COVIDEuroECMO-COVIDNCT04366921
European/Euro-ELSO Survey on Adult and Neonatal/ Pediatric COVID-19 Patients in ECMO
An observational study of COVID and SARS-CoV-2, run by Maastricht University Medical Center at 97 sites in 19 countries.
Trial summary
In the last 10 years, severe acute respiratory infection (SARI) was responsible of multiple outbreaks putting a strain on the public health worldwide. Indeed, SARI had a relevant role in the development of pandemic and epidemic with terrible consequences such as the 2009 H1N1 pandemic which led to more than 200.000… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID, SARS-CoV-2, ARDS, Human
- How many people
- 150 participants
- Where
- 97 sitesin 19 countries
- Study dates
- 10 Apr 2020to Apr 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: patients with confirmed COVID-19 infection who require ECMO support
Who may be able to join
- Laboratory-confirmed COVID-19 infection by real-time PCR (polymerase chain reaction)
- ECMO for treatment severe lung disease COVID-19 related
Who cannot join
- Patients treated with ECMO for other concomitant causes.
Trial locations and contacts
97 sites in 19 countries.
97 sites in 19 countries
Italy23 sites, 23 recruiting
- Recruiting
San Giorgio Clinic
Alessandria
Sandrelli Luca, Dr.
- Recruiting
Ospedali Riuniti Ancona
Ancona
Roberto Carozza
- Recruiting
Papa Giovanni XXIII Hospital
Bergamo
Davide Ghitti, Dr.
- Recruiting
St. Orsola Hospital
Bologna
Antonio Loforte, Dr.
- Recruiting
Azienda Ospedaliera Spedali Civili di Brescia
Brescia
Giovanni Chiarini, Dr.
- Recruiting
Ospedale Maurizio Bufalini
Cesena
Allesandro Circelli, Dr.
- Recruiting
Gaslini Children's Hospital
Genoa
Andrea Moscatelli
- Recruiting
G. Pasquinucci Heart Hospital, Massa
Massa
Paolo Del Sarto
- Recruiting
Niguarda Hospital
Milan
Paolof Meani, Dr.
Antioco Cappai, Dr.
- Recruiting
Ospedale San Donato
Milan
Dario Fina, Dr.
Marco Ranucci, Dr.
- Recruiting
San Raffaele University Hospital, Italy
Milan
Giovenni Landoni
Mara Scandroglio
- Recruiting
Policlinico Hospital Milan
Milan
Giacomo Cavallaro
- Recruiting
San Gerardo Hospital
Monza
Marco Giani, Dr.
Roberto Rona, Dr.
- Recruiting
IRCCS Policlinico S. Matteo
Pavia
Mirko Belliato, Dr.
Antonella Degani
- Recruiting
GVM Care & Research
Puglia
Ignazio Condello
Marco Moscarelli, Dr.
- Recruiting
Bambino Gesù Hospital and Research Institute
Roma
Matteo Di Nardo
- Recruiting
San Camillo Hospital, Rome
Roma
Andrea Montalto, Dr.
- Recruiting
A.O.U. Città della Salute e della Scienza - Molinette Hospital
Turin
Vito Fanelli, Dr.
- Recruiting
Mauriziano Umberto I Hospital
Turin
Maria Elena De Piero, Dr.
- Recruiting
Ospedale S. Giovanni Bosco
Turin
Maria Elena De Piero, Dr.
- Recruiting
University Hospital, Udine, Italy
Udine
Sandro Sponga, Dr.
- Recruiting
Ospedale dell'Angelo, Venezia-Mestre
Venice
Reina Gianfranco, Dr.
- Recruiting
Ospedale San Bortolo di Vicenza
Vicenza
Marco Piccichè
Germany13 sites, 13 recruiting
- Recruiting
University Hospital, Aachen
Aachen
Alexander Kersten, Dr.
- Recruiting
German Heart Center
Berlin
Felix Hennig, Dr.
- Recruiting
Universitätsklinikum Köln
Cologne
Simone Schafer, Dr.
- Recruiting
Universitätsklinikum Düsseldorf
Düsseldorf
Udo Boeken, Prof.
- Recruiting
Children's Medical Hospital, University of Essen, Essen, Germany
Essen
Malaika Mendoca
- Recruiting
University Hospital, Essen
Essen
Matthias Thielman, Prof.
- Recruiting
University Heart Center Freiburg - Bad Krozingen
Freiburg im Breisgau
David Schibilsky, Dr.
Sven Maier, Dr.
- Recruiting
Hannover Medical School
Hanover
Jan Schmitto, Prof.
Christian Napp, Dr.
- Recruiting
Klinikum Kassel
Kassel
Ralf Muellenbach, Prof
Torje Iuliu, Dr.
- Recruiting
Heart Center Leipzig - University Hospital
Leipzig
Diyar Saeed, Prof.
- Recruiting
Klinikum Nürnberg
Nuremberg
Justyna Swol, Dr.
- Recruiting
University Hospital Regensburg
Regensburg
Maximillian Malfertheiner, Dr.
Esther Dreier, Dr.
- Recruiting
University Hospital Tuebingen
Tübingen
Philipp Hen, Dr.
Aron Frederik Popov, Prof.
Belgium11 sites, 11 recruiting
- Recruiting
Onze Lieve Vrouwziekenhuis Aalst
Aalst
Bernard Stockman, Dr.
- Recruiting
University Hospital, Antwerp
Antwerp
Gerdy Debeuckelaere
- Recruiting
Centre Hospitalier Universitaire Saint Pierre
Brussels
Olivier Germay
- Recruiting
Chirec
Brussels
Daniel De Backer, Dr.
- Recruiting
Erasme University Hospital
Brussels
Fabio Taccone, Prof.
- Recruiting
Universitair Ziekenhuis Brussel
Brussels
Dimitri Vandeweghe
- Recruiting
Hôpital Civil Marie Curie de Charleroi
Charleroi
Patrick Biston, Dr.
