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CONTAIN COVID-19: Convalescent Plasma to Limit COVID-19 Complications in Hospitalized Patients
NYU Langone Health
COVID-19
Coronavirus
Coronavirus Infection
This is a randomized, blinded phase 2 trial that will assess the efficacy and safety of
anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory
symptoms requiring oxygen supplementation. expand
This is a randomized, blinded phase 2 trial that will assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms requiring oxygen supplementation. Type: Interventional Start Date: Apr 2020 |
Passive Immunity Trial for Our Nation to Treat COVID-19 in Hospitalized Adults
Vanderbilt University Medical Center
COVID-19
Coronavirus
SARS-CoV-2
The purpose of this study is to test the safety and efficacy of convalescent donor plasma
to treat COVID-19 in hospitalized adults in a randomized, placebo-controlled setting. The
effect of convalescent plasma will be compared to placebo on clinical outcomes, measured
using the COVID-19 7-point Ord1 expand
The purpose of this study is to test the safety and efficacy of convalescent donor plasma to treat COVID-19 in hospitalized adults in a randomized, placebo-controlled setting. The effect of convalescent plasma will be compared to placebo on clinical outcomes, measured using the COVID-19 7-point Ordinal Clinical Progression Outcomes Scale at Day 15, among adults with COVID-19 requiring hospitalization. Type: Interventional Start Date: Apr 2020 |
Convalescent Plasma in Outpatients With COVID-19
Stanford University
Covid19
The overarching goal of this project is to confirm or refute the role of passive
immunization as a safe and efficacious therapy in preventing the progression from mild to
severe/critical COVID-19 illness and to understand the immunologic kinetics of
anti-SARS-CoV-2 antibodies after passive immuniza1 expand
The overarching goal of this project is to confirm or refute the role of passive immunization as a safe and efficacious therapy in preventing the progression from mild to severe/critical COVID-19 illness and to understand the immunologic kinetics of anti-SARS-CoV-2 antibodies after passive immunization.The primary objective is to determine the efficacy and safety of a single dose of convalescent plasma (CP) for preventing the progression from mild to severe COVID-19 illness. The secondary objective is to characterize the immunologic response to CP administration. This study will enroll adults presenting to the emergency department (ED) with mild, symptomatic, laboratory-confirmed COVID-19 illness, who are at high risk for progression to severe/critical illness, but who are clinically stable for outpatient management at randomization. Type: Interventional Start Date: Aug 2020 |
ACTIV-3: Therapeutics for Inpatients With COVID-19
National Institute of Allergy and Infectious Diseases (NIAID)
Covid19
This study looks at the safety and effectiveness of different drugs in treating COVID-19
in people who have been hospitalized with the infection. Participants in the study will
be treated with either a study drug plus current standard of care (SOC), or with placebo
plus current SOC. expand
This study looks at the safety and effectiveness of different drugs in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either a study drug plus current standard of care (SOC), or with placebo plus current SOC. Type: Interventional Start Date: Aug 2020 |
COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80
Frank C Sciurba
COVID-19
A multi-center adaptive randomized placebo-controlled platform trial evaluating the
efficacy and safety of anti-thrombotic strategies in COVID-19 adults not requiring
hospitalization at time of diagnosis expand
A multi-center adaptive randomized placebo-controlled platform trial evaluating the efficacy and safety of anti-thrombotic strategies in COVID-19 adults not requiring hospitalization at time of diagnosis Type: Interventional Start Date: Sep 2020 |
Accelerating COVID-19 Therapeutic Interventions and Vaccines 4 ACUTE
Matthew Neal MD
Covid19
This is a randomized, open label, adaptive platform trial to compare the effectiveness of
antithrombotic and additional strategies for prevention of adverse outcomes in COVID-19
positive inpatients expand
This is a randomized, open label, adaptive platform trial to compare the effectiveness of antithrombotic and additional strategies for prevention of adverse outcomes in COVID-19 positive inpatients Type: Interventional Start Date: Sep 2020 |
The Impact of the COVID-19 Pandemic on Eating Behavior and Weight Change
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
COVID-19
Obesity
Background:
The indirect effects of the COVID-19 pandemic on mental health are of increasing concern.
