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Valacyclovir Plus Celecoxib for Post-Acute Sequelae of SARS-CoV-2
Bateman Horne Center
Long COVID
PASC Post Acute Sequelae of COVID 19
To explore the safety and efficacy of daily doses of celecoxib + valacyclovir in the
treatment of patients with prolonged symptoms caused by COVID-19.
expand
To explore the safety and efficacy of daily doses of celecoxib + valacyclovir in the treatment of patients with prolonged symptoms caused by COVID-19. Type: Interventional Start Date: Oct 2023 |
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,... 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 |
Predictors of Post-COVID Clinical and Cognitive Consequences
John D. Dingell VA Medical Center
Post Acute Sequelae of SARS CoV 2 Infection
Obstructive Sleep Apnea
The CDC describes Post-acute sequalae of SARS-COV-2 infection (PASC) for the wide range of
physical and mental health consequences experienced by some patients. These sequelae may be
present four or more weeks after SARS-COV-2 infection, including patients who had initial... expand
The CDC describes Post-acute sequalae of SARS-COV-2 infection (PASC) for the wide range of physical and mental health consequences experienced by some patients. These sequelae may be present four or more weeks after SARS-COV-2 infection, including patients who had initial mild or asymptomatic acute infection. However, there is complete absence of data whether chronic sleep changes due to COVID-19 infection may influence these physical and mental health consequences. While fatigue is one of the common post-COVID conditions, there are no systematic examinations of sleep disturbances in COVID-19 survivors. This will be a pilot observational retrospective and prospective cohort study, to systematically assess if sleep disturbances and severity of sleep apnea comprise a modifiable facet of PASC as well as the short-term and longer-term effects of COVID-19 infection itself on sleep, cognitive function, exercise capacity and lung function. Type: Observational [Patient Registry] Start Date: Jan 2023 |
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,... 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. Type: Interventional Start Date: Aug 2023 |
Study of Obeldesivir in Children and Adolescents With COVID-19
Gilead Sciences
COVID-19
The goal of this clinical study is to learn more about the safety and tolerability of
obeldesivir (ODV) in children and adolescents with coronavirus disease 2019 (COVID-19).
The primary objectives are to evaluate the plasma pharmacokinetics (PK), safety and
tolerability... expand
The goal of this clinical study is to learn more about the safety and tolerability of obeldesivir (ODV) in children and adolescents with coronavirus disease 2019 (COVID-19). The primary objectives are to evaluate the plasma pharmacokinetics (PK), safety and tolerability of ODV in pediatric participants with COVID-19. Type: Interventional Start Date: Dec 2023 |
Sauna for Long Covid
Massachusetts General Hospital
Long COVID
Research suggests that Whole Body Hyperthermia in a sauna-like environment can reduce
symptoms related to post-acute sequelae of SARS-CoV-2 (PASC), or Long Covid. The
investigators aim to study the feasibility and treatment effect of this procedure for
patients experiencing... expand
Research suggests that Whole Body Hyperthermia in a sauna-like environment can reduce symptoms related to post-acute sequelae of SARS-CoV-2 (PASC), or Long Covid. The investigators aim to study the feasibility and treatment effect of this procedure for patients experiencing Long Covid symptoms. Type: Interventional Start Date: May 2024 |
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... 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 |
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... 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 |
AT1001 for the Treatment of Long COVID
Massachusetts General Hospital
Long COVID
Long COVID-19
Post Acute COVID-19 Syndrome
Post Acute Sequelae of COVID-19
The primary objective of this study is to evaluate the safety and efficacy of Larazotide
(AT1001) versus placebo in children and young adults 7 to ≤21 years of age who present with
symptoms of Long COVID in the presence of SARS-CoV-2 antigenemia. AT1001 (n=32) or placebo
(n=16)... expand
The primary objective of this study is to evaluate the safety and efficacy of Larazotide (AT1001) versus placebo in children and young adults 7 to ≤21 years of age who present with symptoms of Long COVID in the presence of SARS-CoV-2 antigenemia. AT1001 (n=32) or placebo (n=16) will be administered orally four times a day (QID) for 21 days. Type: Interventional Start Date: May 2023 |
A Study of the GRIP Influenza and SARS-CoV-2 POC Assays
Mayo Clinic
COVID-19
Influenza
The purpose of this research is to determine if the use of a new device can accurately detect
a virus infection.
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The purpose of this research is to determine if the use of a new device can accurately detect a virus infection. Type: Interventional Start Date: Feb 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... 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 |
Rutgers Pilot for PREDICT- Patient POC Test
Rutgers, The State University of New Jersey
SARS CoV 2 Infection
A pilot study was initiated to assess feasibility of testing asymptomatic dental patients
presenting to the Oral Medicine Clinic at Rutgers School of Dental Medicine for SARS-CoV-2
viral antigen using a point-of-care (POC) Rapid Antigen test.
14 subjects with upcoming appointment... expand
A pilot study was initiated to assess feasibility of testing asymptomatic dental patients presenting to the Oral Medicine Clinic at Rutgers School of Dental Medicine for SARS-CoV-2 viral antigen using a point-of-care (POC) Rapid Antigen test. 14 subjects with upcoming appointment at the Oral Medicine clinic, Rutgers School of Dental Medicine, with no history of documented COVID-19 infection or viral exposure, were enrolled in a study that interrogated patients' perceptions of safety and feedback regarding their testing experience. All 14 patients expressed initial interest, however, 10 patients completed informed consent and completed study procedures. Institutional Clinical Laboratory Improvement Amendments (CLIA) certification of waiver was obtained prior to conducting the study. Communicable Diseases Reporting and Surveillance System (CDRSS) registration and training were completed to enable reporting results of the POC test. Type: Interventional Start Date: Dec 2020 |
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.
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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 |
A Study to Learn About a Repeat 5-Day Treatment With the Study Medicines (Called Nirmatrelvir/Ritonavir)...
Pfizer
COVID-19
The purpose of this study is to learn about the safety and effects of nirmatrelvir/ritonavir
for the potential treatment of COVID-19 rebound.
The study is seeking participants who:
- Have completed treatment with nirmatrelvir/ritonavir
- Have a rebound in... expand
The purpose of this study is to learn about the safety and effects of nirmatrelvir/ritonavir for the potential treatment of COVID-19 rebound. The study is seeking participants who: - Have completed treatment with nirmatrelvir/ritonavir - Have a rebound in COVID-19 symptoms - Are SARS-CoV-2 (COVID-19) positive All study medications will be taken 2 times a day by mouth for 5 days. The first dose of study medication is taken at the study clinic and the rest at home. We will examine the experiences of people receiving the study medicines to those who do not. This will help us determine if the study medicines are safe and effective. People taking part will be in this study for about 24 weeks. Enrolled participants will need to visit the study clinic at least 8 times during the study. Type: Interventional Start Date: Oct 2022 |
A Study to Learn About New COVID-19 RNA Vaccine Candidates in COVID-19 Vaccine-Experienced Healthy Individuals
BioNTech SE
SARS-CoV-2 Infection
COVID-19
The purpose of this clinical trial is to learn about the safety, tolerability and
immunogenicity of BNT162b RNA-based SARS-CoV-2 vaccine candidates in adults to prevent
COVID-19.
