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Natural History Study of COVID-19 Using Digital Wearables
National Institute on Minority Health and Health Disparities (NIMHD)
COVID-19 Virus Disease
Background:
People with COVID-19 have varying degrees of illness. It can range from no or mild
symptoms to critical illness and death. Some people with COVID-19 have long-term effects
regardless of the severity of their disease initially. Researchers want to learn more to
see if they can better... expand
Background: People with COVID-19 have varying degrees of illness. It can range from no or mild symptoms to critical illness and death. Some people with COVID-19 have long-term effects regardless of the severity of their disease initially. Researchers want to learn more to see if they can better predict where a person may fall on the illness spectrum. Objective: To follow and record symptoms of COVID-19 to see how it progresses in people and why some people stay sick longer than others. Eligibility: People ages 18-65 who received a COVID-19 positive test result in the 72 hours before their enrollment in the study. Design: Participants will complete a 30-minute baseline survey. They will answer questions about themselves and their health. Participants will get a digital wristband and temperature sensor in the mail. They will get instructions on how to set up and wear the devices. They will download a mobile application on their phone. The app will collect data from the devices. Participants will wear the wristband and sensor every day for the first month. Then they will wear the devices for a total of 40 days over the next 5 months. On the days they wear the devices, they will answer a 2-question health survey via the app. Participants will answer a 20-minute online survey about their health every 30 days. If participants are hospitalized, a family member or close friend will be asked to complete a brief 7-minute online survey about their hospital stay and treatment. Participants will be sent alerts and reminders throughout the study. Participation will last for 6 months. Type: Observational Start Date: Oct 2021 |
Improving Attention in Individuals With Long COVID-19
Shirley Ryan AbilityLab
Long Covid
This study is to find out if the Attention Processing Training program is a potential
treatment for brain fog symptoms, reported by people with Long-Covid. Also investigating
the feasibility of completing this program virtually. expand
This study is to find out if the Attention Processing Training program is a potential treatment for brain fog symptoms, reported by people with Long-Covid. Also investigating the feasibility of completing this program virtually. Type: Interventional Start Date: Mar 2024 |
SMILE: Clinical Trial to Evaluate Mindfulness as Intervention for Racial and Ethnic Populations During...
University of North Carolina, Chapel Hill
Anxiety
COVID-19 Pandemic
The goal of this clinical trial is to evaluate the SMILE app, a Digital Health Platform
(DHP), that will deliver a mindfulness intervention, designed to mitigate COVID-19
related stress. Additionally, the SMILE app will remotely collect self-reported
psychological and physiological metrics of mental... expand
The goal of this clinical trial is to evaluate the SMILE app, a Digital Health Platform (DHP), that will deliver a mindfulness intervention, designed to mitigate COVID-19 related stress. Additionally, the SMILE app will remotely collect self-reported psychological and physiological metrics of mental health and autonomic regulation. Study participants are adults who self-identify as African American, Black and/or Latino, and who have clinically significant levels of anxiety. The study aims are: - Aim 1: Establish the effectiveness and durability of an 8-week Mindfulness DHP intervention. The investigators will focus on two constructs important to mental health and hypothesize that: A) Anxiety, self-report stress and quality-of-life measures will significantly improve when comparing: A.1) Pre-to-post intervention, and; A.2) Control vs. intervention groups over 8 weeks and at 1-month follow-up. B) Arousal, autonomic indices of HRV (reflecting parasympathetic activation) will significantly improve, when comparing: B.1) Pre-to-post intervention, and; B.2) Control vs. intervention groups over 8 weeks and at 1-month follow-up. - Aim 2: Establish the sustainability of two Mindfulness DHP interventions utilizing retention, usage (frequency), and participant satisfaction. - Aim 3: Examine associations between COVID-19 related stress, mental health outcomes, and HRV. Examine the extent to which COVID-19 related stress and mental health symptoms are linked to HRV at baseline and how that relationship changes over time. Participants will be assigned to 1 of 3 arms of the study: MTIA intervention, MAPP intervention, or wait-list control. All participants will be mailed a device with the SMILE app installed, and the equipment for recording cardiac data in the home. All participants will complete the baseline psychometrics measures and physiological stress test using the instructions provided on the SMILE app. Those assigned to the MTIA or MAPP intervention groups will then participate in their assigned intervention over the subsequent 8 weeks. During these 8 weeks, psychometric and physiological data will be completed biweekly for all participants. 3 months following the initial baseline, all participants will complete a final psychometric/physiological evaluation. Type: Interventional Start Date: May 2024 |
Mitigating Mental and Social Health Outcomes of COVID-19: A Counseling Approach
Idaho State University
Social Determinants of Health
Mental Health Issue
COVID-19
The goal of this clinical trial is to develop a comprehensive mental health counseling
program purposed to address the social determinant of health impacts of the coronavirus
disease of2019 (COVID-19). The main questions the investigators aim to answer are: 1)
What are the mental and social determinant... expand
The goal of this clinical trial is to develop a comprehensive mental health counseling program purposed to address the social determinant of health impacts of the coronavirus disease of2019 (COVID-19). The main questions the investigators aim to answer are: 1) What are the mental and social determinant of health impacts of a COVID-19 diagnosis, and 2) What are the impacts of a counseling program implemented to address those impacts? Participants will participate in individual interviews, attend individual and group counseling, and be provided resources related to their social determinants of health needs. Type: Interventional Start Date: Apr 2024 |
A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Variants in Healthy Individuals
BioNTech SE
SARS-CoV-2 Infection
COVID-19
The purpose of this clinical protocol is to learn about the safety, tolerability, and
immunogenicity of new BNT162b2 RNA-based vaccine candidates targeting new variants of
SARS-CoV-2 in healthy people.
