Search Clinical Trials
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Human Convalescent Plasma for High Risk Children Exposed or Infected With SARS-CoV-2 (COVID-19)
Johns Hopkins University
SARS-CoV-2 Infection
The purpose of this study is to evaluate the safety of administration of plasma
containing antibodies to the SARS-CoV-2 virus (i.e., convalescent plasma) and if it is
able to prevent disease or lessen the severity of disease in individuals who are at high
risk of developing COVID-19 due to a recent... expand
The purpose of this study is to evaluate the safety of administration of plasma containing antibodies to the SARS-CoV-2 virus (i.e., convalescent plasma) and if it is able to prevent disease or lessen the severity of disease in individuals who are at high risk of developing COVID-19 due to a recent exposure. This study will also measure the level of anti-SARS-CoV-2 antibodies in patient's blood after the administration of the convalescent plasma. Type: Interventional Start Date: May 2020 |
Assessing the System for High-Intensity Evaluation During Radiotherapy During Changes in Response to...
Duke University
COVID-19
Cancer
The primary objective of this research study is to assess Radiation Oncology healthcare
providers (i.e. faculty, residents and advanced practice providers (APPs) implementation
and perception of telehealth for on treatment patients in lieu of in person on treatment
visits during standard of care radiotherapy... expand
The primary objective of this research study is to assess Radiation Oncology healthcare providers (i.e. faculty, residents and advanced practice providers (APPs) implementation and perception of telehealth for on treatment patients in lieu of in person on treatment visits during standard of care radiotherapy during COVID-19. Type: Observational Start Date: Apr 2020 |
SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry
Massive Bio, Inc.
Cancer, Metastatic
Cancer
Cancer of Pancreas
Cancer of Liver
Cancer of Stomach
International registry for cancer patients evaluating the feasibility and clinical
utility of an Artificial Intelligence-based precision oncology clinical trial matching
tool, powered by a virtual tumor boards (VTB) program, and its clinical impact on pts
with advanced cancer to facilitate clinical... expand
International registry for cancer patients evaluating the feasibility and clinical utility of an Artificial Intelligence-based precision oncology clinical trial matching tool, powered by a virtual tumor boards (VTB) program, and its clinical impact on pts with advanced cancer to facilitate clinical trial enrollment (CTE), as well as the financial impact, and potential outcomes of the intervention. Type: Observational [Patient Registry] Start Date: Jan 2018 |
Cardiopulmonary Inflammation and Multi-System Imaging During the Clinical Course of COVID-19 Infection...
National Institutes of Health Clinical Center (CC)
Acute and Long Term Effects of COVID-19 on Systemic Inflammation
Acute and Long Term Effects of COVID-19 on Lung Function
Acute and Long Term Effects of COVID-19 on Cardiac Function
Acute and Long Term Effects of COVID-19 on Kidney Function
Acute and Long Term Effects of COVID-19 on Brain Function
Background:
COVID-19 virus infection differs among people. Some people have no or mild symptoms. For
others, COVID-19 is life threatening and causes damage to the body s organs. Researchers
want to better understand the virus to learn how to kill it.
