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RADx-UP- Impact of Community Health Worker Deployment
Morehouse School of Medicine
Diabetes
COVID-19
Community Health Workers
Health Behavior
Health Knowledge, Attitudes, Practice
The proposed project will implement and evaluate a brief Community Health Worker (CHW)
intervention through the Albany Area Primary Health Care, a rural Federally Qualified
Health Center (FQHC). The primary goal of this study is to maximize effective outreach,
education, and communication through... expand
The proposed project will implement and evaluate a brief Community Health Worker (CHW) intervention through the Albany Area Primary Health Care, a rural Federally Qualified Health Center (FQHC). The primary goal of this study is to maximize effective outreach, education, and communication through CHWs in order to facilitate improved COVID-19 vaccine confidence and uptake in underserved and vulnerable communities. CHWs will be deployed to the homes of adults with increased risk of morbidity and mortality (i.e., African Americans or Latinos with uncontrolled diabetes or prediabetes, age <50 years, and non-COVID-19 vaccinated) in order to educate them about diabetes, COVID-19 and related vaccines. Health assessments, including blood glucose measurement, will be conducted on the indexed patient and offered to all other adult family members in the household (i.e., "bubble"). Adults with Type 2 diabetes likely live in households with other adults who have or are at increased risk for diabetes (i.e., prediabetes and obesity).1 It is expected that they will also share similar COVID-19 exposure risk. The specific aims are to: 1) Evaluate a community-driven education program to increase and enhance COVID-19 vaccine confidence and uptake in individuals with uncontrolled diabetes and their families (i.e., their "bubble") and 2) Evaluate a community-driven education program to improve diabetes self-management behaviors and related outcomes (e.g., blood glucose) in individuals with uncontrolled diabetes in rural, Southwest Georgia. Type: Interventional Start Date: Feb 2022 |
Clinical Evaluation of the Panbio™ COVID-19/Flu A&B Rapid Panel Professional Use Product Using Mid-Turbinate...
Abbott Rapid Dx
COVID-19
Influenza A
Influenza Type B
This study is designed as an international, prospective, multicentric, clinical study to
investigate the performance of the Panbio™ COVID-19/Flu A&B Rapid Panel for the
qualitative detection of COVID-19 antigen, Influenza A antigen, and Influenza B antigen
in human mid-turbinate nasal swabs collected... expand
This study is designed as an international, prospective, multicentric, clinical study to investigate the performance of the Panbio™ COVID-19/Flu A&B Rapid Panel for the qualitative detection of COVID-19 antigen, Influenza A antigen, and Influenza B antigen in human mid-turbinate nasal swabs collected by a trained health worker. This study is part of the performance evaluation to support the CE conformity assessment procedures. Type: Interventional Start Date: Dec 2022 |
Long-term Impact in Intensive Care Survivors of Coronavirus Disease (COVID-19)
Johns Hopkins University
COVID-19
The Investigator seeks to evaluate the long term neurological and pulmonary sequelae of
COVID-19. expand
The Investigator seeks to evaluate the long term neurological and pulmonary sequelae of COVID-19. Type: Observational Start Date: Sep 2021 |
Investigating Immune Escape by SARS-CoV-2 Variants
University of California, Los Angeles
COVID-19; Immunity
The purpose of this protocol is to investigate the ability of pre-existing immunity by
natural infection or vaccination to prevent infections by emerging SARS-CoV-2 variants. expand
The purpose of this protocol is to investigate the ability of pre-existing immunity by natural infection or vaccination to prevent infections by emerging SARS-CoV-2 variants. Type: Observational Start Date: May 2021 |
A Ph 2 Trial With an Oral Tableted COVID-19 Vaccine
Vaxart
COVID-19
Part 1: An open label, dose and age escalation phase to evaluate the safety and
