Multi-centre EuRopean study of MAjor Infectious Disease Syndromes (MERMAIDS) * Acute Respiratory Infections (MERMAIDS ARI) 2.0

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

Patient is admitted to hospital and fulfills selection criteria A or B and
should be able to be enrolled in the study within 48 hours after fulfilling the
eligibility criteria :

A. Patients of all ages with respiratory symptoms as reason for admission Upon
admission, all of the following:
1. Clinical suspicion of a new episode of acute respiratory tract infection
with a high probability of COVID19 diagnosis (eg. based on epidemiological
linkage or diagnostic procedures ).
2. Primary reason for hospital admission is clinical suspicion of a new episode
of ARI
3. Onset of the following symptoms within the time window of last 14days: 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).

B. Patients without respiratory symptoms as reason for admission, one of the
following:

1. Patients of all ages who have a Laboratory confirmed SARS-CoV-2 infection at
the time of eligibility check. Microbiological diagnosis should be confirmed by
molecular testing. If additional tests such as antigen detection are validated
and available at the time of inclusion, it should be confirmed by a reference
method.
This allows for additional identification of 1) severe COVID-19 cases
presenting to care but without fever, and 2) nosocomial cases of COVID-19

2. In In patients <18 years of age only:
Positive serology (and/or PCR-test) for SARS-CoV-2 AND Clinical suspicion of
Paediatric Inflammatory Multi-system Syndrome * temporally associated with
SARS-CoV 2 (PIMS-TS):
See:
https://picsociety.uk/wp-content/uploads/2020/05/PIMS-TS-Critical-Care-Clinical-
Guidance-v4.pdf

Exclusion Criteria

1.Inability to obtain consent from patient or representative
2.Patient transferred from another hospital ,being hospitalized for over 48
hours in total (applicable to patients with respiratory symptoms as reason for
admission) ,
Participation in an interventional study or other observational study will not
be considered an exclusion criteria

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Prevalence of COVID-19 among patients with acute respiratory illness.<br /><br>2. COVID-19 disease spectrum, including:<br /><br>- Severity of illness at enrolment as assessed by severity indexes<br /><br>- Proportion of cases requiring during admission: supplemental oxygen;<br /><br>non-invasive or invasive mechanical ventilation; extra-corporeal life support.<br /><br>- Duration of invasive mechanical ventilation and extra-corporeal life support,<br /><br>if applicable<br /><br>- Proportion of cases requiring Intensive Care Unit (ICU)/High Care Unit (HCU)<br /><br>admission<br /><br>- Hospital - and ICU/HCU length of stay<br /><br>- In-hospital mortality<br /><br>- Key host risk factors for disease severity and predictors of complications<br /><br>3. Proportion hospital-acquired COVID-19 infections and characteristics of<br /><br>nosocomial transmission<br /><br>4. Long-term sequelae of COVID-19 requiring hospital care (variations in<br /><br>quality of life and pulmonary function)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Exhaustive etiologic diagnosis, viral load to be correlated with severity of<br /><br>disease.<br /><br>- Phenotypic characterization of antigenic, virulence, and possible resistance<br /><br>traits<br /><br>- Study of host transcriptome, innate and adaptive immune markers in order to<br /><br>understand identify determinants of severe disease<br /><br>- Detection of pre-existing cross-reactive antibodies and development of<br /><br>specific antibodies.</p><br>

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