Objective:
To understand how the COVID-19... expand
Background: COVID-19 virus infection differs among people. Some people have no or mild symptoms. For others, COVID-19 is life threatening and causes damage to the body s organs. Researchers want to better understand the virus to learn how to kill it. Objective: To understand how the COVID-19 virus causes wide differences in how sick one can become from the infection. Eligibility: People ages 18-80 with COVID-19 infection Design: Participants will be screened with a review of their medical records. Participants who enter the study at the beginning of their COVID-19 infection will stay in the hospital until they are healthy enough to go home. Those who enter after they have recovered may need to stay in the hospital 1-2 nights to perform the study tests. Participants will have MRI and CT scans of the brain, heart, and lungs. They will lie in a machine that takes pictures of the body. For the MRI, soft padding or a coil will be placed around their head and chest. They may receive a dye injected into a vein. Participants will have an ultrasound of the kidneys and heart. Participants will provide blood and urine samples. They will provide nasal swabs. Participants will have a bronchoscopy. A thin tube will be placed through the nose or mouth into the airway. Saltwater will be squirted into the lungs and removed by suction. Participants may provide a spinal fluid sample. A needle injected into the spinal canal will obtain fluid. Participants will have lung and heart function tests. At various points after recovery, participants will repeat many of these tests. Type: Observational Start Date: May 2020 |
PF-07304814 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)
National Institute of Allergy and Infectious Diseases (NIAID)
COVID-19
This study looks at the safety and effectiveness of PF-07304814 in treating COVID-19 in
people who have been hospitalized with the infection. Participants in the study will be
treated with either PF-07304814 plus current standard of care (SOC), or with placebo plus
current SOC. This is ACTIV-3/TICO... expand
This study looks at the safety and effectiveness of PF-07304814 in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either PF-07304814 plus current standard of care (SOC), or with placebo plus current SOC. This is ACTIV-3/TICO Treatment Trial H6. Type: Interventional Start Date: Sep 2021 |
A Vaccine Booster (GEO-CM04S1) for the Prevention of COVID-19 in Patients With Chronic Lymphocytic Leukemia
City of Hope Medical Center
Chronic Lymphocytic Leukemia
COVID-19 Infection
This phase II trial compares the effect of the GEO-CM04S1 vaccine with the current
standard of care vaccine in preventing COVID-19 infections in patients with chronic
lymphocytic leukemia (CLL). The GEO-CM04S1 vaccine uses a modified vaccinia virus (MVA)
backbone that may be more effective at boosting... expand
This phase II trial compares the effect of the GEO-CM04S1 vaccine with the current standard of care vaccine in preventing COVID-19 infections in patients with chronic lymphocytic leukemia (CLL). The GEO-CM04S1 vaccine uses a modified vaccinia virus (MVA) backbone that may be more effective at boosting COVID-19 immunity in patients with poor immune responses. MVA strongly induces T cell expansion (infection fighting blood cells) even in the background of a suppressed immune system, which is the case in the targeted CLL patient population. Using the GEO-CM04S1 vaccine may be more effective at preventing COVID-19 infection in patients diagnosed with CLL. Type: Interventional Start Date: Aug 2023 |
Neuropsychiatric Post-Acute Sequelae of SARS-CoV-2 (PASC) Using TSPO Positron Emission Tomography (PET)...
NYU Langone Health
Neuropsychiatric Post-Acute Sequelae of SARS-CoV-2 Infection
The overarching goal of this study is to develop PET/MR techniques for the diagnosis of
neuropsychiatric post-acute sequelae (PASC) of SARS-CoV-2. The central hypothesis is that
immunological and cerebrovascular dysfunction after acute SARS-CoV-2 infections mediate
neuropsychiatric PASC (NP-PASC). expand
The overarching goal of this study is to develop PET/MR techniques for the diagnosis of neuropsychiatric post-acute sequelae (PASC) of SARS-CoV-2. The central hypothesis is that immunological and cerebrovascular dysfunction after acute SARS-CoV-2 infections mediate neuropsychiatric PASC (NP-PASC). Type: Observational Start Date: Feb 2022 |
A Study Assessing the Safety, Tolerability, Immunogenicity of COVID-19 Vaccine Candidate PRIME-2-CoV_Beta,...