immunogenicity of VXA-CoV2-1.1-S with a repeat-dose vaccination schedule in healthy
adults aged 18 - 75 years old that are either vaccine naive or have received prior
vaccination with an mRNA (messenger ribonucleic acid)... expand
Part 1: An open label, dose and age escalation phase to evaluate the safety and immunogenicity of VXA-CoV2-1.1-S with a repeat-dose vaccination schedule in healthy adults aged 18 - 75 years old that are either vaccine naive or have received prior vaccination with an mRNA (messenger ribonucleic acid) vaccine for the prevention of COVID-19. Part 2: This phase will assess the efficacy of prophylactic VXA-CoV2-1.1-S against confirmed COVID-19 occurring from 7 days after second dose with a repeat-dose vaccination schedule in healthy adults compared to placebo. Safety and immunogenicity of VXA-CoV2-1.1-S will also be evaluated in this phase. Type: Interventional Start Date: Oct 2021 |
Test to Stay in School: COVID-19 Testing Following Exposure in School Communities
Duke University
Covid19
Participants in school communities who have been exposed to SARS-CoV-2 will be tested for
COVID-19 on the day of exposure (day 1) and at days 3, 5, and 7 following initial known
exposure. Mitigation practices including masking, the context of exposure (classroom,
school bus, after school sporting... expand
Participants in school communities who have been exposed to SARS-CoV-2 will be tested for COVID-19 on the day of exposure (day 1) and at days 3, 5, and 7 following initial known exposure. Mitigation practices including masking, the context of exposure (classroom, school bus, after school sporting event, lunch, etc.), and results of COVID-19 test will be documented. Type: Interventional Start Date: Oct 2021 |
COVID-19 International Drug Pregnancy Registry
Pregistry
Covid19
The objective of the COVID-19 International Drug Pregnancy Registry (COVID-PR) is to
evaluate obstetric, neonatal, and infant outcomes among women treated with monoclonal
antibodies or antiviral drugs indicated for mild, moderate, or severe COVID-19 from the
first day of the last menstrual period... expand
The objective of the COVID-19 International Drug Pregnancy Registry (COVID-PR) is to evaluate obstetric, neonatal, and infant outcomes among women treated with monoclonal antibodies or antiviral drugs indicated for mild, moderate, or severe COVID-19 from the first day of the last menstrual period (LMP) to end of pregnancy. For monoclonal antibodies, the exposure period also includes 90 days prior to the first day of the LMP. Type: Observational Start Date: Dec 2021 |
"CHANGE COVID-19 Severity"
Vanderbilt University Medical Center
COVID-19 Infection
We are conducting an investigator-initiated, single center, blinded, placebo-controlled,
randomized clinical trial evaluating magnesium citrate combined with a probiotic for the
treatment of adults hospitalized with COVID-19. expand
We are conducting an investigator-initiated, single center, blinded, placebo-controlled, randomized clinical trial evaluating magnesium citrate combined with a probiotic for the treatment of adults hospitalized with COVID-19. Type: Interventional Start Date: Nov 2021 |
Implementation of COVID-19 Testing Strategies in Community Health Centers
Massachusetts General Hospital
Covid19
This project is part of a competitive revision to accelerate COVID-19 testing in
underserved populations. The overall aim is to implement strategies to expand COVID
testing in hotspot communities in MA, through 6 community health center (CHC)-community
partnerships. A base strategy will be implemented... expand
This project is part of a competitive revision to accelerate COVID-19 testing in underserved populations. The overall aim is to implement strategies to expand COVID testing in hotspot communities in MA, through 6 community health center (CHC)-community partnerships. A base strategy will be implemented at all sites. A tailored strategy unique to local populations will be added and tested in a stepped wedge design. Type: Interventional Start Date: Dec 2020 |
Safety and Efficacy of USB002 for Respiratory Distress Due to COVID-19
US Biotest, Inc.
