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Cognitive Rehabilitation Therapy for COVID-19
VA Office of Research and Development
Post-Acute COVID-19 Syndrome
Cognitive dysfunction, psychiatric symptoms, functional impairment, and disability
following COVID-19 negatively impact Veterans' community functioning and quality of life,
contribute to significant human suffering, and are costly to VHA. Rehabilitation is a
critical priority for Veterans with long... expand
Cognitive dysfunction, psychiatric symptoms, functional impairment, and disability following COVID-19 negatively impact Veterans' community functioning and quality of life, contribute to significant human suffering, and are costly to VHA. Rehabilitation is a critical priority for Veterans with long COVID. One promising treatment to improve functioning in Veterans with post-COVID-19 cognitive symptoms is Compensatory Cognitive Training (CCT). Previous studies have found that CCT is feasible, acceptable, and efficacious in Veteran populations with multiple sources of cognitive dysfunction. This randomized controlled trial aims to address important RR&D priorities by examining feasibility, acceptability, and preliminary efficacy of a COVID-19-specific rehabilitation intervention, CCT for long COVID (CCT-C) compared to a robust control condition. The proposed study has the potential to improve cognitive function, functional independence, and quality of life for Veterans with late or delayed effects of secondary conditions related to COVID-19 infections. Type: Interventional Start Date: Jul 2024 |
Mind Body Intervention for Long COVID-19
Beth Israel Deaconess Medical Center
Long COVID
Post-Acute Sequelae of COVID-19
COVID Long-Haul
The goal of this study is to determine if a mind-body intervention can help people
suffering from symptoms associated with Long COVID. The study is a randomized trial
examining the effectiveness of a mind body intervention in reducing somatic symptoms from
Long COVID in participants as compared to... expand
The goal of this study is to determine if a mind-body intervention can help people suffering from symptoms associated with Long COVID. The study is a randomized trial examining the effectiveness of a mind body intervention in reducing somatic symptoms from Long COVID in participants as compared to usual care and an active control (second mind body intervention). The investigators will secondarily investigate whether the intervention alleviates individual somatic complaints and improves daily functioning, relative to usual care and the active control Type: Interventional Start Date: Nov 2023 |
Phase I Safety Study of B/HPIV3/S-6P Vaccine Via Nasal Spray in Adults
National Institute of Allergy and Infectious Diseases (NIAID)
SARS-CoV-2 Infection
This Phase 1 clinical trial will evaluate the safety and immunogenicity of an intranasal
vaccine candidate, a recombinant, live-attenuated, bovine/human parainfluenza virus
vector vaccine expressing the 6-P prefusion-stabilized version of the SARS-CoV-2 spike
protein. expand
This Phase 1 clinical trial will evaluate the safety and immunogenicity of an intranasal vaccine candidate, a recombinant, live-attenuated, bovine/human parainfluenza virus vector vaccine expressing the 6-P prefusion-stabilized version of the SARS-CoV-2 spike protein. Type: Interventional Start Date: Sep 2023 |
Cereset Research Long-Term Healthcare Worker Study
Wake Forest University Health Sciences
Stress
Anxiety
Autonomic Dysregulation
Acoustic Stimulation
Hyperarousal
Randomized, controlled study of long-term maintenance Cereset Research after an initial
4-session intervention bolus versus usual care control following an initial 4-session
intervention bolus. expand
Randomized, controlled study of long-term maintenance Cereset Research after an initial 4-session intervention bolus versus usual care control following an initial 4-session intervention bolus. Type: Interventional Start Date: Nov 2023 |
COVID-19 Transmission and Morbidity in Malawi
Boston University
SARS CoV 2 Infection
SARS CoV 2 Vaccination
SARS-CoV-2 transmission was expected to have a devastating impact in sub-Saharan African
countries. Instead, morbidity and mortality rates in nearly the whole region are an order
of magnitude lower than in Europe and the Americas. To identify what is different
requires a better understanding of the... expand