Speransa Therapeutics
SARS-CoV-2 Infection
PRIME-2-CoV_Beta is the first clinical candidate based on the attenuated 2nd generation
Orf virus (ORFV) vaccine platform which encodes for the structural spike (S)- and
nucleocapsid (N) protein of SARS-CoV-2. The aim of the multivalent vaccine is to broaden
the specific immune response against SARS-CoV-2... expand
PRIME-2-CoV_Beta is the first clinical candidate based on the attenuated 2nd generation Orf virus (ORFV) vaccine platform which encodes for the structural spike (S)- and nucleocapsid (N) protein of SARS-CoV-2. The aim of the multivalent vaccine is to broaden the specific immune response against SARS-CoV-2 and to increase the probability of cross-protection against emerging variants. Type: Interventional Start Date: Jun 2022 |
COVID-19 Antibody and Reinfection Study
Kaiser Permanente
COVID-19 Testing
The goal of this study is to establish a cohort of Kaiser Permanente Colorado (KPCO)
members who have and have not had COVID-19 infection for serial antibody testing and PCR
testing to:
1. Quantify antibody titers among participants over 9 months.
2. Determine the rates of asymptomatic, mild,... expand
The goal of this study is to establish a cohort of Kaiser Permanente Colorado (KPCO) members who have and have not had COVID-19 infection for serial antibody testing and PCR testing to: 1. Quantify antibody titers among participants over 9 months. 2. Determine the rates of asymptomatic, mild, and severe recurrent infection among participants with prior COVID-19. 3. Examine association between antibody titer levels and risk of recurrent infection using a case control analysis nested in the cohort. Type: Observational [Patient Registry] Start Date: Jun 2020 |
COVID-19 Coagulopathy Extension Study
University of Iowa
COVID-19
At the University of Iowa, the investigators led a multicenter randomized clinical trial
comparing standard prophylactic dose to intermediate dose enoxaparin in hospitalized
patients with COVID-19 (NCT04360824). As part of an exploratory biomarker component of
this trial, blood samples were collected... expand
At the University of Iowa, the investigators led a multicenter randomized clinical trial comparing standard prophylactic dose to intermediate dose enoxaparin in hospitalized patients with COVID-19 (NCT04360824). As part of an exploratory biomarker component of this trial, blood samples were collected from hospitalized COVID-19 patients at enrollment and weekly for up to 30 days of hospitalization. The pilot results, as well as reports from other groups, demonstrate increased potential for thrombin generation in the plasma of COVID-19 patients. In particular, in the COVID-19 patient cohort enhanced thrombin generation potential persisted for at least 30 days of hospitalization. The investigators now propose to explore the mechanistic roles of activation of blood cells (such as platelets and neutrophils) and products of cellular activation as mediators of enhanced thrombin generation in patients with COVID-19. The study design will be a longitudinal cohort study, which will allow for the determination of the time course of enhanced thrombin generation potential in relation to clinical outcomes and changes in markers of cellular activation in serial samples obtained from COVID-19 patients for up to 3 years after infection with SARS-CoV-2. This study may provide clues to why a subset of COVID-19 patients present with late thrombotic complications even after apparent recovery from SARS-CoV-2 infection. An ongoing question in the field relates to the comparative prothrombotic effects of acute COVID-19 versus incidental SARS-CoV-2 infection versus acute infection with influenza viruses. Therefore, we will include three categories of hospitalized patients in this study: (1) acute COVID-19, (2) incidental COVID-19, and (3) acute influenza A or B. This project has a strong scientific rationale with direct clinical implications, especially given the emergence of SARS-CoV-2 variants such as delta and omicron that may prolong the pandemic and/or cause surges of COVID-19 in the coming months. Type: Observational Start Date: Jan 2022 |
Mindfulness Practice in Pregnancy As an Intervention to Decrease Prenatal Stress During the COVID-19...
University of Pennsylvania
Prenatal Stress
The purpose of the study is to examine whether a simple mindfulness intervention
conducted via a virtual platform can reduce stress among pregnant women. expand
The purpose of the study is to examine whether a simple mindfulness intervention conducted via a virtual platform can reduce stress among pregnant women. Type: Interventional Start Date: May 2021 |
Phase 1 Study of Intranasal PIV5 COVID-19 Vaccine Expressing SARS-CoV-2 Spike Protein in Healthy Adults...
