COVID-19MERMAIDS 2NCT04364711
EuRopean Study of MAjor Infectious Disease Syndromes Related to COVID-19
An observational study of COVID-19 and SARS-CoV 2, run by UMC Utrecht at 11 sites in 8 countries.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19, SARS-CoV 2
- How many people
- 300 participants
- Where
- 11 sitesin 8 countries
- Study dates
- 18 Jun 2020to 16 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
- OR
- Laboratory confirmed SARS-CoV-2 infection at the time of eligibility check.
Who cannot join
- Inability to obtain consent from patient or surrogate
- Previous enrollment in current study
Trial locations and contacts
11 sites in 8 countries.
11 sites in 8 countries
Spain3 sites
Hospital Germans Trias i Pujol
Barcelona
Regional Hospital de Malaga
Málaga
Hospital Virgen Macarena
Seville
Serbia2 sites
Clinical Center of Serbia
Belgrade
Clinical Center of Kragujevac
Kraljevo
Serbia and Montenegro1 site
Clinical Center of Podgorica
Podgorica
About this study
Official title: 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.
Read more
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
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Pneumonia Severity indexes
Measured: 2 years
Need for supplemental oxygen; non-invasive or invasive mechanical ventilation; extra-corporeal life support
Measured: 2 years
Hospital - and ICU/HCU length of stay
Measured: 2 years
In-hospital mortality
Measured: 2 years
Activities of daily life, quality of life, variations in home living status and employment status
Measured: 2 years
Proportion of SARS-CoV2 positive patients
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start18 Jun 2020
- Primary completion16 Dec 2022
- Study completion16 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MJM Bonten, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04364711
- Sponsor's protocol ID
- ReCoVer - MERMAIDS 2.0
- Acronym
- MERMAIDS 2
- Status last verified
- May 2023
- First submitted
- 20 Apr 2020
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-centre EuRopean Study of MAjor Infectious Disease Syndromes (MERMAIDS) - Acute Respiratory Infections (MERMAIDS ARI) 2.0
- ClinicalTrials.gov ID
- NCT04364711
- Acronym / sponsor ID
- MERMAIDS 2 / ReCoVer - MERMAIDS 2.0
- Conditions
- COVID-19, SARS-CoV 2
- Keywords
- acute respiratory infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- 18 Jun 2020 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 16 Dec 2022 (actual)
- First posted
- 28 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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)
- OR
Key exclusion criteria (2 listed)
- Inability to obtain consent from patient or surrogate
- Previous enrollment in current study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pneumonia Severity indexes
Time frame: 2 years
Need for supplemental oxygen; non-invasive or invasive mechanical ventilation; extra-corporeal life support
Time frame: 2 years
Hospital - and ICU/HCU length of stay
Time frame: 2 years
In-hospital mortality
Time frame: 2 years
Activities of daily life, quality of life, variations in home living status and employment status
Time frame: 2 years
Proportion of SARS-CoV2 positive patients
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and SARS-CoV 2, run by UMC Utrecht at 11 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Spain, Serbia, Estonia, Greece, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pneumonia Severity indexes (time frame: 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.