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COVID-19 Associated Lymphopenia Pathogenesis Study in Blood
National Institute of Allergy and Infectious Diseases (NIAID)
Coronavirus Disease 2019
Background:
COVID-19 is an acute respiratory syndrome. One symptom of COVID-19 is a reduction in the
number of cells called lymphocytes in the blood. Lymphocytes are a type of white blood
cell that fights infections. With fewer lymphocytes, the body cannot effectively fight
back against SARS CoV-2,... expand
Background: COVID-19 is an acute respiratory syndrome. One symptom of COVID-19 is a reduction in the number of cells called lymphocytes in the blood. Lymphocytes are a type of white blood cell that fights infections. With fewer lymphocytes, the body cannot effectively fight back against SARS CoV-2, the virus that causes COVID-19. Researchers want to better understand how SARS-CoV-2 affects these blood cells. This information may give them ideas for new treatments. Objective: To learn more about how SARS-CoV-2 affects lymphocytes, the immune, and the blood clotting system. Eligibility: Adults age 18 and older who either currently have COVID-19 or have recently recovered from it Design: Participants will give a blood sample. For this, a needle is used to collect blood from an arm vein. For participants who have a central line, blood will be collected through that instead. Participants medical records related to COVID-19 will be reviewed. Participants who have recovered from COVID-19 will be asked to undergo leukapheresis to collect white blood cells. For this, blood is taken from a needle placed in one arm. A machine separates out the white blood cells. The rest of the blood is returned to the participant through a needle placed in the other arm. This takes about 2-3 hours. Recovered participants may have material collected from inside the nostrils and/or rectum. This is done by gently rubbing the area with a sterile cotton swab. Recovered participants may have an echocardiogram to look at their heart. For this, a small probe is held against the chest to get pictures of the heart from different angles. This takes less than 30 minutes. Participation lasts 1-2 days on most cases and may be split in a few visits for recovered patients if leukapheresis and echocardiogram are done. ... Type: Observational Start Date: May 2020 |
Evaluating a Community-Led COVID-19 Testing Intervention to Address Mistrust
Old Dominion University
COVID-19
Trust
The goal of this study is to assess how community-led group discussions about
health-related topics may alter beliefs and intentions regarding healthcare
recommendations, such as COVID-19 testing and vaccination. expand
The goal of this study is to assess how community-led group discussions about health-related topics may alter beliefs and intentions regarding healthcare recommendations, such as COVID-19 testing and vaccination. Type: Interventional Start Date: Jul 2024 |
Impact of Reactogenicity of the 2024-2025 COVID-19 Vaccines on Health Care Workers and First Responders...
Novavax
COVID-19
Vaccine-Preventable Diseases
SARS CoV 2 Infection
To assess the impact of reactogenicity among health care workers and first responders
receiving an updated 2024-25 Novavax COVID-19 vaccine as compared with those receiving an
updated 2024-25 Pfizer-BioNTech mRNA COVID-19 vaccine expand
To assess the impact of reactogenicity among health care workers and first responders receiving an updated 2024-25 Novavax COVID-19 vaccine as compared with those receiving an updated 2024-25 Pfizer-BioNTech mRNA COVID-19 vaccine Type: Interventional Start Date: Sep 2024 |
Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and...
Wes Ely
Long COVID
Sars-CoV-2 Infection
Coronavirus Infections
COVID-19
The overarching goal of this study is to determine if baricitinib, as compared to
placebo, will improve neurocognitive function, along with measures of physical function,
quality of life, post-exertional malaise, effect of breathlessness on daily activities,
post-COVID-19 symptom burden, and biomarkers... expand
The overarching goal of this study is to determine if baricitinib, as compared to placebo, will improve neurocognitive function, along with measures of physical function, quality of life, post-exertional malaise, effect of breathlessness on daily activities, post-COVID-19 symptom burden, and biomarkers of inflammation and viral measures, in participants with Long COVID. Type: Interventional Start Date: Oct 2024 |
Using Data From a Multisensor Rapid Health Assessment Device to Predict Decompensation in Long COVID...
