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COVID-19 Epidemic Response Study (COVeR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04357496
Recruitment Status : Withdrawn (study has never been started and was decided to be cancelled.)
First Posted : April 22, 2020
Last Update Posted : May 19, 2021
Information provided by (Responsible Party):

Brief 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.

Condition or disease
Fever Pneumonia Cough

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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: COVID-19 Epidemic Response Study: A National Observational Longitudinal Non-Interventional Protocol
Estimated Study Start Date : May 2021
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

Participants with SARS-COV-2
Participants tested positive for SARS-COV-2 aged 60 years or older

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Investigation of the kinetics of immune activation and antibody production against SARS-CoV-2 and correlation with clinical course [ Time Frame: 7 months ]
    Systems from Abbott and Euroimmun will be used for IgG and IgM in SARS-CoV-2.

Other Outcome Measures:
  1. Identification of predictive biomarker/s for clinical course in mildly and severely affected Covid-19 patients using genomic, proteomic, and transcriptomic approach. [ Time Frame: 7 months ]
    Genomic, proteomic, and transcriptomic analyses will be performed on the blood samples drawn from Covid-19 infected participants over the course of 6 months.

Biospecimen Retention:   Samples With DNA
Buccal swabs and blood draws. Buccal swabs will be taken once per week within the first 4 weeks. Blood samples will be taken once a week for the first 6 weeks, and then once per month for the following 4.5 months.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants with SARS-C0V-2

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04357496

Sponsors and Collaborators
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Principal Investigator: Arndt Rolfs, Prof. CENTOGENE GmbH Rostock
Additional Information:
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Responsible Party: CENTOGENE GmbH Rostock Identifier: NCT04357496    
Other Study ID Numbers: COVER-2020
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: May 19, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CENTOGENE GmbH Rostock:
Additional relevant MeSH terms:
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Respiratory Tract Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases