FeverCOVeRNCT04357496
COVID-19 Epidemic Response Study
An observational study of Fever and Pneumonia, run by CENTOGENE GmbH Rostock.
Trial summary
A national, observational, longitudinal, non-interventional program aiming to identify prognostic parameters, to investigate the kinetics of the immune response, and to identify predictive biomarkers in SARS-CoV-2 infected patients. Read more about this study
- Who is it for?
- Ages 60 years and older
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2021to May 2021
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with SARS-C0V-2
Who may be able to join
- Informed consent is obtained from the participant/legal guardian
- Participant has been identified to be positive for SARS-C0V-2
- The participant is 60 years old or older
Who cannot join
- The informed consent is not obtained from the participant/legal guardian
- Participant has not been identified to be positive for SARS-C0V-2
- The participant is younger than 60 years of age
About this study
Official title: COVID-19 Epidemic Response Study: A National Observational Longitudinal Non-Interventional Protocol
A national, observational, longitudinal, non-interventional program aiming to identify prognostic parameters, to investigate the kinetics of the immune response, and to identify predictive biomarkers in SARS-CoV-2 infected patients.
Read the detailed description
By 31st December 2019, 27 subjects with pneumonia of unknown aetiology were registered in Wuhan City, China. 7th of January the disease causative agent was identified and turned to be severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The WHO named the disease - coronavirus disease (COVID-19). On March 11, 2020, the World Health Organization (WHO) announced that COVID-19 should be characterized as a pandemic. At great economic cost, many countries have adopted unprecedented measures to curb the spread of the virus, such as large-scale use of isolation and quarantine, closing borders, imposing limits on public gatherings, and implementing nationwide lockdowns.
The most common symptoms of COVID-19 are fever, tiredness, and dry cough. Some patients may exhibit nasal congestion, runny nose, sore throat or diarrhea. These symptoms are usually mild and begin gradually. About 40% of the symptomatic patients recover from the disease without needing special treatment. Around 1 out of every 6 people infected with SARS-CoV-2 becomes seriously ill and develops difficulty breathing. Older people, and those with underlying medical problems like high chronic cardiovascular and respiratory disease or diabetes, are more likely to develop serious illness.
Monitoring patients with resolution of COVID-19 pneumonia is important in terms of when they should be released from isolation and discharged and to what extent this result is correlating with the clinical severity. If patients are still shedding viable coronavirus, they are likely to infect others. Therefore, quarantine for up to one month may be advisable. The optimal method for test of cure most likely will be two consecutive negative real-time RT-PCR tests. Furthermore, people who have cleared SARS-CoV-2 could have developed specific antibodies against the infectious agent in their blood plasma as a result of humoral immune response. This plasma is rich with specific antibodies and is called convalescent plasma (CP) or convalescent serum (CS). CP could treat and eradicate SARS-CoV-2 in infected individuals and could be used as therapy. This therapy concept was centuries old and was previously attempted during several outbreaks. Currently, there are few reports from China and South Korea showing that patients who received CP transfusion together with antiviral drugs and corticosteroids have recovered from the disease.
It is the aim of the COVeR study to enroll 400 patients with COVID-19 from nursing homes of the german state Mecklenburg-Vorpommern. Each patient will enter a follow-up phase of 6 months during which buccal swaps will be collected for judging the viral load, and blood samples for investigation of their immune response and identifying predictive biomarkers.
- Keywords
- COVID-19
- Medical subject headings
- Fever, Pneumonia, Cough, COVID-19
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 |
|---|---|---|
| Participants with SARS-COV-2 | Participants tested positive for SARS-COV-2 aged 60 years or older |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of prognostic parameters for SARS-CoV-2 infected participants.
Blood samples drawn from the infected participants will be analysed for prognostic parameters.
Measured: 7 months
Secondary outcomes (1)
Investigation of the kinetics of immune activation and antibody production against SARS-CoV-2 and correlation with clinical course
Systems from Abbott and Euroimmun will be used for IgG and IgM in SARS-CoV-2.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study startMay 2021 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionMay 2021 (estimated)
Why it stopped: study has never been started and was decided to be cancelled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FeverStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- CENTOGENE GmbH Rostock
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arndt Rolfs, Prof., Principal investigator, CENTOGENE GmbH Rostock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357496
- Sponsor's protocol ID
- COVER-2020
- Acronym
- COVeR
- Status last verified
- May 2021
- First submitted
- 20 Apr 2020
- Last updated
- 19 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Epidemic Response Study: A National Observational Longitudinal Non-Interventional Protocol
- ClinicalTrials.gov ID
- NCT04357496
- Acronym / sponsor ID
- COVeR / COVER-2020
- Keywords
- COVID-19
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: study has never been started and was decided to be cancelled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CENTOGENE GmbH RostockIndustry (pharma, biotech, devices)
- Study start
- May 2021 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 22 Apr 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.