Perceived stress can lead to binge eating and weight gain. Researchers want to learn more
about the relationship between eating behavior and the pandemic.
Objective:
To study how the stress of t1 expand
Background: The indirect effects of the COVID-19 pandemic on mental health are of increasing concern. Perceived stress can lead to binge eating and weight gain. Researchers want to learn more about the relationship between eating behavior and the pandemic. Objective: To study how the stress of the COVID-19 pandemic is affecting eating behaviors and weight. Eligibility: English-speaking adults ages 18 and older who have access to a computer or smartphone connected to the internet. Design: This is an online study. Participants will answer surveys through the study website. Participants will complete a one-time survey. It will ask about their experiences throughout the COVID-19 pandemic, their socioeconomic standing, their mental and physical health, and their eating habits. They will have the option to repeat the survey once a month for the next 12 months. This will show changes in their thoughts and behaviors over time. They will provide their email address to get survey links. Participants will also have the option to complete a 2-minute survey on their smartphone. They will complete the survey daily for 7 days in a row. It will ask about their stress and eating behavior in real time, in their home environment. They will provide their phone number to get survey links via text message. If a participant has taken part in a previous NIH study on the Phoenix AZ campus, they will be asked to share their first and last name, date of birth, and email address. This information will be used to connect data from this study to their past data. Participation is typically 25 minutes but may last up to 1 year. ***To participate in this study go to the REDCap study link: https://redcap.link/nihcovidstudy.***... Type: Observational Start Date: Sep 2022 |
COVID-19, Chronic Adaptation and Response to Exercise (COVID-CARE)
National Institutes of Health Clinical Center (CC)
COVID-19
Background:
People who are recovering from COVID-19 may continue to have problems that affect their
daily life. For instance, they might feel overly tired. Researchers want to learn if
exercise can help people recover after COVID-19 infection.
Objective:
To study if participation in a rehabilita1 expand
Background: People who are recovering from COVID-19 may continue to have problems that affect their daily life. For instance, they might feel overly tired. Researchers want to learn if exercise can help people recover after COVID-19 infection. Objective: To study if participation in a rehabilitation exercise program can help people recovering from COVID-19. Eligibility: Adults ages 18-80 with a lab-confirmed SARS-CoV2 infection (the virus that causes COVID-19), and are still having some symptoms. Design: Participants will have a medical history and physical exam. They will give blood and urine samples. They will have tests to measure heart and lung function. Their blood vessels will be assessed. Participants will have a computed tomography scan of the body. They will have an ultrasound of the muscles in their arms, legs, and chest. Participants will take a 6-minute walk test. They will take other balance and movement tests. Participants will walk on a treadmill while hooked up to a monitor. Then they will be interviewed. It will be audio-recorded. Participants will complete surveys about their symptoms and daily activities. Participants will take a smell test. For this, they will identify different smells. They will also have memory, attention, and mental functioning tests. Participants will wear an activity monitor on their wrist 24 hours a day. They will exercise 3 times a week for 10 weeks by moving vigorously on a track or treadmill for 30 minutes. They will attend education classes once a week for 10 weeks. Participants will be contacted by phone or email every 3 months for 1 year after they complete the exercise part of the study. They will wear an activity monitor for up to 2 weeks. Type: Interventional Start Date: Jan 2021 |
A Study to Learn About Variant-Adapted COVID-19 RNA Vaccine Candidate(s) in Healthy Children
BioNTech SE
SARS-CoV-2 Virus
Severe Acute Respiratory Syndrome Coronavirus 2
COVID-19
The purpose of this clinical trial is to learn about the safety, extent of the side
effects, and immune responses of the study vaccine (called variant-adapted BNT162b2
RNA-based vaccine) in healthy children. The trial is divided into 5 individual studies or
substudies based on age group and prior h1 expand
The purpose of this clinical trial is to learn about the safety, extent of the side effects, and immune responses of the study vaccine (called variant-adapted BNT162b2 RNA-based vaccine) in healthy children. The trial is divided into 5 individual studies or substudies based on age group and prior history of COVID-19 vaccinations. All participants in each of the 5 sub-studies will receive study vaccine as a shot depending on what group they are in. - Substudy A design: Phase 1 includes participants 6 months through less than 4 years 3 months of age who have not received a previous coronavirus vaccination (COVID-19 vaccine naïve) and will receive 3 doses of study vaccine as their initial series, followed by a fourth dose of study vaccine. Phase 2/3 includes participants 6 months through less than 5 years of age who have not received a previous coronavirus vaccination (COVID-19 vaccine naive) and will receive 1, 2, or 3 doses of study vaccine, depending on what group they are in. - Substudy B design: includes participants 6 months through less than 5 years of age who have either received 2 or 3 prior doses of BNT162b2 and will receive study vaccine as their third or fourth dose. - Substudy C design: Phase 1 includes participants 6 months through less than 5 years of age who have received 3 prior doses of BNT162b2 and will receive study vaccine as their fourth dose. - Substudy D design: includes participants 5 through less than12 years of age who have received 2 or 3 prior doses of BNT162b2 and will receive study vaccine as their third or fourth dose. - Substudy E design: includes participants 2 through less than 12 years of age who have not received a previous coronavirus vaccination (COVID-19 vaccine naive) and will receive a single dose of study vaccine. Type: Interventional Start Date: Sep 2022 |
Improving Thinking in Everyday Life After Covid-19
University of Alabama at Birmingham
Covid-19
Cognitive Impairment
The purpose of this initial study is to evaluate a new form of cognitive rehabilitation
therapy for improving your ability to think, particularly how rapidly you process
information that you receive from your senses, e.g., sight, hearing, and smell. The study
will also test how often and how well y1 expand
The purpose of this initial study is to evaluate a new form of cognitive rehabilitation therapy for improving your ability to think, particularly how rapidly you process information that you receive from your senses, e.g., sight, hearing, and smell. The study will also test how often and how well you carry out tasks that rely on thinking in your daily life. You will be randomly assigned to receive the new therapy soon or about three months later. In other words, your treatment schedule will be determined by chance. The new therapy involves intensive, repetitive cognitive exercises (up to 3.5hr/day for 10 consecutive weekdays) with rest periods interspersed as needed. Type: Interventional Start Date: Jan 2021 |
Azithromycin for COVID-19 Treatment in Outpatients Nationwide
Thomas M. Lietman
COVID-19
SARS-CoV-2
This individually randomized telemedicine-based trial aims to evaluate the efficacy of a
single dose of azithromycin for prevention of progression of COVID-19 in patients with a
recent positive SARS-CoV-2 test who are not currently hospitalized. expand
This individually randomized telemedicine-based trial aims to evaluate the efficacy of a single dose of azithromycin for prevention of progression of COVID-19 in patients with a recent positive SARS-CoV-2 test who are not currently hospitalized. Type: Interventional Start Date: May 2020 |
Systems Analyses of the Immune Response to the Seasonal Influenza Vaccine
National Institute of Allergy and Infectious Diseases (NIAID)
Healthy Volunteer
Background:
Vaccines help prevent disease by causing the body to have an immune response. Many parts
of this response happen in the blood. This response happens over days and weeks after
getting the vaccine. Researchers want to how the blood changes over time in response to
vaccines. They want to1 expand
Background: Vaccines help prevent disease by causing the body to have an immune response. Many parts of this response happen in the blood. This response happens over days and weeks after getting the vaccine. Researchers want to how the blood changes over time in response to vaccines. They want to find out why vaccines work better for some people than for others. This could help make more effective vaccines. Objective: To learn about how the body responds to vaccines. Eligibility: Healthy people ages 18 and older Design: Participants will be screened with a medical history, physical exam, and blood and urine tests. Participants will have 9 visits over 6 months. All visits will include blood tests and a physical exam. Participants will have the first visit 1 week before they get the vaccine. Participants will get the flu vaccine at the second visit. The vaccine will be injected into the muscle of the upper arm with a needle. They will be watched for side effects for 15 minutes. Participants will have the next 2 visits exactly 1 day and 1 week after they get the vaccine. They will have the other 5 visits about 14, 28, 70, and 100 days after they get the vaccine. Participants will take email questionnaires about whether they had any side effects. Participants may have optional extra study visits. These will be no more than once a month for up to 1 year after they get the vaccine. Optionally, they can also repeat the study each year through the 2023 - 2024 flu season Type: Interventional Start Date: Oct 2019 |
Convalescent Plasma to Limit SARS-CoV-2 Associated Complications
Johns Hopkins University
SARS-CoV 2
To assess the efficacy and safety of Human coronavirus immune plasma (HCIP) to reduce the
risk of hospitalization or death, the duration of symptoms and duration of nasopharyngeal
or oropharyngeal viral shedding. expand
To assess the efficacy and safety of Human coronavirus immune plasma (HCIP) to reduce the risk of hospitalization or death, the duration of symptoms and duration of nasopharyngeal or oropharyngeal viral shedding. Type: Interventional Start Date: Jun 2020 |
Visual-OLfactory Training in Participants With COVID-19 Resultant Loss of Smell
Washington University School of Medicine
Anosmia
Covid19
Ageusia
Hyposmia
Hypogeusia
Olfactory dysfunction is a defining symptom of COVID-19 infection. As the number of
total, confirmed COVID-19 cases approached 19 million in the United States, it is
estimated that there will be 250,000 to 500,000 new cases of chronically diminished smell
(hyposmia) and loss of smell (anosmia) this1 expand
Olfactory dysfunction is a defining symptom of COVID-19 infection. As the number of total, confirmed COVID-19 cases approached 19 million in the United States, it is estimated that there will be 250,000 to 500,000 new cases of chronically diminished smell (hyposmia) and loss of smell (anosmia) this year. Olfactory dysfunction is proposed to worsen numerous common co-morbidities in patients and has been shown to lead to a decreased quality of life. There are very few effective treatments for hyposmia or anosmia, and there is no gold standard of treatment. One proposed treatment option is smell training, which has shown promising yet variable results in a multitude of studies. It garners its theoretical basis from the high degree of neuroplasticity within the olfactory system, both peripherally and centrally. However, due to a relative inadequacy of proper studies on olfactory training, it is unknown what the most efficacious method in which to undergo the training is. This study proposes two novel procedural modifications to smell training in an attempt to enhance its efficacy. The investigators propose using a bimodal visual-olfactory approach, rather than relying on olfaction alone, during smell training, as well as using patient-preferred scents in the training that are identified as important by the study participant, rather than pre-determined scents with inadequate scientific backing. The investigators hypothesize that by utilizing bimodal visual-olfactory training and patient-selected scents, the olfactory training will be more efficacious and more motivating for participants. Type: Interventional Start Date: Jan 2021 |
ACTIV-6: COVID-19 Study of Repurposed Medications
Susanna Naggie, MD
Covid19
The purpose of this study is to evaluate the effectiveness of repurposed medications
(study drug(s) in reducing symptoms of non-hospitalized participants with mild to
moderate COVID-19. Participants will receive either study drug or placebo. They will
self-report any new or worsening symptoms or me1 expand
The purpose of this study is to evaluate the effectiveness of repurposed medications (study drug(s) in reducing symptoms of non-hospitalized participants with mild to moderate COVID-19. Participants will receive either study drug or placebo. They will self-report any new or worsening symptoms or medical events they may experience while taking study drug or placebo. This study is intended to be all remote with no in person visits, unless the study team feels it is in the best interest of a participant to see them in person. Prior and current drug arms are listed on clinicaltrials.gov and will be updated with the activation of any new drug arms. Each study arm will also have its own clinicaltrials.gov entry and will include "Pro00107921" in the Unique Protocol ID. Pro00107921_A - Arm D (Ivermectin 400) - NCT05736861; Pro00107921_B - Arm B (Fluvoxamine) - NCT05890586; Pro00107921_C - Arm C (Fluticasone) - NCT05736874; Pro00107921_D - Arm D (Ivermectin 600) - NCT05894538; Pro00107921_E - Arm E (Fluvoxamine 100) - NCT05894564; Pro00107921_F - Arm F (Montelukast) - NCT05894577; Pro00107921_G - Arm G (Metformin) - NCT06042855. Type: Interventional Start Date: Jun 2021 |
Cognitive Rehabilitation in Post-COVID-19 Syndrome
University of Missouri-Columbia
Post-COVID-19 Syndrome