SARS-CoV-2 transmission was expected to have a devastating impact in sub-Saharan African countries. Instead, morbidity and mortality rates in nearly the whole region are an order of magnitude lower than in Europe and the Americas. To identify what is different requires a better understanding of the underlying immunological substrate of the population, and how these factors affect susceptibility to infection, progression of symptoms, transmission, and responses to SARS-CoV-2 vaccination. Study objectives 1. Determine the risk and predictors of infection and disease among contacts of SARS-CoV-2 infection subjects in Malawi 2. Determine whether innate immune responses lower the risk of SARS-CoV-2 infection and disease, and acquisition and duration of vaccine responses. 3. Assess whether alterations in innate immune responses relevant to SARS-CoV-2 are associated with malaria or intestinal parasite infections. 4. Assess the acquisition and longevity of antibodies (Ab) and cellular adaptive responses elicited by SARS-CoV-2 infection and vaccination. 5. Assess whether malaria and intestinal parasite infections, chronic/mild undernutrition, and anemia mediate alterations in Ab and other adaptive cellular responses to SARS-CoV-2 through innate immune responses or a different unknown mechanism. Type: Observational Start Date: Jan 2023 |
Smell in COVID-19 and Efficacy of Nasal Theophylline (SCENT 3)
Washington University School of Medicine
COVID-19
The purpose of this Phase II trial is to test the effectiveness of intranasal
theophylline irrigations for the treatment of COVID-19 related smell dysfunction. The
investigators will compare the effect of theophylline nasal rinses versus placebo nasal
rinses on smell symptoms. Participants will be... expand
The purpose of this Phase II trial is to test the effectiveness of intranasal theophylline irrigations for the treatment of COVID-19 related smell dysfunction. The investigators will compare the effect of theophylline nasal rinses versus placebo nasal rinses on smell symptoms. Participants will be asked to rinse their nose with a medication or placebo capsule dissolved in saltwater twice daily for 12 weeks and fill out surveys about smell before, during, and at the end of treatment. This study will also be used to describe adverse effects related to intranasal theophylline irrigation. Type: Interventional Start Date: Nov 2022 |
Working Towards Empowered Community-driven Approaches to Increase Vaccination and Preventive Care Engagement
University of California, San Diego
COVID-19
This study will optimize, implement, and test the impact of our multicomponent health
program that includes three primary implementation strategies (Cultural Weavers and
co-creation, mHealth strategies using culturally meaningful text and voice messages, and
care coordination). The investigators will... expand
This study will optimize, implement, and test the impact of our multicomponent health program that includes three primary implementation strategies (Cultural Weavers and co-creation, mHealth strategies using culturally meaningful text and voice messages, and care coordination). The investigators will use a participatory approach to engage community members in co-creating and optimizing our mHealth outreach and enhanced care coordination program components. The investigators will use a hybrid type 3 effectiveness-implementation sequential multiple assignment randomized trial (SMART) design to assess the impact of our multicomponent health program on implementation and outcome measures. Type: Interventional Start Date: Jul 2024 |
Evaluation of the RD-X19 Treatment Device in Individuals With Mild COVID-19
EmitBio Inc.
COVID-19
This is a randomized, double-blind, sham controlled, stratified, pivotal efficacy and
safety study of the EmitBio RD-X19 treatment device in Individuals 40 Years of age and
older with Mild COVID-19 in the at-home setting. expand
This is a randomized, double-blind, sham controlled, stratified, pivotal efficacy and safety study of the EmitBio RD-X19 treatment device in Individuals 40 Years of age and older with Mild COVID-19 in the at-home setting. Type: Interventional Start Date: Apr 2023 |
AZD7442 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)
National Institute of Allergy and Infectious Diseases (NIAID)
COVID-19
This study looks at the safety and effectiveness of AZD7442 in treating COVID-19 in
people who have been hospitalized with the infection. Participants in the study will be
treated with either a AZD7442 plus current standard of care (SOC), or with placebo plus
current SOC. This is ACTIV-3/TICO Treatment... expand
This study looks at the safety and effectiveness of AZD7442 in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either a AZD7442 plus current standard of care (SOC), or with placebo plus current SOC. This is ACTIV-3/TICO Treatment Trial H4. Type: Interventional Start Date: Feb 2021 |
VNS for Long-COVID-19
Icahn School of Medicine at Mount Sinai
Post-COVID-19 Syndrome
Postural Tachycardia Syndrome
Dysautonomia
The goal of this proposed clinical case series is to evaluate the effect of a
non-invasive vagus nerve stimulation paradigm on: 1) Symptom reporting via validated
patient reported outcomes, and 2) objective clinical biomarkers of autonomic nervous
system function.