For all cohorts (groups of participants), this study is seeking participants who are healthy... expand
The purpose of this clinical trial is to learn about the safety, tolerability and immunogenicity of BNT162b RNA-based SARS-CoV-2 vaccine candidates in adults to prevent COVID-19. For all cohorts (groups of participants), this study is seeking participants who are healthy (who may have preexisting disease if it is stable); All participants will receive a single dose of the study vaccine at the first study clinic and will return to the study clinic at least 4 more times. At each clinic visit, a blood sample will be taken. The study is about 6 months long for each participant. The vaccine candidates in this study are investigational but are very similar to BNT162b2 (Comirnaty), a COVID-19 RNA vaccine approved for use in the US and in many countries. For Cohort 1, this study included participants who were: - 18 through 55 years of age - have received 1 booster dose of a US-authorized COVID-19 vaccine, with the last dose being 90 or more days before Visit 1 of this study. All participants in Cohort 1 will receive 1 of the 2 study vaccines at a 30 microgram dose: BNT162b5 Bivalent (WT/OMI BA.2) or BNT162b2 Bivalent (WT/OMI BA.1). For Cohort 2, this study included participants who were: - 12 years of age and older - have received 3 prior doses of 30 micrograms BNT162b2, with the last dose being 150 to 365 days before Visit 1 of this study. Participants 12 through 17 years of age will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 micrograms. Participants 18 years and older will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at either a 30 microgram or a 60 microgram dose. For Cohort 3, this study included participants who were: - 18 years of age and older - have received 3 prior doses of 30 micrograms BNT162b2, with the last dose being 150 to 365 days before Visit 1 of this study. - Participants will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 micrograms. For Cohort 4, this study is seeking participants who are: - 18 through 55 years of age - have received 3 or 4 prior doses of a US-authorized mRNA COVID-19 vaccine (and dose level), with the last dose being a US-authorized BA.4/BA.5-adapted bivalent vaccine and dose level at least 150 days before Visit 1 of this study. All participants in Cohort 4 will receive 1 of the 5 study vaccines at a 30 microgram dose: BNT162b2 Bivalent (Original/ OMI BA.4/BA.5), BNT162b5 Bivalent (Original/OMI BA.4/BA.5), BNT162b6 Bivalent (Original/OMI BA.4/BA.5), BNT162b7 Bivalent (Original/OMI BA.4/BA.5) or BNT162b7 Monovalent (OMI BA.4/BA.5). Type: Interventional Start Date: Jul 2022 |
Exercise in Child Health
University of California, Irvine
Cystic Fibrosis
Sickle Cell Disease
SARS CoV 2 Infection
This study is a cooperative investigation funded by the NIH. The project is a collaboration
among three major NIH Clinical Translational Science Awardees: 1) UCI (lead site with its
affiliate CHOC), 2) Northwestern University (with its affiliate Lurie Children's Hospital),... expand
This study is a cooperative investigation funded by the NIH. The project is a collaboration among three major NIH Clinical Translational Science Awardees: 1) UCI (lead site with its affiliate CHOC), 2) Northwestern University (with its affiliate Lurie Children's Hospital), and 3) USC (with its affiliate Children's Hospital of Los Angeles). There is an increasing number of children who, through medical advances, now survive diseases and conditions that were once fatal, but which remain chronic and debilitating. A major challenge to improve both the immediate and long term care and health of such children has been the gap in our understanding of how to assess the biological effects of exercise. Like otherwise healthy children, children with chronic diseases and disabilities want to be physically active. The challenge is to determine what constitutes safe and beneficial level of physical activity when the underlying disease or condition [e.g., cystic fibrosis (CF) or sickle cell disease (SCD)] imposes physiological constraints on exercise that are not present in otherwise healthy children. Current exercise testing protocols were based on studies of athletes and high performing healthy individuals and were designed to test limits of performance at very high-intensity, unphysiological, maximal effort. These approaches are not optimal for children and adolescents with disease and disability. This project (REACH-Revamping Exercise Assessment in Child Health) is designed to address this gap. Cohorts of children will be identified with two major genetic diseases (CF and SCD) and measure exercise responses annually as they progress from early puberty to mid or late puberty over a 3-4year period. In addition, in the light of the pandemic, a group of children will be added who were affected by SARS-CoV-2 and investigate their responses to exercise. SARS-CoV-2 has similar long-term symptoms than CF and SCD have. Novel approaches to assessing physiological responses to exercise using advanced data analytics will be examined in relation to metrics of habitual physical activity, circulating biomarkers of inflammation and growth, leukocyte gene expression, and the impact of the underlying CF, SCD or SARS-CoV-2 condition. The data from this study will help to develop a toolkit of innovative metrics for exercise testing that will be made available to the research and clinical community. Type: Interventional Start Date: Nov 2020 |