Michael Piagnerelli
- Recruiting
University Hospital, Ghent
Ghent
Harlinde Peperstraete
- Recruiting
La Louvière Hopital
La Louvière
Romain Courcelle
- Recruiting
Universitaire Ziekenhuizen Leuven
Leuven
Leen Vercaemst, Dr.
- Recruiting
CHU de Liege
Liège
Marc Lagny
France7 sites, 7 recruiting
- Recruiting
University Hospital, Bordeaux
Bourdeaux
Olivier Brissaud
- Recruiting
Hospices Civils de Lyon
Lyon
Matteo Pozzi, Dr.
- Recruiting
University Hospital, Montpellier
Montpellier
Phillipe Gaudard
- Recruiting
Henri Mondor University Hospital
Paris
Gabriel Saiydoun, Dr.
- Recruiting
Paris South University Hospitals
Paris
Pierre Tissieres
- Recruiting
Pitié-Salpêtrière Hospital
Paris
Alain Combes, Prof.
Thierry Folliguet, Prof.
- Recruiting
Rennes University Hospital
Rennes
Alessandro Paradiso, Dr.
Russia7 sites, 7 recruiting
- Recruiting
Chelyabinsk Regional Clinical Hospital
Chelyabinsk
Alexandr Turchaninov
- Recruiting
Kemerovo Regional Clinical Cardiological Center named after academician L.S. Barbarash
Kemerovo
Roman Komelyuk
- Recruiting
Krasnodar Regional Hospital no 1
Krasnodar
Alexander Skopets
- Recruiting
City Clinical Hospital No. 67, Moscow, Russia
Moscow
Ivan Akufov
Alexandra Shilova
- Recruiting
Novosibirsk City Hospital #2
Novosibirsk
Igor Komilov
- Recruiting
City Hospital No 40, Saint Petersburg, Russia
Saint Petersburg
Daniil Shelukhin
Sergei Minin
- Recruiting
City Hospital No 41, Ekaterinburg, Russia
Yekaterinburg
Alexandr Turchaninov
Switzerland7 sites, 7 recruiting
- Recruiting
University Hospital, Basel, Switzerland
Basel
Thomas Doebele
- Recruiting
University of Bern
Bern
Jolanda Consiglio
Jenni Hansjoerg
- Recruiting
University Hospital, Geneva
Geneva
Angelo Polito
- Recruiting
University of Lausanne Hospitals
Lausanne
Xavier Bechtold
- Recruiting
Cardiocentro Ticino
Lugano
Gianluca Agus, Dr.
- Recruiting
Klinik Hirslanden, Zurich
Zurich
Halbe Maximillian, Dr.
- Recruiting
University of Zurich
Zurich
Alberto Weber, Prof. Dr.
Grünenfelder Jürg, Prof. Dr.
United Kingdom6 sites, 6 recruiting
- Recruiting
Royal Brompton & Harefield NHS Foundation Trust
Brompton
Verna Aquino
- Recruiting
Paediatric Intensive Care Glasgow
Glasgow
Mark Davidson
- Recruiting
Leicester Children's Hospital
Leicester
Claire Westrope
- Recruiting
Great Ormond Street Hospital for Children NHS Foundation Trust
London
Katherine Brown
- Recruiting
Guy's and St Thomas' NHS Foundation Trust
London
Nicholas Bartlett, Dr.
- Recruiting
Newcastle-upon-Tyne Hospitals NHS Trust
Newcastle upon Tyne
Judit Llevadias
Netherlands5 sites, 5 recruiting
- Recruiting
University of Groningen
Groningen
Martin Kneyber
- Recruiting
Leiden University Medical Center
Leiden
Dario Candura, Dr.
Jacinta Maas, Dr.
- Recruiting
Maastricht University Medical Center
Maastricht
Lorusso, Prof. Dr.
Lo Coco, Drs.
- Recruiting
Erasmus Medical Center
Rotterdam
Dinis Reis Miranda, Dr.
- Recruiting
UMC Utrecht
Utrecht
J.J. van der Heijden, Dr.
Spain4 sites, 4 recruiting
- Recruiting
Hospital Sant Joan de Deu
Barcelona
Susana Segura Matute
- Recruiting
Hospital Vall d'Hebron
Barcelona
Jordi Riero del Brio, Dr.
- Recruiting
Hospital Universitario Ramon y Cajal
Madrid
Aaron Blandino, Ortiz
- Recruiting
Hospital Miguel Servet
Zaragoza
Pablo Ruiz, Dr.
Austria3 sites, 3 recruiting
- Recruiting
Universitätskliniken Innsbruck
Innsbruck
Nikolaos Bonaros, Prof.
Christoph Krapf, Dr.
- Recruiting
Landesklinikum Sankt Polten
Sankt Pölten
Nikolaos Bonaros, Prof.
- Recruiting
Medical University of Vienna
Vienna
Peter Schellongowski, Dr.
Czechia2 sites, 2 recruiting
- Recruiting
Charles University, Czech Republic
Prague
Vaclav Vobruba
- Recruiting
General University Hospital, Prague
Prague
Jan Belohlavek, Prof.
Sweden2 sites, 2 recruiting
- Recruiting
Lund University Hospital
Lund
Edgars Grins
- Recruiting
Karolinska University Hospital
Stockholm
Lars Broman, Dr.
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen University Hospital at Herlev
Copenhagen
Finn Moeller Pedersen, Dr.
Greece1 site, 1 recruiting
- Recruiting
University Hospital, Alexandroupolis
Alexandroupoli
Dimitrios Soufleris
Hungary1 site, 1 recruiting
- Recruiting
Heim Pal Children's Hospital
Budapest
Veronika Maraczi
Israel1 site, 1 recruiting
- Recruiting
ECMO Centers Israel
Jerusalem
Maged Makhoul, Dr.
Gil Bolotin, Dr.
Lithuania1 site, 1 recruiting
- Recruiting
Vilnius University Hospital Santaros Klinikos
Vilnius
Robertas Samalavicius, Dr.