The first aim of this study is to determine the feasibility of delivering CO-OP remotely
to individuals experiencing cognitive impairments that limit everyday activities in
post-COVID-19 syndrome (PCS). The second aim of this study is to assess the effect of
CO-OP on activity performance, subjectiv1 expand
The first aim of this study is to determine the feasibility of delivering CO-OP remotely to individuals experiencing cognitive impairments that limit everyday activities in post-COVID-19 syndrome (PCS). The second aim of this study is to assess the effect of CO-OP on activity performance, subjective and objective cognition, and quality of life in a sample of individuals with PCS. The research team hypothesizes that effect size estimations will indicate that CO-OP will have a greater positive effect, compared to an inactive control group, on activity performance, subjective and objective cognition, and quality of life in a sample of individuals who self-report PCS and cognitive impairment. Type: Interventional Start Date: Jan 2024 |
ImmunoCARE: Rapid, Accurate COVID Testing to Reduce Hospitalization of Immunocompromised Individuals
Scripps Translational Science Institute
Immunodeficiency
Immunosuppression
HIV Infections
Graft Versus Host Disease
Leukemia
The investigators will examine whether a combination of at-home nucleic acid
amplification tests, on-demand telemedicine, and delivery of prescriptions such as
Paxlovid quickly after testing positive for COVID-19, can reduce severe outcomes and
hospitalization of immunocompromised patients and thos1 expand
The investigators will examine whether a combination of at-home nucleic acid amplification tests, on-demand telemedicine, and delivery of prescriptions such as Paxlovid quickly after testing positive for COVID-19, can reduce severe outcomes and hospitalization of immunocompromised patients and those who are 65 years and older. They will also analyze whether these efforts lower the cost of care compared to standard of care. Type: Interventional Start Date: Dec 2022 |
Study of mRNA Vaccine Formulation Against COVID-19 in Healthy Adults 18 Years of Age and Older
Sanofi Pasteur, a Sanofi Company
COVID-19
The primary objectives of the study are:
- To describe the safety profile of all participants in each age group and each study
intervention group up to 12 months post-last dose.
- To describe the neutralizing antibody profile at Day 1, Day 22, and Day 36 of each
study intervention1 expand
The primary objectives of the study are: - To describe the safety profile of all participants in each age group and each study intervention group up to 12 months post-last dose. - To describe the neutralizing antibody profile at Day 1, Day 22, and Day 36 of each study intervention group. The secondary objectives of the study are: - To describe binding antibody profile from Day 1 to Day 387 of each study intervention group. - To describe the neutralizing antibody profile from Day 91 to Day 387 of each study intervention group. - To describe the occurrence of virologically-confirmed coronavirus disease-2019 (COVID-19)-like illness and serologically-confirmed SARS-CoV-2 infection. - To evaluate the correlation/association between antibody responses to SARS-CoV-2 messenger RNA (mRNA) vaccine and the risk of virologically-confirmed COVID-19-like illness and/or serologically-confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection. Type: Interventional Start Date: Mar 2021 |
Ivabradine for Long-Term Effects of COVID-19 With POTS Cohort
Uniformed Services University of the Health Sciences
Long Haul COVID
Postural Orthostatic Tachycardia Syndrome
The purpose of the study is three-fold. The primary aim is to identify the proportion of
Long-Haul COVID (LHC) and non-LHC volunteers with relevant symptoms actually have
postural orthostatic tachycardia syndrome (POTS). The second is to determine benefit of
ivabradine treatment. Ivabradine is a dr1 expand
The purpose of the study is three-fold. The primary aim is to identify the proportion of Long-Haul COVID (LHC) and non-LHC volunteers with relevant symptoms actually have postural orthostatic tachycardia syndrome (POTS). The second is to determine benefit of ivabradine treatment. Ivabradine is a drug approved to treat tachycardia in persons with heart failure. The third is to characterize risk factors and outcomes among volunteers with and without LHC. This will include comparison with COVID-19-positive individuals who did not develop long-COVID symptoms. The study will improve basic and applied knowledge of LHC and its associated cardiovascular and autonomic consequences. Cellular and molecular characterization of LHC and non-LHC participants will be performed with a nested clinical trial for Ivabradine responsiveness on reduction of tachycardia. It is hoped that a greater understanding of LHC, and related autonomic dysfunction in particular will help to identify treatment paradigms and therapeutic targets for improving recovery and enhancing health for those affected. Type: Interventional Start Date: Jun 2023 |
