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

COVID-19 Clinical Trial

— MERMAIDS 2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04364711
• Other study ID #: ReCoVer - MERMAIDS 2.0
• Status: Completed
• Start date: June 18, 2020
• Est. completion date: December 16, 2022

Study information

• Verified date: May 2023
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 16, 2022
• Est. primary completion date: December 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Infections
• SARS-CoV 2

Locations

Country	Name	City	State
Estonia	Tartu University	Tartu
Former Serbia and Montenegro	Clinical Center of Podgorica	Podgorica
Greece	Attikon Hospital	Athens
Italy	Brescia Hospital	Brescia
Netherlands	UMC Utrecht	Utrecht
Romania	Nat.Inst. For Inf. Dis. Prof. Dr. Matei Bals	Bucharest
Serbia	Clinical Center of Serbia	Belgrad
Serbia	Clinical Center of Kragujevac	Kraljevo
Spain	Hospital Germans Trias i Pujol	Barcelona
Spain	Regional Hospital de Malaga	Málaga
Spain	Hospital Virgen Macarena	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Countries where clinical trial is conducted

Estonia,  Former Serbia and Montenegro,  Greece,  Italy,  Netherlands,  Romania,  Serbia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pneumonia Severity indexes		2 years
Primary	Need for supplemental oxygen; non-invasive or invasive mechanical ventilation; extra-corporeal life support		2 years
Primary	Hospital - and ICU/HCU length of stay		2 years
Primary	In-hospital mortality		2 years
Primary	Activities of daily life, quality of life, variations in home living status and employment status		2 years
Primary	Proportion of SARS-CoV2 positive patients		2 years