Poland1 site, 1 recruiting
- Recruiting
Medical University of Warsaw
Warsaw
Mariusz Kowaleswsky, Dr.
Portugal1 site, 1 recruiting
- Recruiting
Hospital Sao Joao
Porto
Luis Filipe Pinto, Dr.
About this study
Official title: European/Euro-ELSO Survey on Adult and Neonatal/ Pediatric COVID Patients in ECMO
In the last 10 years, severe acute respiratory infection (SARI) was responsible of multiple outbreaks putting a strain on the public health worldwide. Indeed, SARI had a relevant role in the development of pandemic and epidemic with terrible consequences such as the 2009 H1N1 pandemic which led to more than 200.000 respiratory deaths globally.
In late December 2019, in Wuhan, Hubei, China, a new respiratory syndrome emerged with clinical signs of viral pneumonia and person-to-person transmission. Tests showed the appearance of a novel coronavirus, namely the 2019 novel coronavirus (COVID-19). Two other strains, the severe acute respiratory syndrome coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV) have caused severe respiratory illnesses, sometimes fatal. In particular, the mortality rate associated with SARS-CoV and MERS-CoV, was of 10% and 37% respectively.
Read more
Even though COVID-19 appeared from the first time in China, quickly it spread worldwide and cases have been described in other countries such as Thailand, Japan, South Korea, Germany, Italy, France, Iran, USA and many other countries. An early paper reported 41 patients with laboratory-confirmed COVID-19 infection in Wuhan. The median age of the patients was 49 years and mostly men (73%). Among those, 32% were admitted to the ICU because of the severe hypoxemia. The most associated comorbidities were diabetes (20%), hypertension (15%), and cardiovascular diseases (15%). On admission, 98% of the patients had bilateral multiple lobular and sub-segmental areas of consolidation. Importantly, acute respiratory distress syndrome (ARDS) developed in 29% of the patients, while acute cardiac injury in 12%, and secondary infection in 10%. Invasive mechanical ventilation was required in 10% of those patients, and two of these patients (5%) had refractory hypoxemia and received extracorporeal membrane oxygenation (ECMO). In a later retrospective report by Wang and collaborators, clinical characteristics of 138 patients with COVID-19 infection were described. ICU admission was required in 26.1% of the patients for acute respiratory distress syndrome (61.1%), arrhythmia (44.4%), and shock (30.6%). ECMO support was needed in 11% of the patients admitted to the ICU. During the period of follow-up, overall mortality was 4.3%.
The use of ECMO in COVID-19 infection is increasing due to the high transmission rate of the infection and the respiratory-related mortality.
Therefore, the investigators believe that ECMO in case of severe interstitial pneumonia caused by COVID could represent a valid solution in order to avoid lung injuries related to prolonged treatment with non-invasive and invasive mechanical ventilation. In addition, ECMO could have a role for the systemic complications such as septic and cardiogenic shock as well myocarditis scenarios. Potential clinical effects and outcomes of the ECMO support in the novel coronavirus pandemic will be recorded and analyzed in our project.
The researchers hypothesize that a significant percentage of patients with COVID-19 infection will require the utilize of ECMO for refactory hypoxemia, cardiogenic shock or septic shock. This study seeks to prove this hypothesis by conducting an observational retrospective/prospective study of patients in the ICU who underwent ECMO support and describe clinical features, severity of pulmonary dysfunction and risk factors of COVID-patients who need ECMO support, the incidence of ECMO use, ECMO technical characteristics, duration of ECMO, complications and outcomes of COVID-patients requiring ECMO support.
- Conditions
- COVID, SARS-CoV-2, ARDS, Human, Refractory Hypoxemia, Cardiogenic Shock, Septic Shock
- Medical subject headings
- Respiratory Distress Syndrome, Hypoxia, Shock, Cardiogenic, Shock, Septic
What is being measured
The primary outcome is the main question the study is designed to answer.
Age
age in years
Measured: at baseline
Gender
male/female
Measured: at baseline
Weight
in kilograms
Measured: at baseline
Height
in meters
Measured: at baseline
BMI
weight and height combined to calculate BMI in kg/m^2
Measured: at baseline
Pre-existing pulmonary disease y/n
Asthma y/n, cystic fibrosis y/n, chronic obstructive pulmonary disease y/n, pulmonary hypertension y/n, pulmonary fibrosis y/n, chronic restrictive lung disease y/n
Measured: at baseline
Main co-morbidities y/n
diabetes mellitus y/n, chronic renal failure y/n, ischemic heart disease y/n, heart failure y/n, chronic liver failure y/n, neurological impairment y/n
Measured: at baseline
Date of signs of COVID-19 infection
in dd-mm-yyyy or mm-dd-yyyy
Measured: at baseline or date of occurence
Date of positive swab
in dd-mm-yyyy or mm-dd-yyyy
Measured: at baseline or date of occurence
Pre-ECMO length of hospital stay
in days
Measured: at or during ECMO-implant
Pre-ECMO length of ICU stay
in days
Measured: at or during ECMO-implant
Pre-ECMO length of mechanical ventilation days
in days
Measured: at or during ECMO-implant
Use of antibiotics
y/n, what kind
Measured: up to 6 months
Use of anti-viral treatment
y/n, what kind
Measured: up to 6 months
Use of second line treatment
y/n, what kind (eg prone-position, recruitment manoeuvers, neuromuscular blockade etc)
Measured: up to 6 months
Indications for ECMO-implant
respiratory or cardiac
Measured: at ECMO-implant
Type of ECMO-implant
veno-venous, veno-arterial or veno-venoarterial
Measured: at ECMO-implant
Type of access
peripheral or central
Measured: at ECMO-implant
Date of ECMO implant
in dd-mm-yyyy or mm-dd-yyyy
Measured: at ECMO-implant
ECMO blood flow rate
l/min
Measured: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months
ECMO gas flow rate
l/min
Measured: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months
ECMO configuration change
y/n
Measured: up to 6 months
Date of ECMO configuration change
in dd-mm-yyyy or mm-dd-yyyy
Measured: up to 6 months
New ECMO configuration
veno-venous, veno-arterial, veno-venoarterial, other
Measured: up to 6 months
Indications for ECMO configuration change
right ventricular failure, left ventricular failure, refractory hypoxemia
Measured: up to 6 months
Ventilator setting on ECMO
settings of ventilator
Measured: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months
Anticoagulation during ECMO
heparin, bivalirudin, nothing
Measured: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months
Frequency of ECMO circuit change
amount of ECMO circuit changes (1, 2, 3 etc.)
Measured: up to 6 months
ECMO complications
Hemorrhagic, infection, other complications
Measured: up to 6 months
ECMO Weaning
y/n
Measured: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months
ICU discharge
y/n, date
Measured: from day of ICU-admission for every 24 hours until date of discharge or death, up to 6 months
Main cause of death
Measured: 6 months
Type of discharge
Ward, another ICU, rehabilitation center, home
Measured: up to 6 months
Alive/deceased
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start10 Apr 2020
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- European chapter of the Extracorporeal Life Support Organization, Erasmus Medical Center, Leiden University Medical Center, UMC Utrecht, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Papa Giovanni XXIII Hospital, Niguarda Hospital, Ospedale San Donato, Ospedale S. Giovanni Bosco, Fondazione IRCCS Policlinico San Matteo di Pavia, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, Ospedale dell'Angelo, Venezia-Mestre, University Hospital, Udine, Italy, San Gerardo Hospital, Ospedali Riuniti Ancona, San Camillo Hospital, Rome, San Giorgio Clinic, GVM Care & Research, San Raffaele University Hospital, Italy, Ospedale San Bortolo di Vicenza, Klinik Hirslanden, Zurich, University of Zurich, Cardiocentro Ticino, Vilnius University Hospital Santaros Klinikos, University Düsseldorf, Klinikum Nürnberg, Hannover Medical School, Heart Center Leipzig - University Hospital, University Hospital Regensburg, University Hospital, Essen, German Heart Center, University Hospital, Aachen, University Heart Center Freiburg - Bad Krozingen, Klinikum Kassel, General University Hospital, Prague, Universitaire Ziekenhuizen KU Leuven, Onze Lieve Vrouwziekenhuis Aalst, Erasme University Hospital, University Hospital, Antwerp, Hôpital Civil Marie Curie de Charleroi, University Hospital, Ghent, Centre Hospitalier Universitaire Saint Pierre, Hospital Vall d'Hebron, Hospital Universitario Ramon y Cajal, Hospital Miguel Servet, Henri Mondor University Hospital, Hospices Civils de Lyon, Pitié-Salpêtrière Hospital, Rennes University Hospital, Guy's and St Thomas' NHS Foundation Trust, Karolinska University Hospital, Hospital Sao Joao, Medical University of Warsaw, Medical University Innsbruck, Medical University of Vienna, University Hospital, Alexandroupolis, Novosibirsk City Hospital #2, City Clinical Hospital No. 67, Moscow, Russia, City Hospital No 40, Saint Petersburg, Russia, Krasnodar Regional Hospital no 1, Kemerovo Regional Clinical Cardiological Center named after academician L.S. Barbarash, City Hospital No 41, Ekaterinburg, Russia, G. Pasquinucci Heart Hospital, Massa, Charles University, Czech Republic, University Hospital, Bordeaux, Bambino Gesù Hospital and Research Institute, Policlinico Hospital Milan, Gaslini Children's Hospital, Children's Medical Hospital, University of Essen, Essen, Germany, University Hospital, Geneva, Newcastle-upon-Tyne Hospitals NHS Trust, Paediatric Intensive Care Glasgow, Paris South University Hospitals, University of Groningen, Great Ormond Street Hospital for Children NHS Foundation Trust, Hospital Sant Joan de Deu, Heim Pal Children's Hospital, University Hospital, Montpellier, Royal Brompton & Harefield NHS Foundation Trust, Lund University Hospital, Landesklinikum Sankt Polten, Chelyabinsk Regional Clinical Hospital, ECMO Centers Israel, Copenhagen University Hospital at Herlev, Ospedale M. Bufalini Cesena, A.O.U. Città della Salute e della Scienza - Molinette Hospital, Mauriziano Umberto I Hospital, University of Bern, University Hospital, Basel, Switzerland, University of Lausanne Hospitals, University Hospital Tuebingen, Universitätsklinikum Köln, Chirec, Universitair Ziekenhuis Brussel, Centre Hospitalier Universitaire de Liege, La Louvière Hopital, Leicester Royal Infirmary NHS Trust
- Responsible party
- Sponsor
- Investigators
- Lorusso, Prof. Dr., Principal investigator, Maastricht University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366921
- Sponsor's protocol ID
- METC 2020-1343
- Acronym
- EuroECMO-COVID
- Status last verified
- Aug 2021
- First submitted
- 17 Apr 2020
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bolotin S, Pebody R, White PJ, McMenamin J, Perera L, Nguyen-Van-Tam JS, Barlow T, Watson JM; UK Severe Influenza Surveillance System (USISS) Steering Group. A new sentinel surveillance system for severe influenza in England shows a shift in age distribution of hospitalised cases in the post-pandemic period. PLoS One. 2012;7(1):e30279. doi: 10.1371/journal.pone.0030279. Epub 2012 Jan 23.
PubMed 22291929Dawood FS, Iuliano AD, Reed C, Meltzer MI, Shay DK, Cheng PY, Bandaranayake D, Breiman RF, Brooks WA, Buchy P, Feikin DR, Fowler KB, Gordon A, Hien NT, Horby P, Huang QS, Katz MA, Krishnan A, Lal R, Montgomery JM, Molbak K, Pebody R, Presanis AM, Razuri H, Steens A, Tinoco YO, Wallinga J, Yu H, Vong S, Bresee J, Widdowson MA. Estimated global mortality associated with the first 12 months of 2009 pandemic influenza A H1N1 virus circulation: a modelling study. Lancet Infect Dis. 2012 Sep;12(9):687-95. doi: 10.1016/S1473-3099(12)70121-4. Epub 2012 Jun 26.
