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Study of Xiflam™ Treatment in Patients Post COVID-19 Infection Suffering From What is Known as Long COVID...
Inflammx Therapeutics Inc
Long COVID
The primary objective of this study is to evaluate the safety and efficacy of Xiflam
versus Placebo in patients who present with signs and symptoms of Long COVID.
Xiflam (n=10) or placebo (n=5) will be administered orally once a day (QD) for 12 weeks. expand
The primary objective of this study is to evaluate the safety and efficacy of Xiflam versus Placebo in patients who present with signs and symptoms of Long COVID. Xiflam (n=10) or placebo (n=5) will be administered orally once a day (QD) for 12 weeks. Type: Interventional Start Date: Mar 2024 |
Long COVID Ultrasound Trial
SecondWave Systems Inc.
Long Covid
The research objective is to assess the safety and potential efficacy of spleen
ultrasound stimulation as an intervention for Long COVID in a pilot study.
Specific Aims include:
- Measure Long COVID disease activity before, during and after an 8-week course of
spleen-directed daily ultrasound... expand
The research objective is to assess the safety and potential efficacy of spleen ultrasound stimulation as an intervention for Long COVID in a pilot study. Specific Aims include: - Measure Long COVID disease activity before, during and after an 8-week course of spleen-directed daily ultrasound stimulation. - Measure molecular correlates of Long COVID disease activity before, during and after an 8-week course of spleen-directed daily ultrasound stimulation. - Track adverse events throughout the study to assess safety of the ultrasound intervention. Type: Interventional Start Date: Jan 2024 |
Long COVID Brain Fog: Cognitive Rehabilitation Trial
University of Alabama at Birmingham
Long COVID
Brain Fog
Cognitive Impairment
Cognitive Dysfunction
Post-Acute COVID-19 Syndrome
This study will compare two approaches to cognitive rehabilitation in adults with long
COVID with persistent, mild to moderate, cognitive impairment. One approach will feature
(A) web-based computer "games" that trains how quickly individuals process information
that they receive through their senses;... expand
This study will compare two approaches to cognitive rehabilitation in adults with long COVID with persistent, mild to moderate, cognitive impairment. One approach will feature (A) web-based computer "games" that trains how quickly individuals process information that they receive through their senses; (B) in-lab training on everyday activities with important cognitive components, (C) procedures designed to transfer improvements in cognition from the treatment setting to everyday life, and (D) a non-invasive form of vagus nerve stimulation (VNS), i.e., trans-auricular VNS (taVNS). Component B will include work-related tasks. This approach is termed Constraint-Induced Cognitive Therapy (CICT). The other approach will feature (A) web-based computer "games" that train reaction time and eye-hand coordination; (B) in-lab training on relaxation, healthy nutrition, and healthy sleep, (C) procedures designed to promote integration of these lifestyle changes into everyday life, and (D) taVNS. This approach is termed Brain Fitness Training (BFT). A subset of participants, who qualify for and and desire vocational rehabilitation (VR), will receive VR from the Alabama Department of Rehabilitation Services (ADRS) in addition to CICT or BFT. ADRS VR will include career counseling, prescription of on-the-job accommodations, and guidance on return-to-work. Those in the CICT + VR group will also receive on-the-job coaching from a peer mentor for a month after completing training. CICT, with or without VR, will involve 30 hours of training. Ten 3-hour in-lab, face-to-face, therapist-directed sessions will be scheduled. These sessions will feature one hour of gaming; the remainder will be committed to in-lab training on the target behaviors and the procedures designed to promote transfer of therapeutic gains to daily life and improving skills essential to work; the set of the latter procedures is termed the Transfer Package. ta-VNS will administered for 10 minutes before gaming and in-lab target behavior training. To accommodate the demands of participants' other activities, training sessions will be permitted to be scheduled as tightly as every weekday over 2 weeks or as loosely as every other weekday or so over 4 weeks. If a family caregiver is available, they will receive training on how to best support participants in their therapeutic program. After training ends, four follow-up phone calls will be scheduled approximately one-week apart with participants to promote integration of the skills gained during training into everyday life. BFT, with or without VR, will involve 30 hours of training following the same schedule as for CICT. Ten 3-hour in-lab, face-to-face, therapist-directed sessions will be scheduled. These sessions will feature one hour of gaming; the