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NCT04561102
Evaluation of the COVIDSeq Test in Nasal Swab and Saliva From a COVID-19 Asymptomatic Population
trial testing Diagnostic test for detection of SARS-CoV-2 in SARS-CoV-2 in 644 participants. Completed in 28 February 2021.
28 February 2021
Quick facts
| Lead sponsor | Illumina, Inc. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 644 |
| Start date | 11 September 2020 |
| Primary completion | 28 February 2021 |
| Estimated completion | 28 February 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Diagnostic test for detection of SARS-CoV-2
Conditions studied
- SARS-CoV-2 — all drugs for SARS-CoV-2 →
Sponsor
Illumina, Inc. — full company profile →
Who can join
18 and older, any sex, with SARS-CoV-2. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
"This is a prospective, single-center specimen collection study. Subjects 18 years of age or older who do not have symptoms of COVID-19 will be enrolled. Two nasal swab samples and one saliva sample will be collected from each subject. The saliva sample will be tested with the COVIDSeq Test and one nasal swab will be tested with an EUA approved COVID test. The other nasal swab sample will be stored and a subset (approximately 250 specimens) will be tested with the COVIDSeq Test. Results of all testing will be provided to the sponsor for statistical analysis. Results from the comparator EUA test will be provided to the collection site investigator or designated collection site study staff. No medical treatment, guidance on treatment decisions, nor medical care will be provided. "
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04561102
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Illumina, Inc. trials
Trials by the same sponsor.
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- NCT03620110 — A Study Collecting Blood Samples From Pregnant Women to Aid in the Development of a Noninvasive Prenatal Test · completed
- NCT03290469 — NICUSeq: A Trial to Evaluate the Clinical Utility of Human Whole Genome Sequencing (WGS) Compared to Standard of Care in · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04561102 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Illumina, Inc.
- Last refreshed: 21 January 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04561102.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing