SARS-CoV Infection Clinical Trial
Official title:
A Longitudinal Study of COVID-19 Positive Patients Testing Nasal Swabs and Collecting Blood Samples for Research
NCT number | NCT04327804 |
Other study ID # | 20-002 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 25, 2020 |
Est. completion date | October 10, 2020 |
Verified date | April 2022 |
Source | UnitedHealth Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Minimal risk research study: 1. Comparing polyester nasal swabs and foam nasal swabs to detect SARS-CoV-2 virus; 2. Quantifying the development and trajectory of the disease through clinic visits and blood values.
Status | Completed |
Enrollment | 139 |
Est. completion date | October 10, 2020 |
Est. primary completion date | August 18, 2020 |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Existing patient of the Everett Clinic (i.e., has previously sought care) - Tested positive for SARS-CoV-2 virus (confirmed by RT-PCR) prior to time of enrollment Exclusion Criteria: - Not able to demonstrate understanding of the study - Not able to safely travel to the clinic without endangering themselves or risking exposing others to SARS-CoV-2 - Medical history evidencing any of the following - Active nosebleed in the past 24 hours - Nasal surgery in the past two weeks - Chemotherapy treatment with low platelet and low white blood cell counts - Acute facial trauma - Advanced COVID-19 state that would preclude safe and feasible sample collection |
Country | Name | City | State |
---|---|---|---|
United States | Everett Clinic | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
UnitedHealth Group | Bill and Melinda Gates Foundation, Mayo Clinic, PATH |
United States,
Coronavirus Disease 2019 (COVID-19) in the US. Centers for Disease Control and Prevention, accessed March 24, 2020. https://www.cdc.gov/coronavirus/2019-ncov/cases-in-us.html
Frosch, Dan, et al. "Coronavirus Testing Chaos Across America". Wall Street Journal, March 19, 2020
Padilla, Mariel. " 'It feels like a war zone': Doctors and Nurses Plead for Masks on Social Media". New York Times, March 19, 2020
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Detection of SARS-CoV-2 virus | Measure the agreement between the detection of SARS-CoV-2 virus using a foam nasal swab tested directly after collection, a polyester nasal swab tested directly after testing, and a polyester nasal swab stored at room temperature for four days without saline or VTM before being tested. | 42 days | |
Secondary | Trajectory of COVID-19 and antibody development | Longitudinal blood samples from SARS-CoV-2 patients to gain a better understanding of the trajectory of COVID-19 and antibody development | 2 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04961541 -
Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04546776 -
COVID-19 Persistence in Stool
|
||
Terminated |
NCT04542993 -
Can SARS-CoV-2 Viral Load and COVID-19 Disease Severity be Reduced by Resveratrol-assisted Zinc Therapy
|
Phase 2 | |
Completed |
NCT04542915 -
COVID-19-Related Health and Practices Among Dental Hygienists
|
||
Completed |
NCT05065827 -
Lung Ultrasound Findings in Patients With COVID-19 in a UK ED
|
||
Recruiting |
NCT04615052 -
Home-based Exercise in COVID-19 Survivors
|
N/A | |
Enrolling by invitation |
NCT04659486 -
Adolescents With COVID-19/MIS-C at HCFMUSP
|
N/A | |
Recruiting |
NCT04885452 -
Prevention of COVID-19 Complications in High-risk Subjects Infected by SARS-CoV-2 and Eligible for Treatment Under a Cohort ATU ('Autorisation Temporaire d'Utilisation') OR or Authorisation for Early Access (AAP). A Prospectvie Cohort.
|
||
Completed |
NCT04516928 -
Study of SARS-CoV2 Virus (COVID-19) Seroprevalence Among Lyon-Bron Military Health Schools Personnel
|
||
Completed |
NCT05063812 -
Performance of a Remote Monitoring Program for Patients Diagnosed With COVID-19
|
||
Completed |
NCT04530357 -
Reactogenicity, Safety and Immunogenicity of QazCovid-in® COVID-19 Vaccine
|
Phase 1/Phase 2 | |
Recruiting |
NCT04565782 -
Corona Virus Infection Among Liver Transplant Recipients
|
||
Completed |
NCT04733625 -
The Effect of Vitamin D Therapy on Morbidity and Moratlity in Patients With SARS-CoV 2 Infection
|
N/A | |
Completed |
NCT04550390 -
Study of the Analytical Performance of Different Salivary Self-collection Methods for the Detection of COVID-19
|
||
Active, not recruiting |
NCT04517136 -
Impact of Perceived Control on Operational Strain: a Study of COVID-19 Pandemic Caregivers and Military Personnel on Operational Missions
|
||
Recruiting |
NCT04476680 -
Influence of Military Preventive Policy for reCruit Training on COVID-19 Seroconversion
|
N/A | |
Completed |
NCT04514874 -
Assessment of the Prevalence and the Impact of the COVID-19 Epidemic in the French Flight Crew in 2020
|
||
Completed |
NCT04839913 -
Seroprevalence of SARS-CoV-2 in Unselected Surgical Patients: an Unicentric, Regional Study
|
||
Terminated |
NCT04606563 -
Host Response Mediators in Coronavirus (COVID-19) Infection - Is There a Protective Effect of Losartan and Other ARBs on Outcomes of Coronavirus Infection?
|
Phase 3 | |
Completed |
NCT05234359 -
The CHILD Cohort COVID-19 Add-On Study
|