Search Clinical Trials
Sponsor Condition of Interest |
---|
Evaluating the Efficacy of Hydroxychloroquine and Azithromycin to Prevent Hospitalization or Death in...
National Institute of Allergy and Infectious Diseases (NIAID)
COVID-19
SARS-CoV 2
The purpose of this study was to evaluate the efficacy of hydroxychloroquine (HCQ) and
azithromycin (Azithro) to prevent hospitalization or death in symptomatic adult
outpatients with COVID-19 caused by SARS-CoV-2 infection. expand
The purpose of this study was to evaluate the efficacy of hydroxychloroquine (HCQ) and azithromycin (Azithro) to prevent hospitalization or death in symptomatic adult outpatients with COVID-19 caused by SARS-CoV-2 infection. Type: Interventional Start Date: May 2020 |
PATCH 2&3:Prevention & Treatment of COVID-19 (Severe Acute Respiratory Syndrome Coronavirus 2) With Hydroxychloroquine
UnitedHealth Group
Coronavirus
Corona Virus Infection
The proposed hypothesis is that high doses of hydroxychloroquine (HCQ) for at least 2
weeks can be effective antiviral medication both as a treatment in ambulatory patients
and prophylaxis/treatment in health care workers because it impairs lysosomal function
and reorganizes lipid raft (cholesterol... expand
The proposed hypothesis is that high doses of hydroxychloroquine (HCQ) for at least 2 weeks can be effective antiviral medication both as a treatment in ambulatory patients and prophylaxis/treatment in health care workers because it impairs lysosomal function and reorganizes lipid raft (cholesterol and sphingolipid rich microdomains in the plasma membrane) content in cells, which are both critical determinants of Emerging Viral Disease (EVD) infection. This hypothesis is based on a growing literature linking chloroquine to antiviral activity. It is estimated that enough information exists to launch a clinical trial of hydroxychloroquine for COVID-19. Type: Interventional Start Date: Apr 2020 |
Nebulized Heparin for the Treatment of COVID-19
Frederick Health
Covid19
Pneumonia, Viral
Randomized, placebo controlled study to determine if nebulized heparin may reduce the
need for mechanical ventilation in hospitalized patients with the novel coronavirus, also
known as COVID-19. This will be a part of a larger meta-trial. expand
Randomized, placebo controlled study to determine if nebulized heparin may reduce the need for mechanical ventilation in hospitalized patients with the novel coronavirus, also known as COVID-19. This will be a part of a larger meta-trial. Type: Interventional Start Date: Feb 2021 |
ACTIV-5 / Big Effect Trial (BET-A) for the Treatment of COVID-19
National Institute of Allergy and Infectious Diseases (NIAID)
COVID-19
This is a platform trial to conduct a series of randomized, double-blind,
placebo-controlled trials using common assessments and endpoints in hospitalized adults
diagnosed with Coronavirus Disease 2019 (COVID-19). Big Effect Trial (BET) is a
proof-of-concept study with the intent of identifying promising... expand
This is a platform trial to conduct a series of randomized, double-blind, placebo-controlled trials using common assessments and endpoints in hospitalized adults diagnosed with Coronavirus Disease 2019 (COVID-19). Big Effect Trial (BET) is a proof-of-concept study with the intent of identifying promising treatments to enter a more definitive study. The study will be conducted in up to 70 domestic sites and 5 international sites. The study will compare different investigational therapeutic agents to a common control arm and determine which have relatively large effects. In order to maintain the double blind, each intervention will have a matched placebo. However, the control arm will be shared between interventions and may include participants receiving the matched placebo for a different intervention. The goal is not to determine clear statistical significance for an intervention, but rather to determine which products have clinical data suggestive of efficacy and should be moved quickly into larger studies. Estimates produced from BET will provide an improved basis for designing the larger trial, in terms of sample size and endpoint selection. Products with little indication of efficacy will be dropped on the basis of interim evaluations. In addition, some interventions may be discontinued on the basis of interim futility or efficacy analyses. One or more interventions may be started at any time. The number of interventions enrolling are programmatic decisions and will be based on the number of sites and the pace of enrollment. At