Edith Nourse Rogers Memorial Veterans Hospital
COVID-19
Long COVID
We are conducting a research study at the VA hospital in Bedford, MA to learn more about
how a multisensor rapid health assessment device, MouthLab, can help predict or
anticipate future health complications in patients with underline conditions after
contracting COVID-19. The device was created by... expand
We are conducting a research study at the VA hospital in Bedford, MA to learn more about how a multisensor rapid health assessment device, MouthLab, can help predict or anticipate future health complications in patients with underline conditions after contracting COVID-19. The device was created by a health technology and digital medicine company called Aidar Health, Inc. MouthLab is a non-invasive, hand-held device that works like a breathalyzer. An individual breathes into the device for 60 seconds and the MouthLab gathers more than 10 vital health parameters like temperature, heart rate, SpO2, ECG, and basic lung functions. Participation in the study will last for 6 months, and the purpose is to gather health information from people who have been previously hospitalized with COVID-19. We will use the data to develop an algorithm that predicts future complications of COVID-19, especially among patients with complex conditions (i.e., heart failure, chronic kidney disease, diabetes, hypertension, asthma, chronic obstructive pulmonary disease), and enables early intervention. Type: Observational Start Date: Oct 2022 |
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Combined Modified RNA Vaccine Candidates...
BioNTech SE
Influenza, Human
COVID-19
Substudy A: This is a Phase 1 randomized, open-label study to describe the safety and
immunogenicity of up to 3 dose- level combinations of modRNA quadrivalent influenza
vaccine (qIRV (22/23)) and bivalent BNT162b2 (original/Omi BA.4/BA.5). Participants will
receive either:
- qIRV (22/23)/bivalent... expand
Substudy A: This is a Phase 1 randomized, open-label study to describe the safety and immunogenicity of up to 3 dose- level combinations of modRNA quadrivalent influenza vaccine (qIRV (22/23)) and bivalent BNT162b2 (original/Omi BA.4/BA.5). Participants will receive either: - qIRV (22/23)/bivalent BNT162b2 (original/Omi BA.4/BA.5), at 1 of the 3 dose-level combinations - qIRV (22/23) at dose level 1, - qIRV (22/23) at dose level 2, or - bivalent BNT162b2 (original/Omi BA.4/BA.5) at dose level 1 administered concurrently in the opposite arm to commercially licensed quadrivalent influenza vaccine (QIV). Substudy B: This Phase 1/2 study will describe the safety, tolerability, and immunogenicity of quadrivalent influenza vaccine (qIRV)/bivalent BNT162b2 (original/Omi BA.4/BA.5), trivalent influenza vaccine (tIRV)/bivalent BNT162b2 (original/Omi BA.4/BA.5), and bivalent influenza vaccine (bIRV)/bivalent BNT162b2 (original/Omi BA.4/BA.5) when given concurrently with licensed quadrivalent influenza vaccine (QIV). Type: Interventional Start Date: Oct 2022 |
Breathing Techniques and Meditation for Health Care Workers During COVID-19 Pandemic
M.D. Anderson Cancer Center
COVID-19 Infection
This phase I trial investigates breathing techniques and meditation for health care
workers during COVID-19 pandemic. Breathing techniques and medication may help manage
stress and improve lung health. The goal of this trial is to learn if breathing
techniques and meditation may help to reduce stress... expand
This phase I trial investigates breathing techniques and meditation for health care workers during COVID-19 pandemic. Breathing techniques and medication may help manage stress and improve lung health. The goal of this trial is to learn if breathing techniques and meditation may help to reduce stress and improve lung health in health care workers during the COVID-19 pandemic. Type: Interventional Start Date: Jun 2020 |
Reducing Hopelessness Through Improved Physical Activity in Adults With Heart Disease: With COVID-19...
University of Illinois at Chicago
Ischemic Heart Disease
Hopelessness
Physical Activity
Motivation
Social Support
After a 30-year decline, heart disease is projected to increase up to 18% by 2030.
Participation rates in cardiac rehabilitation remain extremely low and hopeless
individuals are less likely to participate. This innovative study has the potential to
advance science, improve patient care, and improve... expand
After a 30-year decline, heart disease is projected to increase up to 18% by 2030. Participation rates in cardiac rehabilitation remain extremely low and hopeless individuals are less likely to participate. This innovative study has the potential to advance science, improve patient care, and improve patient outcomes by demonstrating the effectiveness of the Heart Up! program to increase physical activity and reduce hopelessness in patients with heart disease. Hopelessness is associated with a 3.4 times increased risk of mortality or nonfatal myocardial infarction in patients with ischemic heart disease (IHD), independent of depression. Hopelessness has been identified in 27-52% of patients with IHD and can persist for up to 12 months after hospital discharge. Hopelessness, a negative outlook and sense of helplessness toward the future, can be a temporary response to an event (state) or a habitual outlook (trait). Hopelessness is associated with decreased physical functioning and lower physical activity (PA) levels in individuals with IHD. While research has investigated strategies to increase PA among IHD patients in general, the study team is the only group to design an intervention to promote PA specifically in hopeless IHD patients. The purpose of this randomized controlled trial is to establish the effectiveness of our 6-week mHealth intervention (Heart Up!) to promote increased PA in hopeless patients with IHD. A total of 225 hopeless IHD patients will be enrolled from a large community teaching hospital in the Midwest. Patients will be randomized (75 per group) to one of three groups: 1) motivational social support (MSS) from a nurse, 2) MSS from a nurse with additional significant other support (SOS), or 3) attention control (AC). It is hypothesized that 1) The MSS with SOS group will have the greatest increase in average minutes of moderate to vigorous PA per day at 8 and 24 weeks as compared to the MSS only or AC groups; 2) Greater increase in minutes of moderate to vigorous PA per day will be associated with decreased state hopelessness levels from baseline to weeks 8 and 24; and 3) Increased social support and increased motivation will mediate the effects of Heart Up! on a greater increase in moderate to vigorous PA at 8 and 24 weeks. The findings from this study could transform care for IHD patients who are hopeless by promoting self-management of important PA goals that can contribute to better health outcomes. Type: Interventional Start Date: Aug 2019 |
Genomics, Environmental Factors and Social Determinants of Cardiovascular Disease in African-Americans...
National Human Genome Research Institute (NHGRI)
Heart Disease
Background:
The COVID-19 pandemic infected and killed African Americans at higher rates than other
Americans. Researchers want to understand why.
Objective:
This natural history study will look at how genetic, environmental, and social factors
may predict or affect COVID-19 in African Americans.... expand
Background: The COVID-19 pandemic infected and killed African Americans at higher rates than other Americans. Researchers want to understand why. Objective: This natural history study will look at how genetic, environmental, and social factors may predict or affect COVID-19 in African Americans. Information from this study will be combined with data from the GENE-FORECAST study. Eligibility: African Americans who were previously enrolled in GENE-FORECAST. Design: The study includes a telephone interview and 1 visit to the NIH clinic. Participants may engage in either one or both of these activities. The telephone interview will last 20 minutes. Participants will talk about their experiences during the COVID-19 pandemic. The clinic visit will last up to 4 hours. Participants will have a physical exam. They will have blood and urine tests. They will be tested for COVID-19. A long swab will be inserted into a nostril to get a fluid sample from the back of the nose. They will have noninvasive tests of their blood vessels. One device used is a pen-like probe placed lightly on the wrist. Another is a rubber sleeve placed around a finger while a blood pressure cuff is used on the arm. Participants will have a test to measure the electrical activity in their heart. Stickers attached to wires will be placed on their chest, arms, and legs. Participants will answer more questions about COVID-19. They will talk about their health behavior. They will talk about their family's health and the neighborhood they live in. Other questions will ask how they feel, live, work, and play.... Type: Observational Start Date: Feb 2023 |
Natural History Study of COVID-19 Using Digital Wearables
National Institute on Minority Health and Health Disparities (NIMHD)
COVID-19 Virus Disease
Background:
People with COVID-19 have varying degrees of illness. It can range from no or mild
symptoms to critical illness and death. Some people with COVID-19 have long-term effects
regardless of the severity of their disease initially. Researchers want to learn more to
see if they can better... expand
