Study to evaluate the operational suitability of two point-of-care assay devices in a clinical setting

Evaluation of logistical feasibility in implementation of two point-of-care assay technologies in a clinical trial setting

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN15639880

Enrollment

150

Registered

2022-09-15

Start date

2022-09-19

Completion date

Unknown

Last updated

2022-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 (SARS-CoV-2 infection) or COVID-19 symptoms, or a disease or condition associated with elevated interleukin-6 (IL-6) concentrations Not Applicable

Interventions

Participants will be required to provide a blood sample, drawn via venipuncture, for the Proxim IL-6 assay, and a nasal swab, for the Qorvo COVID-19 antigen assay, during their single visit to the sit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Participants: 1. Diagnosed with COVID-19 or with COVID-19 symptoms; or a disease or condition associated with elevated IL-6 concentrations, such as localized (e.g., prosthetic joint infections, periodontitis) or systemic (e.g., sepsis) infections, autoimmune conditions (e.g., rheumatoid arthritis [RA], systemic lupus erythematosus [SLE], ankylosing spondylitis, inflammatory bowel disease [IBD]), or other inflammatory conditions 2. Aged =21 years at the time of signing Informed Consent Form Users: Users must be either a nurse or a technician

Exclusion criteria

Exclusion criteria: 1. Poor vascular access for venipuncture 2. Currently on anti-IL-6 therapy (e.g., Actemra) 3. Currently participating in another clinical trial of an unapproved investigational medical product (i.e., device, drug, biologic) that has not concluded the follow-up period

Design outcomes

Primary

Measure	Time frame
1. Device training effectiveness for each POC platform, assessed using the device training questionnaire, completed by each user (assessed after training and after processing all three samples from the user’s first participant) 2. Ease of use for each POC platform, assessed using ease of use questionnaire, completed by each user (assessed after training and after processing all three samples from user's fourth participant) 3. User satisfaction for both POC platforms, assessed using satisfaction questionnaire, completed by each user (assessed after processing all three samples from user’s last participant) 4. Elapsed time from starting sample collection to result on the POC instrument assessed using data collected from each sample (blood, plasma, and nasal) for each subject (approximately 6 months for all participants) 5. Number of data queries issued on test results as assessed by the sponsor over 6 months 6. Number of device failures or malfunctions assessed using data collected per sample over 6 months	—

Measure

Time frame

1. Device training effectiveness for each POC platform, assessed using the device training questionnaire, completed by each user (assessed after training and after processing all three samples from the user’s first participant) 2. Ease of use for each POC platform, assessed using ease of use questionnaire, completed by each user (assessed after training and after processing all three samples from user's fourth participant) 3. User satisfaction for both POC platforms, assessed using satisfaction questionnaire, completed by each user (assessed after processing all three samples from user’s last participant) 4. Elapsed time from starting sample collection to result on the POC instrument assessed using data collected from each sample (blood, plasma, and nasal) for each subject (approximately 6 months for all participants) 5. Number of data queries issued on test results as assessed by the sponsor over 6 months 6. Number of device failures or malfunctions assessed using data collected per sample over 6 months

—

Secondary

Measure	Time frame
Comparison of IL-6 results from whole blood and from plasma assessed using data collected from Proxim device for each participant over 6 months	—

Countries

United States of America

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026