remainder will be committed to in-lab training on the target behaviors (healthy sleep, nutrition and relaxation habits) and the procedures designed to promote transfer of behavior change to daily life. ta-VNS will be administered for 10 minutes before gaming and in-lab target behavior training. If a family caregiver is available, they will receive training on how to best support participants in their therapeutic program. After training ends, four follow-up phone calls will be scheduled approximately one-week apart with participants to promote integration of the skills gained during training into everyday life. Participants will be randomly assigned to the interventions. Randomization will be stratified by whether participants qualify for and desire VR from ADRS or not. If yes, participants will be randomized in equal numbers to CICT + VR or BFT + VR. If no, participants will be randomized in equal numbers to CICT or BFT. Testing will happen one month before treatment, one day before treatment, one day afterwards, and 6- and 12-months afterwards. Outcomes measured will include cognitive processing speed, cognitive function on laboratory tests, and spontaneous performance of everyday activities with important cognitive components in daily life. Another important outcome measure will be whether or not participants were able to return back to work or had significant improvements in their work activities. Type: Interventional Start Date: Apr 2024 |
Exercise Interventions in Post-acute Sequelae of Covid-19
University of Virginia
COVID-19
The COVID-19 pandemic severely impacted the medical system both directly but also through
incomplete recovery from the virus in the form of post-acute sequelae of COVID-19 (PASC).
PASC affects at least 9.6 million individuals as of May 2022 and continues to affect many
more. PASC is a multisystem... expand
The COVID-19 pandemic severely impacted the medical system both directly but also through incomplete recovery from the virus in the form of post-acute sequelae of COVID-19 (PASC). PASC affects at least 9.6 million individuals as of May 2022 and continues to affect many more. PASC is a multisystem disorder often presenting with mental fog, dyspnea on exertion, and fatigue among other symptoms. The etiology of PASC is uncertain but theories include direct cytotoxicity, dysregulated immune responses, endotheliitis associated with microthrombi, eNOS uncoupling, and myocardial fibrosis with impaired ventricular compliance. To date, there are no established treatments. Exercise has the potential as a therapeutic option to improve VO2peak and improve each of the aforementioned underlying etiologies. The investigators plan to examine the effect of High-Intensity Interval Training (HIIT) and Moderate intensity exercise training (MOD) on the symptoms and exercise tolerance of patients with PASC. The investigators approach will consist of a randomized, blinded, 2-arm, parallel-group design. Enrolled subjects will be randomly assigned to one of two groups in a 1:1 allocation ratio. All groups will undergo a 4-week intervention of 3 days of HIIT per week and 2 days of MOD per week or control of light stretching and controlled breathing. Subjects will be assessed before and after the 4-week intervention to examine the extent to which 4 weeks of the HIIT and MOD combination improves VO2peak and left ventricular diastolic function, global longitudinal strain (GLS), and global circumferential strain (GCS). Further, the investigators will explore changes in markers such as heart rate, heart rhythm, blood pressure, quality of life, exercise tolerance, and PASC symptoms as well as blood/serum markers. Type: Interventional Start Date: Sep 2023 |
Phase 2/3 Heterologous Boosting Study With Different Dose Levels of Monovalent SARS-CoV-2 rS Vaccines
Novavax
COVID-19
This is a Phase 2/3, randomized, double-blind study to evaluate the safety and
immunogenicity of different booster dose levels of the monovalent severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant (r) spike (S) protein
nanoparticle (SARS-CoV-2 rS) vaccines with Matrix-M™ adjuvant... expand
This is a Phase 2/3, randomized, double-blind study to evaluate the safety and immunogenicity of different booster dose levels of the monovalent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant (r) spike (S) protein nanoparticle (SARS-CoV-2 rS) vaccines with Matrix-M™ adjuvant (NVX-CoV2373 [prototype Wuhan vaccine with Matrix-M adjuvant] or NVX-CoV2601 [Omicron XBB.1.5 subvariant vaccine with Matrix-M adjuvant]). Type: Interventional Start Date: Oct 2023 |
Use and Effectiveness of COVID-19 Vaccines Using State Vaccine Registries and Insurance Claims Data
Pfizer
SARS-CoV-2
COVID-19
Post-Acute COVID-19 Syndrome
This study aims to use vaccination information from state vaccine registries linked with
HealthVerity insurance claims for the following:
- to measure how effective the Pfizer-BioNTech vaccine is at preventing post-COVID
conditions.