Background: People with COVID-19 have varying degrees of illness. It can range from no or mild symptoms to critical illness and death. Some people with COVID-19 have long-term effects regardless of the severity of their disease initially. Researchers want to learn more to see if they can better predict where a person may fall on the illness spectrum. Objective: To follow and record symptoms of COVID-19 to see how it progresses in people and why some people stay sick longer than others. Eligibility: People ages 18-65 who received a COVID-19 positive test result in the 72 hours before their enrollment in the study. Design: Participants will complete a 30-minute baseline survey. They will answer questions about themselves and their health. Participants will get a digital wristband and temperature sensor in the mail. They will get instructions on how to set up and wear the devices. They will download a mobile application on their phone. The app will collect data from the devices. Participants will wear the wristband and sensor every day for the first month. Then they will wear the devices for a total of 40 days over the next 5 months. On the days they wear the devices, they will answer a 2-question health survey via the app. Participants will answer a 20-minute online survey about their health every 30 days. If participants are hospitalized, a family member or close friend will be asked to complete a brief 7-minute online survey about their hospital stay and treatment. Participants will be sent alerts and reminders throughout the study. Participation will last for 6 months. Type: Observational Start Date: Oct 2021 |
Respiratory Virus Sampling and Repository
National Institute of Allergy and Infectious Diseases (NIAID)
Influenza
COVID-19
Background:
Respiratory viruses, like the flu or COVID-19, cause significant illness and death
worldwide. Researchers want to collect samples from people with respiratory virus
infections. The samples in this natural history study will be used in future research.
Objective:
To obtain samples... expand
Background: Respiratory viruses, like the flu or COVID-19, cause significant illness and death worldwide. Researchers want to collect samples from people with respiratory virus infections. The samples in this natural history study will be used in future research. Objective: To obtain samples from people with respiratory viruses to learn more about respiratory virus infections and the immune responses against them. Eligibility: People aged 3 and older who have or are suspected to have a respiratory virus infection. Design: Participants will be screened with a medical record review. Participants will give blood samples. Data from their medical records will be collected. Participants will give nose samples. A soft plastic strip will be put into each nostril for a minute. They may also give nose, mouth (back of the throat), or saliva samples using swabs. Participants may receive kits by mail to collect nose and blood samples at home. They will use soft plastic strips to collect nose samples. To collect blood, they will prick their finger and dab a few drops of blood on four plastic tips. If a participant is in the hospital, air samples may be collected in their room. Participation will last for up to 2 years. After 2 years, participants may be asked for their consent again to give new samples and new medical data. Type: Observational Start Date: Aug 2022 |
Non-invasive Treatment for Long COVID (Post COVID-19 Condition) Brain Fog
Mayo Clinic
Long COVID
This study aims to assess the effects of both acute and chronic exposures to hypoxia and
hypercapnia in patients with Long COVID syndrome. expand
This study aims to assess the effects of both acute and chronic exposures to hypoxia and hypercapnia in patients with Long COVID syndrome. Type: Interventional Start Date: Sep 2024 |
A Study to Learn How Renal Impairment Affects the Pharmacokinetics of PF-07817883.
Pfizer
COVID-19
The purpose of the study is to learn about:
- how PF-07817883 is processed in the body of adult participants.
- the safety of PF-07817883.
These participants will have different levels of kidney function loss:
- moderate
- severe
- none or healthy Participants with moderate,... expand
The purpose of the study is to learn about: - how PF-07817883 is processed in the body of adult participants. - the safety of PF-07817883. These participants will have different levels of kidney function loss: - moderate - severe - none or healthy Participants with moderate, severe or no loss of kidney function may be taken into one of 3 groups. This study is seeking for participants who: - are male or female of 18 to 90 years of age. - have different levels of damage to kidney function or for one of the groups, no damage - are willing to follow the requirements of the study including stay at clinic for 5 nights and 6 days. About, 8 participants may be selected in groups 2 and 3. In group 1, around 8 to 12 participants may be selected. If participants agree to take part in the study, it may take up to 4 weeks to complete all the tests to confirm if they are fit to be in the study. If they seem to be fit for the study, participants will be admitted to a clinic research unit (CRU) at least 8 hours before dosing. On Day 1, participants will receive a single amount of study medicine (Day 1). A series of blood samples will be collected before and after giving medicines. Participants will be discharged from the CRU on Day 5. A follow-up phone call (or CRU visit, if needed), will occur 28-35 days after taking the medicine. The whole study will last for a minimum of 5 weeks and a maximum of 10 weeks. Type: Interventional Start Date: Sep 2024 |
A Study to Investigate the Immunogenicity of mRNA COVID-19 Variant-containing Vaccine Formulations in...