This will be a placebo controlled,... expand
The goal of this proposed clinical case series is to evaluate the effect of a non-invasive vagus nerve stimulation paradigm on: 1) Symptom reporting via validated patient reported outcomes, and 2) objective clinical biomarkers of autonomic nervous system function. This will be a placebo controlled, randomized controlled trial with a crossover design built in. This study will aim to recruit 40 people with Long COVID to be a part of this research. Type: Interventional Start Date: Nov 2022 |
COVID-19 Screening Program
University of Pennsylvania
COVID-19
In view of the recent COVID surge and difficulties in obtaining testing, we aim to
increase Point of Care (POC) testing, whereby University of Pennsylvania (Penn) faculty,
staff, and trainees who are working in person at Perelman School of Medicine (PSOM)
laboratories can self-test. The purpose of... expand
In view of the recent COVID surge and difficulties in obtaining testing, we aim to increase Point of Care (POC) testing, whereby University of Pennsylvania (Penn) faculty, staff, and trainees who are working in person at Perelman School of Medicine (PSOM) laboratories can self-test. The purpose of this study is to evaluate the implementation of this POC testing program. We will not be collecting any samples as part of this study. This will ensure that individuals can rapidly identify if they have COVID-19 while balancing use, acceptability, appropriateness, and feasibility. We will start with a pilot phase whereby we will evaluate the implementation of a POC version of COVID-19 screening program that will coordinate several existing systems at the University of Pennsylvania including voluntary, self-administered saliva-based viral testing. We will pilot this program to a small cohort of PSOM labs and then test implementation of the self-testing of the POC version of COVID-19 screening across all PSOM labs for those who wish to participate. All results will be self-reported and will not be used to validate any tests or support any future approval from the FDA. No data from this study will go into the participants' Electronic Medical Record (EMR). Type: Observational Start Date: Feb 2022 |
Mindfulness Intervention for Post-Covid Symptoms
Mayo Clinic
COVID-19
Post Acute Sequelae of SARS-CoV-2
The purpose of this research is to study if post-Covid patients using a wearable brain
sensing wellness device (Muse-S) to learn meditation practice during a time where they
are experiencing lengthy Covid symptoms will help in decreasing stress and anxiety. expand
The purpose of this research is to study if post-Covid patients using a wearable brain sensing wellness device (Muse-S) to learn meditation practice during a time where they are experiencing lengthy Covid symptoms will help in decreasing stress and anxiety. Type: Interventional Start Date: Jun 2022 |
COVID-19: Healthy Oregon (Oregon Saludable): Together We Can (Juntos Podemos) Phase II
University of Oregon
Health Behavior
Health Care Utilization
The global SARS-CoV-2 pandemic that causes the severe respiratory illness COVID-19 is the
worst health crisis that the United States has faced in a century. Although this highly
contagious virus has infected millions of Americans already, the disease burdens are
disproportionately born by historically... expand