- to understand characteristics of patients who are... expand
This study aims to use vaccination information from state vaccine registries linked with HealthVerity insurance claims for the following: - to measure how effective the Pfizer-BioNTech vaccine is at preventing post-COVID conditions. - to understand characteristics of patients who are receiving COVID-19 vaccines. All patients whose information is kept unidentified in the HealthVerity database are eligible to be included for both aims of this study. Type: Observational Start Date: Oct 2023 |
This Study Intends to Describe the Characteristics of Patients Given the Pfizer-BioNTech Bivalent mRNA...
Pfizer
Influenza, Human
COVID-19
This study intends to describe the characteristics of patients given the Pfizer-BioNTech
bivalent mRNA COVID-19 vaccine and any commercially available influenza vaccines at the
same time versus at different times. expand
This study intends to describe the characteristics of patients given the Pfizer-BioNTech bivalent mRNA COVID-19 vaccine and any commercially available influenza vaccines at the same time versus at different times. Type: Observational Start Date: May 2023 |
A Study of mRNA-based Influenza and SARS-CoV-2 (COVID-19) Multi-component Vaccines in Healthy Adults
ModernaTX, Inc.
SARS-CoV-2
Influenza
The study is divided into 2 parts: Part 1 and Part 2. The purpose of Part 1 of this study
is to generate sufficient safety, reactogenicity, and immunogenicity data to enable
selection of an mRNA-1083 vaccine composition and dose level to evaluate in a subsequent
Phase 3 clinical trial in adults.
The... expand
The study is divided into 2 parts: Part 1 and Part 2. The purpose of Part 1 of this study is to generate sufficient safety, reactogenicity, and immunogenicity data to enable selection of an mRNA-1083 vaccine composition and dose level to evaluate in a subsequent Phase 3 clinical trial in adults. The purpose of Part 2 of this study is to generate safety and immunogenicity data for additional mRNA-1083 compositions and dose levels in young adults ≥18 years and <50 years of age. Type: Interventional Start Date: Apr 2023 |
Brain-Training Treatment for Long COVID in Older Adults
UConn Health
Post-Acute COVID-19 Syndrome
This research is being done to collect preliminary data on the potential of computerized
"brain-training" exercises for treating Long COVID symptoms in older adults. The
investigators hypothesize that computerized brain-training will be an acceptable and
feasible intervention for treating Long COVID... expand
This research is being done to collect preliminary data on the potential of computerized "brain-training" exercises for treating Long COVID symptoms in older adults. The investigators hypothesize that computerized brain-training will be an acceptable and feasible intervention for treating Long COVID symptoms in older adults. The investigators also expect to provide initial evidence that computerized brain-training has potential for improving thinking, mood, and other aspects of everyday functioning in older adults with Long COVID. Type: Interventional Start Date: Apr 2023 |
Fatigability in Long COVID-19
VA Office of Research and Development
Long COVID
The overall goal of this project is to advance the understanding of underlying mechanisms
impacting performance fatigability and perceived fatigability in Veterans with
post-COVID-19 fatigue and explore the safety and feasibility of a home-based
"minimal-dose" resistance exercise program in this population.... expand
The overall goal of this project is to advance the understanding of underlying mechanisms impacting performance fatigability and perceived fatigability in Veterans with post-COVID-19 fatigue and explore the safety and feasibility of a home-based "minimal-dose" resistance exercise program in this population. The central hypothesis is that declines in force capacity, skeletal muscle oxygen extraction, and affective responses to physical activity offer potential mechanisms through which fatigability is increased in Veterans with post-COVID-19 fatigue. Moreover, home-based resistance exercise delivered remotely may provide a safe and feasibility treatment option for targeting neuromuscular and neurobehavioral factors influencing fatigability severity in this population. Type: Interventional Start Date: Jul 2023 |
Merging Yoga and Self-Management Skills for Symptoms of Long COVID
University of Colorado, Denver
Long COVID
Long COVID patients experience high symptom burden for many months after initial
infection of the COVID-19 virus. This study will investigate a mobile intervention
Merging Yoga and Self-Management Skills (MY-Skills Mobile) as a complementary therapy for
fatigue, pain, mood and quality of life in long... expand
Long COVID patients experience high symptom burden for many months after initial infection of the COVID-19 virus. This study will investigate a mobile intervention Merging Yoga and Self-Management Skills (MY-Skills Mobile) as a complementary therapy for fatigue, pain, mood and quality of life in long COVID patients at the UCHealth Center for Integrative Medicine. The study aim is to assess the feasibility and acceptability of MY-Skills Mobile and research procedures including planned assessments. Type: Interventional Start Date: Feb 2023 |
CATCH-UP Vaccines: Engaged Approaches to Testing in Community/Healthcare Settings for the Underserved...