CyanVac LLC
Covid19
This Phase 1 trial is an open-label trial to evaluate the safety, reactogenicity and
immunogenicity of two dosages (10^6 PFU and 10^7 PFU) of intranasal CVXGA1 administered
as a single dose in healthy adults age 18-55 years and in adolescents age 12-17. expand
This Phase 1 trial is an open-label trial to evaluate the safety, reactogenicity and immunogenicity of two dosages (10^6 PFU and 10^7 PFU) of intranasal CVXGA1 administered as a single dose in healthy adults age 18-55 years and in adolescents age 12-17. Type: Interventional Start Date: Aug 2021 |
COVID-19 Vaccine Education at the Point of Testing to Increase Vaccine Uptake in Vulnerable Communities...
Xavier University of Louisiana.
Covid19
Vaccine Refusal
Vaccine Hesitancy
This project is a 2-year study to investigate vaccine hesitancy and vaccine completion
among vulnerable communities in the Southeastern Louisiana region. This study will be
used to track COVID-19 vaccine completion among patients who seek testing, either as
in-person or purchasing at home COVID testing,... expand
This project is a 2-year study to investigate vaccine hesitancy and vaccine completion among vulnerable communities in the Southeastern Louisiana region. This study will be used to track COVID-19 vaccine completion among patients who seek testing, either as in-person or purchasing at home COVID testing, from pharmacies, urgent cares and clinics using a rapid vaccine education model delivered at the point of care. Type: Interventional Start Date: Sep 2022 |
Improving Cognitive Health in COVID-19 Survivors
Weill Medical College of Cornell University
Cognitive Dysfunction
Covid19
The primary objective of this study is to investigate the efficacy of AKL-T01, a
remotely-delivered digital cognitive intervention, relative to a waitlist control in
improving cognitive functioning in COVID-19 survivors. expand
The primary objective of this study is to investigate the efficacy of AKL-T01, a remotely-delivered digital cognitive intervention, relative to a waitlist control in improving cognitive functioning in COVID-19 survivors. Type: Interventional Start Date: Jul 2021 |
Increasing Vaccine Uptake in Underresourced Public Housing Areas
Charles Drew University of Medicine and Science
Coronavirus
Vaccine Refusal
This proposal seeks to enhance uptake and completion of COVID-19 vaccination among
African American and Latinx public housing residents in South Los Angeles. Given the
multiple disparities experienced by public housing residents, the investigators will
utilize a theoretically-based, multidisciplinary... expand
This proposal seeks to enhance uptake and completion of COVID-19 vaccination among African American and Latinx public housing residents in South Los Angeles. Given the multiple disparities experienced by public housing residents, the investigators will utilize a theoretically-based, multidisciplinary and culturally tailored intervention to provide education at multiple levels and implement innovate strategies to engage this population in the uptake of COVID-19 vaccination. Type: Interventional Start Date: Sep 2021 |
Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19
Pharming Technologies B.V.
Confirmed Coronavirus Disease
The primary purpose of this study is to evaluate if adding rhC1-INH to standard of care
(SOC) in patients admitted for stage II COVID-19 infection may reduce the risk of disease
progression, i.e. ALI requiring mechanical ventilation, or increase the chance of a
faster clinical improvement compared... expand
The primary purpose of this study is to evaluate if adding rhC1-INH to standard of care (SOC) in patients admitted for stage II COVID-19 infection may reduce the risk of disease progression, i.e. ALI requiring mechanical ventilation, or increase the chance of a faster clinical improvement compared to SOC alone. Type: Interventional Start Date: Nov 2020 |
Losmapimod Safety and Efficacy in COVID-19
Fulcrum Therapeutics
COVID-19
The therapeutic hypothesis for the use of losmapimod in COVID-19 disease is that
increased mortality and severe disease is caused by p38 mitogen-activated protein kinase
(MAPK)-mediated exaggerated acute inflammatory response resulting from SARS-CoV-2
infection.
