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

• Sponsor: Maastricht University Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04366921
• Collaborator: European chapter of the Extracorporeal Life Support Organization (Other), Erasmus Medical Center (Other), Leiden University Medical Center (Other), UMC Utrecht (Other), IRCCS Azienda Ospedaliero-Universitaria di Bologna (Other), Papa Giovanni XXIII Hospital (Other), Niguarda Hospital (Other), Ospedale San Donato (Other), Ospedale S. Giovanni Bosco (Other), IRCCS Policlinico S. Matteo (Other), The Mediterranean Institute for Transplantation and Advanced Specialized Therapies (Other), Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Other), Ospedale dell'Angelo, Venezia-Mestre (Other), University Hospital, Udine, Italy (Other), San Gerardo Hospital (Other), Ospedali Riuniti Ancona (Other), San Camillo Hospital, Rome (Other), San Giorgio Clinic (Other), GVM Care & Research (Other), San Raffaele University Hospital, Italy (Other), Ospedale San Bortolo di Vicenza (Other), Klinik Hirslanden, Zurich (Other), University of Zurich (Other), Cardiocentro Ticino (Other), Vilnius University Hospital Santaros Klinikos (Other), Universitätsklinikum Düsseldorf (Other), Klinikum Nürnberg (Other), Hannover Medical School (Other), Heart Center Leipzig - University Hospital (Other), University Hospital Regensburg (Other), University Hospital, Essen (Other), German Heart Center (Other), University Hospital, Aachen (Other), University Heart Center Freiburg - Bad Krozingen (Other), Klinikum Kassel (Other), General University Hospital, Prague (Other), Universitaire Ziekenhuizen Leuven (Other), Onze Lieve Vrouwziekenhuis Aalst (Other), Erasme University Hospital (Other), University Hospital, Antwerp (Other), Hôpital Civil Marie Curie de Charleroi (Other), University Hospital, Ghent (Other), Centre Hospitalier Universitaire Saint Pierre (Other), Hospital Vall d'Hebron (Other), Hospital Universitario Ramon y Cajal (Other), Hospital Miguel Servet (Other), Henri Mondor University Hospital (Other), Hospices Civils de Lyon (Other), Pitié-Salpêtrière Hospital (Other), Rennes University Hospital (Other), Guy's and St Thomas' NHS Foundation Trust (Other), Karolinska University Hospital (Other), Hospital Sao Joao (Other), Medical University of Warsaw (Other), Universitätskliniken Innsbruck (Other), Medical University of Vienna (Other), University Hospital, Alexandroupolis (Other), Novosibirsk City Hospital #2 (Other), City Clinical Hospital No. 67, Moscow, Russia (Other), City Hospital No 40, Saint Petersburg, Russia (Other), Krasnodar Regional Hospital no 1 (Other), Kemerovo Regional Clinical Cardiological Center named after academician L.S. Barbarash (Other), City Hospital No 41, Ekaterinburg, Russia (Other), G. Pasquinucci Heart Hospital, Massa (Other), Charles University, Czech Republic (Other), University Hospital, Bordeaux (Other), Bambino Gesù Hospital and Research Institute (Other), Policlinico Hospital Milan (Other), Gaslini Children's Hospital (Other), Children's Medical Hospital, University of Essen, Essen, Germany (Other), University Hospital, Geneva (Other), Newcastle-upon-Tyne Hospitals NHS Trust (Other), Paediatric Intensive Care Glasgow (Other), Paris South University Hospitals (Other), University of Groningen (Other), Great Ormond Street Hospital for Children NHS Foundation Trust (Other), Hospital Sant Joan de Deu (Other), Heim Pal Children's Hospital (Other), University Hospital, Montpellier (Other), Royal Brompton & Harefield NHS Foundation Trust (Other), Lund University Hospital (Other), Landesklinikum Sankt Polten (Other), Chelyabinsk Regional Clinical Hospital (Other), ECMO Centers Israel (Other), Copenhagen University Hospital at Herlev (Other), Ospedale M. Bufalini Cesena (Other), A.O.U. Città della Salute e della Scienza - Molinette Hospital (Other), Mauriziano Umberto I Hospital (Other), University of Bern (Other), University Hospital, Basel, Switzerland (Other), University of Lausanne Hospitals (Other), University Hospital Tuebingen (Other), Universitätsklinikum Köln (Other), Chirec (Other), Universitair Ziekenhuis Brussel (Other), Centre Hospitalier Universitaire de Liege (Other), La Louvière Hopital (Other), Leicester Royal Infirmary NHS Trust (Other)
• Enrollment: 150
• Locations: 97
• Anticipated Duration (Months): 23.7
• Patients Per Site: 1.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
COVID; SARS-CoV-2; ARDS, Human; Refractory Hypoxemia; Cardiogenic Shock; Septic Shock; Extracorporeal Membrane Oxygenation

