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A Study of mRNA-1283 Injection Compared With mRNA-1273 Injection in Participants ≥12 Years of Age to...
ModernaTX, Inc.
COVID-19
The purpose of this study (Part 1 and Part 2) is to evaluate the relative vaccine
efficacy (rVE), safety, reactogenicity, and immunogenicity of mRNA-1283.222 versus
mRNA-1273.222 (Part 1) and mRNA-1283.815 versus mRNA-1273.815 (Part 2). expand
The purpose of this study (Part 1 and Part 2) is to evaluate the relative vaccine efficacy (rVE), safety, reactogenicity, and immunogenicity of mRNA-1283.222 versus mRNA-1273.222 (Part 1) and mRNA-1283.815 versus mRNA-1273.815 (Part 2). Type: Interventional Start Date: Mar 2023 |
Understanding COVID-19 Vaccine Immunity in Tissue and Blood
Stanford University
COVID-19 (Coronavirus Disease 2019)
The purpose of this study is to understand the effects of COVID-19 vaccines on the immune
system and how the COVID-19 vaccines provide protection and induce long term memory.
Adults who are receiving a COVID-19 vaccine will be invited to participate in this study. expand
The purpose of this study is to understand the effects of COVID-19 vaccines on the immune system and how the COVID-19 vaccines provide protection and induce long term memory. Adults who are receiving a COVID-19 vaccine will be invited to participate in this study. Type: Observational Start Date: Oct 2024 |
Methodologies for Observational Studies Comparing Inpatient COVID-19 Treatments
Aetion, Inc.
COVID-19
To apply and compare two different methodological approaches (one applying diagnostics
steps and contingencies and the other not) to the illustrative example described below:
Illustrative Example - Objective I aims to characterize the risk of inpatient mortality
[Primary Outcome] and progression... expand
To apply and compare two different methodological approaches (one applying diagnostics steps and contingencies and the other not) to the illustrative example described below: Illustrative Example - Objective I aims to characterize the risk of inpatient mortality [Primary Outcome] and progression to invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) [Secondary Outcome] up to 28 days after interleukin-6 receptor inhibitors (IL6Ri) or janus kinase inhibitor (JAKi) initiation among patients hospitalized with Coronavirus Disease 2019 (COVID-19) who initiate a corticosteroid of interest and require supplemental oxygen / non-invasive ventilation / high flow oxygen (O2/NIV/HFO) (but not IMV/ECMO). Illustrative Example - Objective II aims to characterize the risk of inpatient mortality [Primary Outcome] up to 28 days after IL6Ri or JAKi initiation among patients admitted to the ICU at hospital admission with COVID-19 who initiate a CSI and require IMV/ECMO. Hazard ratios (HR) and corresponding 95% confidence intervals (CI) will be estimated and reported for all outcome risks in Illustrative Example objectives. Type: Observational Start Date: Jun 2020 |
Paxlovid for Treatment of Long Covid
Stanford University
Post-acute Sequelae of SARS-CoV-2 Infection
Long COVID
The purpose of this study is to compare whether being treated with nirmatrelvir plus
ritonavir for 15 days works better than being treated with placebo plus ritonavir to
reduce severe symptoms of Long Covid.
Participants will have 5 planned visits to the study clinic over 15 weeks and will take
the... expand
The purpose of this study is to compare whether being treated with nirmatrelvir plus ritonavir for 15 days works better than being treated with placebo plus ritonavir to reduce severe symptoms of Long Covid. Participants will have 5 planned visits to the study clinic over 15 weeks and will take the drug (or placebo) for the first 15 days. This study uses the term post-acute sequelae of SARS-CoV-2 (PASC), which is another name for "Long Covid." Type: Interventional Start Date: Nov 2022 |
eVusheld Assessment reaL wORld Effectiveness in DoD Health System
AstraZeneca
COVID-19; SARS-CoV-2; 2019 Novel Coronavirus Disease
An AstraZeneca-sponsored observational, electronic healthcare record (EHR)-embedded
retrospective cohort study to assess the real-world effectiveness of EVUSHELD against
SARS-CoV-2 infection, COVID-19-related hospitalization, and other COVID-19 related
outcomes in the total EUA-eligible patient population... expand
An AstraZeneca-sponsored observational, electronic healthcare record (EHR)-embedded retrospective cohort study to assess the real-world effectiveness of EVUSHELD against SARS-CoV-2 infection, COVID-19-related hospitalization, and other COVID-19 related outcomes in the total EUA-eligible patient population treated in DoD Health system. Type: Observational Start Date: Aug 2023 |
Safety, Tolerability, and Treatment Effect of Belnacasan in Patients With COVID-19
MedStar Health
COVID-19
The purpose of this trial is to assess the safety, tolerability and treatment effect of
the orally administered Caspase-1 inhibitor, belnacasan, for the treatment of patients
with mild to moderate COVID-19 and to generate proof of concept for future trials. expand
The purpose of this trial is to assess the safety, tolerability and treatment effect of the orally administered Caspase-1 inhibitor, belnacasan, for the treatment of patients with mild to moderate COVID-19 and to generate proof of concept for future trials. Type: Interventional Start Date: Dec 2021 |
A Study to Look at the Health Outcomes of Patients With COVID-19 and Influenza
Pfizer
COVID-19
Coronavirus Disease 2019
Influenza
The main purpose of this study is to understand:
- the symptoms of COVID-19 or influenza- health-related outcomes of people with
COVID-19 or influenza (influenza only included in updated study analyses)
- the potential effects of COVID-19 vaccines in people with COVID-19
This study... expand
The main purpose of this study is to understand: - the symptoms of COVID-19 or influenza- health-related outcomes of people with COVID-19 or influenza (influenza only included in updated study analyses) - the potential effects of COVID-19 vaccines in people with COVID-19 This study will enroll participants who are: - 18 years or older - reported to have symptoms with tests that have confirmed illness. The tests can be taken at any of CVS pharmacy COVID-19 or influenza test sites. The study will collect vaccine history information from participants who are ready to take part in the study. Participant will be emailed a form with questions about their health related to COVID-19 or influenza during multiple follow-ups over a 6-month period. Type: Observational Start Date: Jan 2022 |
A Wearable, Battery-free Screening System for SARS-CoV-2, the Virus Causing COVID-19 Infection
University of Nebraska
Covid19
The corona virus disease (COVID) pandemic has highlighted the importance of rapid,
readily available screeners and diagnostics to identify infected individuals. Recent
studies have demonstrated that portable electronic nose sensing devices can detect
volatile organic compounds (VOCs). These compounds... expand
The corona virus disease (COVID) pandemic has highlighted the importance of rapid, readily available screeners and diagnostics to identify infected individuals. Recent studies have demonstrated that portable electronic nose sensing devices can detect volatile organic compounds (VOCs). These compounds are end products of human metabolism or of enteric bacteria and are excreted through the skin or exhaled breath. Importantly, the sensing devices can be adapted into a wearable device providing continuous monitoring. Our goal is to develop a battery-free, electronic nose sensor to serve as a screener and detect VOC patterns associated to patients with symptomatic and asymptomatic COVID-19 without being invasive. To test the screening ability, devices will be worn by COVID-19 positive and negative patients hospitalized at Nebraska Medicine. Type: Observational Start Date: Apr 2021 |
Hearts of Athletes
Duke University
Cardiac Involvement With COVID-19
The Hearts of Athletes study is being conducted to determine the heart involvement with
COVID-19 in athletes. This study aims to enroll any Adult (18 years of age or greater)
• Athlete is defined as NCAA Collegiate Athlete, Professional Athlete, Military, or
Olympic Athlete will be eligible for... expand
The Hearts of Athletes study is being conducted to determine the heart involvement with COVID-19 in athletes. This study aims to enroll any Adult (18 years of age or greater) • Athlete is defined as NCAA Collegiate Athlete, Professional Athlete, Military, or Olympic Athlete will be eligible for the study. With COVID-19 • COVID-19 diagnosed via an RT-PCR (nasal or throat swab test) prior to enrollment Or without COVID-19 • Identified as a local Control participant (similar sport) to a participant with COVID-19, who is willing to undergo a standard cardiovascular evaluation Participants with and without COVID-19 will use their mobile devices to provide health information, like symptoms, by answering survey questions daily for 30 days. Also, participants will allow their de-identified cardiac images to be sent to the Duke Heart Center for blinded analysis. No physical risks are associated with this study. One possible risk, although minimal, is loss of confidentiality. Type: Observational Start Date: Nov 2022 |
Chronic Lung Disease and COVID-19: Understanding Severity, Recovery and Rehabilitation Needs
VA Office of Research and Development
COVID-19
Chronic Lung Diseases
This is study is comprised of three approaches. First, the investigators will conduct a
retrospective cohort study to determine factors associated with COVID-19 severity and
complications and understand COVID-19 outcomes, including all-cause mortality,
post-discharge events, and impacts of rehabilitation... expand
This is study is comprised of three approaches. First, the investigators will conduct a retrospective cohort study to determine factors associated with COVID-19 severity and complications and understand COVID-19 outcomes, including all-cause mortality, post-discharge events, and impacts of rehabilitation services (third aim). The second aim is a mixed-method study and follows COVID-19 patients with repeated surveys to determine patient-reported functional outcomes, health recovery, and rehabilitation needs after COVID-19. The investigators will recruit patients and their informal caregivers for interviews to assess their function and rehabilitation needs. Type: Observational Start Date: May 2021 |
A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults
Janssen Vaccines & Prevention B.V.
Participants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19
The study will evaluate the efficacy of Ad26.COV2.S in the prevention of molecularly
confirmed moderate to severe/critical coronavirus disease-2019 (COVID-19), as compared to
placebo, in SARS-CoV-2 seronegative adults in the double-blind phase and to describe
COVID-19 outcomes, safety, and immunogenicity... expand
The study will evaluate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed moderate to severe/critical coronavirus disease-2019 (COVID-19), as compared to placebo, in SARS-CoV-2 seronegative adults in the double-blind phase and to describe COVID-19 outcomes, safety, and immunogenicity in the different study cohorts in open-label phase. Type: Interventional Start Date: Nov 2020 |
COVID-FIS: Pilot in COVID-19 (SARS-CoV-2) of Fisetin in Older Adults in Nursing Homes
Mayo Clinic
Covid19
SARS-CoV Infection
The purpose of this study is to test whether Fisetin, a senolytic drug, can assist in
preventing an increase in the disease's progression and alleviate complications of
coronavirus due to an excessive inflammatory reaction. expand
The purpose of this study is to test whether Fisetin, a senolytic drug, can assist in preventing an increase in the disease's progression and alleviate complications of coronavirus due to an excessive inflammatory reaction. Type: Interventional Start Date: Apr 2022 |
Decitabine for Coronavirus (COVID-19) Pneumonia- Acute Respiratory Distress Syndrome (ARDS) Treatment:...
Johns Hopkins University
COVID-19
This is a a randomized double blind placebo controlled Phase 2 trial with a 12 patient
lead-in to evaluate safety, prior to full enrollment to an additional 28 patients (for a
total of 40 patients) to assess efficacy of decitabine in the treatment of critically ill
patients with COVID-ARDS. The patients... expand
This is a a randomized double blind placebo controlled Phase 2 trial with a 12 patient lead-in to evaluate safety, prior to full enrollment to an additional 28 patients (for a total of 40 patients) to assess efficacy of decitabine in the treatment of critically ill patients with COVID-ARDS. The patients will be randomized in a 1:1 ratio to receive standard of care plus Decitabine or standard of care plus saline based placebo. The primary objective is to determine safety and efficacy of decitabine for COVID-19 ARDS based on clinical improvement on a 6-point clinical scale. Type: Interventional Start Date: Sep 2020 |
Investigating Otilimab in Patients With Severe Pulmonary COVID-19 Related Disease
GlaxoSmithKline
Severe Acute Respiratory Syndrome
OSCAR (Otilimab in Severe COVID-19 Related Disease) is a multi-center, double-blind,
randomized, placebo-controlled trial to assess the efficacy and safety of otilimab for
the treatment of severe pulmonary COVID-19 related disease. The study is being conducted
in 2 parts (Part 1 and Part 2). Otilimab... expand
OSCAR (Otilimab in Severe COVID-19 Related Disease) is a multi-center, double-blind, randomized, placebo-controlled trial to assess the efficacy and safety of otilimab for the treatment of severe pulmonary COVID-19 related disease. The study is being conducted in 2 parts (Part 1 and Part 2). Otilimab is a human monoclonal anti-granulocyte macrophage colony stimulating factor (GM-CSF) antibody that has not previously been tested in participants with severe pulmonary COVID-19 related disease in Part 1. The aim of this study is to evaluate the benefit-risk of a single infusion of otilimab in the treatment of hospitalized participants with severe COVID-19 related pulmonary disease with new onset hypoxia requiring significant oxygen support or requiring early invasive mechanical ventilation (less than or equal to [<=] 48 hours before dosing). Participants will be randomized to receive a single intravenous (IV) infusion of otilimab or placebo, in addition to standard of care. Type: Interventional Start Date: May 2020 |
Genetics of COVID-19 Susceptibility and Manifestations
National Human Genome Research Institute (NHGRI)
COVID-19
