Search Clinical Trials
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Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis of SARS-CoV-2 Infection...
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 manufactured... 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... 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 |
Long COVID-19 [11C]CPPC Study
Johns Hopkins University
COVID Long-Haul
The goal of this study is to evaluate the safety of using the
[5-cyano-N-(4-(4-[11C]Methylpiperazin-1-yl)-2-(Piperidin-1-yl)Phenyl)Furan-2-carboxamide]
([11C]CPPC) radiotracer in positron emission tomography (PET) imaging of people with
history of COVID-19 infection, with and without symptoms. The... expand
The goal of this study is to evaluate the safety of using the [5-cyano-N-(4-(4-[11C]Methylpiperazin-1-yl)-2-(Piperidin-1-yl)Phenyl)Furan-2-carboxamide] ([11C]CPPC) radiotracer in positron emission tomography (PET) imaging of people with history of COVID-19 infection, with and without symptoms. The investigators are also interested to see whether use of this radiotracer reveals imaging differences between patients with history of COVID-19 infection and still exhibiting symptoms or healthy patients with history of COVID-19 infection but exhibiting no current symptoms. Type: Interventional Start Date: Aug 2024 |
Safety and Immunogenicity Trial of MPV/S-2P SARS-CoV-2 Vaccine in Adults
National Institute of Allergy and Infectious Diseases (NIAID)
COVID-19
A clinical trial to evaluate the safety, reactogenicity, and immunogenicity of MPV/S-2P
administered intranasally to adults who have previously received a primary series and at
least one booster with an authorized or licensed mRNA SARS-CoV-2 parenteral vaccine. The
primary objective is to evaluate... expand
A clinical trial to evaluate the safety, reactogenicity, and immunogenicity of MPV/S-2P administered intranasally to adults who have previously received a primary series and at least one booster with an authorized or licensed mRNA SARS-CoV-2 parenteral vaccine. The primary objective is to evaluate the safety and reactogenicity of a single dose of MPV/S-2P in previously vaccinated healthy adults. Type: Interventional Start Date: Jul 2024 |
Home-Based Respiratory Muscle Strength Training Program for Individuals With Post-COVID-19 Persistent...
University of South Florida
Post-COVID-19 Syndrome
Dyspnea
To evaluate the extent to which a 12-week respiratory rehabilitation program consisting
of inspiratory and expiratory breathing exercises compared to expiratory breathing
exercises alone will help to improve shortness of breath, respiratory symptoms, breathing
function, distance walked, and quality... expand
To evaluate the extent to which a 12-week respiratory rehabilitation program consisting of inspiratory and expiratory breathing exercises compared to expiratory breathing exercises alone will help to improve shortness of breath, respiratory symptoms, breathing function, distance walked, and quality of life in those who are experiencing persistent shortness of breath after having had COVID-19. Measurements will take place at the beginning, 6 weeks, and at 12 weeks in the study. Type: Interventional Start Date: Dec 2023 |
Brain and Gut Plasticity in Mild TBI or Post-acute COVID Syndrome Following Growth Hormone Therapy
The University of Texas Medical Branch, Galveston
Traumatic Brain Injury
Fatigue
Cognitive Impairment
COVID-19
Patients with a history of mild traumatic brain injury (mTBI) or post acute sequelae of
SARS-CoV-2 (PASC) and abnormal growth hormone secretion, as measured by glucagon
stimulation test, will be treated with replacement growth hormone therapy for a period of
6 months (mTBI) or 9 months (PASC). Testing... expand
Patients with a history of mild traumatic brain injury (mTBI) or post acute sequelae of SARS-CoV-2 (PASC) and abnormal growth hormone secretion, as measured by glucagon stimulation test, will be treated with replacement growth hormone therapy for a period of 6 months (mTBI) or 9 months (PASC). Testing of cognition, exercise, fatigue, brain activation and morphology, body composition and measurements of quality of life will be performed before and after the treatment period. Fecal sampling for characterization of the GI microbiome will occur monthly over the treatment period. Control subjects will be enrolled and will provide fecal samples monthly for 6 months. GI microbiomes will be compared between mTBI patients, PASC patients and controls at baseline as well as over the treatment period. Type: Interventional Start Date: Aug 2018 |