the time of enrollment, subjects will be randomized to receive any one of the active arms they are eligible for or placebo. Approximately 200 (100 treatment and 100 shared placebo) subjects will be assigned to each arm entering the platform and a given site will generally have no more than 3 interventions at once. The BET-A stage will evaluate the combination of remdesivir with risankizumab vs remdesivir with a risankizumab placebo. The primary objective is to evaluate the clinical efficacy of different investigational therapeutics relative to the control arm in adults hospitalized with COVID-19 according to clinical status (8-point ordinal scale) at Day 8. Type: Interventional Start Date: Oct 2020 |
COVID-19-Related Health and Practices Among Dental Hygienists
American Dental Association
SARS-CoV Infection
Anxiety
Depression
Occupational Problems
Severe Acute Respiratory Syndrome
As dental practices reopen their practices during a global pandemic, the risk of 2019
novel coronavirus (COVID-19) infection that dental hygienists face in providing dental
care remains unknown. Estimating the occupational risk of COVID-19, and producing
evidence on the types of infection control... expand
As dental practices reopen their practices during a global pandemic, the risk of 2019 novel coronavirus (COVID-19) infection that dental hygienists face in providing dental care remains unknown. Estimating the occupational risk of COVID-19, and producing evidence on the types of infection control practices and dental practices that may affect COVID-19 risk, is therefore imperative. These findings could be used to describe the prevalence and incidence of COVID-19 among dental hygienists, determine what infection control steps dental hygienists take over time, describe dental hygienists' employment during the COVID-19 pandemic, and estimate whether infection control adherence in dental practice is related to COVID-19 incidence. Type: Observational Start Date: Sep 2020 |
Describing Chinese Herbal Medicine Telehealth Care for Symptoms Related to Infectious Diseases Such as...
Center for Integrated Care
Coronavirus Infection
The purpose of the study is to design and execute a prospective, longitudinal,
descriptive cohort study in a pragmatic clinical practice for adults with symptoms that
may be related to COVID-19. expand
The purpose of the study is to design and execute a prospective, longitudinal, descriptive cohort study in a pragmatic clinical practice for adults with symptoms that may be related to COVID-19. Type: Observational Start Date: May 2020 |
MultiStem Administration for COVID-19 Induced ARDS (MACoVIA)
Healios K.K.
ARDS
Multicenter investigation featuring an open-label lead-in followed by a double blinded,
randomized, placebo-controlled Phase 2/3 part to evaluate the safety and efficacy of
MultiStem therapy in subjects with moderate to severe Acute Respiratory Distress Syndrome
(ARDS) due to pathogens including COVID-19. expand
Multicenter investigation featuring an open-label lead-in followed by a double blinded, randomized, placebo-controlled Phase 2/3 part to evaluate the safety and efficacy of MultiStem therapy in subjects with moderate to severe Acute Respiratory Distress Syndrome (ARDS) due to pathogens including COVID-19. Type: Interventional Start Date: Apr 2020 |
MGUS, SMM, and MM Patient Experience With Coronavirus 19 (COVID-19) Survey
HealthTree Foundation
Multiple Myeloma
Smoldering Multiple Myeloma
Monoclonal Gammopathy of Undetermined Significance
Coronavirus
The purpose of this study is to examine how patients with multiple myeloma (MM) have been
impacted by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic.
The study will use a questionnaire to further understand how patients are being affected
and gather information in order... expand
The purpose of this study is to examine how patients with multiple myeloma (MM) have been impacted by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. The study will use a questionnaire to further understand how patients are being affected and gather information in order to track the long-term effects of the coronavirus. The scope of the questionnaire will include, COVID-19 diagnosis and treatment, changes in myeloma treatment and care, clinical trial familiarity, health and fitness, and quality of life. This questionnaire is a follow-on to the "MM and COVID-19" questionnaire. Type: Observational Start Date: Jan 2021 |
Study to Assess Adverse Events and How Intravenous (IV) ABBV-47D11 and IV ABBV-2B04 Given Alone and in...
AbbVie
CoronaVirus Disease-2019 (COVID-19)
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2). Lung failure is the main cause of death
related to COVID-19 infection. The main objective of this study is to evaluate the safety
and tolerability of ABBV-47D11 and... expand
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Lung failure is the main cause of death related to COVID-19 infection. The main objective of this study is to evaluate the safety and tolerability of ABBV-47D11 and ABBV-2B04 given alone and in combination to participants with COVID-19 infection. In addition, this study will evaluate the pharmacokinetics (how the body handles the study drug) and anti-viral activity of the study drug. ABBV-47D11 and ABBV-2B04 are investigational anti-SARS-CoV-2 monoclonal antibodies being developed for the treatment of COVID-19. Study will be conducted in two parts. In part A, participants will receive ABBV-47D11 or placebo. There is a 1 in 4 chance that participants will be assigned to placebo. In part B, participants will receive ABBV-2B04 alone or in combination with ABBV-47D11 or placebo. There is a 1 in 5 chance that participants will be assigned to placebo. Around 54 adult participants with COVID-19 will be enrolled in approximately 10 to 30 sites globally. In part A participants will receive single intravenous (into the veins) infusion of ABBV-47D11 or placebo on Day 1. In part B participants will receive single intravenous (into the veins) infusion of ABBV-2B04 alone or in combination with ABBV-47D11 or placebo on Day 1. Participants will be followed up for 106 days. There may be higher treatment burden for participants in this trial compared to their standard of care. The effect of the treatment will be checked by medical assessments, blood tests, nasal swabs and presence of side effects. Type: Interventional Start Date: Dec 2020 |
Self-Collected Saliva Samples Without Viral Transport Media for COVID-19 Testing Via RT-PCR
David Grant U.S. Air Force Medical Center
SARS-CoV Infection
Polymerase Chain Reaction
Laboratory Testing
This is a study that will attempt to validate the process for detecting SARS-CoV-2
(COVID19) on a non-FDA-approved technology using self-collected saliva as the specimen.
Investigators will compare self-collected saliva samples and healthcare-worker collected
nasopharyngeal samples (Nasal swabs) to... expand
This is a study that will attempt to validate the process for detecting SARS-CoV-2 (COVID19) on a non-FDA-approved technology using self-collected saliva as the specimen. Investigators will compare self-collected saliva samples and healthcare-worker collected nasopharyngeal samples (Nasal swabs) to see if the self-collected saliva samples are similar in terms of diagnostic accuracy. Investigators will be performing this testing at the site where patients regularly go for COVID19 testing. There will be minimal risk of harm as consenting patients will only have to provide a small amount of saliva into a tube. Type: Interventional Start Date: Feb 2021 |
A Clinical Study to Assess the Physiologic Effects of KB109 in Patients With COVID-19 on Gut Microbiota...
Kaleido Biosciences
Mild-to-Moderate COVID-19
This exploratory, open-label clinical study aims to explore the physiologic effects of
KB109, a novel glycan, on adult patients with COVID-19 illness on gut microbiota
structure and function in the outpatient setting. expand
This exploratory, open-label clinical study aims to explore the physiologic effects of KB109, a novel glycan, on adult patients with COVID-19 illness on gut microbiota structure and function in the outpatient setting. Type: Interventional Start Date: Jan 2021 |
A Clinical Study to Assess the Natural History of COVID-19 and Effects of KB109 and Supportive Self-care...
Kaleido Biosciences
Mild-to-moderate COVID-19
This randomized, open-label, prospective, parallel-group controlled clinical study that
aims to explore the natural history of COVID-19 illness and the safety of KB109, a novel
glycan, plus SSC versus SSC alone and measures of health in outpatients with
mild-to-moderate COVID-19. expand
This randomized, open-label, prospective, parallel-group controlled clinical study that aims to explore the natural history of COVID-19 illness and the safety of KB109, a novel glycan, plus SSC versus SSC alone and measures of health in outpatients with mild-to-moderate COVID-19. Type: Interventional Start Date: Aug 2020 |
Study of the Safety of Therapeutic Treatment With an Immunomodulatory Agent (N-803) in Adults With COVID-19
ImmunityBio, Inc.
