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Contrast Enhanced Ultrasound in COVID-19
Children's Hospital of Philadelphia
Covid19
Multisystem Inflammatory Syndrome in Children (MIS-C)
Initial data from COVID-19 patients suggests that one of the primary causes of death is
significant endothelial injury leading to blood clotting and impaired multiorgan
microvascular perfusion. The current study uses a safe, convenient bedside imaging tool
called contrast-enhanced ultrasound (CEUS)... expand
Initial data from COVID-19 patients suggests that one of the primary causes of death is significant endothelial injury leading to blood clotting and impaired multiorgan microvascular perfusion. The current study uses a safe, convenient bedside imaging tool called contrast-enhanced ultrasound (CEUS) to estimate the extent of microvascular perfusion impairment in the heart, kidneys and/or brain of COVID-19 pediatric patients in vivo and assess the significance of imaging findings by correlating to clinical outcomes. This pilot study will be conducted at one site, The Children's Hospital of Philadelphia. The investigators plan to enroll and evaluate 30 patients. Type: Interventional Start Date: Dec 2020 |
Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Post-Exposure Prophylaxis of COVID-19...
Romark Laboratories L.C.
COVID-19
Viral Respiratory Illnesses
Trial to evaluate the efficacy and safety of NTZ for post-exposure prophylaxis of
COVID-19 and other VRIs in elderly LTCF residents. expand
Trial to evaluate the efficacy and safety of NTZ for post-exposure prophylaxis of COVID-19 and other VRIs in elderly LTCF residents. Type: Interventional Start Date: May 2020 |
RECOVER-ENERGIZE Platform Protocol_Appendix B (Structured Pacing (PEM))
Duke University
Long COVID
Long Covid19
Long Covid-19
This is a platform protocol designed to be flexible so that it is suitable for a range of
interventions and settings within diverse health care systems and community settings with
incorporation into clinical COVID-19 management programs and treatment plans if results
achieve key study outcomes.
This... expand
This is a platform protocol designed to be flexible so that it is suitable for a range of interventions and settings within diverse health care systems and community settings with incorporation into clinical COVID-19 management programs and treatment plans if results achieve key study outcomes. This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating interventions to address and improve exercise intolerance and post-exertional malaise (PEM) as manifestations of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC). The focus of this protocol is to assess interventions that can improve exercise capacity, daily activities tolerance, and quality of life in patients with PASC. Type: Interventional Start Date: Jul 2024 |
RECOVER-AUTONOMIC: Platform Protocol, Appendix B (Ivabradine)
Kanecia Obie Zimmerman
Long COVID
Long Covid19
Long Covid-19
This study is a platform protocol designed to be flexible so that it is suitable for a
wide range of settings within health care systems and in community settings where it can
be integrated into COVID-19 programs and subsequent treatment plans.
This protocol is a prospective, multi-center, multi-arm,... expand
This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans. This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating various interventions for use in the treatment of autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (POTS), in PASC participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs. Type: Interventional Start Date: Mar 2024 |
Restoring Energy With Sub-symptom Threshold Optimized Rehabilitation Exercise for Long COVID
Columbia University
Long Covid19
Exercise Intolerance
Riboflavin-Responsive
The overall goal of this study is to find out if rehabilitation exercise can help people
who have long COVID. Participants will be randomized by chance to receive either aerobic
exercise or breathing exercise (combined with stretches). Participants will be guided and
supported in completing a tailored,... expand
The overall goal of this study is to find out if rehabilitation exercise can help people who have long COVID. Participants will be randomized by chance to receive either aerobic exercise or breathing exercise (combined with stretches). Participants will be guided and supported in completing a tailored, 6-week home exercise program to be performed 5 - 6 days a week, prescribed and supervised by rehabilitation therapists. Participants will perform breathing exercises, which will be supervised by an occupational therapist. The focus of Aim 1 is to determine feasibility of implementing RESToRE in long COVID. Type: Interventional Start Date: Oct 2023 |
Long COVID Immune Profiling
Vanderbilt University Medical Center
Long COVID
POTS - Postural Orthostatic Tachycardia Syndrome
Autonomic Dysfunction
Parasympathetic nervous system (PNS) is part of the body's autonomic nervous system(PNS)
protects body against inflammation. Study shows that reduced PNS function activity is
associated with persistent inflammation.