2019 Novel Coronavirus Infection
COVID-19 Virus Infection
SARS Coronavirus 2 Infection
SARS-CoV-2 Infection
Respiratory Distress Syndrome, Adult
This trial will study the use of USB002 given as an intravenous infusion in patients with
respiratory distress due to infection with COVID-19. expand
This trial will study the use of USB002 given as an intravenous infusion in patients with respiratory distress due to infection with COVID-19. Type: Interventional Start Date: Jul 2021 |
COVID19 SARS Vaccinations: Systemic Allergic Reactions to SARS-CoV-2 Vaccinations
National Institute of Allergy and Infectious Diseases (NIAID)
SARS-CoV Infection
COVID-19
Allergic Reaction
Mast Cell Disorder
Background: Allergic reactions have been reported to occur after vaccination with both
the Pfizer-BioNTech COVID-19 Vaccine and Moderna COVID-19 Vaccine. Allergic reactions
range from mild to severe and include life- threatening anaphylactic reactions, although
no deaths have been reported with either... expand
Background: Allergic reactions have been reported to occur after vaccination with both the Pfizer-BioNTech COVID-19 Vaccine and Moderna COVID-19 Vaccine. Allergic reactions range from mild to severe and include life- threatening anaphylactic reactions, although no deaths have been reported with either vaccine. This study is designed with two principal aims: - To estimate the proportions of systemic allergic reactions to the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine in a High-Allergy/Mast Cell Disorder (HA/MCD) population, and - If the risk in the HA/MCD is demonstrable, to determine whether the proportions are higher in the HA/MCD in comparison to a representative population without severe allergies or mast cell disorders Type: Interventional Start Date: Apr 2021 |
COVID-19 Vaccines International Pregnancy Exposure Registry
Pregistry
Covid19
The objective of the COVID-19 Vaccines International Pregnancy Exposure Registry
(C-VIPER) is to evaluate obstetric, neonatal, and infant outcomes among women vaccinated
during pregnancy with a COVID-19 vaccine.
Specifically, the C-VIPER will estimate the risk of obstetric outcomes (spontaneous
abortion,... expand
The objective of the COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER) is to evaluate obstetric, neonatal, and infant outcomes among women vaccinated during pregnancy with a COVID-19 vaccine. Specifically, the C-VIPER will estimate the risk of obstetric outcomes (spontaneous abortion, antenatal bleeding, gestational diabetes, gestational hypertension, intrauterine growth restriction, postpartum hemorrhage, fetal distress, uterine rupture, placenta previa, chorioamnionitis, Caesarean delivery, COVID-19), neonatal outcomes (major congenital malformations, low birth weight, neonatal death, neonatal encephalopathy, neonatal infections, neonatal acute kidney injury, preterm birth, respiratory distress in the newborn, small for gestational age, stillbirth, COVID-19), and infant outcomes (developmental milestones [motor, cognitive, language, social-emotional, and mental health skills], height, weight, failure to thrive, medical conditions during the first 12 months of life, COVID-19) among pregnant women exposed to single (homologous) or mixed (heterologous) COVID-19 vaccine brand series from 30 days prior to the first day of the last menstrual period to end of pregnancy and their offspring relative to a matched reference group who received no COVID-19 vaccines during pregnancy. Type: Observational [Patient Registry] Start Date: Jun 2021 |
COVID-19 Watch + COVID-19 Pulse
University of Pennsylvania
Covid19
The clinical guidance for 90 percent of infected COVID-19 adult patients who do not meet
eligibility for inpatient admission is to self-isolate. To support these patients,
alternatives to in-person care are needed to manage an unpredictable clinical course;
identify and intercept patients rapidly... expand
The clinical guidance for 90 percent of infected COVID-19 adult patients who do not meet eligibility for inpatient admission is to self-isolate. To support these patients, alternatives to in-person care are needed to manage an unpredictable clinical course; identify and intercept patients rapidly deteriorating at home, prevent viral spread during in-person visits; and minimize future surges in emergency departments (EDs). In addition, fingertip pulse oximeters have been proposed to improve in-home early detection of respiratory deteriorations but are untested and the operational infrastructure to support large-scale monitoring is limited. While telemedicine has been widely adopted during the pandemic as an alternative to conventional