A national, observational, longitudinal, non-interventional program aiming to identify prognostic parameters, to investigate the kinetics of the immune response, and to identify predictive biomarkers in SARS-CoV-2 infected patients.
Detailed description
By 31st December 2019, 27 subjects with pneumonia of unknown aetiology were registered in Wuhan City, China. 7th of January the disease causative agent was identified and turned to be severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The WHO named the disease - coronavirus disease (COVID-19). On March 11, 2020, the World Health Organization (WHO) announced that COVID-19 should be characterized as a pandemic. At great economic cost, many countries have adopted unprecedented measures to curb the spread of the virus, such as large-scale use of isolation and quarantine, closing borders, imposing limits on public gatherings, and implementing nationwide lockdowns.
The most common symptoms of COVID-19 are fever, tiredness, and dry cough. Some patients may exhibit nasal congestion, runny nose, sore throat or diarrhea. These symptoms are usually mild and begin gradually. About 40% of the symptomatic patients recover from the disease without needing special treatment. Around 1 out of every 6 people infected with SARS-CoV-2 becomes seriously ill and develops difficulty breathing. Older people, and those with underlying medical problems like high chronic cardiovascular and respiratory disease or diabetes, are more likely to develop serious illness.
Monitoring patients with resolution of COVID-19 pneumonia is important in terms of when they should be released from isolation and discharged and to what extent this result is correlating with the clinical severity. If patients are still shedding viable coronavirus, they are likely to infect others. Therefore, quarantine for up to one month may be advisable. The optimal method for test of cure most likely will be two consecutive negative real-time RT-PCR tests. Furthermore, people who have cleared SARS-CoV-2 could have developed specific antibodies against the infectious agent in their blood plasma as a result of humoral immune response. This plasma is rich with specific antibodies and is called convalescent plasma (CP) or convalescent serum (CS). CP could treat and eradicate SARS-CoV-2 in infected individuals and could be used as therapy. This therapy concept was centuries old and was previously attempted during several outbreaks. Currently, there are few reports from China and South Korea showing that patients who received CP transfusion together with antiviral drugs and corticosteroids have recovered from the disease.
It is the aim of the COVeR study to enroll 400 patients with COVID-19 from nursing homes of the german state Mecklenburg-Vorpommern. Each patient will enter a follow-up phase of 6 months during which buccal swaps will be collected for judging the viral load, and blood samples for investigation of their immune response and identifying predictive biomarkers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with SARS-COV-2 | – | –Participants tested positive for SARS-COV-2 aged 60 years or older |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with SARS-C0V-2
Key inclusion criteria (3 listed)
- Informed consent is obtained from the participant/legal guardian
- Participant has been identified to be positive for SARS-C0V-2
- The participant is 60 years old or older
Key exclusion criteria (3 listed)
- The informed consent is not obtained from the participant/legal guardian
- Participant has not been identified to be positive for SARS-C0V-2
- The participant is younger than 60 years of age
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
Identification of prognostic parameters for SARS-CoV-2 infected participants.
Time frame: 7 months
Blood samples drawn from the infected participants will be analysed for prognostic parameters.
1 secondary outcome
Investigation of the kinetics of immune activation and antibody production against SARS-CoV-2 and correlation with clinical course
Time frame: 7 months
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 19 May 2021.
- CENTOGENE is a rare disease company focused on transforming clinical, genetic, and biochemical data into medical solutions for patientsLink provided by the sponsor.
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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.
Arndt Rolfs, Prof. principal investigator
CENTOGENE GmbH Rostock
Questions about this trial
What is this clinical trial studying?
An observational study of Fever and Pneumonia, run by CENTOGENE GmbH Rostock.
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 3 inclusion and 3 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 19 May 2021. 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?
Identification of prognostic parameters for SARS-CoV-2 infected participants. (time frame: 7 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 19 May 2021.