The global SARS-CoV-2 pandemic that causes the severe respiratory illness COVID-19 is the worst health crisis that the United States has faced in a century. Although this highly contagious virus has infected millions of Americans already, the disease burdens are disproportionately born by historically underserved populations such as Latinx communities. In Oregon, 13% of the population that is Latinx represents approximately 25.7% of COVID-19 cases and are burdened with more than twice the cases per 100,000 individuals compared to non-Hispanic Oregonians (10,677 versus 4,616, respectively). Furthermore, only 54.9% of eligible Latinx Oregonians are vaccinated compared to the 76.2% statewide vaccination rate. An urgent need exists to reach Oregon's Latinx community to prevent SARS-CoV-2 transmission and increase vaccine acceptance. The overall goal of this study is to implement a Promotores de Salud behavioral health intervention to increase the reach, access, uptake, and impact of testing and vaccination in Latinx communities in Oregon. This project will fully integrate with the National institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) consortium and its Coordination and Data Collection Center (CDCC). The study team will add testing venues based on feedback from the Oregon Health Authority (OHA) and our county and community partners to test if a "partner-optimized venue placement strategy" yields more Latinx individuals tested than placement of sites based upon residential density used in the ongoing testing in Phase I of this study (Clinical Trial ID: NCT04793464). In addition, evaluation of the Promotores de Salud intervention held during testing events will test whether culturally competent education results in greater use of strategies that reduce transmission of COVID-19 at the community and individual level and increases the number of individuals who choose to be vaccinated, as a function of fidelity of the intervention. Over time, this project will help communities institutionalize optimal local testing frameworks supported by University of Oregon laboratory facilities for testing capacity, technical support for testing logistics, and collection of data on health behaviors, testing rates, and sustainability. The resulting structures and systems will be poised for future scale-up to other vulnerable communities and/or for other public health purposes. Type: Interventional Start Date: Sep 2021 |
Autoimmune Intervention Mastery Course Study
Terry L. Wahls
Multiple Sclerosis
Clinically Isolated Syndrome
Fibromyalgia
Post Acute Sequelae of COVID-19
Cancer in Remission With Persisting Fatigue
The goal of this project is to critically evaluate the effectiveness of using an online
program to improve diet and self-care in patients with multiple sclerosis (MS),
clinically isolated syndrome (CIS), fibromyalgia, post acute sequela of covid, and cancer
in remission with persisting fatigue. expand
The goal of this project is to critically evaluate the effectiveness of using an online program to improve diet and self-care in patients with multiple sclerosis (MS), clinically isolated syndrome (CIS), fibromyalgia, post acute sequela of covid, and cancer in remission with persisting fatigue. Type: Interventional Start Date: Dec 2021 |
The Impact of COVID-19 on Pulmonary Procedures
M.D. Anderson Cancer Center
COVID-19 Infection
Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
This study investigates the changes in practice by pulmonary procedural programs across
the United States as they faced the coronavirus pandemic. Information gathered from this
study may help guide pulmonary programs on a wider scale and improve their practice. The
study may also help researchers... expand
This study investigates the changes in practice by pulmonary procedural programs across the United States as they faced the coronavirus pandemic. Information gathered from this study may help guide pulmonary programs on a wider scale and improve their practice. The study may also help researchers understand where they should focus research efforts to better respond to a pandemic in the future. Type: Observational Start Date: Nov 2020 |
Assessing the Efficacy of Sirolimus in Patients With COVID-19 Pneumonia for Prevention of Post-COVID...
University of Chicago
Pulmonary Fibrosis
COVID-19 Pneumonia
Long COVID
The primary purpose of this study is to determine whether the drug sirolimus reduces the
likelihood of developing of pulmonary fibrosis in patients who are hospitalized with
COVID-19 pneumonia. expand
The primary purpose of this study is to determine whether the drug sirolimus reduces the likelihood of developing of pulmonary fibrosis in patients who are hospitalized with COVID-19 pneumonia. Type: Interventional Start Date: Jul 2021 |
Use of Behavioral Economics in Repeat SARS-CoV-2 (COVID-19) Antibody Testing in Disadvantaged Communities
University of Southern California
SARS-CoV-2
Repeat testing for SARS-CoV-2 antibodies in disadvantaged communities will help identify
active and recovered infections over time, and as more is understood about antibody
protection, it may help identify persons who have immunity. Many questions about social
barriers and behavioral facilitators... expand
Repeat testing for SARS-CoV-2 antibodies in disadvantaged communities will help identify active and recovered infections over time, and as more is understood about antibody protection, it may help identify persons who have immunity. Many questions about social barriers and behavioral facilitators remain unanswered. This project aims to evaluate the effectiveness of risk-based messaging and incentives that promote repeated testing for SARS-CoV-2 antibodies, as well as to understand social and behavioral determinants of COVID-19 testing and variations within sub-groups of this population. Type: Interventional Start Date: Jun 2021 |
Low-dose Tocilizumab Versus Standard of Care in Hospitalized Patients With COVID-19
University of Chicago
COVID-19
Tocilizumab is an effective treatment for severe coronavirus disease 2019 (Covid-19)
pneumonia and related inflammation. Given limited global supplies, clarification of the
optimal tocilizumab dose is critical. We conducted an open-label, randomized, controlled
trial evaluating two different dose... expand
Tocilizumab is an effective treatment for severe coronavirus disease 2019 (Covid-19) pneumonia and related inflammation. Given limited global supplies, clarification of the optimal tocilizumab dose is critical. We conducted an open-label, randomized, controlled trial evaluating two different dose levels of tocilizumab in Covid-19 (40mg and 120mg). Randomization was stratified on remdesivir and corticosteroid at enrollment. The primary outcome was the time to recovery. The key secondary outcome was 28-day mortality. Type: Interventional Start Date: Sep 2020 |
Saved From COVID-19 - Chloroquine (CQ) Prophylaxis for Health Care Workers at Risk for COVID
Columbia University
COVID
Coronavirus Infection
The primary objective is to determine the clinical efficacy of Chloroquine (CQ) in health
care workers with moderate to high risk of exposure to COVID-19 in preventing symptomatic
COVID-19 infections. Secondary endpoints will explore the efficacy of CQ in preventing
any infection as defined by seroconversion... expand
The primary objective is to determine the clinical efficacy of Chloroquine (CQ) in health care workers with moderate to high risk of exposure to COVID-19 in preventing symptomatic COVID-19 infections. Secondary endpoints will explore the efficacy of CQ in preventing any infection as defined by seroconversion to positive anti-COVID antibody status. Type: Interventional Start Date: Apr 2020 |
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
UMC Utrecht
Community-acquired Pneumonia, Influenza, COVID-19
REMAP-CAP is a randomised, embedded, multifactorial, adaptive platform trial for
community-acquired pneumonia.
The purpose of this study is to evaluate the effect of a range of interventions to
improve outcome of patients admitted to intensive care with community-acquired pneumonia.
In addition,... expand
REMAP-CAP is a randomised, embedded, multifactorial, adaptive platform trial for community-acquired pneumonia. The purpose of this study is to evaluate the effect of a range of interventions to improve outcome of patients admitted to intensive care with community-acquired pneumonia. In addition, REMAP-CAP provides and adaptive research platform for evaluation of multiple treatment modalities in the event of a respiratory pandemic such as COVID-19. REMAP-COVID is a sub-platform of REMAP-CAP that evaluates treatments specific to COVID-19 in the United States of America. Type: Interventional Start Date: Apr 2016 |
Send-In Sample Collection for Comprehensive Analyses of Innate and Adaptive Immune Responses During Acute...
National Institute of Allergy and Infectious Diseases (NIAID)
COVID-19 Infection
Background:
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease
2019 (COVID-19). The global outbreak of COVID-19 is a major public health problem.
