RNA Virus Infections Clinical Trial
Official title:
SARS -CoV-2 Detection in Saliva Samples: A Test Validation Protocol
NCT number | NCT04517682 |
Other study ID # | COV_20_001 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 21, 2020 |
Est. completion date | August 5, 2021 |
Verified date | March 2022 |
Source | Ambry Genetics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study aims to validate the use of human saliva as a substrate for an assay to detect SARS-CoV-2 and define accuracy, analytical sensitivity and specificity of the TaqPath RT-PCR test.
Status | Completed |
Enrollment | 67 |
Est. completion date | August 5, 2021 |
Est. primary completion date | March 16, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Reads and understands English or Spanish - Willing and able to provide consent - Diagnosed with COVID-19 or at high risk of disease based on objective criteria Exclusion Criteria: - Unwilling or unable to provide consent. - Pregnant female |
Country | Name | City | State |
---|---|---|---|
United States | Ambry Genetics | Aliso Viejo | California |
Lead Sponsor | Collaborator |
---|---|
Ambry Genetics | Crozer-Keystone Health System, St. Joseph Hospital of Orange, The Saratoga Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Reason for testing | Participants may be recruited from individuals presenting for various indications for testing including; followup testing after previous positive result, at risk healthcare worker, exposure to known positive or symptomatic, public facing worker or workplace hazards, employee based screening. | Baseline | |
Other | Current symptom status | Participant is symptomatic or asymptomatic | Baseline | |
Other | Current symptoms | Participant reports one or more of the following symptoms at baseline. Cough, Shortness of breath or difficulty breathing, fever, chills, muscle pain, sore throat, new loss of taste or smell, any nausea, vomiting or diarrhea. | Baseline | |
Other | Prior symptoms | Participant reports one or more of the following symptoms at baseline. Cough, Shortness of breath or difficulty breathing, fever, chills, muscle pain, sore throat, new loss of taste or smell, any nausea, vomiting or diarrhea. | Baseline | |
Other | Date of first symptom or number of days since first symptom. | Participant reports date of first symptom or number of days since first symptom. | Baseline | |
Other | Previous test for COVID-19 and date of test. | Participant reported result (positive, negative, inconclusive) of previous test for COVID-19 and date of test . | Baseline | |
Primary | Detection of COVID-19 SARs-CoV-2 in saliva samples versus nasopharyngeal samples | TaqPath RT-PCR assay performed on saliva compared to TaqPath RT-PCR performed on nasopharyngeal samples for assay accuracy, concordance, reproducibility/precision, analytical sensitivity and analytical specificity. | up to 7 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03321968 -
Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults
|
Phase 3 | |
Completed |
NCT04644484 -
A Phase III Clinical Study to Evaluate SYN023's Efficacy and Safety
|
Phase 3 | |
Completed |
NCT00984945 -
Safety Study of a Plant-based H5 Virus-Like Particles (VLP) Vaccine in Healthy Adults
|
Phase 1 | |
Active, not recruiting |
NCT05284097 -
Ad26.ZEBOV, MVA-BN-Filo Vaccination in Children and Adults Previously Vaccinated With Control in the EBOVAC-Salone Study
|
Phase 2 | |
Completed |
NCT03739112 -
Efficacy of a Plant-derived Quadrivalent Virus-like Particle (VLP) Vaccine in the Elderly
|
Phase 3 | |
Completed |
NCT01991587 -
Safety, Tolerability and Immunogenicity of a Plant-made Seasonal Quadrivalent VLP Influenza Vaccine in Adults
|
Phase 1/Phase 2 | |
Completed |
NCT03294473 -
Centralized Reminder Recall - Flu RCT2
|
N/A | |
Completed |
NCT01244867 -
Immunogenicity, Safety, Tolerability of a Plant-Made H5 VLP Influenza Vaccine
|
Phase 2 | |
Not yet recruiting |
NCT05394623 -
Prevalence and Burden of Hepatitis D Virus Infection in China Through Preoperative Examination Test (Predict Study)
|
||
Recruiting |
NCT03776760 -
Strategies for Hepatitis C Testing and Treatment in Aboriginal Communities That Lead to Elimination
|
||
Active, not recruiting |
NCT04365101 -
Natural Killer Cell (CYNK-001) Infusions in Adults With COVID-19
|
Phase 1/Phase 2 | |
Completed |
NCT05307991 -
Integrating Enhanced HIV PrEP Into a STI Clinic in Lilongwe
|
||
Completed |
NCT03110770 -
VRC 705: A Zika Virus DNA Vaccine in Healthy Adults and Adolescents
|
Phase 2 | |
Completed |
NCT04772469 -
Self-Test Strategies and Linkage Incentives to Improve ART and PrEP Uptake in Men
|
N/A | |
Terminated |
NCT02120274 -
Vitamin D and Vitamin B12 Supplementation With Pegylated Interferon-Alfa Plus Ribavirin for Treating Chronic Hepatitis C
|
Phase 4 | |
Completed |
NCT02768805 -
Immunogenicity of a Quadrivalent Virus-Like Particles (VLP) Influenza Vaccine in Healthy Adults
|
Phase 2 | |
Completed |
NCT03642977 -
DNA and RNA Viruses of the Blood Virome of Allogeneic Hematopoietic Stem Cell Transplant Recipients
|
||
Recruiting |
NCT04627623 -
Prevalence and Risk Factors of COVID-19 in the Upper Silesian Agglomeration
|
||
Completed |
NCT01991561 -
Immunogenicity, Safety, Tolerability of a Plant-made H5 Virus-like-particle (VLP) Influenza Vaccine.
|
Phase 2 | |
Completed |
NCT01587131 -
DNA-based Influenza Vaccine in the Elderly
|
Phase 1 |