CBD Oil for Reducing Emotional Impact of COVID-19
University of Texas at Austin
Anxiety Depression
Alcohol Abuse
Substance Abuse
Anger
Sleep Disturbance
Our purpose is to conduct a 4-arm placebo-controlled clinical trial to investigate the
relative clinical efficacy of 300 mg. of pure hemp-derived CBD isolate, 300 mg. of full
spectrum CBD oil, 300 mg. of broad- spectrum CBD Oil, or Placebo oil among adults
presenting with COVID-19 -induced stress... expand
Our purpose is to conduct a 4-arm placebo-controlled clinical trial to investigate the relative clinical efficacy of 300 mg. of pure hemp-derived CBD isolate, 300 mg. of full spectrum CBD oil, 300 mg. of broad- spectrum CBD Oil, or Placebo oil among adults presenting with COVID-19 -induced stress reactions including one or more of the following: anxiety, depression, anger, substance use, or sleep disturbance. Type: Interventional Start Date: Dec 2020 |
Impact on Anxiety and Motivation of COVID-19 and Predictors of Individual Responses
National Institute of Mental Health (NIMH)
Anxiety
Healthy Volunteers
Background:
Researchers think that people s mental health and behavior will be very affected by the
steps taken to slow the spread of COVID-19, such as social distancing. Also, the threat
of disease and death, to people and their loved ones, can cause much stress. Researchers
want to learn more... expand
Background: Researchers think that people s mental health and behavior will be very affected by the steps taken to slow the spread of COVID-19, such as social distancing. Also, the threat of disease and death, to people and their loved ones, can cause much stress. Researchers want to learn more about these stressors and how they are affecting people. Objective: To study the relationship of affective, cognitive, and behavioral responses to stressors related to COVID-19 with neuroimaging and behavioral data collected before COVID-19. Eligibility: English-speaking adults age 18 and older Design: This online study will include both new participants and those who have taken part in past National Institute of Mental Health studies. All will complete the same surveys and tasks. Participants will give their name and email address. They will get a username and password. The file that links their username to their personal data will be kept secure. Participants will complete a set of surveys about the following: - Sociodemographic data, such age, race, and income - Education and work status - Mental and medical illness and treatment - Family medical history - Mood - COVID-19 experience - Anxiety - Substance and alcohol use - Attention control - Other mental health related topics. Participants will complete a finger-tapping task. For this, they will press a key a certain number of times in a limited period. They will get to practice the task. After the task, they will complete a survey about it. It will take about 1 hour to complete the surveys and the task. About 8 months later, participants will be contacted to repeat the surveys and task. Compensation is provided. Type: Observational Start Date: May 2020 |
Using MOST to Optimize an Intervention to Increase COVID-19 Testing for Frontline Essential Workers
New York University
COVID-19
COVID-19 Testing
COVID-19 testing is essential to controlling the COVID-19 pandemic to break transmission
chains and reduce community transmission. However, Black and Latino/Hispanic populations
in lower status frontline essential occupations such as food preparation, retail,
building maintenance, personal services,... expand
COVID-19 testing is essential to controlling the COVID-19 pandemic to break transmission chains and reduce community transmission. However, Black and Latino/Hispanic populations in lower status frontline essential occupations such as food preparation, retail, building maintenance, personal services, and in-home health care have serious barriers to COVID-19 testing and, therefore, insufficient testing rates. The proposed study will use the multiphase optimization strategy framework to address the problem of low COVID-19 testing rates for this population: We will test the effects of four distinct candidate intervention components and then create an efficient multicomponent made up of the most effective combination of the components that can be rapidly scaled up in community settings to boost COVID-19 testing rates. Type: Interventional Start Date: Jun 2022 |
Chimpanzee Adenovirus and Self-Amplifying mRNA Prime-Boost Prophylactic Vaccines Against SARS-CoV-2 in...
National Institute of Allergy and Infectious Diseases (NIAID)
COVID-19
This is a multicenter, US-only, phase 1, open-label, dose escalation, non-randomized
study of the safety, tolerability, and immunogenicity of investigational ChAd and SAM
SARS-CoV-2 vaccines in healthy adult subjects. Homologous and heterologous prime-boost
vaccination schedules (Stage 1), as well... expand
This is a multicenter, US-only, phase 1, open-label, dose escalation, non-randomized study of the safety, tolerability, and immunogenicity of investigational ChAd and SAM SARS-CoV-2 vaccines in healthy adult subjects. Homologous and heterologous prime-boost vaccination schedules (Stage 1), as well as boost(s) after receipt of COVID-19 EUA/licensed vaccines (Stage 2) will be examined. Subjects' willingness to receive ChAd vaccines will be assessed and documented at the time of informed consent and considered to determine group assignments. This phase 1 study will enroll 17 Stage 1 and up to 118 Stage 2 subjects. Eligible subjects will be enrolled in different groups based on their age (18-60 years old and >60 years old) and their EUA/licensed COVID-19 vaccination status. A sentinel approach with 72-hour (Stage 1, and Stage 2, Groups 5, 6, 8-10, 12, 13-15) or 7-day observation times (Groups 7 and 11) will be used, before recruiting the remainder of each dose escalation group. Decisions about dose escalation will be determined by the SSC with consultation with the DSMB as needed after all subjects in each group have been observed through Day 8 post first study vaccination. All subjects will be followed through 12 months after their last study vaccination. Vaccinated subjects will be carefully monitored for exposure and infection to SARS-CoV-2 throughout the study. Escalation to the highest dose (10 µg) of SAM-S-TCE in younger subjects will proceed only following safety assessments of the 10 µg dose in older subjects for a period of 28 days post-vaccination. In addition, the dosage of SAM-S-TCE given as a double boost to subjects previously vaccinated with the Johnson & Johnson/Janssen Ad26 COVID-19 EUA/licensed vaccine in Groups 8A, 8B, and 12A, 12B will be determined based on the dose escalation reactogenicity and immunogenicity results in Groups 5-7 and 9-11, respectively. After protocol version 9.0 was implemented, it was decided not to enroll subjects into Groups 7 and 8 because of competing priorities and predicted difficulties enrolling into these two groups. The primary objectives of this study are 1) To assess the safety and tolerability of different doses of ChAd-S or ChAd-S-TCE, and SAM-S or SAM-S-TCE when administered as prime-boost in healthy naïve adult subjects, 2) To assess the safety and tolerability of different doses of ChAd-S or ChAd-S-TCE, and SAM-S or SAM-S-TCE when administered as first or second boost in healthy adult subjects previously vaccinated with an mRNA or adenoviral-vectored COVID-19 EUA/licensed vaccine. Type: Interventional Start Date: Mar 2021 |
Fostamatinib for Hospitalized Adults With COVID-19
National Heart, Lung, and Blood Institute (NHLBI)
Coronavirus Disease 2019
Background:
COVID-19 is a new disease caused by SARS-CoV-2 that was identified in 2019. Some people
who get sick with COVID-19 become ill requiring hospitalization. There are some medicines
that may help with recovery. Researchers want to see if a drug called fostamatinib may
help people who are... expand
