A Clinical Evaluation of COVID-19 Rapid Point of Care Antigen Tests

NCT04568356 | Completed DMC FDA Device

• 1 other identifier: E25001_NEU2012
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

The current standard of care for diagnosis of Severe Acute Respiratory Syndrome associated Coronavirus -2 (SARS-CoV-2 ) infection involves sample collection to be prepared and measured via real time-polymerase chain reaction (RT-PCR). This process is often time consuming depending on the level of automation within the laboratory processing the samples. In many cases, sample turn-around times can take hours to several days. A rapid assay that does not require the sophisticated laboratory equipment and techniques could provide a significant advantage to the way practitioners screen and ultimately treat patients. Moreover, the collection of samples from the nasal nares should prove useful and less invasive. The study aims to validate the use of nasal swabs and also to validate the antigen test using nasal swabs.

Conditions

SARS CoV-2

Keywords

COVID-19

Outcome Measures

Primary Outcomes (1)

• Percent Positive Agreement and Negative Percent Agreement

  Calculate the performance of the antigen test compared to PCR using nasopharyngeal swab samples

  90 days

Study Arms (1)

Antigen rapid test for COVID-19

EXPERIMENTAL

The same group of patients participated in two arms of the study, one arm was for obtaining data on the rapid antigen test for COVID-19, the comparator arm was to obtain data from the RT-PCR

Diagnostic Test: Direct Antigen Tests for COVID-19

Interventions

Direct Antigen Tests for COVID-19 DIAGNOSTIC_TEST

Rapid Antigen diagnostic device performance comparative to RT-PCR

Antigen rapid test for COVID-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of verbal informed consent form
• Subject is suspected case of COVID-19 by clinical criteria a patient with acute respiratory tract infection (sudden onset of at least one of the following: cough, fever, shortness of breath, fatigue, decreased appetite, myalgia)
• No other etiology that fully explains the clinical presentation
• With or without a history of close contact with a confirmed or probable COVID-19 case in the last 14 days prior to onset of symptoms.
• Subject is an appropriate candidate for Nasopharyngeal sample collection
• Subject is willing to provide nasopharyngeal swab and saliva samples

You may not qualify if:

• Individuals who present to ER with 10 or greater days of COVID-19 Related Symptoms, (Fever, Cough, Fatigue, Decreased Appetite, Shortness of Breath, Myalgia) or post-defervescence and/or convalescence

Sponsors & Collaborators

• E25Bio, Inc.: lead
• SCRI Development Innovations, LLC: collaborator

Study Sites (3)

JFK Medical Center

Miami, Florida, 033401, United States

Location

Kendall Regional

Miami, Florida, 33175, United States

Location

Aventura Hospital and Medical Center

Miami, Florida, 33180, United States

Location

Related Publications (17)

• Dinnes J, Deeks JJ, Adriano A, Berhane S, Davenport C, Dittrich S, Emperador D, Takwoingi Y, Cunningham J, Beese S, Dretzke J, Ferrante di Ruffano L, Harris IM, Price MJ, Taylor-Phillips S, Hooft L, Leeflang MM, Spijker R, Van den Bruel A; Cochrane COVID-19 Diagnostic Test Accuracy Group. Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection. Cochrane Database Syst Rev. 2020 Aug 26;8(8):CD013705. doi: 10.1002/14651858.CD013705.

  PMID: 32845525 RESULT

• Kyosei Y, Namba M, Yamura S, Takeuchi R, Aoki N, Nakaishi K, Watabe S, Ito E. Proposal of De Novo Antigen Test for COVID-19: Ultrasensitive Detection of Spike Proteins of SARS-CoV-2. Diagnostics (Basel). 2020 Aug 14;10(8):594. doi: 10.3390/diagnostics10080594.

