COVID-19Phase 1CATCH COVID-19NCT04372004
Comparison of the Efficacy of Rapid Tests to Identify COVID-19 Infection (CATCh COVID-19)
A Phase 1 study testing diagnostic tests for COVID-19 infection in people with COVID-19, run by Texas Cardiac Arrhythmia Research Foundation at 1 site in United States.
Trial summary
This study is designed to compare the efficacy of detection of COVID-19 infection using the serology test in blood sample and the PCR-based test in the nasopharyngeal (NP) and sputum sample. Furthermore, it aims to evaluate the temporal trend of appearance of IgM and IgG in blood. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- COVID-19
- What is being tested?
- diagnostic tests for COVID-19 infection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2020to Jun 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Male or female over 18 years of age at the time of enrollment
- Current symptoms of COVID-19 ; fever alone or fever and at least one of the following symptoms need to be present
- Dry cough
- Sore throat
- Shortness of breath
- Chills
Show all 10Show fewer
- Muscle pain
- Headache
- New loss of taste or smell
- Chills with repeated shaking
Who cannot join
- • Unwilling to provide informed consent
- Unwilling to undergo bi-weekly serological test during the 1-month enrollment
Trial locations and contacts
1 site in 1 country.
Deb Cardinal, RN MBA contact
United States1 site, 1 recruiting
- Recruiting
Texas Cardiac Arrhythmia Institute
Austin, Texas, 78705
Mitra Mohanty, MD, 512-544-8186, mitra1989@gmail.com
Angel Mayedo, MD, 5125447254
About this study
This study is designed to compare the efficacy of detection of COVID-19 infection using the serology test in blood sample and the PCR-based test in the nasopharyngeal (NP) and sputum sample. Furthermore, it aims to evaluate the temporal trend of appearance of IgM and IgG in blood.
Read the detailed description
The investigators hypothesize that viral-RNA test using sputum will be equally efficient as the test performed in NP swab. Moreover, the serology test and the PCR-based test will be comparable in efficacy for detection of infection
- Conditions
- COVID-19
- Being tested
- diagnostic tests for COVID-19 infection
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnostic tests for COVID-19 infectionDiagnostic test
Compare the efficacy of diagnostic tests for COVID-19 infection in detecting antibodies and viral-RNA
| Study group | Role | What they receive |
|---|---|---|
| Viral RNA test using nasopharyngeal swab | Active comparator | Not described Receives: Diagnostic Test: diagnostic tests for COVID-19 infection |
| Viral RNA test using sputum | Active comparator | Not described Receives: Diagnostic Test: diagnostic tests for COVID-19 infection |
| Serology test using blood | Active comparator | Not described Receives: Diagnostic Test: diagnostic tests for COVID-19 infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
detection of viral infection using serology and viral-RNA detection kits
Detection of viral infection in the two test platforms using 3 specimen (blood, nasal swab and sputum) from the same subject, in detecting COVID-19 infection
Measured: 1 day
Secondary outcomes (1)
Temporal trend of antibodies in blood
Temporal trend of the IgM and IgG production in response to the infection by conducting serial serology tests at bi-weekly interval
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start8 May 2020
- Primary completionMay 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Each subject will be tested using 3 different samples on two testing platforms (serology and viral-RNA detection)
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Cardiac Arrhythmia Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Natale, Texas Cardiac Arrhythmia Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372004
- Sponsor's protocol ID
- TCAI_CATCH COVID-19
- Acronym
- CATCH COVID-19
- Status last verified
- May 2020
- First submitted
- 29 Apr 2020
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Rapid Tests to Identify COVID-19 Infection (CATCh COVID-19)
- ClinicalTrials.gov ID
- NCT04372004
- Acronym / sponsor ID
- CATCH COVID-19 / TCAI_CATCH COVID-19
- Conditions
- COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Texas Cardiac Arrhythmia Research FoundationUniversity, hospital or other
- Study start
- 8 May 2020 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 1 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to compare the efficacy of detection of COVID-19 infection using the serology test in blood sample and the PCR-based test in the nasopharyngeal (NP) and sputum sample. Furthermore, it aims to evaluate the temporal trend of appearance of IgM and IgG in blood.
Detailed description
The investigators hypothesize that viral-RNA test using sputum will be equally efficient as the test performed in NP swab. Moreover, the serology test and the PCR-based test will be comparable in efficacy for detection of infection
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Each subject will be tested using 3 different samples on two testing platforms (serology and viral-RNA detection)
| Arm | Type | Receives |
|---|---|---|
| Viral RNA test using nasopharyngeal swab | Active comparator | Diagnostic Test: diagnostic tests for COVID-19 infection |
| Viral RNA test using sputum | Active comparator | Diagnostic Test: diagnostic tests for COVID-19 infection |
| Serology test using blood | Active comparator | Diagnostic Test: diagnostic tests for COVID-19 infection |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- • Male or female over 18 years of age at the time of enrollment
Key exclusion criteria (2 listed)
- • Unwilling to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diagnostic tests for COVID-19 infectionCompare the efficacy of diagnostic tests for COVID-19 infection in detecting antibodies and viral-RNA | Diagnostic test | Serology test using blood, Viral RNA test using nasopharyngeal swab, Viral RNA test using sputum |
Primary outcome
detection of viral infection using serology and viral-RNA detection kits
Time frame: 1 day
Detection of viral infection in the two test platforms using 3 specimen (blood, nasal swab and sputum) from the same subject, in detecting COVID-19 infection
1 secondary outcome
Temporal trend of antibodies in blood
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deb Cardinal, RN MBA contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing diagnostic tests for COVID-19 infection in people with COVID-19, run by Texas Cardiac Arrhythmia Research Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MITRA Mohanty, MD (5127842651, mitra1989@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detection of viral infection using serology and viral-RNA detection kits (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020.