug 2020

open study

The COVID-19 PUI Reality Check (CPRC) Study
Bassett Healthcare Covid19 Immunology
This study compares SARS-CoV-2 immune responses in high pretest probability swab negative hospitalized PUI patients vs. low pretest probability swab negative hospitalized APS (Asymptomatic Persons being Screened) patients to try to understand the appropriateness and safety... expand

This study compares SARS-CoV-2 immune responses in high pretest probability swab negative hospitalized PUI patients vs. low pretest probability swab negative hospitalized APS (Asymptomatic Persons being Screened) patients to try to understand the appropriateness and safety of clinical decisions made in these patient populations based on swab results.

Type: Observational

Start Date: Jul 2020

open study

Photobiomodulation Laser Therapy for COVID-19 Positive Patients With Pulmonary Disease
Lowell General Hospital COVID-19
The aim of this study is to evaluate the effectiveness of MLS laser therapy as a treatment for pulmonary complications due to COVID-19 infection. expand

The aim of this study is to evaluate the effectiveness of MLS laser therapy as a treatment for pulmonary complications due to COVID-19 infection.

Type: Interventional

Start Date: Apr 2020

open study

Evaluating the Use of Polymyxin B Cartridge Hemoperfusion for Patients With Septic Shock and COVID 19
Spectral Diagnostics (US) Inc. Septic Shock Endotoxemia COVID Corona Virus Infection Sepsis, Severe
Prospective, observational, clinical investigation of PMX cartridge use in COVID 19 patients with septic shock expand

Prospective, observational, clinical investigation of PMX cartridge use in COVID 19 patients with septic shock

Type: Expanded Access

open study

Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19
CytoDyn, Inc. Coronavirus Disease 2019
This is a Phase 2, two-arm, randomized, double blind, placebo controlled multicenter study to evaluate the safety and efficacy of leronlimab (PRO 140) in patients with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection. expand

This is a Phase 2, two-arm, randomized, double blind, placebo controlled multicenter study to evaluate the safety and efficacy of leronlimab (PRO 140) in patients with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection.

Type: Interventional

Start Date: Apr 2020

open study

The Use of Ultrasound in Establishing COVID-19 Infection as Part of a Trauma Evaluation
University of Colorado, Denver COVID Trauma Ultrasound
The current COVID-19 pandemic is providing healthcare organizations with considerable challenges and opportunities for rapid cycle improvement efforts, in diagnostic and patient management arenas. Healthcare providers are tasked with limiting the use of personal protective... expand

The current COVID-19 pandemic is providing healthcare organizations with considerable challenges and opportunities for rapid cycle improvement efforts, in diagnostic and patient management arenas. Healthcare providers are tasked with limiting the use of personal protective equipment while minimizing unnecessary exposures to the virus. Results from real-time PCR tests to detect active COVID-19 infections may not be available in a timely fashion during emergent trauma assessments. Since the start of the COVID-19 pandemic, a rapidly expanding body of literature has identified a pattern of imaged lung abnormalities with CT and ultrasound (US) characteristic of an active viral infection. US evaluation provides a reliable, portable, and reproducible way of evaluating acute patients in a real time setting. During initial trauma evaluations, patients may also receive adjunct imaging modalities like the Focused Assessment with Sonography in Trauma (FAST) exam designed to discover life threatening findings that may require urgent interventions. We therefore propose a study expanding on the current FAST adjunct evaluation in the trauma bay that may include lung parenchyma imaging at the initial assessment to help stratify patients into low or high-risk groups for active COVID-19 infections. We believe the use of point of care US in the initial assessment of the trauma patient may help identify potentially infected individuals and aid ED providers to best directing subsequent laboratory and imaging evaluations for these patients, while further directing the necessary protective measures for additional team members involved in the care of the injured patient.

Type: Observational [Patient Registry]

Start Date: Jul 2020

open study

Viral Infection and Respiratory Illness Universal Study[VIRUS]: COVID-19 Registry
Mayo Clinic Coronavirus
Researchers are creating a real time COVID-19 registry of current ICU/hospital care patterns to allow evaluations of safety and observational effectiveness of COVID-19 practices and to determine the variations in practice across hospitals. expand

Researchers are creating a real time COVID-19 registry of current ICU/hospital care patterns to allow evaluations of safety and observational effectiveness of COVID-19 practices and to determine the variations in practice across hospitals.