Background: COVID-19 is a new disease caused by SARS-CoV-2 that was identified in 2019. Some people who get sick with COVID-19 become ill requiring hospitalization. There are some medicines that may help with recovery. Researchers want to see if a drug called fostamatinib may help people who are hospitalized with COVID-19. Objective: To learn if fostamatinib is safe in patients who are hospitalized with COVID-19 and gain earlier insight into whether it improves outcomes. Eligibility: Adults age 18 and older who are hospitalized with COVID-19. Design: Participants will be screened with a physical exam, including vital signs and weight. They will have a blood test and chest x-ray. They will have a COVID-19 test as a swab of either the back of the throat or the back of the nose. They will take a pregnancy test if needed. Participants will be randomly assigned, to take either fostamatinib pills or a placebo twice daily for up to 14 days in addition to standard of care for COVID-19. If they can swallow, they will take the pills by mouth with water. If they cannot swallow or are on mechanical ventilation, the pills will be crushed, mixed with water, and given through a tube placed through the nostril, or placed in the mouth, down the esophagus, and into the stomach. Blood samples will be taken daily. Participants will return to the Clinical Center for safety follow-up visits. At these visits, they will have a physical exam and blood tests. If they cannot visit the Clinical Center, they will be contacted by phone or have a telehealth visit. Participation will last for about two months Type: Interventional Start Date: Oct 2020 |
Safety, Tolerability, and Pharmacokinetics of SAB-301 in Healthy Adults
National Institute of Allergy and Infectious Diseases (NIAID)
Middle East Respiratory Syndrome Coronavirus
Background:
Middle East Respiratory Syndrome (MERS) is a newly discovered contagious and sometimes
fatal respiratory virus. People often get MERS through close contact with an infected
person. Scientists are worried that MERS may spread and cause more infections. There are
no vaccines or treatments... expand
Background: Middle East Respiratory Syndrome (MERS) is a newly discovered contagious and sometimes fatal respiratory virus. People often get MERS through close contact with an infected person. Scientists are worried that MERS may spread and cause more infections. There are no vaccines or treatments for MERS right now. Researchers think a new therapy called SAB-301 may be able to help. Antibodies are proteins the body makes to attack viruses. SAB-301 is made of antibodies made in cows to fight MERS. The antibodies are collected from plasma, the liquid part of cow blood. Objective: To evaluate the safety and tolerability of SAB-301 in healthy adults. Eligibility: Healthy people ages 18 60 who: Do not have chronic medical problems Do not take any medications (exceptions are acetaminophen, ibuprofen, vitamins, seasonal allergy meds and oral contraception) Do not have allergies to beef products Agree to use two forms of contraception while on study (both men and women) Design: Participants will be screened with: Medical history Physical examination Blood and urine tests Participants will have a return visit. They will have a physical exam and blood tests. They will be randomly assigned to receive either SAB-301 or a placebo which is given by infusion through an arm vein over 1 3 hours. They will be monitored at the clinic for 6 hours after the infusion. They will have additional blood draws. Participants will have 2-hour visits 1, 3, 7, 21, 42, and 90 days after the infusion. At each visit they will be evaluated and have blood and urine tests. Type: Interventional Start Date: May 2016 |
A Longitudinal Study of COVID-19 Sequelae and Immunity
National Institute of Allergy and Infectious Diseases (NIAID)
COVID-19
Background:
COVID-19 is a disease caused by the SARS-CoV-2 virus. It infects the respiratory tract.
