European/Euro-ELSO Survey on Adult and Neonatal/ Pediatric COVID-19 Patients in ECMO

Septic Shock Clinical Trial

— EuroECMO-COVID  

Official title:

European/Euro-ELSO Survey on Adult and Neonatal/ Pediatric COVID Patients in ECMO

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04366921
• Other study ID #: METC 2020-1343
• Status: Recruiting
• Start date: April 10, 2020
• Est. completion date: April 2022

Study information

• Verified date: August 2021
• Source: Maastricht University Medical Center
• Contact: Lorusso, Prof. Dr.
• Phone: + 31(0) 433877095
• Email: roberto.lorussobs[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Laboratory-confirmed COVID-19 infection by real-time PCR (polymerase chain reaction)

• ECMO for treatment severe lung disease COVID-19 related

Exclusion Criteria:

• Patients treated with ECMO for other concomitant causes.

Related Conditions & MeSH terms

• ARDS, Human
• Cardiogenic Shock
• COVID
• Extracorporeal Membrane Oxygenation
• Hypoxia
• Refractory Hypoxemia
• Respiratory Distress Syndrome, Adult
• SARS-CoV-2
• Septic Shock
• Shock
• Shock, Cardiogenic

Locations

Country	Name	City	State
Austria	Universitätskliniken Innsbruck	Innsbruck
Austria	Landesklinikum Sankt Polten	St.Pölten
Austria	Medical University of Vienna	Vienna
Belgium	Onze Lieve Vrouwziekenhuis Aalst	Aalst
Belgium	University Hospital, Antwerp	Antwerp
Belgium	Erasme University Hospital	Brussel
Belgium	Universitair Ziekenhuis Brussel	Brussel
Belgium	Centre Hospitalier Universitaire Saint Pierre	Brussels
Belgium	Chirec	Brussels
Belgium	Hôpital Civil Marie Curie de Charleroi	Charleroi
Belgium	University Hospital, Ghent	Ghent
Belgium	La Louvière Hopital	La Louvière
Belgium	Universitaire Ziekenhuizen Leuven	Leuven
Belgium	CHU de Liege	Liège
Czechia	Charles University, Czech Republic	Praha
Czechia	General University Hospital, Prague	Praha
Denmark	Copenhagen University Hospital at Herlev	Copenhagen
France	University Hospital, Bordeaux	Bourdeaux
France	Hospices Civils de Lyon	Lyon
France	University Hospital, Montpellier	Montpellier
France	Henri Mondor University Hospital	Paris
France	Paris South University Hospitals	Paris
France	Pitié-Salpêtrière Hospital	Paris
France	Rennes University Hospital	Rennes
Germany	University Hospital, Aachen	Aachen
Germany	German Heart Center	Berlin
Germany	Universitätsklinikum Düsseldorf	Düsseldorf
Germany	Children's Medical Hospital, University of Essen, Essen, Germany	Essen
Germany	University Hospital, Essen	Essen
Germany	University Heart Center Freiburg - Bad Krozingen	Freiburg
Germany	Hannover Medical School	Hannover
Germany	Klinikum Kassel	Kassel
Germany	Universitätsklinikum Köln	Köln
Germany	Heart Center Leipzig - University Hospital	Leipzig
Germany	Klinikum Nürnberg	Nürnberg
Germany	University Hospital Regensburg	Regensburg
Germany	University Hospital Tuebingen	Tuebingen
Greece	University Hospital, Alexandroupolis	Alexandroupolis
Hungary	Heim Pal Children's Hospital	Budapest
Israel	ECMO Centers Israel	Jerusalem
Italy	San Giorgio Clinic	Alessandria
Italy	Ospedali Riuniti Ancona	Ancona
Italy	Papa Giovanni XXIII Hospital	Bergamo
Italy	St. Orsola Hospital	Bologna
Italy	Azienda Ospedaliera Spedali Civili di Brescia	Brescia
Italy	Ospedale Maurizio Bufalini	Cesena
Italy	Gaslini Children's Hospital	Genua
Italy	G. Pasquinucci Heart Hospital, Massa	Massa
Italy	Niguarda Hospital	Milan
Italy	Ospedale San Donato	Milan
Italy	San Raffaele University Hospital, Italy	Milan
Italy	Policlinico Hospital Milan	Milano
Italy	San Gerardo Hospital	Monza
Italy	IRCCS Policlinico S. Matteo	Pavia
Italy	GVM Care & Research	Puglia
Italy	Bambino Gesù Hospital and Research Institute	Roma
Italy	San Camillo Hospital, Rome	Roma
Italy	A.O.U. Città della Salute e della Scienza - Molinette Hospital	Turin
Italy	Mauriziano Umberto I Hospital	Turin
Italy	Ospedale S. Giovanni Bosco	Turin
Italy	University Hospital, Udine, Italy	Udine
Italy	Ospedale dell'Angelo, Venezia-Mestre	Venice
Italy	Ospedale San Bortolo di Vicenza	Vicenza
Lithuania	Vilnius University Hospital Santaros Klinikos	Vilnius
Netherlands	University of Groningen	Groningen
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Maastricht University Medical Center	Maastricht
Netherlands	Erasmus Medical Center	Rotterdam
Netherlands	UMC Utrecht	Utrecht
Poland	Medical University of Warsaw	Warsaw
Portugal	Hospital Sao Joao	Porto
Russian Federation	Chelyabinsk Regional Clinical Hospital	Chelyabinsk
Russian Federation	City Hospital No 41, Ekaterinburg, Russia	Ekaterinburg
Russian Federation	Kemerovo Regional Clinical Cardiological Center named after academician L.S. Barbarash	Kemerovo
Russian Federation	Krasnodar Regional Hospital no 1	Krasnodar
Russian Federation	City Clinical Hospital No. 67, Moscow, Russia	Moscow
Russian Federation	Novosibirsk City Hospital #2	Novosibirsk
Russian Federation	City Hospital No 40, Saint Petersburg, Russia	Saint Petersburg
Spain	Hospital Sant Joan de Deu	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	Hospital Miguel Servet	Zaragoza
Sweden	Lund University Hospital	Lund
Sweden	Karolinska University Hospital	Stockholm
Switzerland	University Hospital, Basel, Switzerland	Basel
Switzerland	University of Bern	Bern
Switzerland	University Hospital, Geneva	Geneva
Switzerland	University of Lausanne Hospitals	Lausanne
Switzerland	Cardiocentro Ticino	Lugano
Switzerland	Klinik Hirslanden, Zurich	Zürich
Switzerland	University of Zurich	Zürich
United Kingdom	Royal Brompton & Harefield NHS Foundation Trust	Brompton
United Kingdom	Paediatric Intensive Care Glasgow	Glasgow
United Kingdom	Leicester Children's Hospital	Leicester
United Kingdom	Great Ormond Street Hospital for Children NHS Foundation Trust	London
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London
United Kingdom	Newcastle-upon-Tyne Hospitals NHS Trust	Newcastle Upon Tyne