Preliminary data from the studies shows, that post-COVID-19 POTS patients have reduced
parasympathetic... expand
Parasympathetic nervous system (PNS) is part of the body's autonomic nervous system(PNS) protects body against inflammation. Study shows that reduced PNS function activity is associated with persistent inflammation. Preliminary data from the studies shows, that post-COVID-19 POTS patients have reduced parasympathetic (PNS) function. Given that the PNS protects against inflammation, this clinical trial aims to prove that post-COVID-19 POTS is caused by reduced PNS activity, which in turn, contributes to persistent inflammation, orthostatic intolerance, and OI symptoms. The study will evaluate immune cell activation in post-COVID-19 POTS and patients with history of COVID-19 infection without sequelae and correlate this with the degree of decreased PNS activity. Type: Interventional Start Date: Apr 2024 |
A 2nd Generation E1/E2B/E3-Deleted Adenoviral COVID-19 Vaccine: The TCELL VACCINE TRIAL
ImmunityBio, Inc.
COVID-19
This is a phase 2/3, multicenter, randomized, placebo-controlled, observer-blind study
assessing the safety, tolerability, immunogenicity, and efficacy of prophylactic
hAd5-S-Fusion+N-ETSD against COVID-19. It is intended that a minimum of 25% of subjects
will be in the >55-year stratum. Safety, immunogenicity,... expand
This is a phase 2/3, multicenter, randomized, placebo-controlled, observer-blind study assessing the safety, tolerability, immunogenicity, and efficacy of prophylactic hAd5-S-Fusion+N-ETSD against COVID-19. It is intended that a minimum of 25% of subjects will be in the >55-year stratum. Safety, immunogenicity, and efficacy assessments will be conducted per the Schedule of Events (SoE) and subjects are expected to participate for up to a maximum of approximately 2 years. Type: Interventional Start Date: Dec 2020 |
Comprehensive Imaging Exam of Convalesced COVID-19 Patients
Johns Hopkins University
COVID-19
COVID Long-Haul
COVID-19 is a systemic inflammatory disease involving many organs including the lungs,
vascular system liver and myocardium that lead to severe pathologies. Patients with
severe cardiopulmonary symptoms usually require weeks to months to fully recover. Studies
of clinical and subclinical impairments... expand
COVID-19 is a systemic inflammatory disease involving many organs including the lungs, vascular system liver and myocardium that lead to severe pathologies. Patients with severe cardiopulmonary symptoms usually require weeks to months to fully recover. Studies of clinical and subclinical impairments of COVID-19 patients are important for medical practice and public health as well as providing pathogenic insight to the viral infection and secondary immune response. Chronic damage of vital organs and systems, and the potential long-term effects is of serious concern. In this study the investigators plan to quantify and characterize chronic consequences of COVID-19 in individuals who receive similar medical care related to disease severity and duration in a single health care system. Using state-of-the-art Computed Tomography (CT) and Magnetic Resonance Imaging (MRI) technology, we will study the pathology in major organ systems in comparison to matched controls. The results of this study may facilitate measures to prevent, detect, and manage complications from COVID-19 infections. Type: Interventional Start Date: Oct 2020 |
Modifying Adiposity Through Behavioral Strategies to Improve COVID-19 Rehabilitation
VA Office of Research and Development
Post-COVID Conditions
Obesity
The research in this VA Merit will examine the effects of obesity and Post-COVID
Conditions (PCC) on physical functioning, health-related quality of life, and adipose
tissue inflammatory and cellular senescence profiles in older Veterans. Further, it will
evaluate whether a weight loss intervention,... expand
The research in this VA Merit will examine the effects of obesity and Post-COVID Conditions (PCC) on physical functioning, health-related quality of life, and adipose tissue inflammatory and cellular senescence profiles in older Veterans. Further, it will evaluate whether a weight loss intervention, including dietary modification and exercise, in obese Veterans with and without PCC will reduce systemic and adipose tissue inflammation and senescence and promote PCC recovery. Type: Interventional Start Date: Jun 2024 |
Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study: Study Understanding...
