COVID-19 Epidemic Response Study

NCT04357496 | Withdrawn DMC

• 1 other identifier: COVER-2020
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fever; Pneumonia; Cough

Keywords

COVID-19

Outcome Measures

Primary Outcomes (1)

• Identification of prognostic parameters for SARS-CoV-2 infected participants.

  Blood samples drawn from the infected participants will be analysed for prognostic parameters.

  7 months

Secondary Outcomes (1)

• Investigation of the kinetics of immune activation and antibody production against SARS-CoV-2 and correlation with clinical course

  7 months

Other Outcomes (1)

• Identification of predictive biomarker/s for clinical course in mildly and severely affected Covid-19 patients using genomic, proteomic, and transcriptomic approach.

  7 months

Study Arms (1)

Participants with SARS-COV-2

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

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with SARS-C0V-2

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CENTOGENE GmbH Rostock: lead

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.

MeSH Terms

Conditions

Fever; Pneumonia; Cough; COVID-19

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Pneumonia, Viral; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Officials

• Arndt Rolfs, Prof.

  CENTOGENE GmbH Rostock

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 22, 2020
• Study Start: May 1, 2021
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: May 19, 2021

Record last verified: 2021-05