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Open Label Extension of Efgartigimod in Adults With Post-COVID-19 POTS
argenx
Post-COVID Postural Orthostatic Tachycardia Syndrome Postural Orthostatic Tachycardia Syndrome
The OLE study aims to investigate the safety, efficacy, pharmacodynamics (PD),
pharmacokinetics (PK), and immunogenicity of efgartigimod in participants with
post-COVID-19 postural orthostatic. expand
The OLE study aims to investigate the safety, efficacy, pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity of efgartigimod in participants with post-COVID-19 postural orthostatic. Type: Interventional Start Date: Jun 2023 |
A Study to Learn About How Itraconazole Affects the Blood Level of Study Medicine (PF-07817883) in Healthy...
Pfizer
Healthy
The purpose of this study is to learn how Itraconazole affects the blood level of
PF-07817883 in Healthy Adults.
This study is seeking participants who are:
- male and female aged 18 to 65 years old,
- overtly healthy. This can be determined my medical evaluation, medical history, lab... expand
The purpose of this study is to learn how Itraconazole affects the blood level of PF-07817883 in Healthy Adults. This study is seeking participants who are: - male and female aged 18 to 65 years old, - overtly healthy. This can be determined my medical evaluation, medical history, lab tests etc. This study will consist of 2 parts, Period 1 and Period 2. Period 1: participants will take PF-07817883 one time by mouth at the study clinic. Period 2: participants will take PF-07817883 one time by mouth at the study clinic. They will also take daily itraconazole by mouth for 7 days. Participants will stay at the study clinic for 2 weeks in total. The study doctors will collect blood and urine samples from everyone. The study doctors will check participants' reactions to the study medicine for safety measures. There is a follow-up call at 28 to 35 days from the last dose of PF-07817883. Itraconazole is an approved medicine. It is also a metabolism inhibitor. When taken with some medicines, it affects the actual level of these medicines in the body. This study will compare blood levels of PF-07817883 given with and without Itraconazole. This will help decide safety and right amount for PF-07817883 when given with metabolism inhibitors. Type: Interventional Start Date: Apr 2023 |
Glutamatergic Modulation as a Treatment for Depressive Symptoms Among Patients With Post-acute Sequelae...
New York State Psychiatric Institute
Post-acute Sequelae of COVID-19
Depressive Symptoms
Cognitive Dysfunction
Post-acute sequelae of SARS-CoV2 (PASC), colloquially known as "long-COVID," is thought
to affect between 10-30% of all COVID-19 survivors. Patients with PASC also report
worsening behavioral health symptoms over time that include new-onset depression,
anxiety, and even suicidal behavior. The purpose... expand
Post-acute sequelae of SARS-CoV2 (PASC), colloquially known as "long-COVID," is thought to affect between 10-30% of all COVID-19 survivors. Patients with PASC also report worsening behavioral health symptoms over time that include new-onset depression, anxiety, and even suicidal behavior. The purpose of this randomized, double-blind, controlled trial is to test the efficacy of a glutamate modulator among PASC patients suffering from new-onset or worsening of depressive symptoms. Type: Interventional Start Date: Mar 2023 |
Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273.214 SARS-CoV-2 (COVID-19)...
ModernaTX, Inc.
SARS-CoV-2
The study will evaluate the safety, tolerability, reactogenicity, and effectiveness of
mRNA-1273.214 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine in
infants aged 12 weeks to < 6 months. expand
The study will evaluate the safety, tolerability, reactogenicity, and effectiveness of mRNA-1273.214 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine in infants aged 12 weeks to < 6 months. Type: Interventional Start Date: Sep 2022 |
COVID-19 Testing and Vaccination Among Spanish Speakers
Wake Forest University Health Sciences
COVID-19
Vaccinations
Latinx communities are disproportionately affected by the COVID-19 pandemic, with
Spanish-speaking Latinx communities carrying even heavier burdens of infection,
hospitalization, and mortality. Major barriers to COVID-19 testing and vaccination exist,
and a profound need remains to understand and... expand
Latinx communities are disproportionately affected by the COVID-19 pandemic, with Spanish-speaking Latinx communities carrying even heavier burdens of infection, hospitalization, and mortality. Major barriers to COVID-19 testing and vaccination exist, and a profound need remains to understand and address the social, ethical, and behavioral implications (SEBI) of COVID-19 testing and vaccination within Latinx communities. Our community-academic partnership proposes a rigorous mixed-methods, community-based participatory research study to better understand the SEBI of COVID-19 testing and vaccination and to refine and test a novel and culturally congruent intervention that integrates two evidenced-based strategies - peer navigation and mHealth - to increase COVID-19 testing and vaccination within Spanish-speaking Latinx communities. Type: Interventional Start Date: Feb 2023 |
Leidos-Enabled Adaptive Protocol (LEAP-CT) for Evaluation of Post-exposure Prophylaxis for Newly-infected...
Leidos Life Sciences
2019 Novel Coronavirus Disease
2019 Novel Coronavirus Infection
2019-nCoV Disease
2019-nCoV Infection
COVID-19
This study is designed to test the efficacy and safety of combinations of two
well-understood agents - famotidine and celecoxib. Each of these agents separately
demonstrate clinical activity in mitigating COVID-19 disease symptoms or severity, and
each of which appear to have separate and complementary... expand
This study is designed to test the efficacy and safety of combinations of two well-understood agents - famotidine and celecoxib. Each of these agents separately demonstrate clinical activity in mitigating COVID-19 disease symptoms or severity, and each of which appear to have separate and complementary mechanisms of action. Type: Interventional Start Date: Dec 2021 |
Cellular Senescence and COVID-19 Long-Hauler Syndrome
Mayo Clinic
SARS-CoV2 Infection
The purpose of this study is to test if senescent cells and their secretome contribute to
Long-Hauler Syndrome and if a clinical trial of senolytic drugs, which selectively
eliminate senescent cells, should be initiated. expand
The purpose of this study is to test if senescent cells and their secretome contribute to Long-Hauler Syndrome and if a clinical trial of senolytic drugs, which selectively eliminate senescent cells, should be initiated. Type: Observational Start Date: Mar 2021 |
Comparative Effectiveness of Readmission Reduction Interventions for Individuals With Sepsis or Pneumonia
University of Pittsburgh
Sepsis
Pneumonia
Lower Resp Tract Infection
Covid19
An adaptive platform trial to compare effectiveness of different care models to prevent
readmissions for patients hospitalized with sepsis or lower respiratory tract infection.
The primary outcome is number of days spent at home within 90 days after hospital
discharge. expand
An adaptive platform trial to compare effectiveness of different care models to prevent readmissions for patients hospitalized with sepsis or lower respiratory tract infection. The primary outcome is number of days spent at home within 90 days after hospital discharge. Type: Interventional Start Date: Mar 2021 |
Community Collaboration to Combat COVID-19 (C-FORWARD)
Johns Hopkins University
Coronavirus Infection
This is randomized trial where households will be randomized to identify the optimal
SARS-CoV-2 (COVID-19) testing modality in a population-representative sample of
households in Baltimore City, Maryland. 1,386 households in Baltimore City will be
randomized 1:1:1 to one of three testing modalities:... expand
This is randomized trial where households will be randomized to identify the optimal SARS-CoV-2 (COVID-19) testing modality in a population-representative sample of households in Baltimore City, Maryland. 1,386 households in Baltimore City will be randomized 1:1:1 to one of three testing modalities: 1) fixed-site standard of care testing; 2) community-based mobile van testing; or 3) self-collected home, based testing. Type: Interventional Start Date: Feb 2021 |
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 |
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