PubMed 22738893Simonsen L, Spreeuwenberg P, Lustig R, Taylor RJ, Fleming DM, Kroneman M, Van Kerkhove MD, Mounts AW, Paget WJ; GLaMOR Collaborating Teams. Global mortality estimates for the 2009 Influenza Pandemic from the GLaMOR project: a modeling study. PLoS Med. 2013 Nov;10(11):e1001558. doi: 10.1371/journal.pmed.1001558. Epub 2013 Nov 26.
PubMed 24302890Chan JF, Yuan S, Kok KH, To KK, Chu H, Yang J, Xing F, Liu J, Yip CC, Poon RW, Tsoi HW, Lo SK, Chan KH, Poon VK, Chan WM, Ip JD, Cai JP, Cheng VC, Chen H, Hui CK, Yuen KY. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. Lancet. 2020 Feb 15;395(10223):514-523. doi: 10.1016/S0140-6736(20)30154-9. Epub 2020 Jan 24.
PubMed 31986261Drosten C, Gunther S, Preiser W, van der Werf S, Brodt HR, Becker S, Rabenau H, Panning M, Kolesnikova L, Fouchier RA, Berger A, Burguiere AM, Cinatl J, Eickmann M, Escriou N, Grywna K, Kramme S, Manuguerra JC, Muller S, Rickerts V, Sturmer M, Vieth S, Klenk HD, Osterhaus AD, Schmitz H, Doerr HW. Identification of a novel coronavirus in patients with severe acute respiratory syndrome. N Engl J Med. 2003 May 15;348(20):1967-76. doi: 10.1056/NEJMoa030747. Epub 2003 Apr 10.
PubMed 12690091Ksiazek TG, Erdman D, Goldsmith CS, Zaki SR, Peret T, Emery S, Tong S, Urbani C, Comer JA, Lim W, Rollin PE, Dowell SF, Ling AE, Humphrey CD, Shieh WJ, Guarner J, Paddock CD, Rota P, Fields B, DeRisi J, Yang JY, Cox N, Hughes JM, LeDuc JW, Bellini WJ, Anderson LJ; SARS Working Group. A novel coronavirus associated with severe acute respiratory syndrome. N Engl J Med. 2003 May 15;348(20):1953-66. doi: 10.1056/NEJMoa030781. Epub 2003 Apr 10.
PubMed 12690092Zaki AM, van Boheemen S, Bestebroer TM, Osterhaus AD, Fouchier RA. Isolation of a novel coronavirus from a man with pneumonia in Saudi Arabia. N Engl J Med. 2012 Nov 8;367(19):1814-20. doi: 10.1056/NEJMoa1211721. Epub 2012 Oct 17.
PubMed 23075143de Groot RJ, Baker SC, Baric RS, Brown CS, Drosten C, Enjuanes L, Fouchier RA, Galiano M, Gorbalenya AE, Memish ZA, Perlman S, Poon LL, Snijder EJ, Stephens GM, Woo PC, Zaki AM, Zambon M, Ziebuhr J. Middle East respiratory syndrome coronavirus (MERS-CoV): announcement of the Coronavirus Study Group. J Virol. 2013 Jul;87(14):7790-2. doi: 10.1128/JVI.01244-13. Epub 2013 May 15. No abstract available.
PubMed 23678167Spina S, Marrazzo F, Migliari M, Stucchi R, Sforza A, Fumagalli R. The response of Milan's Emergency Medical System to the COVID-19 outbreak in Italy. Lancet. 2020 Mar 14;395(10227):e49-e50. doi: 10.1016/S0140-6736(20)30493-1. Epub 2020 Feb 28. No abstract available.
PubMed 32119824Ebrahim SH, Memish ZA. COVID-19: preparing for superspreader potential among Umrah pilgrims to Saudi Arabia. Lancet. 2020 Mar 14;395(10227):e48. doi: 10.1016/S0140-6736(20)30466-9. Epub 2020 Feb 27. No abstract available.
PubMed 32113506Holshue ML, DeBolt C, Lindquist S, Lofy KH, Wiesman J, Bruce H, Spitters C, Ericson K, Wilkerson S, Tural A, Diaz G, Cohn A, Fox L, Patel A, Gerber SI, Kim L, Tong S, Lu X, Lindstrom S, Pallansch MA, Weldon WC, Biggs HM, Uyeki TM, Pillai SK; Washington State 2019-nCoV Case Investigation Team. First Case of 2019 Novel Coronavirus in the United States. N Engl J Med. 2020 Mar 5;382(10):929-936. doi: 10.1056/NEJMoa2001191. Epub 2020 Jan 31.
PubMed 32004427Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
PubMed 31986264Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.
PubMed 32031570De Piero ME, Mariani S, van Bussel BCT, Jarczak D, Krenner N, de la Sota EP, Silva PE, Roemmer M, Kowalewski M, Carelli S, Broman LM, Vuylsteke A, Fortuna P, Alessandri F, Martucci G, Patel BV, Lotz G, Boeken U, Maier S, Filip B, Meyns B, Haenggi M, Puss S, Schellongowski P, Kirali K, Bolotin G, Barrett N, Riera J, Mueller T, Belohlavek J, Lorusso R; EuroECMO-COVID Study Group. In-hospital outcomes and 6-month follow-up results of patients supported with extracorporeal membrane oxygenation for COVID-19 from the second wave to the end of the pandemic (EuroECMO-COVID): a prospective, international, multicentre, observational study. Lancet Respir Med. 2025 Apr;13(4):307-317. doi: 10.1016/S2213-2600(24)00369-2. Epub 2025 Feb 23.