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:... 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 |
Understanding the Long-term Impact of COVID on Children and Families
NYU Langone Health
SARS-CoV-2 Infection
This is a combined retrospective and prospective, longitudinal, observational meta-cohort of
individuals age 0-25 years who will enter the cohort with and without SARS-CoV-2 infection at
varying stages before and after infection. Individuals with and without SARS-CoV-2 infection... expand
This is a combined retrospective and prospective, longitudinal, observational meta-cohort of individuals age 0-25 years who will enter the cohort with and without SARS-CoV-2 infection at varying stages before and after infection. Individuals with and without SARS-CoV-2 infection and with or without PASC symptoms will be followed to identify risk factors and occurrence of PASC. This study will be conducted in the United States and participants will be recruited through inpatient, outpatient, and community-based settings. Study data including age, demographics, social determinants of health, medical history, vaccination history, details of acute SARS-CoV-2 infection, overall health and physical function, and PASC symptoms will be reported by participants or collected from the electronic health record using a case report form at specified intervals. Biologic specimens will be collected at specified intervals, with some tests performed in local clinical laboratories and others performed by centralized research centers or banked in the Biospecimen Repository. Advanced clinical examinations and radiologic examinations will be performed at local study sites with cross-site standardization. Type: Observational Start Date: Mar 2022 |
Cardiac Magnetic Resonance Tissue Characterization in COVID-19 Survivors
Weill Medical College of Cornell University
COVID-19 Pneumonia
COVID-19
COVID-19 Respiratory Infection
COVID-19 Acute Respiratory Distress Syndrome
COVID-19 Lower Respiratory Infection
The purpose of this study is to test if visualizing the heart with cardiac MRI/echo will be
important in the understanding cardiac function and prediction of cardiopulmonary symptoms,
physical effort tolerance, and outcomes in COVID-19 survivors. If successful, the research... expand
The purpose of this study is to test if visualizing the heart with cardiac MRI/echo will be important in the understanding cardiac function and prediction of cardiopulmonary symptoms, physical effort tolerance, and outcomes in COVID-19 survivors. If successful, the research will allow us to identify the causes of lasting cardiopulmonary symptoms and begin developing cardiac and lung directed therapies accordingly. Type: Observational Start Date: Jul 2021 |
A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Vaccine Boosters
ModernaTX, Inc.
SARS-CoV-2
The main goal of Part A of this study is to assess the safety, reactogenicity, and
immunogenicity of the study vaccine candidates. The main goal of Part B of this study is to
assess the safety, reactogenicity, and immunogenicity of the mRNA-1283.529 booster vaccine
candidate.... expand
The main goal of Part A of this study is to assess the safety, reactogenicity, and immunogenicity of the study vaccine candidates. The main goal of Part B of this study is to assess the safety, reactogenicity, and immunogenicity of the mRNA-1283.529 booster vaccine candidate. Type: Interventional Start Date: Dec 2021 |
Allogeneic Natural Killer (NK) Cell Therapy in Subjects Hospitalized for COVID-19
Deverra Therapeutics, Inc.
COVID-19 Pneumonia
This study is being done to determine the highest tolerated dose of an investigational cell
therapy called DVX201 in patients hospitalized with COVID-19. DVX201 is an allogeneic NK
(natural killer) cell therapy. NK cells are a normal part of your immune system that have the... expand
This study is being done to determine the highest tolerated dose of an investigational cell therapy called DVX201 in patients hospitalized with COVID-19. DVX201 is an allogeneic NK (natural killer) cell therapy. NK cells are a normal part of your immune system that have the ability to identify and kill cells in the body that are infected by viruses such as COVID-19. There is evidence that both NK cell exhaustion and low numbers of NK cell in the blood occur in COVID-19 patients, and this may contribute to worsening of the infection. Therefore, infusion of healthy functional NK cells (like DVX201) may help overcome COVID-19 infection and prevent progression of the disease. This study is being done to look at the safety and tolerability of DVX201 in patients with COVID-19 and to gather information on how COVID-19 responds to treatment with DVX201. Type: Interventional Start Date: Aug 2021 |
Impact of COVID-19 on the Incidence, Characteristics, Management and Outcome of Sepsis
National Institutes of Health Clinical Center (CC)
Sepsis
Septic Shock
This study seeks to determine the the impact of COVID-19 on the incidence, characteristics,
management and outcome of patients admitted to U.S. hospitals with non-COVID-19 related
sepsis.