ModernaTX, Inc.
SARS-CoV-2
The purpose of this study is to investigate the immunogenicity of mRNA COVID-19
variant-containing vaccine formulations against the vaccine matched variants and newly
emerged variants of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in
previously vaccinated adults. expand
The purpose of this study is to investigate the immunogenicity of mRNA COVID-19 variant-containing vaccine formulations against the vaccine matched variants and newly emerged variants of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in previously vaccinated adults. Type: Interventional Start Date: Sep 2024 |
Evaluating the Effects of a Fermented Diet on Microbiome Diversity in Individuals With Long COVID
Mayo Clinic
Long COVID
The purpose of this study is to evaluate the effects of fermented foods on bacterial gut
microbiome diversity of long-COVID subjects. expand
The purpose of this study is to evaluate the effects of fermented foods on bacterial gut microbiome diversity of long-COVID subjects. Type: Interventional Start Date: Sep 2024 |
Improving Attention in Individuals With Long COVID-19
Shirley Ryan AbilityLab
Long Covid
This study is to find out if the Attention Processing Training program is a potential
treatment for brain fog symptoms, reported by people with Long-Covid. Also investigating
the feasibility of completing this program virtually. expand
This study is to find out if the Attention Processing Training program is a potential treatment for brain fog symptoms, reported by people with Long-Covid. Also investigating the feasibility of completing this program virtually. Type: Interventional Start Date: Mar 2024 |
Wearable Assisted Viral Evidence (WAVE) Study A Decentralized, Prospective Study Exploring the Relationship...
Evidation Health
Influenza, Human
COVID-19
Influenza A
Influenza B
Respiratory Syncytial Virus (RSV)
The goal of this decentralized, observational study is to enroll and observe adults in
the contingent United States during the 2023-2024 flu season. The main study objectives
are to create a dataset of paired wearable data, self-reported symptoms, and respiratory
viral infection (RVI) from PCR testing... expand
The goal of this decentralized, observational study is to enroll and observe adults in the contingent United States during the 2023-2024 flu season. The main study objectives are to create a dataset of paired wearable data, self-reported symptoms, and respiratory viral infection (RVI) from PCR testing during the 2023-2024 flu season and to develop algorithm that is able to accurately classify asymptomatic and symptomatic RVI and understand the algorithm's performance metrics. Type: Observational Start Date: Jan 2024 |
A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Variants in Healthy Individuals
BioNTech SE
SARS-CoV-2 Infection
COVID-19
The purpose of this clinical protocol is to learn about the safety, tolerability, and
immunogenicity of new BNT162b2 RNA-based vaccine candidates targeting new variants of
SARS-CoV-2 in healthy people.
Substudy A:
- This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2... expand
The purpose of this clinical protocol is to learn about the safety, tolerability, and immunogenicity of new BNT162b2 RNA-based vaccine candidates targeting new variants of SARS-CoV-2 in healthy people. Substudy A: - This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi XBB.1.5) given as a single 30 µg dose, - in people who are 12 years of age and older, - who previously received at least 3 doses of a US-authorized mRNA COVID-19 vaccine, with the most recent dose being an Omicron BA.4/BA.5-adapted bivalent vaccine received at least 150 days before the study vaccination (Visit 1). - The study is about 6 months long for each participant. - Participants will have at least 5 visits to the clinic. - At each clinic visit a blood sample will be taken. - At least 1 nasal swab will taken. Substudy B: - This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi XBB.1.5) given as a single 30 µg dose, - in people who are 12 years of age and older, - who are COVID-19 vaccine-naïve - who have had any positive SARS-CoV-2 test result >28 days before study vaccine administration. - The study is about 6 months long for each participant. - Participants will have at least 5 visits to the clinic. - At each clinic visit a blood sample will be taken. - At least 1 nasal swab will taken. Substudy C: - This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi JN.1) and BNT162b2 (Omi KP.2) given as a single 30 µg dose to: - Cohort 1: people who are 18 years of age and older, who will receive BNT162b2 (Omi JN.1), and, - Cohort 2: people who are 12 years of age and older, who will receive BNT162b2 (Omi JN.1), and, - Cohort 3: people who are 18 years of age and older who will receive BNT162b2 (Omi KP.2). - Participants may have never received a COVID-19 vaccine or, may have previously received COVID-19 vaccine(s), with the most recent dose received at least 150 days before the study vaccination (Visit 1). - The study is about 6 months long for each participant. - Participants will have at least 6 visits (Cohorts 1 and 3) or at least 5 visits (Cohort 2) to the clinic. - At each clinic visit a blood sample will be taken. - At least 1 nasal swab will taken. Type: Interventional Start Date: Aug 2023 |
Strategies and Treatments for Respiratory Infections &Amp; Viral Emergencies (STRIVE): Immune Modulation...
