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NCT05596032
Prospective Study to Validate the Diagnostic Performance of IVD CAPSULE COVID-19-NP Test for the Detection of SARS-CoV-2
trial in COVID-19 in 440 participants. Completed in 1 February 2023.
27 January 2023
Quick facts
| Lead sponsor | Abionic SA |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 440 |
| Start date | 23 October 2022 |
| Primary completion | 27 January 2023 |
| Estimated completion | 1 February 2023 |
| Sites | 1 location across Italy |
Conditions studied
- COVID-19 — all drugs for COVID-19 →
- COVID-19 Pandemic — all drugs for COVID-19 Pandemic →
Sponsor
Abionic SA
Who can join
18 and older, any sex, with COVID-19 or COVID-19 Pandemic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of the study is to conduct a prospective evaluation of the diagnostic performance of the IVD CAPSULE COVID-19-NP test for antigenic determination of SARS-CoV-2 virus on the abioSCOPE® instrument. The objective of the clinical study is to demonstrate that the IVD CAPSULE COVID-19-NP test: 1. shows sensitivity: * ≥ 80% when testing unselected symptomatic participants within the first seven days of symptom onset or asymptomatic participants when diagnosis is confirmed by RT-PCR; Or * ≥ 90% for subjects with Ct ≤ 25. 2. show ≥ 98% specificity.
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 NCT05596032
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for COVID-19
Currently open trials in the same condition.
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- NCT07300839 — A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age · Phase 3 · active not recruiting
- NCT07221162 — A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes · Phase 1 · recruiting
- NCT07215520 — Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults · Phase 2 · recruiting
- NCT07222384 — A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That A · Phase 3 · active not recruiting
Other Abionic SA trials
Trials by the same sponsor.
- NCT05849935 — abioSCOPE PSP Reference Range Study; Extension of AB-PSP-003 · completed
- NCT05627076 — Analytical Validation of the abioSCOPE Device With the IVD CAPSULE PSP Test: Comparison of PSP Values Measured With Veno · completed
- NCT04409561 — Reference Range for abioSCOPE® Device With the PSP Assay in a Generally Healthy Adult Population · completed
- NCT04442932 — abioSCOPE IgE Assay to Aid in the Diagnosis of Allergies · withdrawn
- NCT04105699 — Evaluation of Immunoassay Measurements of Pancreatic Stone Protein Performed on abioSCOPE® Device With the PSP Assay on · 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 NCT05596032 (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 Abionic SA
- Last refreshed: 3 May 2023
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/NCT05596032.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing