EuRopean Study of MAjor Infectious Disease Syndromes Related to COVID-19
EuRopean Study of MAjor Infectious Disease Syndromes Related to COVID-19
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 0 (Clinical data collection only) - Clinical data will be collected but no biological
 samples will be obtained for research purposes. Summary of the illness episode and outcome,
 including a selection of risk factors and comorbidities and medications.

 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).

 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.
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