Sponsors (99)

Lead Sponsor

Collaborator

Maastricht University Medical Center

A.O.U. Città della Salute e della Scienza - Molinette Hospital, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, Bambino Gesù Hospital and Research Institute, Cardiocentro Ticino, Centre Hospitalier Universitaire de Liège, Centre Hospitalier Universitaire Saint Pierre, Charles University, Czech Republic, Chelyabinsk Regional Clinical Hospital, Children's Medical Hospital, University of Essen, Essen, Germany, Chirec, City Clinical Hospital No. 67, Moscow, Russia, City Hospital No 40, Saint Petersburg, Russia, City Hospital No 41, Ekaterinburg, Russia, Copenhagen University Hospital at Herlev, ECMO Centers Israel, Erasme University Hospital, Erasmus Medical Center, European chapter of the Extracorporeal Life Support Organization, G. Pasquinucci Heart Hospital, Massa, Gaslini Children's Hospital, General University Hospital, Prague, German Heart Center, Great Ormond Street Hospital for Children NHS Foundation Trust, Guy's and St Thomas' NHS Foundation Trust, GVM Care & Research, Hannover Medical School, Heart Center Leipzig - University Hospital, Heim Pal Children's Hospital, Henri Mondor University Hospital, Hôpital Civil Marie Curie de Charleroi, Hospices Civils de Lyon, Hospital Miguel Servet, Hospital Sant Joan de Deu, Hospital Sao Joao, Hospital Universitario Ramon y Cajal, Hospital Vall d'Hebron, IRCCS Azienda Ospedaliero-Universitaria di Bologna, IRCCS Policlinico S. Matteo, Karolinska University Hospital, Kemerovo Regional Clinical Cardiological Center named after academician L.S. Barbarash, Klinik Hirslanden, Zurich, Klinikum Kassel, Klinikum Nürnberg, Krasnodar Regional Hospital no 1, La Louvière Hopital, Landesklinikum Sankt Polten, Leicester Royal Infirmary NHS Trust, Leiden University Medical Center, Lund University Hospital, Mauriziano Umberto I Hospital, Medical University of Vienna, Medical University of Warsaw, Newcastle-upon-Tyne Hospitals NHS Trust, Niguarda Hospital, Novosibirsk City Hospital #2, Onze Lieve Vrouwziekenhuis Aalst, Ospedale dell'Angelo, Venezia-Mestre, Ospedale M. Bufalini Cesena, Ospedale S. Giovanni Bosco, Ospedale San Bortolo di Vicenza, Ospedale San Donato, Ospedali Riuniti Ancona, Paediatric Intensive Care Glasgow, Papa Giovanni XXIII Hospital, Paris South University Hospitals, Pitié-Salpêtrière Hospital, Policlinico Hospital Milan, Rennes University Hospital, Royal Brompton & Harefield NHS Foundation Trust, San Camillo Hospital, Rome, San Gerardo Hospital, San Giorgio Clinic, San Raffaele University Hospital, Italy, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies, UMC Utrecht, Universitair Ziekenhuis Brussel, Universitaire Ziekenhuizen Leuven, Universitätskliniken Innsbruck, Universitätsklinikum Düsseldorf, Universitätsklinikum Köln, University Heart Center Freiburg - Bad Krozingen, University Hospital Regensburg, University Hospital Tuebingen, University Hospital, Aachen, University Hospital, Alexandroupolis, University Hospital, Antwerp, University Hospital, Basel, Switzerland, University Hospital, Bordeaux, University Hospital, Essen, University Hospital, Geneva, University Hospital, Ghent, University Hospital, Montpellier, University Hospital, Udine, Italy, University of Bern, University of Groningen, University of Lausanne Hospitals, University of Zurich, Vilnius University Hospital Santaros Klinikos