Some people who get COVID-19 have only mild symptoms. But for others, infection leads to
pneumonia, respiratory failure, and, in some cases, death. Researchers want to learn more
about any effects... expand
Background: COVID-19 is a disease caused by the SARS-CoV-2 virus. It infects the respiratory tract. Some people who get COVID-19 have only mild symptoms. But for others, infection leads to pneumonia, respiratory failure, and, in some cases, death. Researchers want to learn more about any effects that may persist after people recover from COVID-19. Objective: To learn about any long-term medical problems that people who have recovered from COVID-19 might have, and whether they develop an immune response to SARS-CoV-2 that provides protection against reinfection. Eligibility: People age 18 and older who have recovered from documented COVID-19 or were in close contact with someone who had COVID-19 but did not get the infection Design: Participants will be screened over 2 visits. During visit 1, they will answer questions about any symptoms they are having and will be tested for SARS-CoV-2 infection which will involve a nasal swab sample or other FDA approved test. If the test is negative, they will proceed to the second visit, which will include: Physical examination Medical history Mental health interview (which may be recorded if the participant agrees) Chest x-ray (for recovered COVID-19 participants only) Blood and urine tests Pregnancy test (if needed) Lung function test (for recovered COVID-19 participants only) 6-minute walk test (for recovered COVID-19 participants only) Questionnaires about their general and mental health Leukapheresis to collect white blood cells (optional). Participants will be put into 1 of 2 groups: the COVID-19 group or the close contact group. Participants will have study visits every 6 months for 3 years. They will repeat some of the screening tests. Participants in the COVID-19 group may have visits more often if they develop symptoms that suggest re-infection with SARS-CoV-2. Type: Observational Start Date: Jun 2020 |
A Study to Evaluate the Safety and Immunogenicity of the mRNA COVID-19 Vaccines in Healthy Children Between...
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... 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 |
Cardiovascular Autonomic and Immune Mechanism of Post COVID-19 Tachycardia Syndrome
Vanderbilt University Medical Center
Post-acute COVID-19 Syndrome
Postural Tachycardia Syndrome (POTS)
Long COVID
SARS CoV 2 Infection
The term post-acute COVID-19 syndrome or Long COVID is a disabling syndrome that persists
beyond the 3-month convalescence period after COVID-19 infections.
This syndrome affects mostly women (~80%), present with chronic tachycardia and
Orthostatic intolerance symptoms without any identifiable cause.... expand
The term post-acute COVID-19 syndrome or Long COVID is a disabling syndrome that persists beyond the 3-month convalescence period after COVID-19 infections. This syndrome affects mostly women (~80%), present with chronic tachycardia and Orthostatic intolerance symptoms without any identifiable cause. In addition, non-specific symptoms such as fatigue, headache, and "brain fog", commonly described in POTS patients are also present in this novel condition, recently named post-COVID-19 tachycardia syndrome, POTS variant. Reduced Vagal activity and unresolved inflammation is post-COVID-19 POTS is hypothesized as the cause of Long COVID Type: Interventional Start Date: Jun 2022 |
The Study of the Use of Nintedanib in Slowing Lung Disease in Patients With Fibrotic or Non-Fibrotic...
Icahn School of Medicine at Mount Sinai
Pulmonary Fibrosis
Interstitial Lung Disease
Respiratory Disease
This is a collaborative study between Icahn School of Medicine at Mount Sinai, Boehringer
Ingelheim Pharmaceuticals and up to 9 other clinical centers across the US to determine
the effect of nintedanib on slowing the rate of lung disease in patients who have been
diagnosed with COVID-19, and have... expand
This is a collaborative study between Icahn School of Medicine at Mount Sinai, Boehringer Ingelheim Pharmaceuticals and up to 9 other clinical centers across the US to determine the effect of nintedanib on slowing the rate of lung disease in patients who have been diagnosed with COVID-19, and have ongoing lung injury more than 30 days out from their diagnosis. Required one of the following after diagnosis with SARS-CoV-2: supplemental oxygen by nasal cannula, high flow oxygen, non invasive ventilation such as CPAP or BIPAP, or mechanical ventilation or a history of desaturation below 90%. Type: Interventional Start Date: Nov 2020 |
Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies
National Institute of Allergy and Infectious Diseases (NIAID)
Influenza
Respiratory Virus
Coronavirus
Background:
Respiratory viruses circulate throughout the year and around the globe. Wearable and
sensor devices, like smartwatches, may be able to help monitor infectious diseases.
Researchers want to use them to learn how respiratory viruses affect people in different
ways.