University of Oklahoma
COVID-19
Vaccine Refusal
Oklahoma has high COVID-19 incidence, particularly among underserved minority and rural
Oklahomans. Oklahoman's are also reporting SARS-CoV-2 vaccine hesitancy and signs of
slowing vaccine uptake, with increased hesitancy among American Indian and rural
populations. The project aims to work with ongoing... expand
Oklahoma has high COVID-19 incidence, particularly among underserved minority and rural Oklahomans. Oklahoman's are also reporting SARS-CoV-2 vaccine hesitancy and signs of slowing vaccine uptake, with increased hesitancy among American Indian and rural populations. The project aims to work with ongoing community testing events to implement interventions to improve vaccine uptake among Oklahoma's underserved populations. Type: Interventional Start Date: Mar 2022 |
Increasing COVID-19 Testing in Chicago's African American Testing Desserts
Rush University Medical Center
COVID-19 Pandemic
This study uses a population-based approach to increase uptake of COVID-19 testing within
a highly segregated and underserved African American community in Chicago. expand
This study uses a population-based approach to increase uptake of COVID-19 testing within a highly segregated and underserved African American community in Chicago. Type: Interventional Start Date: Mar 2021 |
Healthcare Provider Human Papillomavirus Education and Professional Skills Intervention
University of Texas, El Paso
Health Personnel Attitude
Health Knowledge, Attitudes, Practice
Healthcare providers (HCP) serving the El Paso U.S.-Mexico Border Region will be
recruited to compare educational and professional skills interventions focused on the
human papillomavirus (HPV). Our hypothesis is that improving provider knowledge and
communication strategies about HPV and its vaccine... expand
Healthcare providers (HCP) serving the El Paso U.S.-Mexico Border Region will be recruited to compare educational and professional skills interventions focused on the human papillomavirus (HPV). Our hypothesis is that improving provider knowledge and communication strategies about HPV and its vaccine will reduce hesitancy and increase uptake and completion among the populations they serve. Type: Interventional Start Date: Dec 2023 |
Home-based Brain Stimulation Treatment for Post-acute Sequelae of COVID-19 (PASC)
Massachusetts General Hospital
Dysexecutive Syndrome
Post-Acute Sequelae of COVID-19
The main goal of this study is to improve dysexecutive symptoms (e.g., sustained
attention, processing speed) in patients exhibiting post-acute sequelae of COVID-19
(PASC) through home-based transcranial direct current stimulation (tDCS), a noninvasive
method that uses low intensity electric currents... expand
The main goal of this study is to improve dysexecutive symptoms (e.g., sustained attention, processing speed) in patients exhibiting post-acute sequelae of COVID-19 (PASC) through home-based transcranial direct current stimulation (tDCS), a noninvasive method that uses low intensity electric currents delivered to the brain through stimulation electrodes on the scalp. Type: Interventional Start Date: Jun 2022 |
Chinese Herbal Formula for COVID-19
University of California, San Diego
Covid19
This is a multi-center, randomized, double-blind, placebo-controlled clinical trial to
evaluate a 21-herb formula named modified Qing Fei Pai Du Tang (mQFPD) to treat
COVID-19-positive outpatients with mild-to-moderate symptoms assigned to self-quarantined
and home management. This the study aims... expand
This is a multi-center, randomized, double-blind, placebo-controlled clinical trial to evaluate a 21-herb formula named modified Qing Fei Pai Du Tang (mQFPD) to treat COVID-19-positive outpatients with mild-to-moderate symptoms assigned to self-quarantined and home management. This the study aims to establish the safety and feasibility of the use of mQFPD vs placebo in 66 total subjects. Subsequent trials will evaluate other therapeutics as well as the efficacy of mQFPD in a larger study population. Type: Interventional Start Date: Jul 2021 |
Study on Efficacy and Safety of Reparixin in the Treatment of Hospitalized Patients With Severe COVID-19...
