EuRopean Study of MAjor Infectious Disease Syndromes Related to COVID-19

NCT04364711 | Completed

• 1 other identifier: ReCoVer - MERMAIDS 2.0
• Study Type: observational
• Target: 300
• Locations: 6 countries
• Sites: 6

Brief Summary

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.

Conditions

COVID-19; SARS-CoV 2

Keywords

acute respiratory infection

Outcome Measures

Primary Outcomes (6)

• Pneumonia Severity indexes

  2 years

• Need for supplemental oxygen; non-invasive or invasive mechanical ventilation; extra-corporeal life support

  2 years

• Hospital - and ICU/HCU length of stay

  2 years

• In-hospital mortality

  2 years

• Activities of daily life, quality of life, variations in home living status and employment status

  2 years

• Proportion of SARS-CoV2 positive patients

  2 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)
• Laboratory confirmed SARS-CoV-2 infection at the time of eligibility check.

You may not qualify if:

• Inability to obtain consent from patient or surrogate
• Previous enrollment in current study

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (11)

Tartu University

Tartu, Estonia

Location

Attikon Hospital

Athens, Greece

Location

Brescia Hospital

Brescia, Italy

Location

UMC Utrecht

Utrecht, Netherlands

Location

Nat.Inst. For Inf. Dis. Prof. Dr. Matei Bals

Bucharest, Romania

Location

Clinical Center of Podgorica

Podgorica, Serbia and Montenegro

Location

Clinical Center of Serbia

Belgrade, Serbia

Location

Clinical Center of Kragujevac

Kraljevo, Serbia

Location

Hospital Germans Trias i Pujol

Barcelona, Spain

Location

Regional Hospital de Malaga

Málaga, Spain

Location

Hospital Virgen Macarena

Seville, Spain

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Medical Microbiology

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 28, 2020
• Study Start: June 18, 2020
• Primary Completion: December 16, 2022
• Study Completion: December 16, 2022
• Last Updated: May 12, 2023

Record last verified: 2023-05

Locations

GR (1); SE (1); IT (1); ES (1); NL (1); RO (1)