PubMed 40010369Lorusso R, De Piero ME, Mariani S, Di Mauro M, Folliguet T, Taccone FS, Camporota L, Swol J, Wiedemann D, Belliato M, Broman LM, Vuylsteke A, Kassif Y, Scandroglio AM, Fanelli V, Gaudard P, Ledot S, Barker J, Boeken U, Maier S, Kersten A, Meyns B, Pozzi M, Pedersen FM, Schellongowski P, Kirali K, Barrett N, Riera J, Mueller T, Belohlavek J; EuroECMO-COVID Study Group. In-hospital and 6-month outcomes in patients with COVID-19 supported with extracorporeal membrane oxygenation (EuroECMO-COVID): a multicentre, prospective observational study. Lancet Respir Med. 2023 Feb;11(2):151-162. doi: 10.1016/S2213-2600(22)00403-9. Epub 2022 Nov 16.
PubMed 36402148
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European/Euro-ELSO Survey on Adult and Neonatal/ Pediatric COVID Patients in ECMO
- ClinicalTrials.gov ID
- NCT04366921
- Acronym / sponsor ID
- EuroECMO-COVID / METC 2020-1343
- Conditions
- COVID, SARS-CoV-2, ARDS, Human, Refractory Hypoxemia, Cardiogenic Shock, Septic Shock
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- European chapter of the Extracorporeal Life Support Organization, Erasmus Medical Center, Leiden University Medical Center, UMC Utrecht, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Papa Giovanni XXIII Hospital, Niguarda Hospital, Ospedale San Donato, Ospedale S. Giovanni Bosco, Fondazione IRCCS Policlinico San Matteo di Pavia, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, Ospedale dell'Angelo, Venezia-Mestre, University Hospital, Udine, Italy, San Gerardo Hospital, Ospedali Riuniti Ancona, San Camillo Hospital, Rome, San Giorgio Clinic, GVM Care & Research, San Raffaele University Hospital, Italy, Ospedale San Bortolo di Vicenza, Klinik Hirslanden, Zurich, University of Zurich, Cardiocentro Ticino, Vilnius University Hospital Santaros Klinikos, University Düsseldorf, Klinikum Nürnberg, Hannover Medical School, Heart Center Leipzig - University Hospital, University Hospital Regensburg, University Hospital, Essen, German Heart Center, University Hospital, Aachen, University Heart Center Freiburg - Bad Krozingen, Klinikum Kassel, General University Hospital, Prague, Universitaire Ziekenhuizen KU Leuven, Onze Lieve Vrouwziekenhuis Aalst, Erasme University Hospital, University Hospital, Antwerp, Hôpital Civil Marie Curie de Charleroi, University Hospital, Ghent, Centre Hospitalier Universitaire Saint Pierre, Hospital Vall d'Hebron, Hospital Universitario Ramon y Cajal, Hospital Miguel Servet, Henri Mondor University Hospital, Hospices Civils de Lyon, Pitié-Salpêtrière Hospital, Rennes University Hospital, Guy's and St Thomas' NHS Foundation Trust, Karolinska University Hospital, Hospital Sao Joao, Medical University of Warsaw, Medical University Innsbruck, Medical University of Vienna, University Hospital, Alexandroupolis, Novosibirsk City Hospital #2, City Clinical Hospital No. 67, Moscow, Russia, City Hospital No 40, Saint Petersburg, Russia, Krasnodar Regional Hospital no 1, Kemerovo Regional Clinical Cardiological Center named after academician L.S. Barbarash, City Hospital No 41, Ekaterinburg, Russia, G. Pasquinucci Heart Hospital, Massa, Charles University, Czech Republic, University Hospital, Bordeaux, Bambino Gesù Hospital and Research Institute, Policlinico Hospital Milan, Gaslini Children's Hospital, Children's Medical Hospital, University of Essen, Essen, Germany, University Hospital, Geneva, Newcastle-upon-Tyne Hospitals NHS Trust, Paediatric Intensive Care Glasgow, Paris South University Hospitals, University of Groningen, Great Ormond Street Hospital for Children NHS Foundation Trust, Hospital Sant Joan de Deu, Heim Pal Children's Hospital, University Hospital, Montpellier, Royal Brompton & Harefield NHS Foundation Trust, Lund University Hospital, Landesklinikum Sankt Polten, Chelyabinsk Regional Clinical Hospital, ECMO Centers Israel, Copenhagen University Hospital at Herlev, Ospedale M. Bufalini Cesena, A.O.U. Città della Salute e della Scienza - Molinette Hospital, Mauriziano Umberto I Hospital, University of Bern, University Hospital, Basel, Switzerland, University of Lausanne Hospitals, University Hospital Tuebingen, Universitätsklinikum Köln, Chirec, Universitair Ziekenhuis Brussel, Centre Hospitalier Universitaire de Liege, La Louvière Hopital, Leicester Royal Infirmary NHS Trust
- Study start
- 10 Apr 2020 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 29 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.
In the last 10 years, severe acute respiratory infection (SARI) was responsible of multiple outbreaks putting a strain on the public health worldwide. Indeed, SARI had a relevant role in the development of pandemic and epidemic with terrible consequences such as the 2009 H1N1 pandemic which led to more than 200.000 respiratory deaths globally.
In late December 2019, in Wuhan, Hubei, China, a new respiratory syndrome emerged with clinical signs of viral pneumonia and person-to-person transmission. Tests showed the appearance of a novel coronavirus, namely the 2019 novel coronavirus (COVID-19). Two other strains, the severe acute respiratory syndrome coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV) have caused severe respiratory illnesses, sometimes fatal. In particular, the mortality rate associated with SARS-CoV and MERS-CoV, was of 10% and 37% respectively.
Even though COVID-19 appeared from the first time in China, quickly it spread worldwide and cases have been described in other countries such as Thailand, Japan, South Korea, Germany, Italy, France, Iran, USA and many other countries. An early paper reported 41 patients with laboratory-confirmed COVID-19 infection in Wuhan. The median age of the patients was 49 years and mostly men (73%). Among those, 32% were admitted to the ICU because of the severe hypoxemia. The most associated comorbidities were diabetes (20%), hypertension (15%), and cardiovascular diseases (15%). On admission, 98% of the patients had bilateral multiple lobular and sub-segmental areas of consolidation. Importantly, acute respiratory distress syndrome (ARDS) developed in 29% of the patients, while acute cardiac injury in 12%, and secondary infection in 10%. Invasive mechanical ventilation was required in 10% of those patients, and two of these patients (5%) had refractory hypoxemia and received extracorporeal membrane oxygenation (ECMO). In a later retrospective report by Wang and collaborators, clinical characteristics of 138 patients with COVID-19 infection were described. ICU admission was required in 26.1% of the patients for acute respiratory distress syndrome (61.1%), arrhythmia (44.4%), and shock (30.6%). ECMO support was needed in 11% of the patients admitted to the ICU. During the period of follow-up, overall mortality was 4.3%.
The use of ECMO in COVID-19 infection is increasing due to the high transmission rate of the infection and the respiratory-related mortality.
Therefore, the investigators believe that ECMO in case of severe interstitial pneumonia caused by COVID could represent a valid solution in order to avoid lung injuries related to prolonged treatment with non-invasive and invasive mechanical ventilation. In addition, ECMO could have a role for the systemic complications such as septic and cardiogenic shock as well myocarditis scenarios. Potential clinical effects and outcomes of the ECMO support in the novel coronavirus pandemic will be recorded and analyzed in our project.
The researchers hypothesize that a significant percentage of patients with COVID-19 infection will require the utilize of ECMO for refactory hypoxemia, cardiogenic shock or septic shock. This study seeks to prove this hypothesis by conducting an observational retrospective/prospective study of patients in the ICU who underwent ECMO support and describe clinical features, severity of pulmonary dysfunction and risk factors of COVID-patients who need ECMO support, the incidence of ECMO use, ECMO technical characteristics, duration of ECMO, complications and outcomes of COVID-patients requiring ECMO support.
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
- patients with confirmed COVID-19 infection who require ECMO support
Key inclusion criteria (2 listed)
- Laboratory-confirmed COVID-19 infection by real-time PCR (polymerase chain reaction)
- ECMO for treatment severe lung disease COVID-19 related
Key exclusion criteria (1 listed)
- Patients treated with ECMO for other concomitant causes.
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
Age
Time frame: at baseline
age in years
Gender
Time frame: at baseline
male/female
Weight
Time frame: at baseline
in kilograms
Height
Time frame: at baseline
in meters
BMI
Time frame: at baseline
weight and height combined to calculate BMI in kg/m^2
Pre-existing pulmonary disease y/n
Time frame: at baseline
Asthma y/n, cystic fibrosis y/n, chronic obstructive pulmonary disease y/n, pulmonary hypertension y/n, pulmonary fibrosis y/n, chronic restrictive lung disease y/n
Main co-morbidities y/n
Time frame: at baseline
diabetes mellitus y/n, chronic renal failure y/n, ischemic heart disease y/n, heart failure y/n, chronic liver failure y/n, neurological impairment y/n
Date of signs of COVID-19 infection
Time frame: at baseline or date of occurence
in dd-mm-yyyy or mm-dd-yyyy
Date of positive swab
Time frame: at baseline or date of occurence
in dd-mm-yyyy or mm-dd-yyyy
Pre-ECMO length of hospital stay
Time frame: at or during ECMO-implant
in days
Pre-ECMO length of ICU stay
Time frame: at or during ECMO-implant
in days
Pre-ECMO length of mechanical ventilation days
Time frame: at or during ECMO-implant
in days
Use of antibiotics
Time frame: up to 6 months
y/n, what kind
Use of anti-viral treatment
Time frame: up to 6 months
y/n, what kind
Use of second line treatment
Time frame: up to 6 months
y/n, what kind (eg prone-position, recruitment manoeuvers, neuromuscular blockade etc)
Indications for ECMO-implant
Time frame: at ECMO-implant
respiratory or cardiac
Type of ECMO-implant
Time frame: at ECMO-implant
veno-venous, veno-arterial or veno-venoarterial
Type of access
Time frame: at ECMO-implant
peripheral or central
Date of ECMO implant
Time frame: at ECMO-implant
in dd-mm-yyyy or mm-dd-yyyy
ECMO blood flow rate
Time frame: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months
l/min
ECMO gas flow rate
Time frame: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months
l/min
ECMO configuration change
Time frame: up to 6 months
y/n
Date of ECMO configuration change
Time frame: up to 6 months
in dd-mm-yyyy or mm-dd-yyyy
New ECMO configuration
Time frame: up to 6 months
veno-venous, veno-arterial, veno-venoarterial, other
Indications for ECMO configuration change
Time frame: up to 6 months
right ventricular failure, left ventricular failure, refractory hypoxemia
Ventilator setting on ECMO
Time frame: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months
settings of ventilator
Anticoagulation during ECMO
Time frame: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months
heparin, bivalirudin, nothing
Frequency of ECMO circuit change
Time frame: up to 6 months
amount of ECMO circuit changes (1, 2, 3 etc.)
ECMO complications
Time frame: up to 6 months
Hemorrhagic, infection, other complications
ECMO Weaning
Time frame: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months
y/n
ICU discharge
Time frame: from day of ICU-admission for every 24 hours until date of discharge or death, up to 6 months
y/n, date
Main cause of death
Time frame: 6 months
Type of discharge
Time frame: up to 6 months
Ward, another ICU, rehabilitation center, home
Alive/deceased
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Background: PubMed 22291929Bolotin S, Pebody R, White PJ, McMenamin J, Perera L, Nguyen-Van-Tam JS, Barlow T, Watson JM; UK Severe Influenza Surveillance System (USISS) Steering Group. A new sentinel surveillance system for severe influenza in England shows a shift in age distribution of hospitalised cases in the post-pandemic period. PLoS One. 2012;7(1):e30279. doi: 10.1371/journal.pone.0030279. Epub 2012 Jan 23.
