SARS-CoV 2 InfectionNCT04542980
Qualitative Evaluation of Tear Fluid and Blood for Auto Antibodies Produced in Response to COVID-19
An observational study of SARS-CoV 2 Infection and Covid19, run by Namida Lab at 1 site in United States.
Trial summary
This study objective is to collect tear and blood samples from individuals with positive SARS-COV2 diagnosis and test those samples for the presence of various SARS-COV2 viral antigens and autoantibodies. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- SARS-CoV 2 Infection, Covid19
- What is being tested?
- SARS-CoV2 Autoantibody detection
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2020to 31 Dec 2020
- Phase
- Observational
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study participants will be recruited from hospital and health care settings testing and/or treating individuals for the presence of the SARS-CoV2 virus and resulting COVID-19 disease.
Who may be able to join
- 18 years of age or older Has been tested for SARS-CoV2 and awaiting results Sample collection for SARS-CoV2 testing Tested positive for SARS-CoV2 virus (confirmed by RT-PCR) prior to enrollment
Who cannot join
- Under 18 years of age Concurrent eye infection or trauma unrelated to presence of SARS-CoV2 virus. Advanced COVID-19 state what would preclude safe and feasible sample collection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Qualitative Evaluation of Tear Fluid and Blood for IgM and IgG Produced in Response to SARS-CoV2, the Virus Responsible for COVID-19.
This study objective is to collect tear and blood samples from individuals with positive SARS-COV2 diagnosis and test those samples for the presence of various SARS-COV2 viral antigens and autoantibodies.
- Conditions
- SARS-CoV 2 Infection, Covid19
- Being tested
- SARS-CoV2 Autoantibody detection
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV2 Autoantibody detectionDiagnostic test
Through the data collected from this study we hope to support the development of an ELISA assay for the detection of IgM and IgG autoantibodies produced in response to the presence of SARS-CoV2
| Study group | Role | What they receive |
|---|---|---|
| SARS-CoV2 Positive | Tear Samples: Tear samples will be collected from 100 patients who have tested positive for the SARS-CoV2 virus.
A total of 100 Blood samples will be drawn using standard phlebotomy techniques for venipuncture from patients who have tested positive for the SARS-CoV2 virus. Receives: Diagnostic Test: SARS-CoV2 Autoantibody detection | |
| Control | Control tear and serum samples will be selected from Namida Lab's own biorepository. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative assessment of IgM and/or IgG by indirect ELISA assay.
Determination of the presence or absence of IgM and/or IgG autoantibodies in response to SARS-CoV2 infection. In the case of presence, concentration may be determined as well.
Measured: through study completion, up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start15 Sep 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV 2 InfectionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Namida Lab
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04542980
- Sponsor's protocol ID
- CVDTRS001
- Status last verified
- Sep 2020
- First submitted
- 13 Apr 2020
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Evaluation of Tear Fluid and Blood for IgM and IgG Produced in Response to SARS-CoV2, the Virus Responsible for COVID-19.
- ClinicalTrials.gov ID
- NCT04542980
- Acronym / sponsor ID
- CVDTRS001
- Conditions
- SARS-CoV 2 Infection, Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Namida LabIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 9 Sep 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 objective is to collect tear and blood samples from individuals with positive SARS-COV2 diagnosis and test those samples for the presence of various SARS-COV2 viral antigens and autoantibodies.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV2 Positive | – | Diagnostic Test: SARS-CoV2 Autoantibody detectionTear Samples: Tear samples will be collected from 100 patients who have tested positive for the SARS-CoV2 virus. A total of 100 Blood samples will be drawn using standard phlebotomy techniques for venipuncture from patients who have tested positive for the SARS-CoV2 virus. |
| Control | – | –Control tear and serum samples will be selected from Namida Lab's own biorepository. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be recruited from hospital and health care settings testing and/or treating individuals for the presence of the SARS-CoV2 virus and resulting COVID-19 disease.
Key inclusion criteria (1 listed)
- 18 years of age or older Has been tested for SARS-CoV2 and awaiting results Sample collection for SARS-CoV2 testing Tested positive for SARS-CoV2 virus (confirmed by RT-PCR) prior to enrollment
Key exclusion criteria (1 listed)
- Under 18 years of age Concurrent eye infection or trauma unrelated to presence of SARS-CoV2 virus. Advanced COVID-19 state what would preclude safe and feasible sample collection.
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 |
|---|---|---|
| SARS-CoV2 Autoantibody detectionThrough the data collected from this study we hope to support the development of an ELISA assay for the detection of IgM and IgG autoantibodies produced in response to the presence of SARS-CoV2 | Diagnostic test | SARS-CoV2 Positive |
Primary outcome
Qualitative assessment of IgM and/or IgG by indirect ELISA assay.
Time frame: through study completion, up to 8 months
Determination of the presence or absence of IgM and/or IgG autoantibodies in response to SARS-CoV2 infection. In the case of presence, concentration may be determined as well.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV 2 Infection and Covid19, run by Namida Lab 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 21 Mar 2022. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative assessment of IgM and/or IgG by indirect ELISA assay. (time frame: through study completion, up to 8 months). 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 21 Mar 2022.