outpatient care, limited telemedicine access may be exacerbating observed disparities for Black and Latino patients. In our health system, Black and Latino patients used video-visits 15 percent less often than white patients. Text messaging and phone calls may improve healthcare access for communities of color, but the evidence for these telecommunication modalities to be effective and improve equity are limited. The University of Pennsylvania Health System (UPHS) developed and deployed COVID Watch to improve access to health care for COVID-19 patients who are self-isolating at home. COVID Watch sends twice-daily, scheduled text messages to assess patients for shortness of breath using a clinical algorithm to determine whether patients need an urgent escalation to a team of dedicated, on-call nurses within one hour. These nurses are supported by an on-call team of clinicians who can conduct urgent phone or video assessments. Patients can also trigger the algorithmic assessment independent of the scheduled messages. As of May 21, 2020, COVID Watch has managed 3,628 COVID-19 patients at home, of which 1,295 are confirmed COVID-19 positive; of these, 61 percent are Black or Latino, higher than the proportion of all UPHS COVID-19 positive patients that are Black or Latino (55 percent). Type: Interventional Start Date: Nov 2020 |
In-Utero Vascular Accidents in Neonates From COVID-19 Infected Mothers
University of Colorado, Denver
Pregnancy Related
COVID
Intestinal Atresia
Limb Anomaly
The pregnancy related pro-thrombotic state, in addition to the COVID-19 associated
hypercoagulability may have unknown consequences to the developing fetus. Hence, this
proposal seeks to address this question that may have important implications for women
that contract this virus during gestation. expand
The pregnancy related pro-thrombotic state, in addition to the COVID-19 associated hypercoagulability may have unknown consequences to the developing fetus. Hence, this proposal seeks to address this question that may have important implications for women that contract this virus during gestation. Type: Observational [Patient Registry] Start Date: Aug 2020 |
Narrative Intervention for Long COVID-19 (NICO)
University of Colorado, Denver
Long COVID
Long Covid19
This T1 proof of concept trial is designed to test the Narrative Intervention for Long
COVID-19 intervention. expand
This T1 proof of concept trial is designed to test the Narrative Intervention for Long COVID-19 intervention. Type: Interventional Start Date: Oct 2022 |
Comparative Immunogenicity of Concomitant vs Sequential mRNA COVID-19 and Influenza Vaccinations
Duke University
Influenza
COVID-19
This is a prospective, randomized randomized immunologic study of response to influenza
and SARS-CoV-2 vaccination across four of the US Influenza Vaccine Effectiveness (Flu VE)
Network study sites. expand
This is a prospective, randomized randomized immunologic study of response to influenza and SARS-CoV-2 vaccination across four of the US Influenza Vaccine Effectiveness (Flu VE) Network study sites. Type: Interventional Start Date: Sep 2023 |
Supplemental Citicoline Administration to Reduce Lung Injury Efficacy Trial (SCARLET)
Ohio State University
COVID-19
The goal of this single center, double-blinded, placebo-controlled, and randomized Phase
1 trial is to determine if i.v. citicoline is safe and efficacious compared to i.v.
saline/control in adults presenting with SARS CoV-2 infection complicated by acute
hypoxemic respiratory failure. The main questions... expand
The goal of this single center, double-blinded, placebo-controlled, and randomized Phase 1 trial is to determine if i.v. citicoline is safe and efficacious compared to i.v. saline/control in adults presenting with SARS CoV-2 infection complicated by acute hypoxemic respiratory failure. The main questions it aims to answer: - Is citicoline safe in this patient population? - Does citicoline have a benefit in terms of improving oxygenation? - Does citicoline reduce overall severity of illness as reflected by standardized scales. Patients will be assigned to i.v. treatment with citicoline or saline twice daily for 5 consecutive days. SpO2/FiO2 ratios will be recorded daily as per standard clinical practice to compare citicoline treatments at three different doses to placebo. Type: Interventional Start Date: Jun 2023 |
Butterfly - Clinical Performance Study
Thermo Fisher Scientific, Inc
COVID-19
Coronavirus Infections
This prospective clinical performance study is a non-interventional, multi-center study
to evaluate the assay performance of the COVID-19 test using upper respiratory specimens.
Prospectively collected nasopharyngeal and anterior nasal swabs will be collected from
each participant recruited in the... expand
This prospective clinical performance study is a non-interventional, multi-center study to evaluate the assay performance of the COVID-19 test using upper respiratory specimens. Prospectively collected nasopharyngeal and anterior nasal swabs will be collected from each participant recruited in the study. Type: Observational Start Date: Apr 2023 |
Effect of Lithium Therapy on Long COVID Symptoms
State University of New York at Buffalo
Long COVID
This study will assess low-dose lithium's effects on several different symptoms
experienced by long COVID patients. expand
This study will assess low-dose lithium's effects on several different symptoms experienced by long COVID patients. Type: Interventional Start Date: Nov 2022 |
Stellate Ganglion Block for COVID-19-Induced Olfactory Dysfunction
Washington University School of Medicine
Anosmia
Hyposmia
Parosmia
Olfactory Disorder
Chronic olfactory dysfunction from the COVID-19 pandemic is a growing public health
crisis with up to 1.2 million people in the Unites States affected. Olfactory dysfunction
impacts one's quality of life significantly by decreasing the enjoyment of foods,
creating environmental safety concerns, and... expand
Chronic olfactory dysfunction from the COVID-19 pandemic is a growing public health crisis with up to 1.2 million people in the Unites States affected. Olfactory dysfunction impacts one's quality of life significantly by decreasing the enjoyment of foods, creating environmental safety concerns, and affecting one's ability to perform certain jobs. Olfactory dysfunction is also an independent predictor of anxiety, depression, and even mortality. While the pandemic has increased the interest by the scientific community in combating the burgeoning health crisis, few effective treatments currently exist for olfactory dysfunction. Furthermore, patients impacted by "long COVID," or chronic symptoms after an acute COVID-19 infection, experience impairments other than olfactory and gustatory dysfunction, such as chronic dyspnea, impaired memory and concentration, and severe fatigue. These symptoms have been hypothesized to be a result of sympathetic positive feedback loops and dysautonomia. Stellate ganglion blocks have been proposed to treat this hyper-sympathetic activation by blocking the sympathetic neuronal firing and resetting the balance of the autonomic nervous system. Studies prior to the COVID-19 pandemic have supported a beneficial effect of stellate ganglion blocks on olfactory dysfunction, and recent news reports and a published case series have described a dramatic benefit in both olfactory function and other long COVID symptoms in patients receiving stellate ganglion blocks. Therefore, we propose a single cohort prospective study to generate pilot data on the efficacy and safety of sequential stellate ganglion blocks for the treatment of COVID-19-induced olfactory dysfunction and other long COVID symptoms. Type: Interventional Start Date: Sep 2022 |
ABNCoV2 Vaccine in Adult Subjects Previously Vaccinated for SARS-CoV-2
Bavarian Nordic
COVID-19 Disease
This trial is composed of a randomized, double-blind, active controlled component (Part
A) and an open-label, single-arm component (Part B) conducted in parallel.
