COVIDNCT04409184
Whole Blood Collection From Individuals in the Convalescent Phase of SARS-CoV-2 Infection
An observational study of COVID and Sars-CoV2, run by Medical College of Wisconsin.
Trial summary
The study was not opened. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 14 Aug 2020to 14 Aug 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals cared for at Froedtert Hospital, Milwaukee, Wisconsin who meet the inclusion and exclusion criteria as outlined.
Who may be able to join
- Patients who have previously been diagnosed with COVID-19 but are now asymptomatic >14 days and a matched number of healthy controls:
- Consent: Subject able to provide voluntary written consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- SARS-CoV-2 Testing Status:
- Experimental Population: Subject has had positive SARS-CoV-2 verified by clinical laboratory OR
- Control Population: Subject without testing or negative SARS-CoV-2 testing
- Complete resolution and current absence of clinical symptoms Symptoms Defined as: Fever, Dry cough, Fatigue, Difficulty breathing, Sore throat, Diarrhea, Rhinorrhea (runny nose), or new aches/pains.
- Age: Greater or equal to 18 years of age. a. Subject must be able to provide voluntary written consent
Who cannot join
- Ongoing symptoms of COVID19 due to SARS-CoV-2 infection
- Symptoms Defined as: Fever, Dry cough, Fatigue, Difficulty breathing, Sore throat, Diarrhea, Rhinorrhea (runny nose), or new aches/pains.
- Ongoing symptoms not due or not known to be due to SARS-CoV-2 infection
- Symptoms Defined as: Fever, Dry cough, Fatigue, Difficulty breathing, Sore throat, Diarrhea, Rhinorrhea (runny nose), or new aches/pains.
- Patients receiving ongoing medical symptomatic treatment or prophylaxis treatment related to COVID-19 due to SARS-CoV-2
About this study
Official title: Evaluation of Whole Blood Samples From Coronavirus Disease 2019 (COVID-19) Convalescent Patients to Study Immune Response and Severity of Disease Predictors
The study was not opened.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Convalescent subjects | Convalescent, now asymptomatic, subjects with documented prior COVID-19 due to SARS-CoV-2 infection | |
| Healthy controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of specific T cell responses in peripheral blood isolated from patients that have been exposed to SARS-CoV-2.
Measured: Up to 1 year post infection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start14 Aug 2020
- Primary completion14 Aug 2020
- Study completion14 Aug 2020
Why it stopped: Study was not opened.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Versiti Blood Health
- Responsible party
- Principal investigator, Weiguo Cui, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409184
- Sponsor's protocol ID
- PRO00037957
- Status last verified
- Aug 2020
- First submitted
- 28 May 2020
- Last updated
- 18 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Whole Blood Samples From Coronavirus Disease 2019 (COVID-19) Convalescent Patients to Study Immune Response and Severity of Disease Predictors
- ClinicalTrials.gov ID
- NCT04409184
- Acronym / sponsor ID
- PRO00037957
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study was not opened.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Versiti Blood Health
- Study start
- 14 Aug 2020 (actual)
- Primary completion
- 14 Aug 2020 (actual)
- Study completion
- 14 Aug 2020 (actual)
- First posted
- 1 Jun 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.
The study was not opened.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Convalescent subjects | – | –Convalescent, now asymptomatic, subjects with documented prior COVID-19 due to SARS-CoV-2 infection |
| Healthy controls | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals cared for at Froedtert Hospital, Milwaukee, Wisconsin who meet the inclusion and exclusion criteria as outlined.
Key inclusion criteria (7 listed)
- Patients who have previously been diagnosed with COVID-19 but are now asymptomatic >14 days and a matched number of healthy controls:
- Consent: Subject able to provide voluntary written consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- SARS-CoV-2 Testing Status:
- Complete resolution and current absence of clinical symptoms Symptoms Defined as: Fever, Dry cough, Fatigue, Difficulty breathing, Sore throat, Diarrhea, Rhinorrhea (runny nose), or new aches/pains.
- Age: Greater or equal to 18 years of age. a. Subject must be able to provide voluntary written consent
Key exclusion criteria (5 listed)
- Ongoing symptoms of COVID19 due to SARS-CoV-2 infection
- Ongoing symptoms not due or not known to be due to SARS-CoV-2 infection
- Patients receiving ongoing medical symptomatic treatment or prophylaxis treatment related to COVID-19 due to SARS-CoV-2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterization of specific T cell responses in peripheral blood isolated from patients that have been exposed to SARS-CoV-2.
Time frame: Up to 1 year post infection.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID and Sars-CoV2, run by Medical College of Wisconsin.
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 7 inclusion and 5 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: withdrawn, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Characterization of specific T cell responses in peripheral blood isolated from patients that have been exposed to SARS-CoV-2. (time frame: Up to 1 year post infection.). 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 18 Aug 2020.