AstraZeneca
COVID-19, SARS-CoV-2
AZD3152, a single mAb, is being developed to have broad neutralizing activity across
known SARS-CoV-2 variants of concern for pre-exposure prophylaxis of COVID-19.
The aim of the Phase I/III study (Parent Study) will be to evaluate the safety, efficacy
and neutralizing activity of AZD3152 compared... expand
AZD3152, a single mAb, is being developed to have broad neutralizing activity across known SARS-CoV-2 variants of concern for pre-exposure prophylaxis of COVID-19. The aim of the Phase I/III study (Parent Study) will be to evaluate the safety, efficacy and neutralizing activity of AZD3152 compared with comparator for pre exposure prophylaxis of COVID-19, and separately evaluate the safety and PK of AZD5156, a combination of AZD3152 and AZD1061. Sub-study: This Phase II sub-study of SUPERNOVA will assess the safety, PK, and predicted neutralizing activity of AZD3152 compared with EVUSHELD for pre-exposure prophylaxis of COVID-19. Type: Interventional Start Date: Dec 2022 |
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Combined Modified RNA Vaccine Candidates...
BioNTech SE
Influenza, Human
COVID-19
Substudy A: This is a Phase 1 randomized, open-label study to describe the safety and
immunogenicity of up to 3 dose- level combinations of modRNA quadrivalent influenza
vaccine (qIRV (22/23)) and bivalent BNT162b2 (original/Omi BA.4/BA.5). Participants will
receive either:
- qIRV (22/23)/bivalent... expand
Substudy A: This is a Phase 1 randomized, open-label study to describe the safety and immunogenicity of up to 3 dose- level combinations of modRNA quadrivalent influenza vaccine (qIRV (22/23)) and bivalent BNT162b2 (original/Omi BA.4/BA.5). Participants will receive either: - qIRV (22/23)/bivalent BNT162b2 (original/Omi BA.4/BA.5), at 1 of the 3 dose-level combinations - qIRV (22/23) at dose level 1, - qIRV (22/23) at dose level 2, or - bivalent BNT162b2 (original/Omi BA.4/BA.5) at dose level 1 administered concurrently in the opposite arm to commercially licensed quadrivalent influenza vaccine (QIV). Substudy B: This Phase 1/2 study will describe the safety, tolerability, and immunogenicity of quadrivalent influenza vaccine (qIRV)/bivalent BNT162b2 (original/Omi BA.4/BA.5), trivalent influenza vaccine (tIRV)/bivalent BNT162b2 (original/Omi BA.4/BA.5), and bivalent influenza vaccine (bIRV)/bivalent BNT162b2 (original/Omi BA.4/BA.5) when given concurrently with licensed quadrivalent influenza vaccine (QIV). Type: Interventional Start Date: Oct 2022 |
COVID-19 Vaccine Responses in PIDD Subjects
Duke University
X-linked Agammaglobulinemia
XLA
Primary Immune Deficiency
CVID
Common Variable Immunodeficiency
The goal of our study is to assess the cellular immune responses of participants with
antibody deficiency disease before and after immunization with SARS-CoV-2 mRNA vaccines. expand
The goal of our study is to assess the cellular immune responses of participants with antibody deficiency disease before and after immunization with SARS-CoV-2 mRNA vaccines. Type: Observational Start Date: Sep 2021 |
Relative Bioavailability Study of PF-07321332/Ritonavir Oral Powder Relative to the Commercial Tablets...
Pfizer
Bioavailability
The purpose of this study is to estimate the relative bioavailability of
PF-07321332/ritonavir oral powder relative to the commercial tablet formulation under
fasted condition in healthy adult participants. The study will also assess the effect of
3 different food vehicles on the relative bioavailability... expand
The purpose of this study is to estimate the relative bioavailability of PF-07321332/ritonavir oral powder relative to the commercial tablet formulation under fasted condition in healthy adult participants. The study will also assess the effect of 3 different food vehicles on the relative bioavailability of the PF-07321332/ritonavir oral powder formulation as well as the safety, tolerability, and palatability of PF-07321332/ritonavir oral powder in healthy adult participants. Type: Interventional Start Date: Mar 2022 |
Reparixin add-on Therapy to Std Care to Limit Progression in Pts With COVID19 & Other Community Acquired...
Dompé Farmaceutici S.p.A
Infectious Pneumonia
Severe COVID-19
Primary objective:
- To evaluate the efficacy of oral reparixin versus standard care alone in limiting
disease progression in adult patients hospitalised for infectious pneumonia acquired
in the community (CAP), including COVID-19.
Secondary objectives:
- To determine the effect... expand
Primary objective: - To evaluate the efficacy of oral reparixin versus standard care alone in limiting disease progression in adult patients hospitalised for infectious pneumonia acquired in the community (CAP), including COVID-19. Secondary objectives: - To determine the effect of reparixin on several disease severity/progression measures including recovery, ventilatory free days and mortality. Safety objectives: - To evaluate the safety of oral reparixin versus placebo in the specific clinical setting. Type: Interventional Start Date: Apr 2022 |
Communities Fighting COVID-19!
San Diego State University
Covid19
To create and evaluate effective COVID-19 testing uptake strategies that focus on
underserved individuals who are exposed but have not accessed testing, and underserved
individuals who are not routinely tested because they are unaware of their exposure or
risk status in order to increase testing among... expand
To create and evaluate effective COVID-19 testing uptake strategies that focus on underserved individuals who are exposed but have not accessed testing, and underserved individuals who are not routinely tested because they are unaware of their exposure or risk status in order to increase testing among these populations and reduce Covid-19 related disparities. Type: Interventional Start Date: Oct 2020 |
COVID-19 Vaccine Response in Sickle Cell Disease
ASH Research Collaborative
Sickle Cell Disease
COVID-19
The purpose of this study is to assess the antibody response to COVID-19 vaccination in a
cohort of patients with sickle cell disease (SCD) and to assess vaccine and SCD related
complications around the time of vaccination. expand
The purpose of this study is to assess the antibody response to COVID-19 vaccination in a cohort of patients with sickle cell disease (SCD) and to assess vaccine and SCD related complications around the time of vaccination. Type: Observational Start Date: Dec 2021 |
Yogic Breathing and Guided Meditation for Long Covid Symptoms
Beth Israel Deaconess Medical Center
COVID-19
Stress
Shortness of Breath
This study aims to assess the impact of brief digitally delivered breathing practice and
guided meditation on post-Covid physical and mental symptoms in Long Covid Patients. expand
This study aims to assess the impact of brief digitally delivered breathing practice and guided meditation on post-Covid physical and mental symptoms in Long Covid Patients. Type: Interventional Start Date: Sep 2021 |
Protecting With ARNI Against Cardiac Consequences of Coronavirus Disease 2019
Duke University
Covid19
The purpose of this study is to determine the effect of sacubitril/valsartan versus
placebo on markers of cardiac injury, structure, and function among patients who
recovered from acute COVID-19 infection. expand
The purpose of this study is to determine the effect of sacubitril/valsartan versus placebo on markers of cardiac injury, structure, and function among patients who recovered from acute COVID-19 infection. Type: Interventional Start Date: Aug 2021 |
A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated...
Novartis Pharmaceuticals
Relapsing Multiple Sclerosis (RMS)
This study evaluated if relapsing multiple sclerosis (MS) participants treated with
ofatumumab 20 mg subcutaneous (s.c.) administered once monthly could develop an adequate
immune response to the COVID-19 mRNA vaccine compared to participants on an interferon or
glatiramer acetate. expand
This study evaluated if relapsing multiple sclerosis (MS) participants treated with ofatumumab 20 mg subcutaneous (s.c.) administered once monthly could develop an adequate immune response to the COVID-19 mRNA vaccine compared to participants on an interferon or glatiramer acetate. Type: Interventional Start Date: Jun 2021 |
REsearching Covid-19 Outcomes in Diabetes (RECODE)
AdventHealth Translational Research Institute
Covid19
Diabetes
The purpose of this study is to observe any changes that may occur to certain organs
following a confirmed diagnosis of COVID-19 in people with and without diabetes. expand
The purpose of this study is to observe any changes that may occur to certain organs following a confirmed diagnosis of COVID-19 in people with and without diabetes. Type: Observational Start Date: Mar 2021 |
A Study to Evaluate Safety and Effectiveness of mRNA-1273 COVID-19 Vaccine in Healthy Children Between...
ModernaTX, Inc.
SARS-CoV-2
The primary goal for this study is to evaluate up to 3 dose levels of mRNA-1273 vaccine
given to healthy children as intramuscular (IM) injection in 2 doses (in Parts 1 and 2)
and 3 doses (in Part 3), and a third dose or an optional booster dose (BD) (in Parts 1
and 2). expand
The primary goal for this study is to evaluate up to 3 dose levels of mRNA-1273 vaccine given to healthy children as intramuscular (IM) injection in 2 doses (in Parts 1 and 2) and 3 doses (in Part 3), and a third dose or an optional booster dose (BD) (in Parts 1 and 2). Type: Interventional Start Date: Mar 2021 |
Study of Recombinant Protein Vaccines With Adjuvant as a Primary Series and as a Booster Dose Against...
Sanofi Pasteur, a Sanofi Company
COVID-19
The primary objectives of the study are:
To assess the safety profile of the study vaccines in each study intervention group.
To assess the neutralizing antibody profile after primary series vaccination in
SARS-CoV-2-naïve adults.
To demonstrate that a booster dose of monovalent or bivalent... expand
The primary objectives of the study are: To assess the safety profile of the study vaccines in each study intervention group. To assess the neutralizing antibody profile after primary series vaccination in SARS-CoV-2-naïve adults. To demonstrate that a booster dose of monovalent or bivalent SARS-CoV-2 vaccine given to adults previously vaccinated with an authorized/approved COVID-19 vaccine induces an immune response that is non-inferior to the response induced by a twodose priming series with the monovalent vaccine, and superior to that observed immediately before booster. The secondary objectives of the study are: To assess the neutralizing and binding antibody profiles after primary series vaccination at pre-defined time points during the study. To assess the neutralizing and binding antibody responses of booster vaccination. To describe the occurrences of laboratory-confirmed symptomatic COVID19 after primary series and booster vaccination. To describe the occurrences of serologically-confirmed SARS-CoV-2 infection after primary series vaccination. Type: Interventional Start Date: Feb 2021 |
A Synthetic MVA-based SARS-CoV-2 Vaccine, GEO-CM04S1, for the Prevention of COVID-19 Infection
GeoVax, Inc.