  PMID: 32823866 RESULT

• Hirotsu Y, Maejima M, Shibusawa M, Nagakubo Y, Hosaka K, Amemiya K, Sueki H, Hayakawa M, Mochizuki H, Tsutsui T, Kakizaki Y, Miyashita Y, Yagi S, Kojima S, Omata M. Comparison of automated SARS-CoV-2 antigen test for COVID-19 infection with quantitative RT-PCR using 313 nasopharyngeal swabs, including from seven serially followed patients. Int J Infect Dis. 2020 Oct;99:397-402. doi: 10.1016/j.ijid.2020.08.029. Epub 2020 Aug 12.

  PMID: 32800855 RESULT

• Nagura-Ikeda M, Imai K, Tabata S, Miyoshi K, Murahara N, Mizuno T, Horiuchi M, Kato K, Imoto Y, Iwata M, Mimura S, Ito T, Tamura K, Kato Y. Clinical Evaluation of Self-Collected Saliva by Quantitative Reverse Transcription-PCR (RT-qPCR), Direct RT-qPCR, Reverse Transcription-Loop-Mediated Isothermal Amplification, and a Rapid Antigen Test To Diagnose COVID-19. J Clin Microbiol. 2020 Aug 24;58(9):e01438-20. doi: 10.1128/JCM.01438-20. Print 2020 Aug 24.

  PMID: 32636214 RESULT

• Mak GC, Cheng PK, Lau SS, Wong KK, Lau CS, Lam ET, Chan RC, Tsang DN. Evaluation of rapid antigen test for detection of SARS-CoV-2 virus. J Clin Virol. 2020 Aug;129:104500. doi: 10.1016/j.jcv.2020.104500. Epub 2020 Jun 8.

  PMID: 32585619 RESULT

• Blairon L, Wilmet A, Beukinga I, Tre-Hardy M. Implementation of rapid SARS-CoV-2 antigenic testing in a laboratory without access to molecular methods: Experiences of a general hospital. J Clin Virol. 2020 Aug;129:104472. doi: 10.1016/j.jcv.2020.104472. Epub 2020 May 30.

  PMID: 32504944 RESULT

• Porte L, Legarraga P, Vollrath V, Aguilera X, Munita JM, Araos R, Pizarro G, Vial P, Iruretagoyena M, Dittrich S, Weitzel T. Evaluation of a novel antigen-based rapid detection test for the diagnosis of SARS-CoV-2 in respiratory samples. Int J Infect Dis. 2020 Oct;99:328-333. doi: 10.1016/j.ijid.2020.05.098. Epub 2020 Jun 1.

  PMID: 32497809 RESULT

• Scohy A, Anantharajah A, Bodeus M, Kabamba-Mukadi B, Verroken A, Rodriguez-Villalobos H. Low performance of rapid antigen detection test as frontline testing for COVID-19 diagnosis. J Clin Virol. 2020 Aug;129:104455. doi: 10.1016/j.jcv.2020.104455. Epub 2020 May 21.

  PMID: 32485618 RESULT

• Lambert-Niclot S, Cuffel A, Le Pape S, Vauloup-Fellous C, Morand-Joubert L, Roque-Afonso AM, Le Goff J, Delaugerre C. Evaluation of a Rapid Diagnostic Assay for Detection of SARS-CoV-2 Antigen in Nasopharyngeal Swabs. J Clin Microbiol. 2020 Jul 23;58(8):e00977-20. doi: 10.1128/JCM.00977-20. Print 2020 Jul 23. No abstract available.

  PMID: 32404480 RESULT

• Cui Z, Chang H, Wang H, Lim B, Hsu CC, Yu Y, Jia H, Wang Y, Zeng Y, Ji M, Liu W, Inverarity C, Huang WE. Development of a rapid test kit for SARS-CoV-2: an example of product design. Biodes Manuf. 2020;3(2):83-86. doi: 10.1007/s42242-020-00075-7. Epub 2020 May 11.