The study Sponsor hypothesizes that... expand
The therapeutic hypothesis for the use of losmapimod in COVID-19 disease is that increased mortality and severe disease is caused by p38 mitogen-activated protein kinase (MAPK)-mediated exaggerated acute inflammatory response resulting from SARS-CoV-2 infection. The study Sponsor hypothesizes that the early initiation of p38α/β inhibitor therapy in patients hospitalized with moderate COVID-19 who are at increased risk of a poor prognosis based on older age and elevated systemic inflammation will reduce clinical deterioration including progression to respiratory failure and death. To address this hypothesis, Fulcrum Therapeutics is conducting a Phase 3, multicenter, randomized, double-blind, placebo-controlled study that will evaluate the safety and efficacy of losmapimod versus placebo in subjects 40 and older who are hospitalized with moderate COVID-19 disease. Type: Interventional Start Date: Aug 2020 |
Plasma Collection From Convalescent and/or Immunized Donors for the Treatment of COVID-19
National Institutes of Health Clinical Center (CC)
COVID-19
Background:
The Coronavirus disease 2019 (COVID-19) pandemic is a major public health issue.
Researchers want to collect plasma from people who have recovered from COVID-19, and use
this plasma to treat people who are sick with the disease. The plasma will have
antibodies against the virus that... expand
Background: The Coronavirus disease 2019 (COVID-19) pandemic is a major public health issue. Researchers want to collect plasma from people who have recovered from COVID-19, and use this plasma to treat people who are sick with the disease. The plasma will have antibodies against the virus that causes COVID-19. Persons who have received a COVID-19 vaccine may also donate plasma that contains antibodies against the virus if they meet criteria according to the FDA. Objective: To collect plasma from people who have recovered from COVID-19 or have been vaccinated against the coronavirus that causes COVID-19, so that the plasma can be used to treat people with the disease. Eligibility: Adults ages 18 and older who have been diagnosed with, and have recovered from, COVID-19. Design: Participants will be screened with a physical exam, medical history, and blood sample. Their pulse, blood pressure, and temperature will be taken. Their height and weight will be recorded. Participants will donate plasma. It will be collected through whole blood donation or through apheresis. For whole blood donation, a needle will be placed in the participant s arm vein. Blood will be withdrawn. For apheresis, a needle will be placed in the participant s arm vein. Blood will be withdrawn. A machine will separate the plasma from the red cells. The plasma will be removed, and the rest of the cells will be returned to the participant either through the same needle or through a needle in their other arm. Participants will have 3 to 20 plasma donations. Participation will last up to 3 years. Type: Observational Start Date: Apr 2020 |
Prospective Natural History Study of Smoking, Immune Cell Profiles, Epigenetics and COVID-19
National Institute of Environmental Health Sciences (NIEHS)
COVID-19
Background:
Early evidence in the COVID-19 pandemic suggests that smokers are at a higher risk of
having severe effects or dying from the disease. Smoking causes changes in immune cells.
