ImmuneSense™ COVID-19 Study

Status Completed

Clinical Trial Summary

Coronavirus disease is of an urgent global priority. The purpose of ImmuneSense™ COVID-19 study is to evaluate the clinical performance and to provide data for clinical validation for the T-Detect™ SARS-CoV-2 (previously referred to as immunoSEQ Dx SARS-CoV-2) Assay in support of Adaptive's Emergency Use Authorization (EUA) request for T-Detect™ SARS-CoV-2 and secondary aims. This assay is intended to detect immune response to the virus that causes coronavirus disease (COVID-19), SARS-CoV-2. This is critically important because the immune system may be able to tell us important information about how our own bodies detect and respond to the disease that current tests cannot.

Clinical Trial Description

Comprehensive diagnostic testing has an important role to play in the control and containment of the current pandemic. Adaptive Biotechnologies Corporation (Adaptive) has developed an immunosequencing technology, called immunoSEQ®, which utilizes polymerase chain reaction (PCR) and next-generation sequencing (NGS) to identify and quantify rearranged T-cell receptor (TCR) gene sequences from peripheral blood, collectively referred to as the T-cell repertoire. The T-cell repertoire can be further analyzed using indication-specific algorithms that are based on disease-associated TCR sequences. Adaptive has developed a clinical test called T-Detect™ SARS-CoV-2, which is intended to identify a T-cell response to the SARS-CoV-2 virus, indicating recent or prior infection. In this investigational study, Adaptive plans to clinically validate samples acquired from patients with COVID-19 and present results for an eventual EUA-submission for the T-Detect™ SARS-CoV-2 Assay. T-Detect™ SARS-CoV-2 is a single-site assay performed at Adaptive Biotechnologies Corporation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04583982
Study type	Observational
Source	Adaptive Biotechnologies
Contact
Status	Completed
Phase
Start date	October 9, 2020
Completion date	December 4, 2020

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT04555096` - A Trial of GC4419 in Patients With Critical Illness Due to COVID-19	Phase 2
Completed	`NCT04593641` - This is a Phase 1 Study to Evaluate the Safety,Tolerability and Virology of CT P59 in Patients With Mild Symptoms of Symptoms of Coronavirus Disease (COVID-19)	Phase 1
Recruiting	`NCT05200754` - Trial With or Without Infusion of SARS-CoV-2 Antibody Containing Plasma in High-Risk Patients With COVID-19	Phase 2
Completed	`NCT04583995` - A Study Looking at the Effectiveness, Immune Response, and Safety of a COVID-19 Vaccine in Adults in the United Kingdom	Phase 3
Recruiting	`NCT06255860` - SARS-COV-2 Reinfection and Multisystem Inflammatory Syndrome in Children (MIS-C) Risk: Matched Case-control Study
Recruiting	`NCT04516811` - Therapeutic Use of Convalescent Plasma in the Treatment of Patients With Moderate to Severe COVID-19	Phase 3
Recruiting	`NCT05012826` - Osteopathy and Physiotherapy Compared to Physiotherapy Alone on Fatigue and Functional Status in Long COVID	N/A
Completed	`NCT05007236` - Study to Evaluate the Efficacy and Safety of Oral RP7214, a DHODH Inhibitor, in Patients With Symptomatic Mild COVID-19 Infection.	Phase 2
Recruiting	`NCT06026514` - Phase I Safety Study of B/HPIV3/S-6P Vaccine Via Nasal Spray in Adults	Phase 1
Completed	`NCT05523739` - Safety and Efficacy Study of STI-1558 in Healthy Adults and SARS-CoV-2-Positive Patients	Phase 1
Suspended	`NCT04738136` - Safety, Tolerability and Efficacy Of S-1226 in Moderate Severity Covid-19 Bronchiolitis/Pneumonia	Phase 2
Recruiting	`NCT04584658` - Dysphagia and Dysphonia Outcomes in SARS CoV-2 (COVID-19) Infection (DYADS Study)
Recruiting	`NCT04547114` - Breath Analysis for SARS-CoV-2 in Infected and Healthy Subjects
Completed	`NCT05119348` - Transmission of Coronavirus Disease 2019 (COVID19) in Crowded Environments	N/A
Completed	`NCT05096962` - COVID-19: SARS-CoV-2-CZ-PREVAL-II Study
Recruiting	`NCT04534400` - Automated Quantification of Radiologic Pulmonary Alteration During Acute Respiratory Failure
Completed	`NCT04527354` - Pilot Study to Assess Efficacy and Safety of Treamid in the Rehabilitation of Patients After COVID-19 Pneumonia	Phase 2
Completed	`NCT05077176` - Phase 3 Booster Vaccination Against COVID-19	Phase 3
Completed	`NCT05584189` - COVID-19 MP Biomedicals Rapid SARS-CoV-2 Antigen Test Usability	N/A
Terminated	`NCT04815018` - Shifts in the Respiratory Microbiome and Clinical Outcomes of SARS-CoV-2