COVID-19
This is a phase 1b, randomized, blinded, placebo-controlled study in adult subjects with
COVID-19. This clinical trial is designed to assess the safety and immunostimulatory
activity of N-803. expand
This is a phase 1b, randomized, blinded, placebo-controlled study in adult subjects with COVID-19. This clinical trial is designed to assess the safety and immunostimulatory activity of N-803. Type: Interventional Start Date: Jul 2020 |
Building Resiliency and Vital Equity (BRAVE) Project: Understanding Native Americans' Perceptions/Beliefs...
North Carolina Central University
Covid19 Virus Infection
The Building Resilience and Vital Equity (BRAVE) project seeks to partner with American
Indian tribal communities in North Carolina to establish COVID-19 services and resources
for American Indian communities. The goal of this study is to 1) understand the barriers
and social implications of COVID19... expand
The Building Resilience and Vital Equity (BRAVE) project seeks to partner with American Indian tribal communities in North Carolina to establish COVID-19 services and resources for American Indian communities. The goal of this study is to 1) understand the barriers and social implications of COVID19 testing and vaccination among American Indians by designing and implementing culturally sensitive survey tools and intervention materials; 2) Implement BRAVE outreach and testing interventions to increase testing in American Indian communities; 3) analyze data and share back with tribal communities to improve perceptions of COVID-19 testing in the AI community and decrease in vaccine hesitancy. Type: Interventional Start Date: Feb 2021 |
Apple Respiratory Study
Apple Inc.
Acute Respiratory Infection
Coronavirus Infection
Influenza
The Apple Respiratory Study, a collaboration between researchers at Apple Inc. (the
"Study Sponsor" or "Sponsor") and the Seattle Flu Study team at the University of
Washington (UW) (the "UW Study Team"), is a prospective, longitudinal cohort, low risk
Study to collect certain data from Apple Watch... expand
The Apple Respiratory Study, a collaboration between researchers at Apple Inc. (the "Study Sponsor" or "Sponsor") and the Seattle Flu Study team at the University of Washington (UW) (the "UW Study Team"), is a prospective, longitudinal cohort, low risk Study to collect certain data from Apple Watch and iPhone to determine whether such data can detect physiologic and non-physiologic changes in individuals associated with respiratory illnesses due to influenza, SARS-CoV-2 and other respiratory pathogens (the "Study"). Type: Observational Start Date: Apr 2021 |
Humoral and T-Cell Responses to COVID-19 Vaccination in Multiple Sclerosis Patients Treated With Ocrelizumab...
Dragonfly Research, LLC
Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
The primary goal of this study is to provide additional data regarding B and T-cell
mediated responses to COVID-19 vaccines in MS patients treated with OCR and to determine
which clinical and paraclinical variables correlating with vaccine immunogenicity. B-cell
mediated humoral responses and adaptive... expand
The primary goal of this study is to provide additional data regarding B and T-cell mediated responses to COVID-19 vaccines in MS patients treated with OCR and to determine which clinical and paraclinical variables correlating with vaccine immunogenicity. B-cell mediated humoral responses and adaptive T-cell mediated cellular responses were measured in patients treated with OCR who received any of the available SARS-CoV-2 vaccines, 3-4 weeks after completion of vaccination. Type: Observational Start Date: Mar 2021 |
Self-Help for Stress Related to COVID-19
Penn State University
Stress
This is a study on internet-based self-help for stress related to the COVID-19 pandemic.
College and university students who score in the moderate or higher range on a stress
measure during the COVID-19 pandemic will be invited to participate in this study.
Participants will be randomly assigned to... expand
This is a study on internet-based self-help for stress related to the COVID-19 pandemic. College and university students who score in the moderate or higher range on a stress measure during the COVID-19 pandemic will be invited to participate in this study. Participants will be randomly assigned to receive access to an internet-based self-help program for stress resilience and coping with the COVID-19 pandemic or care as usual. Stress and psychosocial symptoms will be assessed via questionnaire at baseline (pre-randomization), one month post-randomization, and three months post-randomization. Type: Interventional Start Date: Nov 2020 |
Characterizing the Perioperative Epidemiology of SARS-CoV-2 (COVID-19) Spread for Quality Improvement...
Randy Loftus
COVID-19
In a case-series analysis, up to 20 patients undergoing elective or urgent/emergent
surgery that are COVID-19 positive will be approached for patient consent.