expand
This study seeks to determine the the impact of COVID-19 on the incidence, characteristics, management and outcome of patients admitted to U.S. hospitals with non-COVID-19 related sepsis. Type: Observational Start Date: Aug 2020 |
COVID-19 Risk Assessment for Hospitalization Outcomes and Epidemiology Efficacy
Aventyn, Inc.
Covid19
Researchers are creating real-time epidemiology registry to evaluate the efficacy of COVID-19
subject risk assessment scores based on recording of symptoms, biomarkers, chronic illness
and mental health assessments with digital technology using wearables and mobile app tools.... expand
Researchers are creating real-time epidemiology registry to evaluate the efficacy of COVID-19 subject risk assessment scores based on recording of symptoms, biomarkers, chronic illness and mental health assessments with digital technology using wearables and mobile app tools. Researchers aim to study in Phase 1, epidemiological variations in COVID-19 presentation in both PCR positive and negative subjects in the registry. Assessment of variables, predictive modeling of variables that impact severity of COVID-19 positive and negative subjects and assessment of predictors for post COVID-19 complications. In Phase 2, 2700 subjects with COVID-19 positive test will be studied in the intervention group comparing ECL-19 vs placebo with primary end point of hospital admission assessment. Treatment strategy for PCR positive COVID-19 subjects in the registry who are in Stage I of the disease process with ECL-19 drug compared to placebo in reducing hospital admissions Type: Observational [Patient Registry] Start Date: Dec 2020 |
A COVID-19 Study to Evaluate Safety and Pharmacokinetics of COVID-HIGIV Administered in Healthy Adults
Emergent BioSolutions
COVID-19
This study is designed to evaluate three dose levels of Anti-SARS-CoV-2 Immunoglobulin
Intravenous (Human) (COVID-HIGIV) for safety and pharmacokinetics (PK) in healthy adults.
Twenty-eight healthy adult subjects will be enrolled into the study to receive a single dose
of... expand
This study is designed to evaluate three dose levels of Anti-SARS-CoV-2 Immunoglobulin Intravenous (Human) (COVID-HIGIV) for safety and pharmacokinetics (PK) in healthy adults. Twenty-eight healthy adult subjects will be enrolled into the study to receive a single dose of COVID-HIGIV or placebo with 84 days of safety and PK follow-up post-administration. Type: Interventional Start Date: Dec 2020 |
Reward Re-Training: A New Treatment to Address Reward Imbalance During the COVID-19 Pandemic
Drexel University
Bulimia Nervosa
Bulimia; Atypical
Binge Eating
Binge-Eating Disorder
In the current study, the investigators will revise our existing 10-session group RRT
treatment manual to specifically address the challenges in building social support and
enhancing both momentary and sustained reward during the COVID-19 pandemic (Preliminary Aim
1). In months... expand
In the current study, the investigators will revise our existing 10-session group RRT treatment manual to specifically address the challenges in building social support and enhancing both momentary and sustained reward during the COVID-19 pandemic (Preliminary Aim 1). In months 2-18, the investigators will conduct a small pilot RCT that will randomize individuals to receive either 10-sessions of RRT (n=30) or supportive therapy (n=30), both delivered as group-treatments via videoconferencing software. The specific aims of the current study are to confirm the feasibility and acceptability of RRT for EDs (Primary Aim 1), evaluate the ability of RRT to engage critical targets including reward to day-to-day life activities, reward to palatable foods, social isolation, and loneliness (Primary Aim 2), and provide preliminary estimates of efficacy in reducing ED symptoms at both post-treatment and a 3-month follow-up (Primary Aim 3). the investigators will also evaluate the impact of RRT on secondary outcome variables including depression, substance use, and quality of life (Secondary Aim 1). Type: Interventional Start Date: Dec 2020 |
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