Study to evaluate the operational suitability of two point-of-care assay devices in a clinical setting
| ISRCTN | ISRCTN15639880 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15639880 |
| Secondary identifying numbers | XE43505 |
- Submission date
- 12/09/2022
- Registration date
- 15/09/2022
- Last edited
- 15/09/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
COVID-19 is caused by a novel beta-coronavirus known as Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Interleukin-6 (IL-6) is a protein that is produced in response to injury or severe infections such as COVID-19. In response, the patient’s immune system tries to defend the body by producing antibodies. An antibody is a protein used by the immune system to identify and neutralize foreign objects such as bacteria and viruses.
The aim of this study is to evaluate and establish the feasibility of using two medical devices as point of contact (POC) test platforms in a clinical trial setting. A point of care test is a test that can be performed in a doctor’s office or emergency room instead of a laboratory. The two platforms being assessed are an IL-6 test developed by Proxim and a COVID-19 test developed Qorvo. The Proxim IL-6 test helps to quantify the level of IL-6 in blood samples rapidly and Qorvo COVID-19 test is used for fast detection of SARS-CoV-2. At the start of this study, neither the Qorvo COVID-19 test, and Proxim IL-6 test are approved by health authorities for the diagnosis of COVID-19 and conditions related to elevated IL-6 levels in blood.
Who can participate?
People who are over 21 years of age and have a confirmed diagnosis of COVID-19, have COVID-19 symptoms and/or have a condition associated with elevated IL-6
What does the study involve?
Participants will be a part of this study for one day. The study includes:
Screening period: All participants will be screened to make sure they are a good fit before the study begins.
Sample collection: A blood sample and nasal swab sample will be collected from all participants to test for IL-6 using the Proxim IL-6 test and for COVID-19 using the Qorvo COVID-19 test. A blood sample will be drawn from a vein (venipuncture).
Follow up: To check on the participants after sample collection.
Users (nurses or lab technicians who load the sample in the cartridge and run the samples on both POC devices) will provide feedback on device training effectiveness, ease of use, and user satisfaction through completion of the Device Training questionnaire, Ease of Use questionnaire, and the Satisfaction Questionnaire, respectively.
What are the possible benefits and risks of participating?
Participants will not receive any benefit from participating in this study. Participants will receive IRB-approved monetary compensation for one single visit. Participants may experience some side effects during blood draw and nasal swab sample collection. The most common risks from blood sample collection through venipuncture include discomfort, pain, collection/pooling of blood outside blood vessels (hematoma), bruising/discoloration of the skin due to rupture of blood vessels under it (ecchymosis), and rarely feeling faint (vasovagal reaction).Nasal swab sample collection has essentially no risks, other than slight discomfort. On very few occasions, people experience nosebleeds (epistaxis) and broken swab tips.
Where is the study run from?
F. Hoffmann-La Roche Ltd (USA)
When is the study starting and how long is it expected to run for?
June 2021 to December 2022
Who is funding the study?
F. Hoffmann-La Roche Ltd (USA)
Who is the main contact?
global-roche-genentech-trials@gene.com
Contact information
Scientific
1 DNA Way
South San Francisco
94080
United States of America
| Phone | +1 (0)888 662 6728 |
|---|---|
| global-roche-genentech-trials@gene.com |
Study information
| Study design | Single-arm unblinded clinical trial logistics study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Clinical trial logistics study |
| Study setting(s) | Other |
| Study type | Other |
| Scientific title | Evaluation of logistical feasibility in implementation of two point-of-care assay technologies in a clinical trial setting |
| Study objectives | The purpose of this study, and intended use of these devices, is to establish feasibility of two point-of-care (POC) assay technology platforms as bioanalytical tools for soluble biomarkers, pharmacokinetics (PK), and anti-drug antibodies (ADA) for routine use in a clinical trial setting. |
| Ethics approval(s) | Approved 19/08/2022, Advarra, Inc. (6100 Merriweather Dr. Suite 600, Columbia, MD 21044, USA; +1 (0)410 884 2900; cirbi@advarra.com), ref: Pro00063146 |
| Health condition(s) or problem(s) studied | COVID-19 (SARS-CoV-2 infection) or COVID-19 symptoms, or a disease or condition associated with elevated interleukin-6 (IL-6) concentrations |
| Intervention | 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 site (Day 1). Thereafter, users, who are lab technicians or trained nurses, will run the samples on the POC instruments. This will allow the users to compare the two instruments and provide feedback on device training effectiveness, ease of use, and user satisfaction for each POC platform through completion of the Device Training questionnaires, the Ease of Use questionnaires, and the Satisfaction questionnaire, respectively. |
| Intervention type | Other |
| Primary outcome measure | 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 outcome measures | Comparison of IL-6 results from whole blood and from plasma assessed using data collected from Proxim device for each participant over 6 months |
| Overall study start date | 07/06/2021 |
| Completion date | 30/12/2022 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Approximately 150 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 19/09/2022 |
| Date of final enrolment | 30/12/2022 |
Locations
Countries of recruitment
- United States of America
Study participating centres
91403
United States of America
70124
United States of America
Sponsor information
Industry
1 DNA Way
South San Francisco
94080
United States of America
| Phone | +1 (0)888 662 6728 |
|---|---|
| global-roche-genentech-trials@gene.com | |
| Website | https://www.roche.com/about_roche/roche_worldwide.htm |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Hoffman-La Roche, F. Hoffmann-La Roche Ltd.
- Location
- Switzerland
Results and Publications
| Intention to publish date | 30/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to participant-level data not being a regulatory requirement. |
Editorial Notes
14/09/2022: Trial's existence confirmed by Advarra, Inc.