Dompé Farmaceutici S.p.A
Pneumonia, Viral
The study objective is to assess Efficacy and safety of Reparixin treatment as compared
to placebo (both on top of standard treatment) in adult patients with severe COVID-19
pneumonia. expand
The study objective is to assess Efficacy and safety of Reparixin treatment as compared to placebo (both on top of standard treatment) in adult patients with severe COVID-19 pneumonia. Type: Interventional Start Date: Feb 2021 |
Dual MRI for Cardiopulmonary COVID-19 Long Haulers
Bastiaan Driehuys
Covid19
The next phase of the COVID-19 pandemic is likely to see a surge in an associated chronic
cardiopulmonary disease that will challenge health systems. Recovered patients are
presenting with persistent dyspnea at the Duke Pulmonary Post-COVID clinic. Evidence is
now mounting that recovered patients... expand
The next phase of the COVID-19 pandemic is likely to see a surge in an associated chronic cardiopulmonary disease that will challenge health systems. Recovered patients are presenting with persistent dyspnea at the Duke Pulmonary Post-COVID clinic. Evidence is now mounting that recovered patients have significant residual pulmonary disease, while myocardial injury has also been increasingly reported. To optimally care for these patients, Duke Pulmonary study team must comprehensively assess and monitor the changes in cardiopulmonary function and relate the changes to physiologic and quality of life outcomes. The study team will deploy cutting-edge MRI to fully characterize cardiopulmonary function in enrolled 30 subjects (accrual 23 subjects) at time point 60-120 days post recovery and 6-9 months later. Cardiac MRI will assess the myocardial status and right ventricular function, while hyperpolarized 129Xe MRI will provide a 3D assessment of pulmonary ventilation, interstitial barrier integrity, and pulmonary vascular hemodynamics. The overall objective outlined in this study is to demonstrate the feasibility and value of comprehensive longitudinal imaging characterization of cardiopulmonary structure and function in patients recovered from Covid-19. Type: Interventional Start Date: May 2021 |
UNITE Study (UMN-GE) for COVID-19
University of Minnesota
Covid19
Cytokine Storm
Inflammation
The research objective of the UNITE Study is to assess device feasibility of ultrasound
application to the spleen to assess its effect on coronavirus disease 2019 (COVID-19) in
a pilot study with an off-the-shelf ultrasound GE device originally used for diagnostic
applications.
Specific Aims:... expand
The research objective of the UNITE Study is to assess device feasibility of ultrasound application to the spleen to assess its effect on coronavirus disease 2019 (COVID-19) in a pilot study with an off-the-shelf ultrasound GE device originally used for diagnostic applications. Specific Aims: 1. Determine the feasibility of splenic ultrasound with an ultrasound device in affecting physiological markers in COVID-19 infected patients between an ultrasound group versus a control group for the primary analyses; and 2. Evaluate the potential capabilities of splenic ultrasound in affecting additional outcomes in COVID-19 infected patients in the ultrasound group compared to a control group. Type: Interventional Start Date: Jan 2021 |
Attitudes Towards Receiving Mental Health Care Using Telehealth During the Coronavirus Disease 2019 (COVID-19)...