COVID-19 Anosmia Study
Icahn School of Medicine at Mount Sinai
Anosmia
Covid19
To capture the natural history of COVID-19 associated olfactory dysfunction as measured
by two patient reported outcome measures (SNOT-22, QOD-NS) and a 6-week BSIT with a
comparison to an intervention arm receiving daily omega-3 supplements. expand
To capture the natural history of COVID-19 associated olfactory dysfunction as measured by two patient reported outcome measures (SNOT-22, QOD-NS) and a 6-week BSIT with a comparison to an intervention arm receiving daily omega-3 supplements. Type: Interventional Start Date: Jul 2020 |
Characterizing SARS-CoV-2-specific Immunity in Individuals Who Have Recovered From COVID-19
HIV Vaccine Trials Network
SARS-CoV-2
COVID-19
The purpose of this study is to learn more about infection with and recovery from the
virus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Some people
know this virus by the name "coronavirus." It can cause the disease called COVID-19.
The information gained from the study wi1 expand
The purpose of this study is to learn more about infection with and recovery from the virus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Some people know this virus by the name "coronavirus." It can cause the disease called COVID-19. The information gained from the study will be used to help develop better tests for SARS-CoV-2 infection and COVID-19 disease and may help in developing future vaccines and treatments by allowing researchers to determine the difference between the body's immune response to natural SARS-CoV-2 infection and immunization with a SARS-CoV-2 vaccine. Type: Observational Start Date: May 2020 |
Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis of SARS-CoV-2 Infe1
National Institute of Allergy and Infectious Diseases (NIAID)
COVID-19
COVID-19 Immunisation
This is a phase I, open-label, dose-ranging clinical trial in males and non-pregnant
females, starting at 18 years of age, inclusive, who are in good health and meet all
eligibility criteria. This clinical trial is designed to assess the safety,
reactogenicity and immunogenicity of mRNA-1273 manufa1 expand
This is a phase I, open-label, dose-ranging clinical trial in males and non-pregnant females, starting at 18 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of mRNA-1273 manufactured by ModernaTX, Inc. mRNA-1273 is a novel lipid nanoparticle (LNP)-encapsulated mRNA-based vaccine that encodes for a full-length, prefusion stabilized spike (S) protein of SARS-CoV-2. Enrollment will occur at up to 3 domestic clinical research sites. Up to one hundred and fifty-five subjects will be enrolled into one of thirteen cohorts (10 micrograms [mcg], 25 mcg, 50 mcg, 100 mcg, and 250 mcg). Subjects will receive an intramuscular (IM) injection (0.5 milliliters [mL]) of mRNA-1273 on Days 1 and 29 in the deltoid muscle and will be followed through 12 months post second vaccination (Day 394). Follow-up visits will occur 1, 2, and 4 weeks post each vaccination (Days 8, 15, 29, 36, 43, and 57), as well as 3, 6, and 12 months post second vaccination (Days 119, 209, and 394). The primary objective is to evaluate the safety and reactogenicity of a 2-dose vaccination schedule of mRNA-1273, given 28 days apart, across 5 dosages in healthy adults. Optional Substudy: This is an optional third mRNA-1273 vaccination substudy, in subjects 18 years of age and older, who received both the first and second mRNA-1273 vaccinations in the main study and meet all other substudy eligibility criteria. This optional third mRNA-1273 vaccination substudy is designed to assess safety, reactogenicity, and immunogenicity through 12 months post third vaccination (Day 731). Subjects who receive the third mRNA-1273 vaccination will exit the Schedule of Activities for the main study and will enter the Schedule of Activities for the optional substudy. Up to one hundred and twenty subject will be enrolled into two cohorts (consisting of participating subjects who received 2 doses of 25 or 50 mcg and participating subjects who received 2 doses of 100 and 250 mcg). Subjects will receive an IM injection (0.5 mL) at a dosage of 100 mcg/0.5 mL. The primary objective is to evaluate the safety and reactogenicity of a third mRNA-1273 vaccination, at a dosage of 100 mcg. Type: Interventional Start Date: Mar 2020 |
Post-exposure Prophylaxis / Preemptive Therapy for SARS-Coronavirus-2
University of Minnesota
Corona Virus Infection
Acute Respiratory Distress Syndrome
SARS-CoV Infection
Coronavirus
Coronavirus Infections
Study Objective:
1. To test if post-exposure prophylaxis with hydroxychloroquine can prevent symptomatic
COVID-19 disease after known exposure to the SARS-CoV-2 coronavirus.
2. To test if early preemptive hydroxychloroquine therapy can prevent disease
progression in persons with kno1 expand
Study Objective: 1. To test if post-exposure prophylaxis with hydroxychloroquine can prevent symptomatic COVID-19 disease after known exposure to the SARS-CoV-2 coronavirus. 2. To test if early preemptive hydroxychloroquine therapy can prevent disease progression in persons with known symptomatic COVID-19 disease, decreasing hospitalizations and symptom severity. Type: Interventional Start Date: Mar 2020 |
Dietary Intervention to Mitigate Post-Acute COVID-19 Syndrome
University of Maryland, Baltimore
Post-Acute COVID-19 Syndrome
Fatigue
The primary objective of this study is to conduct a 16-week randomized controlled trial
aimed at investigating the effectiveness of the Whole-Diet Approach when following a
healthy US-style diet rich in anti-inflammatory properties. The study will focus on
evaluating its impact on reducing symptoms1 expand
The primary objective of this study is to conduct a 16-week randomized controlled trial aimed at investigating the effectiveness of the Whole-Diet Approach when following a healthy US-style diet rich in anti-inflammatory properties. The study will focus on evaluating its impact on reducing symptoms related to Post-Acute Sequelae of SARS-CoV-2 Infection (PACS) in adults aged 50 years and older. The main research questions this study aims to answer are: 1. Does adhering to a healthy US-style diet, which is abundant in anti-inflammatory properties, effectively mitigate fatigue symptoms in adults with PACS? 2. Does adhering to a healthy US-style diet, which is abundant in anti-inflammatory properties, effectively mitigate declines in muscle function and physical performance in adults with PACS? At the beginning of the study, eligible participants will be randomly assigned to either the Dietary Intervention Group, where they will receive personalized dietary plans and weekly sessions, or the Attention Control Group, where they will attend general health sessions on a weekly basis as well. This research intends to shed light on the potential benefits of the Whole-Diet Approach and its role in ameliorating PACS-related symptoms among older adults. By comparing the outcomes of the two groups, we hope to gain valuable insights into the effectiveness of this dietary intervention in improving the quality of life for individuals dealing with PACS. Type: Interventional Start Date: Nov 2024 |
A Study to Evaluate the Safety and Immunogenicity of the mRNA COVID-19 Vaccines in Healthy Children1
ModernaTX, Inc.
SARS-CoV-2
This study will evaluate the safety and immunogenicity of the mRNA-1273.214 vaccine for
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant of concerns (VOCs)
in participants aged 6 months to <6 years, when administered as a primary series in
SARS-CoV-2 vaccine-naïve participants (1 expand
This study will evaluate the safety and immunogenicity of the mRNA-1273.214 vaccine for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant of concerns (VOCs) in participants aged 6 months to <6 years, when administered as a primary series in SARS-CoV-2 vaccine-naïve participants (Part 1) and a single booster dose (BD) given to participants who previously received 2 doses of the mRNA-1273 vaccine as a primary series (Part 2); and will evaluate the safety and immunogenicity of the mRNA-1273.815 vaccine, when administered as a BD in participants aged 6 months to <6 years (Part 3) and when administered to SARS-CoV-2 vaccine-naïve participants aged 2 years to <5 years of age (Part 4). Type: Interventional Start Date: Jun 2022 |