EuRopean Study of MAjor Infectious Disease Syndromes Related to COVID-19 (MERMAIDS 2)

May 10, 2023 updated by: MJM Bonten, UMC Utrecht

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

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This is a descriptive study of the clinical syndrome caused by SARS-CoV-2. Patients will only be considered for enrolment if appropriate local infection control and prevention measures are in place and can be maintained. In hospital, potential participants will be identified through hospital workers upon presentation at recruiting sites. The clinical research infrastructures of COMBACTE CLIN-NET will be used for site selection for an efficient establishment of a clinical network with broad European coverage providing access to a large patient population across all age groups and differing healthcare environments.

Description

Inclusion Criteria:

  1. Clinical suspicion of a new episode of acute respiratory tract infection.
  2. Patient is admitted to hospital
  3. Primary reason for hospital admission is clinical suspicion of a new episode of ARI
  4. 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:

  1. Inability to obtain consent from patient or surrogate
  2. Previous enrollment in current study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2020

Primary Completion (Actual)

December 16, 2022

Study Completion (Actual)

December 16, 2022

Study Registration Dates

First Submitted

April 20, 2020

First Submitted That Met QC Criteria

April 24, 2020

First Posted (Actual)

April 28, 2020

Study Record Updates

Last Update Posted (Actual)

May 12, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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