- Background: PubMed 22738893Dawood FS, Iuliano AD, Reed C, Meltzer MI, Shay DK, Cheng PY, Bandaranayake D, Breiman RF, Brooks WA, Buchy P, Feikin DR, Fowler KB, Gordon A, Hien NT, Horby P, Huang QS, Katz MA, Krishnan A, Lal R, Montgomery JM, Molbak K, Pebody R, Presanis AM, Razuri H, Steens A, Tinoco YO, Wallinga J, Yu H, Vong S, Bresee J, Widdowson MA. Estimated global mortality associated with the first 12 months of 2009 pandemic influenza A H1N1 virus circulation: a modelling study. Lancet Infect Dis. 2012 Sep;12(9):687-95. doi: 10.1016/S1473-3099(12)70121-4. Epub 2012 Jun 26.
- Background: PubMed 24302890Simonsen L, Spreeuwenberg P, Lustig R, Taylor RJ, Fleming DM, Kroneman M, Van Kerkhove MD, Mounts AW, Paget WJ; GLaMOR Collaborating Teams. Global mortality estimates for the 2009 Influenza Pandemic from the GLaMOR project: a modeling study. PLoS Med. 2013 Nov;10(11):e1001558. doi: 10.1371/journal.pmed.1001558. Epub 2013 Nov 26.
- Background: PubMed 31986261Chan JF, Yuan S, Kok KH, To KK, Chu H, Yang J, Xing F, Liu J, Yip CC, Poon RW, Tsoi HW, Lo SK, Chan KH, Poon VK, Chan WM, Ip JD, Cai JP, Cheng VC, Chen H, Hui CK, Yuen KY. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. Lancet. 2020 Feb 15;395(10223):514-523. doi: 10.1016/S0140-6736(20)30154-9. Epub 2020 Jan 24.
- Background: PubMed 12690091Drosten C, Gunther S, Preiser W, van der Werf S, Brodt HR, Becker S, Rabenau H, Panning M, Kolesnikova L, Fouchier RA, Berger A, Burguiere AM, Cinatl J, Eickmann M, Escriou N, Grywna K, Kramme S, Manuguerra JC, Muller S, Rickerts V, Sturmer M, Vieth S, Klenk HD, Osterhaus AD, Schmitz H, Doerr HW. Identification of a novel coronavirus in patients with severe acute respiratory syndrome. N Engl J Med. 2003 May 15;348(20):1967-76. doi: 10.1056/NEJMoa030747. Epub 2003 Apr 10.
- Background: PubMed 12690092Ksiazek TG, Erdman D, Goldsmith CS, Zaki SR, Peret T, Emery S, Tong S, Urbani C, Comer JA, Lim W, Rollin PE, Dowell SF, Ling AE, Humphrey CD, Shieh WJ, Guarner J, Paddock CD, Rota P, Fields B, DeRisi J, Yang JY, Cox N, Hughes JM, LeDuc JW, Bellini WJ, Anderson LJ; SARS Working Group. A novel coronavirus associated with severe acute respiratory syndrome. N Engl J Med. 2003 May 15;348(20):1953-66. doi: 10.1056/NEJMoa030781. Epub 2003 Apr 10.
- Background: PubMed 23075143Zaki AM, van Boheemen S, Bestebroer TM, Osterhaus AD, Fouchier RA. Isolation of a novel coronavirus from a man with pneumonia in Saudi Arabia. N Engl J Med. 2012 Nov 8;367(19):1814-20. doi: 10.1056/NEJMoa1211721. Epub 2012 Oct 17.
- Background: PubMed 23678167de Groot RJ, Baker SC, Baric RS, Brown CS, Drosten C, Enjuanes L, Fouchier RA, Galiano M, Gorbalenya AE, Memish ZA, Perlman S, Poon LL, Snijder EJ, Stephens GM, Woo PC, Zaki AM, Zambon M, Ziebuhr J. Middle East respiratory syndrome coronavirus (MERS-CoV): announcement of the Coronavirus Study Group. J Virol. 2013 Jul;87(14):7790-2. doi: 10.1128/JVI.01244-13. Epub 2013 May 15. No abstract available.
- Background: PubMed 32119824Spina S, Marrazzo F, Migliari M, Stucchi R, Sforza A, Fumagalli R. The response of Milan's Emergency Medical System to the COVID-19 outbreak in Italy. Lancet. 2020 Mar 14;395(10227):e49-e50. doi: 10.1016/S0140-6736(20)30493-1. Epub 2020 Feb 28. No abstract available.
- Background: PubMed 32113506Ebrahim SH, Memish ZA. COVID-19: preparing for superspreader potential among Umrah pilgrims to Saudi Arabia. Lancet. 2020 Mar 14;395(10227):e48. doi: 10.1016/S0140-6736(20)30466-9. Epub 2020 Feb 27. No abstract available.
- Background: PubMed 32004427Holshue ML, DeBolt C, Lindquist S, Lofy KH, Wiesman J, Bruce H, Spitters C, Ericson K, Wilkerson S, Tural A, Diaz G, Cohn A, Fox L, Patel A, Gerber SI, Kim L, Tong S, Lu X, Lindstrom S, Pallansch MA, Weldon WC, Biggs HM, Uyeki TM, Pillai SK; Washington State 2019-nCoV Case Investigation Team. First Case of 2019 Novel Coronavirus in the United States. N Engl J Med. 2020 Mar 5;382(10):929-936. doi: 10.1056/NEJMoa2001191. Epub 2020 Jan 31.
- Background: PubMed 31986264Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
- Individual participant dataSharing planned: No
Related trials for COVID
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Lorusso, Prof. Dr. principal investigator
Maastricht University Hospital
97 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID and SARS-CoV-2, run by Maastricht University Medical Center at 97 sites in 19 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 97 sites in Italy, Germany, Belgium, France, Russia and 14 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lorusso, Prof. Dr. (+ 31(0) 433877095, roberto.lorussobs@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age (time frame: at baseline). The study lists 34 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04366921, which also lists 15 linked publications.
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 5 Sep 2021.