Primary objectives * To establish the prevalence, disease spectrum and severity, clinical features, management, risk factors, spread and outcomes of novel 2019 coronavirus infection (SARS-CoV-2) in Hospital Care in selected European countries;* To…
ID
Source
Brief title
Condition
- Viral infectious disorders
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Prevalence of COVID-19 among patients with acute respiratory illness.
2. COVID-19 disease spectrum, including:
- Severity of illness at enrolment as assessed by severity indexes
- Proportion of cases requiring during admission: supplemental oxygen;
non-invasive or invasive mechanical ventilation; extra-corporeal life support.
- Duration of invasive mechanical ventilation and extra-corporeal life support,
if applicable
- Proportion of cases requiring Intensive Care Unit (ICU)/High Care Unit (HCU)
admission
- Hospital - and ICU/HCU length of stay
- In-hospital mortality
- Key host risk factors for disease severity and predictors of complications
3. Proportion hospital-acquired COVID-19 infections and characteristics of
nosocomial transmission
4. Long-term sequelae of COVID-19 requiring hospital care (variations in
quality of life and pulmonary function)
Secondary outcome
- Exhaustive etiologic diagnosis, viral load to be correlated with severity of
disease.
- Phenotypic characterization of antigenic, virulence, and possible resistance
traits
- Study of host transcriptome, innate and adaptive immune markers in order to
understand identify determinants of severe disease
- Detection of pre-existing cross-reactive antibodies and development of
specific antibodies.
Background summary
SARS-CoV-2 outbreak was first reported in the city of Wuhan, China, on 31
December 2019 and was declared a Public Health Emergency of International
Concern (PHEIC) by WHO on 30 January 2020. On march 11th t the global COVID-19
outbreak was described as a pandemic. On March 13th, the WHO declared that
Europe was the epicenter of the COVID-19 epidemic, with the largest number of
cases reported from Italy. Since then the speed and scale of transmission has
been increasing. To date (WHO dashboard updated 08_04 8h) more than one million
cases have now been reported to WHO, from more than 200 countries and
territories. The number of cases in other European countries has been rapidly
increasing with Spain and Germany following Italy but also the United States of
America are now in third position in number of cases. Fierce measures to slow
the spread of the epidemic are being taken in many European countries. It is
expected that these measure will, at least to some extent, *flatten the
epidemic curve** by spreading out the number of new infections over a longer
period of time. Europe has to prepare itself for a prolonged period of
SARS-CoV-2 circulation in the population. In the meantime, it is crucial and
extremely urgent that we gain further insight in the clinical disease course
and risk factors of COVID-19 in European population and identify those
individuals most at risk for severe disease, who should be prioritized for
medical and preventive interventions, once these become available.
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. RECoVER responds to
call topic SC1-PHE-CORONAVIRUS-2020: Advancing knowledge for the clinical and
public health response to the SARS-CoV-2 epidemic and builds on many years of
investment by the European Commission in clinical research preparedness for
epidemic response. RECoVER will address the most urgent questions for patient
and public health by conducting medical research to address key knowledge gaps,
such as those about best approaches to prevent further spread of the disease
and about the virus interactions with the human host. In this way, RECOVER will
provide scientific evidence that can be used by clinical, public health and
policy decision-makers about how best to protect health and save lives. These
efforts will complement ongoing research in China and other parts of the
world.
Study objective
Primary objectives
* To establish the prevalence, disease spectrum and severity, clinical
features, management, risk factors, spread and outcomes of novel 2019
coronavirus infection (SARS-CoV-2) in Hospital Care in selected European
countries;
* To determine the risk of hospital-acquired SARS-CoV-2 infection during the
COVID-19 epidemic in Europe.
* To determine the long-term sequelae of COVID-19 requiring hospital care.
Secondary objectives
* To collect the appropriate clinical samples for the study of pathogen
replication and excretion within the host, and identify determinants of
severity
* To collect the appropriate samples for studying the host responses to
infection and therapy over time, including innate and acquired immune
responses, circulating levels of immune signalling molecules and gene
expression profiling in peripheral blood, as well as
* To identify host genetic variants associated with disease progression or
severity
* To determine infectivity and appropriate infection control measures
* To develop clinical guidance documents and offer clinical recommendations to
policy makers on the basis of evidence obtained
Study design
Prospective observational cohort study. An outbreak involving a pathogen of
public health interest or pandemic is an emergency. Patients of all ages
presenting to the Emergency Room or admitted in hospital suspected of or
diagnosed with SARS-CoV-2 infection are eligible.
Study burden and risks
Participation in this research study poses a minimal risk of inconvenience.
Risks are limited to discomfort resulting from phlebotomy procedures,
respiratory swabs, and pulmonary function tests in some individuals.
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. The results of this study will not be available in
time to contribute to the participant's care. Where possible, test results with
potential relevance to patient care will be informed to the participant and/or
treating doctor.
Staff who enrol, examine and take samples from study patients are at risk of
infection. Care of study participants will require increased sampling and
contact frequency added to normally heavy clinical workloads. All staff must be
trained in recognised infection control measures and have ready access to
appropriate personal protective equipment. In collaboration with the public
health authorities, there will be on-going communication with hospital staff to
ensure the appropriate training is given, to support the work and to ensure
that there is no excess burden on the health system. Where appropriate,
dedicated research staff will be available to support the study activities.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04364711 |
| CCMO | NL73771.041.20 |