Substudy A:
- This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2... expand
The purpose of this clinical protocol is to learn about the safety, tolerability, and immunogenicity of new BNT162b2 RNA-based vaccine candidates targeting new variants of SARS-CoV-2 in healthy people. Substudy A: - This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi XBB.1.5) given as a single 30 µg dose, - in people who are 12 years of age and older, - who previously received at least 3 doses of a US-authorized mRNA COVID-19 vaccine, with the most recent dose being an Omicron BA.4/BA.5-adapted bivalent vaccine received at least 150 days before the study vaccination (Visit 1). - The study is about 6 months long for each participant. - Participants will have at least 5 visits to the clinic. - At each clinic visit a blood sample will be taken. - At least 1 nasal swab will taken. Substudy B: - This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi XBB.1.5) given as a single 30 µg dose, - in people who are 12 years of age and older, - who are COVID-19 vaccine-naïve - who have had any positive SARS-CoV-2 test result >28 days before study vaccine administration. - The study is about 6 months long for each participant. - Participants will have at least 5 visits to the clinic. - At each clinic visit a blood sample will be taken. - At least 1 nasal swab will taken. Substudy C: - This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi JN.1) and BNT162b2 "(2024-2025 variant)" given as a single 30 µg dose to: - Cohort 1: people who are 18 years of age and older, who will receive BNT162b2 (Omi JN.1), and, - Cohort 2: people who are 12 years of age and older, who will receive BNT162b2 "(2024-2025 variant)" (the variant selected for US vaccines to be given in the 2024-2025 season). - Participants may have never received a COVID-19 vaccine or, may have previously received COVID-19 vaccine(s), with the most recent dose received at least 150 days before the study vaccination (Visit 1). - The study is about 6 months long for each participant. - Participants will have at least 6 visits (Cohort 1) or at least 5 visits (Cohort 2) to the clinic. - At each clinic visit a blood sample will be taken. - At least 1 nasal swab will taken. Type: Interventional Start Date: Aug 2023 |
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 |
Strategies and Treatments for Respiratory Infections &Amp; Viral Emergencies (STRIVE): Immune Modulation...
University of Minnesota
COVID-19
COVID-19 can trigger a dysregulated immune response, and previous studies have shown that
immune modulation can improve outcomes in hospitalized patients. This trial is designed
to determine whether intensification of immune modulation early in the course of the
disease (while patients are on low... expand
COVID-19 can trigger a dysregulated immune response, and previous studies have shown that immune modulation can improve outcomes in hospitalized patients. This trial is designed to determine whether intensification of immune modulation early in the course of the disease (while patients are on low flow oxygen) with abatacept (active arm) combined with standard of care (SOC) improves recovery as compared with placebo + SOC (placebo arm). For both groups, intensification of immunomodulation will be provided as part of SOC in case of signs of disease progression (patient requires high flow nasal oxygen (HFNO) or more support) and/or if the patient has rapidly increasing oxygen requirement. Type: Interventional Start Date: Jul 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 |
A Decentralized, Randomized Phase 2 Efficacy and Safety Study of Nirmatrelvir/Ritonavir in Adults With...
Harlan M Krumholz
Long COVID
This decentralized trial is a Phase 2, 1:1 randomized, double-blind, superiority,
placebo-controlled study in an anticipated 100 non-hospitalized highly symptomatic adult
participants with long COVID. It seeks to determine the efficacy, safety, and
tolerability of 15 days of Paxlovid (nirmatrelvir/ritonavir),... expand
This decentralized trial is a Phase 2, 1:1 randomized, double-blind, superiority, placebo-controlled study in an anticipated 100 non-hospitalized highly symptomatic adult participants with long COVID. It seeks to determine the efficacy, safety, and tolerability of 15 days of Paxlovid (nirmatrelvir/ritonavir), an anti-viral agent, compared with placebo plus ritonavir. The hypothesis is that viral persistence contributes to long COVID in some patients and nirmatrelvir/ritonavir compared with placebo/ritonavir can improve general health status in participants with long COVID. The study will also seek immune signatures associated with treatment response (overseen by Professor Akiko Iwasaki). The decentralized study does not require site visits, and participants in all 48 states including the District of Columbia, who meet entry criteria can enroll. It is designed to make it convenient to participate. The study drugs will be delivered to the participant's designated address. Long COVID is also known as post-acute sequelae of SARS-CoV-2 (PASC). Type: Interventional Start Date: Apr 2023 |
Baby2Home (B2H) Mobile Health Application
Women and Infants Hospital of Rhode Island
COVID-19 Pandemic
Health Knowledge, Attitudes, Practice
Perinatal Depression
Mental Health Wellness
Post Partum Depression
The COVID-19 pandemic has transformed healthcare delivery; arguably, the fields of
obstetrics and pediatrics have experienced some of the greatest changes as they have
transitioned away from their role as a medical home and into more of an urgent care model
of care. Baby2Home is a digital health intervention... expand
The COVID-19 pandemic has transformed healthcare delivery; arguably, the fields of obstetrics and pediatrics have experienced some of the greatest changes as they have transitioned away from their role as a medical home and into more of an urgent care model of care. Baby2Home is a digital health intervention designed to bridge the resultant gaps in obstetrics and pediatrics healthcare services for new families over the first year of life. This randomized controlled trial will evaluate whether, compared to usual care, Baby2Home 1) improves maternal, paternal, and infant health service utilization outcomes over the first year postpartum, 2) improves maternal and paternal patient reported outcomes, and 3) reduces racial/ethnic and income-based disparities in preventive health services utilization and parental patient reported outcomes. Type: Interventional Start Date: Nov 2022 |
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 |
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 |
RECOVER-NEURO: Platform Protocol to Measure the Effects of Cognitive Dysfunction Interventions on Long...
Duke University
Long COVID
Long Covid19
Long Covid-19
This platform protocol is designed to be flexible so that it is suitable for a wide range
of settings within health care systems, for remote settings, and in community settings
where it can be integrated into COVID-19 programs and subsequent treatment plans.
This protocol is a prospective, multi-center,... expand
This platform protocol is designed to be flexible so that it is suitable for a wide range of settings within health care systems, for remote settings, 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 potential interventions for PASC-mediated cognitive dysfunction. The hypothesis is that PASC associated dysfunction in cognitive domains, such as executive function and attention, may be improved by interventions that selectively focus on enhancing those domains. Type: Interventional Start Date: Sep 2023 |
RECOVER-NEURO: Platform Protocol, Appendix_A to Measure the Effects of BrainHQ, PASC CoRE and tDCS Interventions...
Duke University
Long COVID
Long Covid19
Long Covid-19
This platform protocol is designed to be flexible so that it is suitable for a wide range
of settings within health care systems, for remote settings, and in community settings
where it can be integrated into COVID-19 programs and subsequent treatment plans.
This protocol is a prospective, multi-center,... expand
This platform protocol is designed to be flexible so that it is suitable for a wide range of settings within health care systems, for remote settings, 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 potential interventions for PASC-mediated cognitive dysfunction. The hypothesis is that PASC-associated dysfunction in cognitive domains, such as executive function and attention, may be improved by interventions that selectively focus on enhancing those domains. This design seeks to evaluate each intervention relative to the Active Comparator. The BrainHQ (alone) arm is important because the intervention is commercially available, accessible, relatively inexpensive, and does not require trained personnel to administer. BrainHQ has been also been proven effective in other studies of cognitive dysfunction such as studies in aging, mild cognitive impairment, traumatic brain injury, among others. The BrainHQ + PASC CoRE arm and the BrainHQ + tDCS arms are suspected to provide cognitive improvements beyond BrainHQ alone through different mechanisms. Both PASC CoRE and tDCS have extensive prior use and have demonstrated utility in improving aspects of cognitive function in other clinical settings.. Type: Interventional Start Date: Sep 2023 |
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 |
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