COVID-19 Infection
This phase I trial evaluates the side effects and best dose of GEO-CM04S1 (previously
designated as COH04S1), a synthetic modified vaccinia Ankara (MVA)-based SARS-CoV-2
vaccine, for the prevention of COVID-19 infection. COVID-19 infection is caused by the
SARS-CoV-2 virus. SARS-CoV-2 has demonstrated... expand
This phase I trial evaluates the side effects and best dose of GEO-CM04S1 (previously designated as COH04S1), a synthetic modified vaccinia Ankara (MVA)-based SARS-CoV-2 vaccine, for the prevention of COVID-19 infection. COVID-19 infection is caused by the SARS-CoV-2 virus. SARS-CoV-2 has demonstrated the capability to spread rapidly, leading to significant impacts on healthcare systems and causing societal disruption. GEO-CM04S1 was created by placing small pieces of SARS-CoV-2 DNA (the chemical form of genes) into synthetic MVA, which may be able to induce immunity (the ability to recognize and fight against an infection) to SARS-CoV-2. The purpose of the Phase 1 study is to determine the safety and the optimal dose of the GEO-CM04S1 vaccine. The Phase 2 study is designed as a multi-center, double-blind, randomized, parallel, study to evaluate the safety profile of 2 dose levels of GEO-CM04S1 as a single booster shot to assess the immune response measured by the fold-increase in antibody against SARS-CoV-2 Spike protein at day 28 post-injection among healthy adult volunteers. Type: Interventional Start Date: Nov 2020 |
Trans Thoracic Manipulation of Ventilation/Perfusion: the V/Q System
Emory University
Acute Respiratory Distress Syndrome
COVID-19
The purpose of this pilot study is to measure the impact of non-invasive pneumatic
manipulation of transthoracic pressure on oxygenation in patients with Acute Respiratory
Distress Syndrome (ARDS) due to Coronavirus Disease 2019 (COVID 19) who are on mechanical
ventilator support. This will be achieved... expand
The purpose of this pilot study is to measure the impact of non-invasive pneumatic manipulation of transthoracic pressure on oxygenation in patients with Acute Respiratory Distress Syndrome (ARDS) due to Coronavirus Disease 2019 (COVID 19) who are on mechanical ventilator support. This will be achieved by a pneumatic Vest placed around the chest wall of consenting patients who meet inclusion criteria. The Vest is essentially a non-invasive segmental device placed upon the anterior and posterior right and left aspects of the chest wall. The researchers have the ability to inflate and deflate the chambers of the Vest to achieve preset pressures as determined by the protocol and observe the patient's physiological response. Participants will have up to four hours of intervention with the study intervention, followed by 1 hour of post-intervention observation. Type: Interventional Start Date: Aug 2020 |
COVID-19 Pandemic Impact on Alcohol (PIA) - A Natural History Study
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Alcohol Drinking
Alcohol-Related Disorders
Pandemic
Psychological Stress
Background:
The SARS-CoV-2 virus has caused a pandemic infection called COVID-19. It is a global
threat to people, communities, and health systems. Researchers are concerned about the
mental health effects of the pandemic. They want to learn more about how it is affecting
people s alcohol use and... expand
Background: The SARS-CoV-2 virus has caused a pandemic infection called COVID-19. It is a global threat to people, communities, and health systems. Researchers are concerned about the mental health effects of the pandemic. They want to learn more about how it is affecting people s alcohol use and problems, and how it may continue to affect them over time. Objective: To study the impact of the COVID-19 pandemic on alcohol use and consequences in individuals across the spectrum of alcohol use and those with alcohol use disorder. Eligibility: Participants who have been screened under the NIAAA Screening, Assessment and Management Protocol (14-AA-0181) Design: Participants will complete a baseline survey by phone. It will ask about alcohol use, alcohol dependence, and stress. It covers 2 time periods: the 12 months before the pandemic started and the time since it started. Participants will get an ID code and a link to an online survey. They will complete the online survey within a week of the phone survey. Participants will complete a series of online surveys over 24 months. For the first year, surveys will be completed weekly for the first 4 weeks, then biweekly for the next 8 weeks, and then every 1-2 months for the rest of the year. For the second year, surveys will be completed every 6 months. Surveys will cover the following topics: - Alcohol use and its consequences - Other substance use - Stress - Impact of the COVID-19 pandemic - Pain - Physical health - Sleep - Quality of life. Because the course of the pandemic may change, the frequency of the surveys may change. Participation lasts 2 years. Type: Observational Start Date: Jun 2020 |
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