Type: Observational

Start Date: Mar 2020

open study

ImmuneRACE - Immune Response Action to COVID-19 Events
Adaptive Biotechnologies Covid19
ImmuneRACE is a study, which is designed to better understand the immune response to COVID-19. This is critically important because the immune system may be able to tell us important information about how our own bodies detect and respond to the disease that current tests... expand

ImmuneRACE is a study, which is designed to better understand the immune response to COVID-19. This is critically important because the immune system may be able to tell us important information about how our own bodies detect and respond to the disease that current tests cannot. De-identified data collected from this study may accelerate the development of better diagnostics for COVID-19 and improve outcomes for many.

Type: Observational

Start Date: Apr 2020

open study

Tele-health Enabled Clinical Trial for COVID-19
University Hospitals Cleveland Medical Center SARS-CoV Infection
To determine the efficacy of high dose Vitamin D (an over-the-counter nutritional supplement) in preventing immune-related complications in outpatients with confirmed SARS-CoV-2 infection. expand

To determine the efficacy of high dose Vitamin D (an over-the-counter nutritional supplement) in preventing immune-related complications in outpatients with confirmed SARS-CoV-2 infection.

Type: Interventional

Start Date: Aug 2020

open study

Thymalfasin (Thymosin Alpha 1) to Treat COVID-19 Infection
Rhode Island Hospital Covid19
It is our hypothesis that a course of Ta1 administered to hospitalized individuals with COVID-19 infection and lymphocytopenia will improve the time to recovery (primary objective) and severity of infection (secondary objectives) compared to untreated individuals in the same... expand

It is our hypothesis that a course of Ta1 administered to hospitalized individuals with COVID-19 infection and lymphocytopenia will improve the time to recovery (primary objective) and severity of infection (secondary objectives) compared to untreated individuals in the same hospital with comparable lymphocytopenia. After screening, hospitalized patients with COVID-19 and lymphocytopenia who meet the inclusion criteria will receive Ta1 (1.6 mg) administered subcutaneously (SC) daily for 1 week. Individuals in the control arm will be followed on the identical protocol but will not receive daily Ta1.

Type: Interventional

Start Date: Sep 2020

open study

Vitamin D Supplementation in the Prevention and Mitigation of COVID-19 Infection
Medical University of South Carolina COVID-19 Vitamin D Deficiency Respiratory Viral Infection
The purpose of this study is to evaluate how useful vitamin D supplementation is in reducing the severity of COVID-19 symptoms and the body's inflammatory and infection-fighting response to COVID-19. Individuals ≥50 years of age and older who are tested for COVID-19 and negative... expand

The purpose of this study is to evaluate how useful vitamin D supplementation is in reducing the severity of COVID-19 symptoms and the body's inflammatory and infection-fighting response to COVID-19. Individuals ≥50 years of age and older who are tested for COVID-19 and negative will be randomized (like flipping a coin) to either daily high dose vitamin D supplementation (6000 IU vitamin D3/day) vs. standard of care. Those individuals ≥50 years of age or older who test positive for COVID-19 at baseline will be randomized to bolus vitamin D (20,000 IU/day for 3 days) followed by high dose (6000 IU vitamin D/day) vs. standard of care for 12 months. All participants will receive a multivitamin containing vitamin D.

Type: Interventional

Start Date: Jul 2020

open study

Repeated Employee Testing for Understanding Our Recovery to Normal
Children's Hospital Medical Center, Cincinnati COVID-19
The purpose of this research study is 1) to conduct a prospective longitudinal surveillance research trial, enrolling up to 200 CCHMC employees as they come back to work, and then following their clinical and laboratory parameters for up to 12 months; and 2) to support the... expand

The purpose of this research study is 1) to conduct a prospective longitudinal surveillance research trial, enrolling up to 200 CCHMC employees as they come back to work, and then following their clinical and laboratory parameters for up to 12 months; and 2) to support the ongoing development of diagnostic techniques for COVID-19. The overall goal is to investigate patterns of SARS-COV-2 infection, including immunological recovery and genetic risk factors, among CCHMC employees to better understand how to safely reintroduce the CCHMC work force back into their normal routines.

Type: Observational

Start Date: May 2020

open study

Testing the Efficacy and Safety of BIO101 for the Prevention of Respiratory Deterioration in COVID-19...
Biophytis Covid-19 SARS-CoV2
The COVA clinical study is a global multicentric, double-blind, placebo-controlled, group sequential and adaptive 2 parts phase 2-3 study targeting in patients with SARS-CoV-2 pneumonia. Part 1 is a Phase 2 exploratory Proof of Concept (PoC) study to provide preliminary data... expand

The COVA clinical study is a global multicentric, double-blind, placebo-controlled, group sequential and adaptive 2 parts phase 2-3 study targeting in patients with SARS-CoV-2 pneumonia. Part 1 is a Phase 2 exploratory Proof of Concept (PoC) study to provide preliminary data on the activity, safety and tolerability of BIO101 in the target population. Part 2 is a phase 3 pivotal randomized study to provide further evidence of safety and efficacy of BIO101 after 28 days of double-blind dosing. BIO101 is the investigational new drug that activates the Mas receptor (MasR) through the protective arm of the Renin Angiotensin System (RAS).

