- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04364711
EuRopean Study of MAjor Infectious Disease Syndromes Related to COVID-19 (MERMAIDS 2)
Multi-centre EuRopean Study of MAjor Infectious Disease Syndromes (MERMAIDS) - Acute Respiratory Infections (MERMAIDS ARI) 2.0
Background Rapid European COVID-19 Emergency Research response (RECoVER), is a project involving 10 international partners that has been selected for funding by the European Union under the Horizon 2020 research framework responding to call topic SC1-PHE-CORONAVIRUS-2020: Advancing knowledge for the clinical and public health response to the SARS-CoV-2 epidemic. MERMAIDS 2.0 is the hospital care study within RECOVER.
Rationale Detailed patient-oriented studies are needed to determine the spectrum of SARS-CoV-2 disease and the combined influences of age, comorbidities and pathogen co-infections on the development of severe disease, together with virological and immunological profiles. This research is key to understanding the pathophysiology and epidemiology of this new disease, as well as to identifying potential targets for therapeutic or preventive interventions.
Objective To establish the prevalence, disease spectrum and severity, clinical features, risk factors, spread and outcomes of novel 2019 coronavirus infection (SARS-CoV-2) in Hospital Care.
Study design Prospective observational cohort study in selected European countries.
Study population
Children and adults with 1) acute respiratory illness (ARI) presenting to hospital care during the SARS-CoV-2 epidemic (including both COVID-19 and non-COVID-19 patients) and 2) patients with confirmed COVID-19 infection, but with atypical presentation (non-ARI) or with nosocomial acquisition. Sites can optionally participate in the following tiers:
Tier 1 (Clinical data and biological sampling) - Clinical samples and data will be collected on enrolment day and then at scheduled time points.
Tier 2 (Clinical data an extended biological sampling). - incl. PBMC collection
Optional add-on study In a subset of sites and patients, COVID-19 positive patients will be followed post-discharge for 6 months to study clinical recovery and long-term sequelae Main study parameters/endpoints: Prevalence of COVID-19 among patients with acute respiratory illness. COVID-19 disease spectrum and host and pathogen risk factors for severity. Long-term sequelae of COVID-19 requiring hospital care. Proportion hospital-acquired COVID-19 infections and characteristics of nosocomial transmission.
Study Duration Scheduled 2 years and based on COVID-19 dynamics.
Nature and extent of the burden associated with participation, benefit and group relatedness This study is observational in nature. There will be no direct benefit to research participants. The study may include biological sampling in addition to sampling required for medical management. The results of the tests done on these samples may not contribute to improving the participant's health. Minimal inconvenience and discomfort to the participant may arise from study visits and biological sampling.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Tartu, Estonia
- Tartu University
-
-
-
-
-
Podgorica, Former Serbia and Montenegro
- Clinical Center of Podgorica
-
-
-
-
-
Athens, Greece
- Attikon Hospital
-
-
-
-
-
Brescia, Italy
- Brescia Hospital
-
-
-
-
-
Utrecht, Netherlands
- UMC Utrecht
-
-
-
-
-
Bucharest, Romania
- Nat.Inst. For Inf. Dis. Prof. Dr. Matei Bals
-
-
-
-
-
Belgrad, Serbia
- Clinical Center of Serbia
-
Kraljevo, Serbia
- Clinical Center of Kragujevac
-
-
-
-
-
Barcelona, Spain
- Hospital Germans Trias i Pujol
-
Málaga, Spain
- Regional Hospital de Malaga
-
Sevilla, Spain
- Hospital Virgen Macarena
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Clinical suspicion of a new episode of acute respiratory tract infection.
- Patient is admitted to hospital
- Primary reason for hospital admission is clinical suspicion of a new episode of ARI
- Onset of the following symptoms within the last 7 days: i. Sudden onset of self-reported fever OR temperature of ≥ 38°C at presentation AND ii. At least one respiratory symptom (cough, sore throat, runny or congested nose, dyspnea) AND iii. At least one systemic symptom (headache, muscle ache, sweats or chills or tiredness)
OR
Laboratory confirmed SARS-CoV-2 infection at the time of eligibility check.
Exclusion Criteria:
- Inability to obtain consent from patient or surrogate
- Previous enrollment in current study
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pneumonia Severity indexes
Time Frame: 2 years
|
2 years
|
Need for supplemental oxygen; non-invasive or invasive mechanical ventilation; extra-corporeal life support
Time Frame: 2 years
|
2 years
|
Hospital - and ICU/HCU length of stay
Time Frame: 2 years
|
2 years
|
In-hospital mortality
Time Frame: 2 years
|
2 years
|
Activities of daily life, quality of life, variations in home living status and employment status
Time Frame: 2 years
|
2 years
|
Proportion of SARS-CoV2 positive patients
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ReCoVer - MERMAIDS 2.0
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COVID-19
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention SrlCompletedPost Acute Sequelae of COVID-19 | Post COVID-19 Condition | Long-COVID | Chronic COVID-19 SyndromeItaly
-
Yang I. PachankisActive, not recruitingCOVID-19 Respiratory Infection | COVID-19 Stress Syndrome | COVID-19 Vaccine Adverse Reaction | COVID-19-Associated Thromboembolism | COVID-19 Post-Intensive Care Syndrome | COVID-19-Associated StrokeChina
-
Massachusetts General HospitalRecruitingPost Acute COVID-19 Syndrome | Long COVID | Post Acute Sequelae of COVID-19 | Long COVID-19United States
-
Indonesia UniversityRecruitingPost-COVID-19 Syndrome | Long COVID | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19Indonesia
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkNot yet recruitingPost-COVID-19 Syndrome | Long COVID | Long Covid19 | Post COVID-19 Condition | Post-COVID Syndrome | Post COVID-19 Condition, Unspecified | Post-COVID ConditionNetherlands
-
Dr. Soetomo General HospitalIndonesia-MoH; Universitas Airlangga; Biotis Pharmaceuticals, IndonesiaRecruitingCOVID-19 Pandemic | COVID-19 Vaccines | COVID-19 Virus DiseaseIndonesia
-
University of Witten/HerdeckeInstitut für Rehabilitationsforschung NorderneyCompletedPost-COVID-19 Syndrome | Long-COVID-19 SyndromeGermany
-
Jonathann Kuo, MDActive, not recruitingSARS-CoV2 Infection | Post-COVID-19 Syndrome | Dysautonomia | Post Acute COVID-19 Syndrome | Long COVID | Long Covid19 | COVID-19 Recurrent | Post-Acute COVID-19 | Post-Acute COVID-19 Infection | Post Acute Sequelae of COVID-19 | Dysautonomia Like Disorder | Dysautonomia Orthostatic Hypotension Syndrome | Post... and other conditionsUnited States
-
First Affiliated Hospital Xi'an Jiaotong UniversityShangluo Central Hospital; Ankang Central Hospital; Hanzhong Central Hospital; Yulin... and other collaboratorsRecruitingCOVID-19 | Post-COVID-19 Syndrome | Post-Acute COVID-19 | Acute COVID-19China