Coronavirus 2019
Background:
Coronavirus 2019 (COVID-19, or SARS-CoV-2) is a serious public health problem, and
genetics may play a role in how serious the illness becomes in certain people. Genes are
the instructions that our body uses to grow and develop. Variations in our genes can
cause medical conditions and... expand
Background: Coronavirus 2019 (COVID-19, or SARS-CoV-2) is a serious public health problem, and genetics may play a role in how serious the illness becomes in certain people. Genes are the instructions that our body uses to grow and develop. Variations in our genes can cause medical conditions and may be the reason why some people get sicker than others. Objective: This study aims to learn more about the genetic contributions to the severity of COVID-19. We hope to use this information to develop therapies that reduce the severity of COVID-19 symptoms in some people. Eligibility: Anyone located in the United States who has tested positive for SARS-CoV-2 infection may be eligible to join (including NIH staff). Design: Participants will complete a questionnaire about their health history and COVID-19 symptoms. Participants will give a blood or saliva sample. It will be about 2 tablespoons of blood, or we will send a saliva collection kit. Researchers will use this blood or saliva sample to study the participant s DNA. The data about participants genes will be stored in a large database. The database will be shared with other qualified researchers who are trying to learn about COVID-19. Participants names and other personal details will not be shared. Instead, the data will be labeled with a code. Participants may be contacted by study team members for up to a year after they join the study. Type: Observational Start Date: May 2020 |
Cross-Sectional Evaluation of Persistence of SARS-CoV-2 Remnants After Recovery From Acute Infection
National Institute of Neurological Disorders and Stroke (NINDS)
PASC Post Acute Sequelae of COVID-19
Background:
SARS-CoV-2 is the virus that causes COVID-19. Some people who recover from COVID-19 have
symptoms that last long after the active infection ends. This is called long COVID.
Sometimes, long COVID can affect the nerves and cause problems with sleep, thinking, the
senses, and movement.... expand
Background: SARS-CoV-2 is the virus that causes COVID-19. Some people who recover from COVID-19 have symptoms that last long after the active infection ends. This is called long COVID. Sometimes, long COVID can affect the nerves and cause problems with sleep, thinking, the senses, and movement. Researchers want to find out whether people with long COVID have retained inactive remnants of SARS-CoV-2 in their bodies. Objective: To collect tissue samples to see if people with long COVID have remnants of SARS-CoV-2 in their bodies. Eligibility: People 18 years or older who have recovered from COVID-19, both with and without neurologic symptoms. Design: Participants will have 2 to 4 inpatient or outpatient visits over 4 months. Each visit will last 4 to 5 days. Participants will be screened to make sure it is safe to collect tissue samples from their body. They will have a physical and dental exam. They will have imaging scans and a test of their heart function. They will complete questionnaires about their health. They will give blood, urine, saliva, and stool samples. Their sense of taste and smell will be tested. Tissue samples will be taken from the digestive tract, lungs, colon, skin, muscle, lymph nodes, nasal passages, and mouth. Participants may be numbed or sedated for some of the procedures. Swabs will be used to collect cells from inside the mouth and nose. Participants will undergo lumbar puncture. A thin needle will be inserted into their lower back to draw out a sample of the fluid around their spinal cord. Participants will have follow-up phone calls after each clinic visit. Type: Observational Start Date: Oct 2024 |
A Clinical Study to Investigate the Safety and Immunogenicity in Relation to Product Attributes of mRNA-1083...
ModernaTX, Inc.
Influenza
SARS-CoV-2
The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity
in relation to the product attributes of mRNA-1083 vaccine when administered as a single
intramuscular (IM) injection in adults ≥50 to <65 years of age. expand
The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity in relation to the product attributes of mRNA-1083 vaccine when administered as a single intramuscular (IM) injection in adults ≥50 to <65 years of age. Type: Interventional Start Date: Jul 2024 |
Treatment of Long CoronaVirus Disease (COVID) (TLC) Feasibility Trial
Emory University
COVID-19
The primary objective of this study is to assess the feasibility and acceptability of
methods and procedures to be employed in a larger scale decentralized platform adaptive
randomized clinical trial in patients with a history of a Severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2) Polymerase... expand
The primary objective of this study is to assess the feasibility and acceptability of methods and procedures to be employed in a larger scale decentralized platform adaptive randomized clinical trial in patients with a history of a Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Polymerase Chain Reaction (PCR) positive test and/or medical records from a healthcare provider that coincides with the diagnosis of long-COVID. Type: Interventional Start Date: Mar 2024 |
Intervention to Prevent Behavioral Health Symptoms Among Pandemic Affected Children
University of Illinois at Urbana-Champaign
Emotional Distress
Prosocial Behavior
Pandemic, COVID-19
Coping Skills
Social Support
Racial and ethnic minority children who live in socioeconomically disadvantaged
communities are disproportionately impacted by pandemic and climate-induced disasters.
Although effective interventions have been designed to treat mental health related
symptoms in post-disaster settings, accessible,... expand
Racial and ethnic minority children who live in socioeconomically disadvantaged communities are disproportionately impacted by pandemic and climate-induced disasters. Although effective interventions have been designed to treat mental health related symptoms in post-disaster settings, accessible, empirically supported prevention interventions are needed to prevent the onset of mental and behavioral health issues among these children. Building on our preliminary findings, the proposed study examines the efficacy and implementation of a COVID-19 adapted disaster focused prevention intervention, Journey of Hope-C19, in preventing behavioral health and interpersonal problems among racial and ethnic minority children who live in low-resource high poverty communities. Type: Interventional Start Date: Nov 2022 |
Improving Mental Health Among the LGBTQ+ Community
Brown University
Anxiety
Depression
The overall aim of this program of research is to improve the mental health of people who
identify as LGBTQ+ by increasing their social support through a brief intervention. The
purpose of the proposed project is to establish the effectiveness of our
empirically-supported, brief acceptance-based behavioral... expand
The overall aim of this program of research is to improve the mental health of people who identify as LGBTQ+ by increasing their social support through a brief intervention. The purpose of the proposed project is to establish the effectiveness of our empirically-supported, brief acceptance-based behavioral therapy (ABBT). To achieve the specific aims, the investigators will conduct a fully-powered, randomized clinical trial (n=240) with two treatment arms: treatment-as-usual (TAU) vs. ABBT. Type: Interventional Start Date: Jan 2023 |
A Multimodal Parent-focused Intervention for Vulnerable Populations in the Bronx
Albert Einstein College of Medicine
Parenting
Covid19
For caregivers in the Bronx, the pandemic has caused unprecedented psychological
distress; in addition to combating social determinants of health (SDOH), these families
now face greater financial insecurity and challenges related to their school-aged
children. Furthermore, social distancing requirements... expand
For caregivers in the Bronx, the pandemic has caused unprecedented psychological distress; in addition to combating social determinants of health (SDOH), these families now face greater financial insecurity and challenges related to their school-aged children. Furthermore, social distancing requirements and limited telehealth resources for Bronx families have posed greater barriers to healthcare. Such parental distress contributes to heightened risk of transgenerational cycles of psychological stress, trauma and maltreatment. The social and economic impacts of the COVID-19 pandemic have had significant consequences for family well-being, putting parents at higher risk of experiencing distress and potentially impairing their ability to provide supportive care to their children. Although children may be less susceptible to the most damaging physical consequences of COVID-19, there are growing concerns regarding the short-and long-term impacts of pandemic-related stressors on children. The marked upheaval of family life over an extended period may make children vulnerable to mental health consequences associated with the public health crisis and infection mitigation efforts. School and childcare closures, unstable financial circumstances, social isolation and lack of support have a disproportionate, cumulative impact on parents and may undermine their capacities to provide support for their children. Importantly, a large body of evidence suggests that parental stress during times of disasters induces psychopathologies in family members including children. Further, high anxiety and depressive symptoms in parents during the pandemic have been associated with higher child abuse potential, whereas greater parental support was associated with lower perceived stress and child abuse potential. In addition to psychological impacts, stress associated with caregiving can interfere with parents' ability to maintain their own health. This multimodal study addresses key strategies to mitigate the psychological and health impact of COVID-19 in parents. Type: Interventional Start Date: Dec 2021 |
Evaluation of the RD-X19 Treatment Device in Individuals With Mild to Moderate COVID-19
EmitBio Inc.