Objective:
To... expand
Background: Respiratory viruses circulate throughout the year and around the globe. Wearable and sensor devices, like smartwatches, may be able to help monitor infectious diseases. Researchers want to use them to learn how respiratory viruses affect people in different ways. Objective: To use digital devices to collect data from participants in challenge studies that could indicate subtle changes in health during an infection that might otherwise go unnoticed. Eligibility: Healthy adults who have enrolled in a challenge study. Design: Participants will stay at NIH for at least 9 days and then they will have outpatient visits. While at NIH, participants will wear a smartwatch at all times. It will record data like temperature, heart rate, breathing rate, and movements. Participants will have 2 smartphones. One will be recording at all times to listen for coughing. Participants will use the other smartphone to check their vital signs. They will collect data like heart rate, temperature, and the level of oxygen in the blood every 4 hours during the daytime. Participants will perform tasks every 4 hours during the daytime. They will record themselves coughing, breathing in deeply, and reading aloud. They will take pictures and videos of their face. A bedside sensor will record participants while they sleep. It will record heart rate and breathing rate. It will also look at sleep activity, such as movements participants make during sleep and how deeply they sleep. Participants sharing the same room will be exposed to the same challenge virus. For outpatient visits, participants will use one smartphone and the smartwatch to complete the above tasks. Participation will last from 10 weeks to 1 year. Type: Observational Start Date: Oct 2023 |
Innovative Support for Patients With SARS-COV2 Infections (COVID-19) Registry (INSPIRE)
Rush University Medical Center
Covid19
ME/CFS
SARS COV2
Novel Coronavirus Infection
Neurocognitive Disorders
The Innovative Support for Patients with SARS COV-2 Infections Registry (INSPIRE) study
is a CDC-funded COVID-19 project to understand the long-term health outcomes in recently
tested adults, both negative and positive, who have suspected COVID symptoms at the time
of their test. Participants will... expand
The Innovative Support for Patients with SARS COV-2 Infections Registry (INSPIRE) study is a CDC-funded COVID-19 project to understand the long-term health outcomes in recently tested adults, both negative and positive, who have suspected COVID symptoms at the time of their test. Participants will complete short online surveys every 3 months for 18 months, share information about their health using a secure web-based platform, and are compensated for their time. Type: Observational [Patient Registry] Start Date: Dec 2020 |
Serological Surveillance for COVID-19 in Central North Carolina
National Institute of Environmental Health Sciences (NIEHS)
COVID-19
Background:
The SARS-CoV-2 virus has caused a pandemic. Little is known about the virus, so data is
needed to form an effective public health response. Researchers want to count how many
people have been exposed to COVID-19, learn about symptoms, and find out how many
antibodies to the SARS-CoV-2... expand
Background: The SARS-CoV-2 virus has caused a pandemic. Little is known about the virus, so data is needed to form an effective public health response. Researchers want to count how many people have been exposed to COVID-19, learn about symptoms, and find out how many antibodies to the SARS-CoV-2 virus a person may have in their blood over 1 year. This data could affect the response to current and future pandemics. Objective: To learn how many people from a sampling of adults in North Carolina develop antibodies to the SARS-CoV-2 virus over 1 year. Eligibility: Healthy people age 18 and older who do not currently have COVID-19 Design: Participants will be screened with questions about their health. Participants will have five 30-minute visits at the Clinical Research Unit. At each visit, they will have blood drawn to see if they have SARS-CoV-2 antibodies. If the test result is positive for antibodies, the participant will be tested to see if they currently have COVID-19. For this, a nasal or throat swab will be done, or saliva will be collected. They may do this test at the same visit as the blood draw, or they may schedule an extra visit. Around the time of their study visits, participants will take an online survey about themselves, their health, and COVID-19. It takes 10 minutes to complete. Every week for 52 weeks, they will also take a brief online survey about their symptoms. It takes 2 minutes to complete. They will be emailed a link to log in and fill out the surveys on a secure website. Participation will last for 1 year. ... Type: Observational Start Date: Aug 2020 |