OR PathTrac (RDB Bioinformatics, Omaha, NE 68154) collection kits will be utilized for
sampling of 48 sampled time/locations per patient.... expand
In a case-series analysis, up to 20 patients undergoing elective or urgent/emergent surgery that are COVID-19 positive will be approached for patient consent. OR PathTrac (RDB Bioinformatics, Omaha, NE 68154) collection kits will be utilized for sampling of 48 sampled time/locations per patient. Patient sampling locations will include the nasopharynx and oropharynx. Operating room environmental locations will include areas in the patient care arena such as the anesthesia machine. Samples of each location will be obtained before and after treatment with UV-C (Helios, Surfacide), germicidal, ultraviolet light and other infection control practices that are currently in place, such as utilization of preoperative chlorhexidine wipes, nasal iodine, improved hand hygiene, and improved vascular care. UV-C light for environmental cleaning is not regulated by the FDA. Samples will be processed by RT-PCR for presence of SARS-CoV-2 nucleic acid. Positive samples will be sent to Dr. Stanley Perlman's lab to assess viability. Samples will also be assessed for S. aureus as a process control. We will characterize the epidemiology of perioperative SARS-CoV-2 spread as a quality improvement initiative to improve our current perioperative infection control bundle and to serve as the platform for national dissemination of a perioperative COVID-19 defense strategy. Type: Observational Start Date: Jul 2020 |
COVID-19 Health Messaging to Underserved Communities
National Bureau of Economic Research, Inc.
Coronavirus
Recent data have shown that covid19 is disproportionately infecting and killing African
Americans and Latinx people in the United States. The aim of the study is to determine
which messages are most effective at increasing knowledge and changing behaviors that can
protect individuals and their communities... expand
Recent data have shown that covid19 is disproportionately infecting and killing African Americans and Latinx people in the United States. The aim of the study is to determine which messages are most effective at increasing knowledge and changing behaviors that can protect individuals and their communities from the virus. To accomplish this aim, we plan to recruit approximately 20,000 Hispanic and African-American individuals and randomly assign them to videos that vary either the sender or the framing of the message, while providing the relevant public health information. Type: Interventional Start Date: May 2020 |
Efficacy of Tocilizumab on Patients With COVID-19
Massachusetts General Hospital
SARS-CoV 2
This is a randomized, double blind, multi-center study to evaluate the effects of
tocilizumab compared to placebo on patient outcomes in participants with confirmed
SARS-CoV-2 infection and evidence of systemic inflammation.
The aim of this study is to test the effect of Tocilizumab on multi-organ... expand
This is a randomized, double blind, multi-center study to evaluate the effects of tocilizumab compared to placebo on patient outcomes in participants with confirmed SARS-CoV-2 infection and evidence of systemic inflammation. The aim of this study is to test the effect of Tocilizumab on multi-organ dysfunction in a phase 3 randomized controlled trial among hospitalized patients with COVID-19 infection. Specifically, as compared to placebo, we will test whether tocilizumab is associated with a reduction in multi-organ dysfunction among hospitalized COVID-19 adult patients with elevated inflammatory measures. Multi-organ dysfunction will be measured as the incidence of the following composite endpoint (mechanical ventilation, renal replacement therapy, mechanical support, need for inotropes or vasopressors, liver dysfunction (increased bilirubin), and all-cause mortality). We will also assess multiple pre-specified secondary (exploratory) endpoints and safety endpoints. We hypothesize that, as compared to placebo, tocilizumab will reduce transfer to the ICU, need for mechanical ventilation, increase rates of hospital discharge in patients diagnosed with severe COVID-19 infection and evidence of exaggerated inflammatory response. Type: Interventional Start Date: Apr 2020 |
A Study of Auxora in Patients With Severe COVID-19 Pneumonia
CalciMedica, Inc.
Pneumonia
Part 1 of this trial enrolled 30 patients to receive Auxora (formerly CM4620) in a 2:1
randomized, open label trial of patients with severe and critical COVID-19 pneumonia.