Part A is designed to compare vaccination with a single 100 µg dose of ABNCoV2 to a
single 30 µg adult booster dose of Comirnaty (active... expand
This trial is composed of a randomized, double-blind, active controlled component (Part A) and an open-label, single-arm component (Part B) conducted in parallel. Part A is designed to compare vaccination with a single 100 µg dose of ABNCoV2 to a single 30 µg adult booster dose of Comirnaty (active control) in adult subjects who either previously completed primary vaccination (Cohort 1) or have already received 1 booster dose (Cohort 2) of SARS-CoV-2 locally authorized vaccine(s), and whose last locally authorized SARS-CoV-2 vaccination was at least 3 months prior to the screening visit. Subjects will be randomized in a 1:1 ratio to receive either ABNCoV2 or Comirnaty. Part B is designed to collect ABNCoV2 safety and tolerability data from a larger population of adult subjects, as well as additional immunogenicity data from a subset. Part B involves vaccination with the same single 100 µg dose of ABNCoV2 in the same population of adult subjects as the randomized component, and subjects will similarly be enrolled into 2 cohorts according to whether they have completed primary vaccination only or primary plus booster vaccination. Type: Interventional Start Date: Aug 2022 |
PF-07321332/Ritonavir and Ritonavir on Dabigatran Study in Healthy Participants
Pfizer
Healthy Participants
This is a drug-drug interaction study to assess the effects of PF-07321332/ritonavir and
ritonavir on the Pharmacokinetic (PK) of dabigatran in healthy volunteers. PK will be
evaluated for PF-07321332 and ritonavir. Dabigatran is being utilized as a P-gp substrate expand
This is a drug-drug interaction study to assess the effects of PF-07321332/ritonavir and ritonavir on the Pharmacokinetic (PK) of dabigatran in healthy volunteers. PK will be evaluated for PF-07321332 and ritonavir. Dabigatran is being utilized as a P-gp substrate Type: Interventional Start Date: Sep 2021 |
Developing and Testing a COVID-19 Vaccination Acceptance Intervention
VA Office of Research and Development
COVID-19 Vaccination
The COVID-19 pandemic has resulted in significant loss of life and suffering with total
case and death counts increasing daily, particularly with the emergence of the delta
variant. COVID-19 vaccines have proven highly effective in preventing severe illness,
hospitalization, and death. Nevertheless,... expand
The COVID-19 pandemic has resulted in significant loss of life and suffering with total case and death counts increasing daily, particularly with the emergence of the delta variant. COVID-19 vaccines have proven highly effective in preventing severe illness, hospitalization, and death. Nevertheless, according to VA data sources, only 56% of all U.S. Veterans have been vaccinated to date, largely owing to vaccine hesitancy and lack of access to vaccination. Thus, there is a critical need for evidence-based interventions to increase COVID-19 vaccine acceptance and access among Veterans, many of whom are vulnerable to poor outcomes of COVID-19. The overall goal of this study is to increase COVID-19 vaccination in Veterans of VISNs 16 and 21 who remain unvaccinated either because of vaccine hesitancy or lack of access to COVID-19 vaccine. Specifically, the investigators will test a COVID-19 Vaccine Acceptance Intervention (Motivational Interviewing) plus Implementation Facilitation. Type: Interventional Start Date: Apr 2022 |
Michigan Medicine COVID-19 Cohort: Clinical Characteristics, Inflammatory Markers and Outcomes of Patients...
University of Michigan
Covid19
Kidney Diseases
Inflammation
SARS-CoV Infection
To better understand the role of inflammation in COVID-19, we established the Michigan
Medicine COVID-19 Cohort (M2C2). M2C2 is a funded and ongoing cohort which has currently
enrolled over 1500 adult patients (≥18 years) with severe COVID-19 admitted at the
University of Michigan. The purpose of... expand
To better understand the role of inflammation in COVID-19, we established the Michigan Medicine COVID-19 Cohort (M2C2). M2C2 is a funded and ongoing cohort which has currently enrolled over 1500 adult patients (≥18 years) with severe COVID-19 admitted at the University of Michigan. The purpose of M2C2 is to define the in-hospital course of these patients and understand the role of inflammation as a determinant of organ injury and outcomes in COVID-19. Type: Observational Start Date: Mar 2020 |
Use of Combined Prone Positioning and High-Flow Nasal Cannula, and Non-invasive Positive Pressure Ventilation...
Mayo Clinic
Prone Positioning
Covid19
Hypoxemic Respiratory Failure
ARDS
Non Invasive Ventilation
This research aims to understand if prone positioning combined with high-flow nasal
cannula (HFNC) or non-invasive positive pressure ventilation (NIPPV) safely reduce the
rate of intubation in acute hypoxemic and/or hypercapnic respiratory failure secondary to
COVID-19 infection. expand
This research aims to understand if prone positioning combined with high-flow nasal cannula (HFNC) or non-invasive positive pressure ventilation (NIPPV) safely reduce the rate of intubation in acute hypoxemic and/or hypercapnic respiratory failure secondary to COVID-19 infection. Type: Interventional Start Date: May 2020 |
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