COVID19
This is a randomized, sham controlled, dose finding study of the EmitBio RD-X19 device in
individuals with symptomatic COVID-19 in the outpatient setting. expand
This is a randomized, sham controlled, dose finding study of the EmitBio RD-X19 device in individuals with symptomatic COVID-19 in the outpatient setting. Type: Interventional Start Date: Jun 2021 |
Digital Interventions to Treat Hazardous Drinking
Yale University
Hazardous Drinking
Stress
There has been a significant increase in the prevalence of stress- and alcohol- related
disorders during the COVID-19 pandemic. This project aims to conduct a feasibility study
to evaluate the preliminary efficacy of a digital intervention designed to reduce stress
and alcohol use. Additionally, this... expand
There has been a significant increase in the prevalence of stress- and alcohol- related disorders during the COVID-19 pandemic. This project aims to conduct a feasibility study to evaluate the preliminary efficacy of a digital intervention designed to reduce stress and alcohol use. Additionally, this study will examine the impact of stress, including COVID-19 related stress, on the risk of alcohol misuse and the outcomes of the intervention in risky social drinkers. Type: Interventional Start Date: Oct 2021 |
Double-Blind, Multicenter, Study to Evaluate the Efficacy of PLX PAD for the Treatment of COVID-19
Pluristem Ltd.
COVID
ARDS
This clinical trial will examine if a new treatment of Mesenchymal-like Adherent stromal
Cells (called PLX-PAD) can help patients intubated and mechanically ventilated due to
COVID-19 to recover more quickly with less complications. expand
This clinical trial will examine if a new treatment of Mesenchymal-like Adherent stromal Cells (called PLX-PAD) can help patients intubated and mechanically ventilated due to COVID-19 to recover more quickly with less complications. Type: Interventional Start Date: Oct 2020 |
Identification and Characterization of SARS-CoV-2 Specific CD8 T Cells in Humans
National Institute on Aging (NIA)
COVID-19
Background:
The higher death rate from COVID-19 in the older population is associated with low CD8 T
cell counts in the blood. Researchers want to learn the status of CD8 T cells specific to
SARS-CoV-2 and their changes with aging and in COVID-19. This may help to identify why
COVID-19 is particularly... expand
Background: The higher death rate from COVID-19 in the older population is associated with low CD8 T cell counts in the blood. Researchers want to learn the status of CD8 T cells specific to SARS-CoV-2 and their changes with aging and in COVID-19. This may help to identify why COVID-19 is particularly lethal in the elderly and help to create an effective vaccine against SARS-CoV-2 in the elderly. Objective: To identify SARS-CoV-2 specific CD8 T cells in humans, and to determine their quantity and quality in people who have recovered from COVID-19. Eligibility: Maryland residents age 18 and older who have tested positive for and recovered from COVID-19. Design: Participants will be screened by phone. They must be able to provide a copy of their positive COVID-19 test result. Participants will visit the NIA/Clinical Research Unit. The visit will take about 1 hour. Laboratory tests showing a positive COVID-19 result will be verified. Participants vital signs will be checked. This will include blood pressure, temperature, pulse, and respiration. Height and weight will be measured. Participants will have a medical history and medicine review. They will complete a COVID-19 questionnaire. Participants will have blood drawn. They will give a urine sample. Participants will give a saliva sample. They will rinse their mouth with water. After about 3 minutes, they will let saliva pool in the base of their mouth and then spit into a sterile container. Participants may be asked if they would be willing to return for optional visits at about 4 months and 1 year later. They will repeat the same laboratory sampling performed at the first visit. ... Type: Observational Start Date: Sep 2020 |
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