Researchers think this may be the reason why smokers are more likely to have severe
effects from COVID-19. Researchers... expand
Background: Early evidence in the COVID-19 pandemic suggests that smokers are at a higher risk of having severe effects or dying from the disease. Smoking causes changes in immune cells. Researchers think this may be the reason why smokers are more likely to have severe effects from COVID-19. Researchers want to better understand the interaction between smoking history, the immune system, and COVID-19. Objective: To better understand how COVID-19 affects smokers and non-smokers immune systems before and after being infected with the virus. Eligibility: Healthy people ages 30-55 who are a smokers or non-smokers who may potentially contract COVID-19 Design: Participants will be screened over the phone. They will answer questions about their demographics, medical history, medications, and smoking status. Participants will have up to 6 monthly visits. At the first visit, participants will have blood tests. Blood will be drawn through a needle in an arm vein. They will provide a saliva sample in a container and have a cheek swab. The participant will also have a nasal swab to see if they currently have COVID-19. Their height and weight will be taken. They will complete questionnaires about their medical history and smoking status. Participants will then have monthly visits. They will have blood draws to test for COVID-19 antibodies. They will provide a saliva sample in a container and have a cheek swab. The participant will also have a nasal swab to see if they currently have COVID-19. These visits will occur 4 times or until they have a positive antibody result. Participants will have a final visit. They will have blood tests. They will provide a saliva sample in a container and have a cheek swab. The participant will also have a nasal swab to see if they currently have COVID-19. If at any time participants test positive for a COVID-19, they will be rescheduled 14 days or more after they no longer have symptoms.... Type: Observational Start Date: Jun 2020 |
Mental Health Impact of the COVID-19 Pandemic on Amish and Mennonite Participants in AMBiGen
National Institute of Mental Health (NIMH)
Depression
Anxiety
Bipolar Disorder
People have had to make a lot of changes to their lives due to the COVID-19 health
crisis. Most experts agree that social distancing and other safety measures have taken a
toll on people s mental health. Amish and Mennonite communities often have large
families. They may have limited access to health... expand
People have had to make a lot of changes to their lives due to the COVID-19 health crisis. Most experts agree that social distancing and other safety measures have taken a toll on people s mental health. Amish and Mennonite communities often have large families. They may have limited access to health care. Their lifestyle is based on interaction and group events rather than technology. So people in Amish and Mennonite communities may experience the pandemic in their own special ways. Objective: To describe the relationship between stress related to the pandemic and self-rated measures of mental health symptoms and distress among Amish and Mennonite people with bipolar disorder and related conditions, and their family members. Eligibility: Adults ages 18 and older who are taking part in the NIMH AMBiGen study (80-M-0083). Design: Participants will be mailed 4 surveys. One survey will ask about depression symptoms. One survey will ask about mania symptoms. One survey will assess a broad range of psychological problems. One survey will assess the impact of COVID-19 on their mental health. They will fill out the surveys 4 times over 24 months. The surveys will not include participants names, just codes. This will help protect privacy. Data collected in 80-M-0083 will be used. This includes data about participants genes, medical conditions, and assessments. Participants will get an 800 number they can call to speak to the research team. They can also write to the team if they prefer. Participants who wish will get referrals for mental health services. Participation will last up to 24 months. There will be an option for recontact in the future. Type: Observational Start Date: Dec 2020 |
Impact of COVID-19 on Surgical Outcomes
Kern Medical Center
COVID-19
Surgical Outcomes
Postoperative Complications
Following the introduction of the COVID-19 vaccination, elective surgeries have resumed,
allowing for greater insight into the postoperative period and outcomes aims on-going
COVID-19 infections. This study aimed to evaluate risk factors of postoperative morbidity
and mortality in patients who had... expand
Following the introduction of the COVID-19 vaccination, elective surgeries have resumed, allowing for greater insight into the postoperative period and outcomes aims on-going COVID-19 infections. This study aimed to evaluate risk factors of postoperative morbidity and mortality in patients who had surgery within one year of testing positive for COVID-19. Type: Observational Start Date: May 2020 |
Promoting Engagement and COVID-19 Testing for Health
Emory University
COVID-19
PEACH2 is a community-based study, targeting individuals affected by diabetes. Study
participants will be randomized into the PEACH2 Intervention Arm or the Control Arm. The
intervention lasts for 16 weeks and participants will be followed for 12 months in total. expand
PEACH2 is a community-based study, targeting individuals affected by diabetes. Study participants will be randomized into the PEACH2 Intervention Arm or the Control Arm. The intervention lasts for 16 weeks and participants will be followed for 12 months in total. Type: Interventional Start Date: Dec 2023 |
Have Physical Therapists Attitudes and Beliefs Towards Vital Assessment Changed Following the COVID-19...