Mobile Health and COVID-19
University of Houston
Anxiety Depression
The proposed research focuses on evaluating the mobile application, Easing Anxiety
Sensitivity for Everyone (EASE), to improve overall public health that concerns risks and
mental health status during the COVID-19 pandemic and to minimize the existing health
disparities among Black, Latinx, and American... expand
The proposed research focuses on evaluating the mobile application, Easing Anxiety Sensitivity for Everyone (EASE), to improve overall public health that concerns risks and mental health status during the COVID-19 pandemic and to minimize the existing health disparities among Black, Latinx, and American Indian (BLAI) individuals during this time. EASE provides COVID-19 symptom monitoring, exposure management skills, and psychoeducation on stress and it's impact on infection and disease susceptibility. This study aims to compare the effect of EASE to an empirical measurement of standard-of-care digital intervention and to identify the effective mechanisms in EASE. Type: Interventional Start Date: Dec 2021 |
A Trial of NT-I7 in COVID-19 (SPESELPIS)
NeoImmuneTech
COVID-19
The main purposes of this study is to determine the following in participants with mild
coronavirus disease 2019 (COVID-19):
- Safety of a single dose of NT-I7
- The immunological effects of NT-I7 on peripheral lymphocyte counts in COVID-19
patients. expand
The main purposes of this study is to determine the following in participants with mild coronavirus disease 2019 (COVID-19): - Safety of a single dose of NT-I7 - The immunological effects of NT-I7 on peripheral lymphocyte counts in COVID-19 patients. Type: Interventional Start Date: Nov 2020 |
Endocrine, Metabolic and Microbiome Influence on the Post COVID-19 Syndrome
The University of Texas Medical Branch, Galveston
Covid19
The aim of this study is characterize the endocrine, metabolic and microbiomes of
patients with post-COVID syndrome and patients that have recovered from COVID without
lingering symptoms. expand
The aim of this study is characterize the endocrine, metabolic and microbiomes of patients with post-COVID syndrome and patients that have recovered from COVID without lingering symptoms. Type: Observational Start Date: May 2021 |
Convalescent Plasma to Stem Coronavirus (CSSC-001)
Johns Hopkins University
Coronavirus
Convalescence
Evaluate the efficacy of treatment with high-titer Anti- SARS-CoV-2 plasma versus control
(SARS-CoV-2 non-immune plasma) in subjects exposed to Coronavirus disease (COVID-19) at
day 28. expand
Evaluate the efficacy of treatment with high-titer Anti- SARS-CoV-2 plasma versus control (SARS-CoV-2 non-immune plasma) in subjects exposed to Coronavirus disease (COVID-19) at day 28. Type: Interventional Start Date: Jun 2020 |
Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA)
Montreal Heart Institute
Corona Virus Infection
This is a phase 3, randomized, double-blind, placebo-controlled multicenter study to
evaluate the efficacy and safety of colchicine in adult patients diagnosed with COVID-19
infection and have at least one high-risk criterion. Approximately 6000 subjects meeting
all inclusion and no exclusion criteria... expand
This is a phase 3, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of colchicine in adult patients diagnosed with COVID-19 infection and have at least one high-risk criterion. Approximately 6000 subjects meeting all inclusion and no exclusion criteria will be randomized to receive either colchicine or placebo tablets for 30 days. Type: Interventional Start Date: Mar 2020 |
Physical Rehabilitation of COVID-19 Survivors by Heat Therapy
University of Massachusetts, Amherst
Covid19
Physical Disability
Older adults and people with underlying medical conditions are at higher risk for
developing serious complications related to SARS-CoV-2 resulting in prolonged sequelae.
The goal of this proposal is to compare the benefits of home-based lower limb heat
therapy to exercise training on cardio-metabolic... expand
Older adults and people with underlying medical conditions are at higher risk for developing serious complications related to SARS-CoV-2 resulting in prolonged sequelae. The goal of this proposal is to compare the benefits of home-based lower limb heat therapy to exercise training on cardio-metabolic function and mobility in older adults during their convalescence from hospitalization due to SARS-CoV-2. Type: Interventional Start Date: Feb 2021 |
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