  PMID: 32395391 RESULT

• Bosch I, de Puig H, Hiley M, Carre-Camps M, Perdomo-Celis F, Narvaez CF, Salgado DM, Senthoor D, O'Grady M, Phillips E, Durbin A, Fandos D, Miyazaki H, Yen CW, Gelvez-Ramirez M, Warke RV, Ribeiro LS, Teixeira MM, Almeida RP, Munoz-Medina JE, Ludert JE, Nogueira ML, Colombo TE, Terzian ACB, Bozza PT, Calheiros AS, Vieira YR, Barbosa-Lima G, Vizzoni A, Cerbino-Neto J, Bozza FA, Souza TML, Trugilho MRO, de Filippis AMB, de Sequeira PC, Marques ETA, Magalhaes T, Diaz FJ, Restrepo BN, Marin K, Mattar S, Olson D, Asturias EJ, Lucera M, Singla M, Medigeshi GR, de Bosch N, Tam J, Gomez-Marquez J, Clavet C, Villar L, Hamad-Schifferli K, Gehrke L. Rapid antigen tests for dengue virus serotypes and Zika virus in patient serum. Sci Transl Med. 2017 Sep 27;9(409):eaan1589. doi: 10.1126/scitranslmed.aan1589.

  PMID: 28954927 RESULT

• Arnaout R, Lee RA, Lee GR, Callahan C, Yen CF, Smith KP, Arora R, Kirby JE. SARS-CoV2 Testing: The Limit of Detection Matters. bioRxiv [Preprint]. 2020 Jun 4:2020.06.02.131144. doi: 10.1101/2020.06.02.131144.

  PMID: 32577640 RESULT

• Carpenter CR, Mudd PA, West CP, Wilber E, Wilber ST. Diagnosing COVID-19 in the Emergency Department: A Scoping Review of Clinical Examinations, Laboratory Tests, Imaging Accuracy, and Biases. Acad Emerg Med. 2020 Aug;27(8):653-670. doi: 10.1111/acem.14048. Epub 2020 Jul 26.

  PMID: 32542934 RESULT

• Kucirka LM, Lauer SA, Laeyendecker O, Boon D, Lessler J. Variation in False-Negative Rate of Reverse Transcriptase Polymerase Chain Reaction-Based SARS-CoV-2 Tests by Time Since Exposure. Ann Intern Med. 2020 Aug 18;173(4):262-267. doi: 10.7326/M20-1495. Epub 2020 May 13.

  PMID: 32422057 RESULT

• Wang X, Tan L, Wang X, Liu W, Lu Y, Cheng L, Sun Z. Comparison of nasopharyngeal and oropharyngeal swabs for SARS-CoV-2 detection in 353 patients received tests with both specimens simultaneously. Int J Infect Dis. 2020 May;94:107-109. doi: 10.1016/j.ijid.2020.04.023. Epub 2020 Apr 18.

  PMID: 32315809 RESULT

• Buitrago-Garcia D, Egli-Gany D, Counotte MJ, Hossmann S, Imeri H, Ipekci AM, Salanti G, Low N. Occurrence and transmission potential of asymptomatic and presymptomatic SARS-CoV-2 infections: A living systematic review and meta-analysis. PLoS Med. 2020 Sep 22;17(9):e1003346. doi: 10.1371/journal.pmed.1003346. eCollection 2020 Sep.

  PMID: 32960881 RESULT

• Pondaven-Letourmy S, Alvin F, Boumghit Y, Simon F. How to perform a nasopharyngeal swab in adults and children in the COVID-19 era. Eur Ann Otorhinolaryngol Head Neck Dis. 2020 Sep;137(4):325-327. doi: 10.1016/j.anorl.2020.06.001. Epub 2020 Jun 5.

  PMID: 32646750 RESULT

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Gina Remington, RN MSN

  HCA Healthcare Director of Research. Neuroscience and Orthopedic

  STUDY DIRECTOR

• Patrice Feaster, RN

  SCRI Development Innovations, LLC

  STUDY DIRECTOR

• Klepler N De Almeida, MD

  JFK Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2020
• First Posted: September 29, 2020
• Study Start: April 24, 2020
• Primary Completion: June 12, 2020
• Study Completion: September 24, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: One month after the USA-FDA approval date and for the duration of one year after the date of approval
• Access Criteria: via email to: Irene Bosch, PhD at ibosch@e25bio.com

Locations

US (3)