Type: Interventional

Start Date: Jun 2020

open study

An Observational Cohort Trial of Outcomes and Antibody Responses Following Treatment With COVID19 Convalescent...
University of Colorado, Denver Covid19
This is an observational study designed to learn more about how COVID19 convalescent plasma works in patients with COVID19 compared to those patients who did not receive convalescent plasma treatment. Information about patient recovery will be collected from participants'... expand

This is an observational study designed to learn more about how COVID19 convalescent plasma works in patients with COVID19 compared to those patients who did not receive convalescent plasma treatment. Information about patient recovery will be collected from participants' electronic medical records to evaluate safety, clinical outcomes, and SARS-CoV2 antibody responses in patients who were treated with convalescent plasma under a separate expanded access protocol, NCT04372368.

Type: Observational

Start Date: Apr 2020

open study

Changes in Cellular Immune Profile During COVID-19 Infection
Serhat Gumrukcu, MD PhD Covid19 SARS-CoV-2
Clinical specimens are collected from individuals either recovered from or with active SARS-CoV-2 infection to support process and analytical development for a potential cell-based immunotherapy in preclinical research, SRPH-CVD-01. SRPH-CVD-01 is an allogeneic cell-based... expand

Clinical specimens are collected from individuals either recovered from or with active SARS-CoV-2 infection to support process and analytical development for a potential cell-based immunotherapy in preclinical research, SRPH-CVD-01. SRPH-CVD-01 is an allogeneic cell-based immunotherapy candidate to be investigated in a subsequent clinical trial under a future FDA IND to treat people suffering from COVID-19. Enrolled participants provide a venous blood specimen (up to 40mL) to be used in preclinical studies and research and development of SRPH-CVD-01. Subjects may eventually be asked to undergo leukapheresis for peripheral blood mononuclear cell (PBMC) collection and their specimens will be used to further develop the SRPH-CVD-01 cell product, including a cGMP compliant process to be applied under the future FDA IND.

Type: Interventional

Start Date: Apr 2020

open study

Investigation of Antibody and Immune Responses to SARS-CoV-2 Proteins
INanoBio Inc. COVID-19 Corona Virus Infection
SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), has negatively impacted global health and requires more research to develop better tests and to improve disease treatment. The purpose of this research is to aid in the testing effort by collecting samples... expand

SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), has negatively impacted global health and requires more research to develop better tests and to improve disease treatment. The purpose of this research is to aid in the testing effort by collecting samples from people who have been diagnosed with COVID-19 or are suspected of having COVID-19. Samples you provide will be used investigationally by INanoBio to develop a test to determine when antibodies against various SARS-CoV-2 proteins are detectable. Up to approximately 80 subjects of all ages with either a suspected or lab-confirmed diagnosis of COVID-19 will take part in this research.

Type: Observational

Start Date: Jul 2020

open study

A Study of Combination Therapies to Treat COVID-19 Infection
ProgenaBiome COVID COVID-19 Corona Virus Infection Coronavirus Infection Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere
This study seeks to determine whether dual or quadruple therapy is more effective in treating COVID-19. expand

This study seeks to determine whether dual or quadruple therapy is more effective in treating COVID-19.

Type: Interventional

Start Date: Jul 2020

open study

Use of Convalescent Plasma for COVID-19
Northside Hospital, Inc. COVID
The plan is to transfuse COVID-19 infected patients with convalescent plasma and observe whether this will result in a significant improvement in clinical outcome in comparison to historical experience. expand

The plan is to transfuse COVID-19 infected patients with convalescent plasma and observe whether this will result in a significant improvement in clinical outcome in comparison to historical experience.

Type: Interventional

Start Date: Jul 2020

open study

IgG/IgM Antibody Test in Patients Who Have Tested Negative or Positive for COVID-19 With the Standard...
Fadi Haddad, M.D. SARS-CoV 2
The purpose of this study is to evaluate point of care SARS-Cov2 Virus IgG/IgM rapid test cassette Clungene test and correlate it with the standard method of testing in inpatients who have tested positive or negative for COVID19. expand

The purpose of this study is to evaluate point of care SARS-Cov2 Virus IgG/IgM rapid test cassette Clungene test and correlate it with the standard method of testing in inpatients who have tested positive or negative for COVID19.

Type: Observational

Start Date: May 2020

open study