COVID-19 causes a wide range of symptoms. These symptoms range from mild breathing
problems to life-threatening... expand
Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19). The global outbreak of COVID-19 is a major public health problem. COVID-19 causes a wide range of symptoms. These symptoms range from mild breathing problems to life-threatening problems or death. Some people have no symptoms. This study aims to learn how acute and late immune responses to COVID-19 lead to different outcomes. The immune system is the body s defense against germs, including viruses, that invade the body. Objective: To characterize the immune responses during and after SARS-CoV-2 infection and determine if there is any relationship to clinical course and outcome. Eligibility: People ages 0 99 who have confirmed or suspected SARS-CoV-2 infection, people who are not infected despite heavy exposure, and relatives of enrolled participants. Design: This is a sample collection protocol to receive send-in biological specimens for exploratory studies, including gene testing. Participants will not be seen at the NIH for study visits. Study staff will talk with participants health care providers to screen them for the study. Participants enrolled into the protocol will send samples and clinical information at least once and more often if the participant has COVID-19. All participants will provide blood samples and possibly stool. We may also ask for left over specimens from any medical procedures completed as part of medical care. The study staff will also request participants health care providers to complete a survey to collect demographic and medical data. Some of this information may need to be provided directly by the participant. Pregnant individuals are invited to participate and may be asked to give cord blood samples after delivery. Study findings that affect participants health may be shared with their health care provider. Depending on findings, participants may be contacted to take part in other NIH studies. Type: Observational Start Date: Oct 2020 |
Pain Relief With Integrative Medicine (PRIMe)?: Feasibility of Acupuncture for Long COVID
University of Washington
Long COVID
Pain
The goal of this preliminary study is to test methods and procedures to be used in a
fully-powered trial to evaluate acupuncture treatment effectiveness. Specifically, we
will test the feasibility of conducting a 2-arm randomized clinical trial for evaluating
the effectiveness of acupuncture for pain... expand
The goal of this preliminary study is to test methods and procedures to be used in a fully-powered trial to evaluate acupuncture treatment effectiveness. Specifically, we will test the feasibility of conducting a 2-arm randomized clinical trial for evaluating the effectiveness of acupuncture for pain in patients with long COVID. Researchers will compare pain intensity and impact on general activities over 5 months in those who receive acupuncture treatment compared to patients who are receiving usual long COVID care. Participants will complete 4 online surveys at weeks 0, 4, 8, and 20. These surveys include validated mental and physical health questionnaires. Participants who are randomly selected to receive the intervention will receive 8 acupuncture treatment sessions. Type: Interventional Start Date: Jun 2024 |
COVID-19 SARS-CoV-2 RAST Study
Columbia University
SARS-CoV2 Infection
The SARS-CoV-2 BioMedomics Rapid Antigen Screening Test (COV-SCAN) is an at-home rapid
antigen COVID-19 antigen screening test device. The primary objectives of this study are
to 1) Evaluate the clinical performance of COV-SCAN; 2.) Assess the usability of COV-SCAN
and the paired app as an over-the-counter... expand
The SARS-CoV-2 BioMedomics Rapid Antigen Screening Test (COV-SCAN) is an at-home rapid antigen COVID-19 antigen screening test device. The primary objectives of this study are to 1) Evaluate the clinical performance of COV-SCAN; 2.) Assess the usability of COV-SCAN and the paired app as an over-the-counter product to be used by lay persons in non- laboratory settings. The clinical performance and usability data will be submitted as part of an application for Emergency Use Authorization (EUA) to the FDA. 3) Assess acceptability and feasibility of the COV-SCAN test, paired app, and frequent testing regimen in demonstration projects in university and workforce settings. Type: Observational Start Date: Jan 2021 |
RECOVER-AUTONOMIC: Platform Protocol, Appendix A (IVIG)
Kanecia Obie Zimmerman
Long COVID
Long Coronavirus Disease 2019 (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 Post-Acute Sequelae of SARS-CoV-2 infection (PASC) participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs. Type: Interventional Start Date: Mar 2024 |
Lithium Long COVID Dose-finding Study
State University of New York at Buffalo
Long COVID
This open-label study will assess if lithium dosages of 30-45mg/day are associated with
greater symptomatic benefit than dosages of 10-15mg/day previously assessed among 50
patients with long COVID. expand
This open-label study will assess if lithium dosages of 30-45mg/day are associated with greater symptomatic benefit than dosages of 10-15mg/day previously assessed among 50 patients with long COVID. Type: Interventional Start Date: Oct 2023 |
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