University of Minnesota
COVID-19
COVID-19 can trigger a dysregulated immune response, and previous studies have shown that
immune modulation can improve outcomes in hospitalized patients. This trial is designed
to determine whether intensification of immune modulation early in the course of the
disease (while patients are on low... expand
COVID-19 can trigger a dysregulated immune response, and previous studies have shown that immune modulation can improve outcomes in hospitalized patients. This trial is designed to determine whether intensification of immune modulation early in the course of the disease (while patients are on low flow oxygen) with abatacept (active arm) combined with standard of care (SOC) improves recovery as compared with placebo + SOC (placebo arm). For both groups, intensification of immunomodulation will be provided as part of SOC in case of signs of disease progression (patient requires high flow nasal oxygen (HFNO) or more support) and/or if the patient has rapidly increasing oxygen requirement. Type: Interventional Start Date: Jul 2023 |
A Study to Understand the Effect and Safety of the Study Medicine PF-07817883 in Adults Who Have Symptoms...
Pfizer
SARS-CoV-2 Infection
The purpose of the study is to understand the effects and safety of PF-07817883
treatment. The study wants to know how PF-07817883 treatment lowers the level of the
virus that causes COVID 19. To understand that samples are collected from adult
participants who have the symptoms of COVID 19 but are... expand
The purpose of the study is to understand the effects and safety of PF-07817883 treatment. The study wants to know how PF-07817883 treatment lowers the level of the virus that causes COVID 19. To understand that samples are collected from adult participants who have the symptoms of COVID 19 but are not hospitalized. The study is seeking for participants who: - are 18 years of age or older at the time of entering the study. - have a positive rapid antigen test within 48 hours before entering the study. Rapid antigen test is a test done to confirm the presence of a specific virus in the body. - have onset of signs or symptoms of COVID-19 within 5 days before entering the study. - have at least 1 of the specified signs or symptoms of COVID-19 present on the day of entering the study. Around 228 participants with a confirmed case of COVID 19 are planned to be taken into the study. Participants will be randomly grouped to receive PF-07817883. Three groups will receive 100, 300, 600mg of PF-07817883 and one of the groups will receive placebo (a pill that doesn't have any medicines) orally every 12 hours for 5 days. The study is going to last up to 5 weeks. This includes the initial period of selecting participants, participants receiving the medicine or the placebo and then a 4-week follow-up period after giving the participants the last medicine. The study team will monitor how each participant is doing with the study treatment during the study. Type: Interventional Start Date: May 2023 |
Immune Registry for Organ Transplantation From COVID Positive Donors.