Youngstown State University
Vital Signs
Previous studies prior to the COVID-19 pandemic show that cardiovascular and blood
pressure assessment by physical therapists is inadequate or lacking despite prior
training. Since the COVID-19 pandemic, assessment of cardiovascular and respiratory
function may become more critical as the manifestation... expand
Previous studies prior to the COVID-19 pandemic show that cardiovascular and blood pressure assessment by physical therapists is inadequate or lacking despite prior training. Since the COVID-19 pandemic, assessment of cardiovascular and respiratory function may become more critical as the manifestation of long COVID has become a concern. The purpose of this study is to determine whether physical therapists' attitudes and beliefs towards vital sign assessment have changed following the COVID-19 pandemic. Type: Observational Start Date: Sep 2023 |
Anti-SARS-CoV-2 Monoclonal Antibodies for Long COVID (COVID-19)
Michael Peluso, MD
Long COVID
Post-Acute Sequela of COVID-19
Post-Acute COVID-19
Persistent viral infection with viral reservoirs and detection of circulating spike
protein after the initial acute illness is one potential pathogenic mechanism for Long
COVID. This mechanism may be able to be targeted by SARS-CoV-2 monoclonal antibodies
(mAbs). This trial will study the safety and... expand
Persistent viral infection with viral reservoirs and detection of circulating spike protein after the initial acute illness is one potential pathogenic mechanism for Long COVID. This mechanism may be able to be targeted by SARS-CoV-2 monoclonal antibodies (mAbs). This trial will study the safety and efficacy of AER002 to treat individuals with Long COVID in an adult population. Type: Interventional Start Date: Aug 2023 |
The Safer At School Early Alert HUB
University of California, San Diego
COVID-19
Schools serve important community roles beyond academic education. In historically
marginalized communities they are trusted providers for a range of support services for
families in need. The tradeoff between these crucial benefits of in-person learning
against the risk of SARS-CoV-2 transmission... expand
Schools serve important community roles beyond academic education. In historically marginalized communities they are trusted providers for a range of support services for families in need. The tradeoff between these crucial benefits of in-person learning against the risk of SARS-CoV-2 transmission in school settings has been hotly debated throughout much of 2020 and 2021. The stakes are particularly high in historically marginalized communities which rely most heavily on school services, but have also been hit the hardest by COVID-19 primarily due to structural issues. The Safer at School Early Alert (SASEA) program was co-developed by the University of California, San Diego, the County of San Diego, and 15 partner schools serving socially vulnerable students in 5 school districts across San Diego County. SASEA utilizes daily wastewater and surface (floor) environmental monitoring to detect asymptomatic SARS-CoV-2 infections among students and staff on campus. Positive environmental signals are immediately followed by targeted responsive testing for a whole school (in the case of wastewater) or classroom (for a positive surface sample). In this project, we will develop the Safer at School Early Alert HUB (SASEA HUB), an online school environmental monitoring report dashboard with resources to address structural barriers to COVID-19 diagnostic testing in historically marginalized communities (Aim 1). We will also create a toolkit to allow any school to rapidly adapt the template to their specific setting. In Aims 2 and 3, we will use a randomized stepped wedge trial to compare SASEA (control) vs SASEA HUB (intervention) in 26 schools across 3 diverse school clusters in San Diego County. Our primary outcome (Aim 2) is higher rates of diagnostic testing in intervention schools. Our secondary outcome (Aim 3) is increased risk mitigation behaviors in school community members when environmental surveillance data suggests a potential case on campus. In Aim 4, we will use parent-child narrative interviews with 40 parent-student pairs to understand how children perceive COVID-19 risk at school, assess differences in perceptions of testing barriers between intervention and control sites, and better understand how children understand the process of environmental surveillance and responsive testing. Type: Interventional Start Date: Sep 2022 |
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