Northwestern University
Psychiatric Disorder
Mental Health Disorder
Stress
Adjustment Disorders
The purpose of this study is to collect patients' experiences and feedback to better
understand and improve mental health care using telehealth services. This is critically
important as telehealth appointments, including both phone and video calls, continue to
be offered for regular appointments to... expand
The purpose of this study is to collect patients' experiences and feedback to better understand and improve mental health care using telehealth services. This is critically important as telehealth appointments, including both phone and video calls, continue to be offered for regular appointments to reduce in-person interaction as a preventive measure to help control the spread of COVID-19. Type: Observational Start Date: Dec 2020 |
Evaluation of Aerosol in a Dental Clinic
The University of Texas Health Science Center, Houston
Covid19
The purpose of this study is to evaluate the effectiveness of external evacuation units
and mouth rinses during aerosol generating procedures in a dental clinic and to determine
the risk level to the dental practitioners during aerosol generating procedures. expand
The purpose of this study is to evaluate the effectiveness of external evacuation units and mouth rinses during aerosol generating procedures in a dental clinic and to determine the risk level to the dental practitioners during aerosol generating procedures. Type: Interventional Start Date: Jul 2021 |
Safety and Efficacy of Rayaldee for Treating Mild to Moderate COVID-19
OPKO Health, Inc.
COVID-19
Coronavirus
SARS-CoV2 Infection
This is a phase 2, single or multi-center, randomized, double-blind placebo-controlled
study to evaluate the safety and efficacy of Rayaldee (CTAP101 Capsules) to treat adult
subjects with mild to moderate COVID-19 who test positive for SARS-CoV-2. expand
This is a phase 2, single or multi-center, randomized, double-blind placebo-controlled study to evaluate the safety and efficacy of Rayaldee (CTAP101 Capsules) to treat adult subjects with mild to moderate COVID-19 who test positive for SARS-CoV-2. Type: Interventional Start Date: Nov 2020 |
COVID-OUT: Early Outpatient Treatment for SARS-CoV-2 Infection (COVID-19)
University of Minnesota
Covid19
SARS-CoV Infection
The purpose of this trial is to understand whether:
1. Metformin vs fluvoxamine vs ivermectin vs metformin+fluvoxamine vs
metformin+ivermectin is superior to placebo in non-hospitalized adults with
SARS-CoV-2 disease for preventing Covid-19 disease progression.
2. To understand... expand
The purpose of this trial is to understand whether: 1. Metformin vs fluvoxamine vs ivermectin vs metformin+fluvoxamine vs metformin+ivermectin is superior to placebo in non-hospitalized adults with SARS-CoV-2 disease for preventing Covid-19 disease progression. 2. To understand if the active treatment arms are superior to placebo in improving viral load, serologic markers associated with Covid-19, and gut microbiome in non-hospitalized adults with SARS-CoV-2 infection. 3. To understand if any of the active treatment arms prevent long-covid syndrome, PASC (post-acute sequelae of SARS-CoV-2 infection). Type: Interventional Start Date: Jan 2021 |
PRE-VENT Study in Hospitalized Patients With Severe COVID-19 With or Without Cancer
CTI BioPharma
COVID19
COVID-19
COVID
This is a Phase 2 randomized, double-blind, placebo-controlled, multicenter study to
evaluate the efficacy and safety of pacritinib in hospitalized patients with severe
COVID-19 with or without cancer. expand
This is a Phase 2 randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of pacritinib in hospitalized patients with severe COVID-19 with or without cancer. Type: Interventional Start Date: May 2020 |
COVID-19: Human Epidemiology and Response to SARS-CoV-2
National Institute of Allergy and Infectious Diseases (NIAID)
Coronavirus Disease 2019 (COVID-19)
SARS-CoV-2
The human disease caused by SARS-CoV-2 is called COVID-19. In most cases, COVID-19
presents as a mild to moderate respiratory illness. But it can also be more severe and
even lead to death.
The purpose of this study is to:
- Determine the prevalence of SARS-CoV-2 carrier status over time in... expand
The human disease caused by SARS-CoV-2 is called COVID-19. In most cases, COVID-19 presents as a mild to moderate respiratory illness. But it can also be more severe and even lead to death. The purpose of this study is to: - Determine the prevalence of SARS-CoV-2 carrier status over time in children and parents - Determine the prevalence of antibody development over time in children and parents - Compare carrier status and antibody development for children with asthma and/or other atopic conditions (e.g. eczema) versus children without asthma and/or other atopic conditions - Investigate the presence of SARS-CoV-2 exposure in historical samples from enrolled participants Type: Observational Start Date: May 2020 |
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