Virginia Commonwealth University
COVID-19
Organ Transplant
The purpose of this study is to collect data generated by standard clinical practice to
determine the short term and long term clinical outcomes of recipients of solid organ
transplantation from COVID-19 infected donors and compare it to recipients with organ
transplant from COVID-19 negative donors. expand
The purpose of this study is to collect data generated by standard clinical practice to determine the short term and long term clinical outcomes of recipients of solid organ transplantation from COVID-19 infected donors and compare it to recipients with organ transplant from COVID-19 negative donors. Type: Observational [Patient Registry] Start Date: Dec 2022 |
Baby2Home (B2H) Mobile Health Application
Women and Infants Hospital of Rhode Island
COVID-19 Pandemic
Health Knowledge, Attitudes, Practice
Perinatal Depression
Mental Health Wellness
Post Partum Depression
The COVID-19 pandemic has transformed healthcare delivery; arguably, the fields of
obstetrics and pediatrics have experienced some of the greatest changes as they have
transitioned away from their role as a medical home and into more of an urgent care model
of care. Baby2Home is a digital health intervention... expand
The COVID-19 pandemic has transformed healthcare delivery; arguably, the fields of obstetrics and pediatrics have experienced some of the greatest changes as they have transitioned away from their role as a medical home and into more of an urgent care model of care. Baby2Home is a digital health intervention designed to bridge the resultant gaps in obstetrics and pediatrics healthcare services for new families over the first year of life. This randomized controlled trial will evaluate whether, compared to usual care, Baby2Home 1) improves maternal, paternal, and infant health service utilization outcomes over the first year postpartum, 2) improves maternal and paternal patient reported outcomes, and 3) reduces racial/ethnic and income-based disparities in preventive health services utilization and parental patient reported outcomes. Type: Interventional Start Date: Nov 2022 |
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 COVID-19 symptoms
- Are... 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 the Study Medicines (Nirmatrelvir Plus Ritonavir) in People Aged 12 Years or Older...
Pfizer
COVID-19
The purpose of this clinical trial is to learn about the safety and effects of the study
medicine (called Nirmatrelvir/Ritonavir) for the possible treatment of COVID-19.
Patients with COVID-19 who have more difficulty in fighting against infections have a
higher chance of severe illness. Such patients... expand
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Nirmatrelvir/Ritonavir) for the possible treatment of COVID-19. Patients with COVID-19 who have more difficulty in fighting against infections have a higher chance of severe illness. Such patients may benefit from longer treatment durations compared to the standard treatment regimen. The study is seeking participants who: - Have a confirmed COVID-19 infection - Are Immunocompromised - Experience onset of signs/symptoms attributable to the current COVID-19 infection within 5 days prior to screening and ≥1 signs/symptoms attributable to COVID-19 present on the day of randomization. In addition, this study will also evaluate the efficacy and safety of a second treatment course of nirmatrelvir/ritonavir in people who experience that their COVID-19 is flaring up within 14 days of having taken a 5-day treatment course of nirmatrelvir/ritonavir. For this group, the study is seeking participants who: - Have a confirmed COVID-19 infection - Experience a worsening of signs/symptoms after completing an initial 5-day course of nirmatrelvir/ritonavir - The worsening of COVID-19 symptoms must occur within 14 days after completion of the initial 5-day course of nirmatrelvir/ritonavir - Are Immunocompromised - Experience onset of signs/symptoms attributable to the current COVID-19 infection within 48 hours prior to screening and ≥1 signs/symptoms attributable to COVID-19 present on the day of randomization. All participants will be taking the study medicine for either 5, 10, or 15 days. The study medication will be taken by mouth 2 times a day. Participants will take part in this study for about 24 weeks. The first dose of study medication is taken at the study site and the rest at home. Selected participants will need to visit the study site at least 10 times during the study. Type: Interventional Start Date: Aug 2022 |
IMM-BCP-01 in Mild to Moderate COVID-19
Immunome, Inc.
SARS-CoV2 Infection
COVID-19
The primary objective of this study is to evaluate the safety and tolerability of
intravenous (IV) IMM-BCP-01 in subjects with mild to moderate COVID-19 through Day 28.
The secondary objectives of the study are to:
- Determine pharmacokinetics (PK) and evaluate viral clearance after single... expand
The primary objective of this study is to evaluate the safety and tolerability of intravenous (IV) IMM-BCP-01 in subjects with mild to moderate COVID-19 through Day 28. The secondary objectives of the study are to: - Determine pharmacokinetics (PK) and evaluate viral clearance after single ascending doses of IV IMM-BCP-01 in subjects with mild to moderate COVID-19 through Day 28. - Evaluate the safety and tolerability, determine PK, and evaluate viral clearance of single ascending doses of IV IMM-BCP-01 in subjects with mild to moderate COVID-19 through Week 12. Type: Interventional Start Date: Jun 2022 |
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