Part 2 will consist of a randomized, double blind, placebo-controlled (RCT) study that
will evaluate efficacy, safety, and the... expand
Part 1 of this trial enrolled 30 patients to receive Auxora (formerly CM4620) in a 2:1 randomized, open label trial of patients with severe and critical COVID-19 pneumonia. Part 2 will consist of a randomized, double blind, placebo-controlled (RCT) study that will evaluate efficacy, safety, and the pharmacokinetic profile of Auxora in patients with severe COVID-19 pneumonia. The number of patients with an imputed PaO2/FiO2 >200 randomized into the study will be capped at 26. 320 patients with a PaO2/FiO2 ≤200 will be enrolled. Patients with an estimated PaO2/FiO2 of 75-200 will be stratified to ensure balanced randomization between the Auxora and placebo arms. Subgroup analyses will be performed to explore how time to recovery is influenced by baseline variables and to evaluate the treatment effect at different levels of each of these variables. The dose of Auxora will be 2.0 mg/kg (1.25 mL/kg) administered at 0 hour, and then 1.6 mg/kg (1 mL/kg) at 24 hours and 1.6 mg/kg (1 mL/kg) at 48 hours from the SFISD. The dose of placebo will be 1.25 mL/kg administered at 0 hour and then 1 mL/kg at 24 hours and 1 mL/kg at 48 hours from the SFISD. Remdesivir, corticosteroids and convalescent plasma will be allowed. The infusion of Auxora will start within 12 hours from the time the patient or LAR provides informed consent. Efficacy analyses will be presented by treatment group (Auxora vs Placebo) based on the Efficacy Analysis Set of the imputed PaO2/FiO2 ≤200 subgroup, except where it is specified otherwise. The statistical analysis approach will be designed to assess the significance of the primary and first secondary endpoint using the Benjamini and Hochberg method to control the overall trial level alpha level. Type: Interventional Start Date: Apr 2020 |
Methylation Effects of COV-19 Infection and Vaccinations
TruDiagnostic
Covid19
This is a retrospective non-randomized clinical study of 60 patients total to assess the
effects of SARS-CoV-2 infection and the SARS-CoV-2 vaccination. This study will have 2
arms evaluating the epigenomes of patients pre and post-exposure to one of the
interventions. The first arm of the study will... expand
This is a retrospective non-randomized clinical study of 60 patients total to assess the effects of SARS-CoV-2 infection and the SARS-CoV-2 vaccination. This study will have 2 arms evaluating the epigenomes of patients pre and post-exposure to one of the interventions. The first arm of the study will analyze 40 patients' epigenomes whose DNA methylation was examined pre and post SARS-CoV-2 infection. The second arm of this study is analyzing 20 patients' epigenomes whose DNA methylation was examined pre and post-injection of the SARS-CoV-2 vaccine. Type: Observational Start Date: Mar 2021 |
Critical Care Results of SARS-CoV-2 ARDS by Dapsone and Standard COVID-19 Treatment
Hunt Regional Medical Center
SARS-CoV-2
Hypoxia
ARDS
Abstract Background: Clinicians in pulmonary critical care medicine and critical care
medicine considered dapsone administration to treat SARS-CoV-2 inflammasome. Dapsone is
useful in the molecular regulation of Nod-like receptor family pyrin domain-containing 3
(NLRP3).
Objective: To study the... expand
Abstract Background: Clinicians in pulmonary critical care medicine and critical care medicine considered dapsone administration to treat SARS-CoV-2 inflammasome. Dapsone is useful in the molecular regulation of Nod-like receptor family pyrin domain-containing 3 (NLRP3). Objective: To study the targeting of NLRP3 itself or up-/downstream factors of the NLRP3 inflammasome by dapsone must be responsible for its observed preventive effects, functioning as a competitor. Methods: Patients who were on standard COVID-19 therapy are also after obtaining off label uses and explanation of side effects are started on dapsone 100-200 mg daily along with Cimetadine 400 mg three times daily. Type: Interventional Start Date: Oct 2020 |
Quantification of Binding and Neutralizing Antibody Levels in COVID-19 Vaccinated Health Care Workers...
LifeBridge Health
COVID-19 Vaccine
Corona Virus Infection
Vaccine Adverse Reaction
Vaccine Response
Inflammation
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic presents a
great challenge to global health. The first case was identified in December 2019 in
Wuhan, China and since has infected nearly 100 million people and claimed almost 2
million lives worldwide. In response, the medical... expand
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic presents a great challenge to global health. The first case was identified in December 2019 in Wuhan, China and since has infected nearly 100 million people and claimed almost 2 million lives worldwide. In response, the medical community and scientists have worked hard to develop effective therapies and guidelines to treat a wide range of symptoms including the use of the antiviral drug remdesivir, convalescent plasma, antibiotics, steroids, and anticoagulant therapy. To prevent the spread of the disease, multiple vaccines based on mRNA and DNA technologies that include inactivated viral components have been developed and millions of doses are currently being administered worldwide. Early analysis of data from the phase III Pfizer/BioNTech and Moderna vaccine trials suggested the vaccine was more than 90% effective in preventing the illness with a good safety profile (Polack et al., 2020). However, there are still many unknowns regarding the long-term safety of these newer vaccine technologies and the level and duration of immunogenicity. SARS-CoV-2 infection results in seroconversion and production of anti-SARS-CoV-2 antibodies. The antibodies may suppress viral replication through neutralization but might also participate in COVID-19 pathogenesis through a process termed antibody-dependent enhancement (Lu et al., 2020). Rapid progress has been made in the research of antibody response and therapy in COVID-19 patients, including characterization of the clinical features of antibody responses in different populations infected by SARS-CoV-2, treatment of COVID-19 patients with convalescent plasma and intravenous immunoglobin products, isolation and characterization of a large panel of monoclonal neutralizing antibodies and early clinical testing, as well as clinical results from several COVID-19 vaccine candidates. In this study, we plan to assess the effic of both vaccines on the healthcare workers. As healthcare workers begin to receive their first vaccination dosage, we will start looking for traces of antibodies within the blood and saliva. The data provided will help us determine the efficacy of the vaccine over a period of 1 year, identify any difference in efficacy amongst different populations (gender, age, and ethnicities) differences among vaccine types, demographics and follow-up on any potential side effects. We will collaborate with Nirmidas Biotech Inc. based in Palto Alto, California, a Stanford University spinoff on this project. Nirmidas Biotech. Inc is a young diagnostic company that have received several FDA EUA tests for COVID-19. We will perform IgG/IgM antibody detection by the NIRMIDAS MidaSpot™ COVID-19 Antibody Combo Detection Kit approved by FDA EUA for POC testing in our hospital site for qualitative antibody testing. We will then send dry blood spot and saliva to Nirmidas for the pGOLD™ COVID-19 High Accuracy IgG/IgM Assay to quantify antibody levels and avidity, both of which are important to immunity. The pGOLD assay is a novel nanotechnology assay platform capable of quantifying antibody levels and binding affinity to viruses. We collaborated recently with Nirmidas on this platform and published a joint paper in Nature Biomedical Engineering on COVID-19 Ab pGOLD assay (Liu et al., 2020). It is also capable of detecting antibodies in saliva samples and could offer a non-invasive approach to assessing antibody response for vaccination. Type: Observational Start Date: Jan 2021 |
Non-invasive Biometric Monitoring in Nursing Homes to Fight COVID-19
Health Stream Analytics, LLC
Covid19
Community-Acquired Respiratory Tract Infection
Solving the problem of detecting asymptomatic carriers who can transmit infection is key
to protecting vulnerable residents of nursing homes and assisted living facilities, to
protecting frontline workers who care for them, and to facilitating return to work
(including return of nurses and medical... expand
Solving the problem of detecting asymptomatic carriers who can transmit infection is key to protecting vulnerable residents of nursing homes and assisted living facilities, to protecting frontline workers who care for them, and to facilitating return to work (including return of nurses and medical assistants). The wearable biometric technology, if widely disseminated among vulnerable populations and the community-at-large, will help avoid the ravages of seasonal flu and other contagious illnesses, and the society will be better prepared for future waves of COVID-19 or other pandemics. Even if a vaccine is developed, due to immune senescence and immunocompromise, elderly people and those with chronic medical conditions may not be well protected by it. Continuous biomonitoring provides another layer of protection for them. Type: Observational Start Date: Dec 2020 |
- Previous
- Next