Countries where clinical trial is conducted

Austria,  Belgium,  Czechia,  Denmark,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Lithuania,  Netherlands,  Poland,  Portugal,  Russian Federation,  Spain,  Sweden,  Switzerland,  United Kingdom, 

References & Publications (13)

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Chan 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. — View Citation

Dawood 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, Mølbak 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. Erratum in: Lancet Infect Dis. 2012 Sep;12(9):655. — View Citation

de 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. — View Citation

Drosten C, Günther S, Preiser W, van der Werf S, Brodt HR, Becker S, Rabenau H, Panning M, Kolesnikova L, Fouchier RA, Berger A, Burguière AM, Cinatl J, Eickmann M, Escriou N, Grywna K, Kramme S, Manuguerra JC, Müller S, Rickerts V, Stürmer 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. Epub 2003 Apr 10. — View Citation

Ebrahim 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. — View Citation

Holshue 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. — View Citation

Huang 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. Erratum in: Lancet. 2020 Jan 30;:. — View Citation

Ksiazek 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. Epub 2003 Apr 10. — View Citation

Simonsen 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. — View Citation

Spina 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. — View Citation

Wang 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. Erratum in: JAMA. 2021 Mar 16;325(11):1113. — View Citation

Zaki 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. Erratum in: N Engl J Med. 2013 Jul 25;369(4):394. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Age	age in years	at baseline
Primary	Gender	male/female	at baseline
Primary	Weight	in kilograms	at baseline
Primary	Height	in meters	at baseline
Primary	BMI	weight and height combined to calculate BMI in kg/m^2	at baseline
Primary	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	at baseline
Primary	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	at baseline
Primary	Date of signs of COVID-19 infection	in dd-mm-yyyy or mm-dd-yyyy	at baseline or date of occurence
Primary	Date of positive swab	in dd-mm-yyyy or mm-dd-yyyy	at baseline or date of occurence
Primary	Pre-ECMO length of hospital stay	in days	at or during ECMO-implant
Primary	Pre-ECMO length of ICU stay	in days	at or during ECMO-implant
Primary	Pre-ECMO length of mechanical ventilation days	in days	at or during ECMO-implant
Primary	Use of antibiotics	y/n, what kind	up to 6 months
Primary	Use of anti-viral treatment	y/n, what kind	up to 6 months
Primary	Use of second line treatment	y/n, what kind (eg prone-position, recruitment manoeuvers, neuromuscular blockade etc)	up to 6 months
Primary	Indications for ECMO-implant	respiratory or cardiac	at ECMO-implant
Primary	Type of ECMO-implant	veno-venous, veno-arterial or veno-venoarterial	at ECMO-implant
Primary	Type of access	peripheral or central	at ECMO-implant
Primary	Date of ECMO implant	in dd-mm-yyyy or mm-dd-yyyy	at ECMO-implant
Primary	ECMO blood flow rate	l/min	from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months
Primary	ECMO gas flow rate	l/min	from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months
Primary	ECMO configuration change	y/n	up to 6 months
Primary	Date of ECMO configuration change	in dd-mm-yyyy or mm-dd-yyyy	up to 6 months
Primary	New ECMO configuration	veno-venous, veno-arterial, veno-venoarterial, other	up to 6 months
Primary	Indications for ECMO configuration change	right ventricular failure, left ventricular failure, refractory hypoxemia	up to 6 months
Primary	Ventilator setting on ECMO	settings of ventilator	from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months
Primary	Anticoagulation during ECMO	heparin, bivalirudin, nothing	from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months
Primary	Frequency of ECMO circuit change	amount of ECMO circuit changes (1, 2, 3 etc.)	up to 6 months
Primary	ECMO complications	Hemorrhagic, infection, other complications	up to 6 months
Primary	ECMO Weaning	y/n	from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months
Primary	ICU discharge	y/n, date	from day of ICU-admission for every 24 hours until date of discharge or death, up to 6 months
Primary	Main cause of death		6 months
Primary	Type of discharge	Ward, another ICU, rehabilitation center, home	up to 6 months
Primary	Alive/deceased		6 months