Study Design

• Study Type: Observational
• Anticipated Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: European/Euro-ELSO Survey on Adult and Neonatal/ Pediatric COVID Patients in ECMO
• Actual Study Start Date: Apr 10, 2020
• Anticipated Primary Completion Date: Apr 1, 2022
• Anticipated Study Completion Date: Apr 1, 2022

Outcome Measures

Primary Outcome Measures

1. Age [at baseline]

   age in years

2. Gender [at baseline]

   male/female

3. Weight [at baseline]

   in kilograms

4. Height [at baseline]

   in meters

5. BMI [at baseline]

   weight and height combined to calculate BMI in kg/m^2

6. Pre-existing pulmonary disease y/n [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

7. Main co-morbidities y/n [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

8. Date of signs of COVID-19 infection [at baseline or date of occurence]

   in dd-mm-yyyy or mm-dd-yyyy

9. Date of positive swab [at baseline or date of occurence]

   in dd-mm-yyyy or mm-dd-yyyy

10. Pre-ECMO length of hospital stay [at or during ECMO-implant]

    in days

11. Pre-ECMO length of ICU stay [at or during ECMO-implant]

    in days

12. Pre-ECMO length of mechanical ventilation days [at or during ECMO-implant]

    in days

13. Use of antibiotics [up to 6 months]

    y/n, what kind

14. Use of anti-viral treatment [up to 6 months]

    y/n, what kind

15. Use of second line treatment [up to 6 months]

    y/n, what kind (eg prone-position, recruitment manoeuvers, neuromuscular blockade etc)

16. Indications for ECMO-implant [at ECMO-implant]

    respiratory or cardiac

17. Type of ECMO-implant [at ECMO-implant]

    veno-venous, veno-arterial or veno-venoarterial

18. Type of access [at ECMO-implant]

    peripheral or central

19. Date of ECMO implant [at ECMO-implant]

    in dd-mm-yyyy or mm-dd-yyyy

20. ECMO blood flow rate [from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months]

    l/min

21. ECMO gas flow rate [from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months]

    l/min

22. ECMO configuration change [up to 6 months]

    y/n

23. Date of ECMO configuration change [up to 6 months]

    in dd-mm-yyyy or mm-dd-yyyy

24. New ECMO configuration [up to 6 months]

    veno-venous, veno-arterial, veno-venoarterial, other

25. Indications for ECMO configuration change [up to 6 months]

    right ventricular failure, left ventricular failure, refractory hypoxemia

26. Ventilator setting on ECMO [from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months]

    settings of ventilator

27. Anticoagulation during ECMO [from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months]

    heparin, bivalirudin, nothing

28. Frequency of ECMO circuit change [up to 6 months]

    amount of ECMO circuit changes (1, 2, 3 etc.)

29. ECMO complications [up to 6 months]

    Hemorrhagic, infection, other complications

30. ECMO Weaning [from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months]

    y/n

31. ICU discharge [from day of ICU-admission for every 24 hours until date of discharge or death, up to 6 months]

    y/n, date

32. Main cause of death [6 months]

33. Type of discharge [up to 6 months]

    Ward, another ICU, rehabilitation center, home

34. Alive/deceased [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitätskliniken Innsbruck	Innsbruck		Austria
2	Landesklinikum Sankt Polten	St.Pölten		Austria
3	Medical University of Vienna	Vienna		Austria
4	Onze Lieve Vrouwziekenhuis Aalst	Aalst		Belgium
5	University Hospital, Antwerp	Antwerp		Belgium
6	Centre Hospitalier Universitaire Saint Pierre	Brussels		Belgium
7	Chirec	Brussels		Belgium
8	Erasme University Hospital	Brussel		Belgium
9	Universitair Ziekenhuis Brussel	Brussel		Belgium
10	Hôpital Civil Marie Curie de Charleroi	Charleroi		Belgium
11	University Hospital, Ghent	Ghent		Belgium
12	La Louvière Hopital	La Louvière		Belgium
13	Universitaire Ziekenhuizen Leuven	Leuven		Belgium
14	CHU de Liege	Liège		Belgium
15	Charles University, Czech Republic	Praha		Czechia
16	General University Hospital, Prague	Praha		Czechia
17	Copenhagen University Hospital at Herlev	Copenhagen		Denmark
18	University Hospital, Bordeaux	Bourdeaux		France
19	Hospices Civils de Lyon	Lyon		France
20	University Hospital, Montpellier	Montpellier		France
21	Henri Mondor University Hospital	Paris		France
22	Paris South University Hospitals	Paris		France
23	Pitié-Salpêtrière Hospital	Paris		France
24	Rennes University Hospital	Rennes		France
25	University Hospital, Aachen	Aachen		Germany
26	German Heart Center	Berlin		Germany
27	Universitätsklinikum Düsseldorf	Düsseldorf		Germany
28	Children's Medical Hospital, University of Essen, Essen, Germany	Essen		Germany
29	University Hospital, Essen	Essen		Germany
30	University Heart Center Freiburg - Bad Krozingen	Freiburg		Germany
31	Hannover Medical School	Hannover		Germany
32	Klinikum Kassel	Kassel		Germany
33	Universitätsklinikum Köln	Köln		Germany
34	Heart Center Leipzig - University Hospital	Leipzig		Germany
35	Klinikum Nürnberg	Nürnberg		Germany
36	University Hospital Regensburg	Regensburg		Germany
37	University Hospital Tuebingen	Tuebingen		Germany
38	University Hospital, Alexandroupolis	Alexandroupolis		Greece
39	Heim Pal Children's Hospital	Budapest		Hungary
40	ECMO Centers Israel	Jerusalem		Israel
41	San Giorgio Clinic	Alessandria		Italy
42	Ospedali Riuniti Ancona	Ancona		Italy
43	Papa Giovanni XXIII Hospital	Bergamo		Italy
44	St. Orsola Hospital	Bologna		Italy
45	Azienda Ospedaliera Spedali Civili di Brescia	Brescia		Italy
46	Ospedale Maurizio Bufalini	Cesena		Italy
47	Gaslini Children's Hospital	Genua		Italy
48	G. Pasquinucci Heart Hospital, Massa	Massa		Italy
49	Policlinico Hospital Milan	Milano		Italy
50	Niguarda Hospital	Milan		Italy
51	Ospedale San Donato	Milan		Italy
52	San Raffaele University Hospital, Italy	Milan		Italy
53	San Gerardo Hospital	Monza		Italy
54	IRCCS Policlinico S. Matteo	Pavia		Italy
55	GVM Care & Research	Puglia		Italy
56	Bambino Gesù Hospital and Research Institute	Roma		Italy
57	San Camillo Hospital, Rome	Roma		Italy
58	A.O.U. Città della Salute e della Scienza - Molinette Hospital	Turin		Italy
59	Mauriziano Umberto I Hospital	Turin		Italy
60	Ospedale S. Giovanni Bosco	Turin		Italy
61	University Hospital, Udine, Italy	Udine		Italy
62	Ospedale dell'Angelo, Venezia-Mestre	Venice		Italy
63	Ospedale San Bortolo di Vicenza	Vicenza		Italy
64	Vilnius University Hospital Santaros Klinikos	Vilnius		Lithuania
65	University of Groningen	Groningen		Netherlands
66	Leiden University Medical Center	Leiden		Netherlands
67	Maastricht University Medical Center	Maastricht		Netherlands
68	Erasmus Medical Center	Rotterdam		Netherlands
69	UMC Utrecht	Utrecht		Netherlands
70	Medical University of Warsaw	Warsaw		Poland
71	Hospital Sao Joao	Porto		Portugal
72	Chelyabinsk Regional Clinical Hospital	Chelyabinsk		Russian Federation
73	City Hospital No 41, Ekaterinburg, Russia	Ekaterinburg		Russian Federation
74	Kemerovo Regional Clinical Cardiological Center named after academician L.S. Barbarash	Kemerovo		Russian Federation
75	Krasnodar Regional Hospital no 1	Krasnodar		Russian Federation
76	City Clinical Hospital No. 67, Moscow, Russia	Moscow		Russian Federation
77	Novosibirsk City Hospital #2	Novosibirsk		Russian Federation
78	City Hospital No 40, Saint Petersburg, Russia	Saint Petersburg		Russian Federation
79	Hospital Sant Joan de Deu	Barcelona		Spain
80	Hospital Vall d'Hebron	Barcelona		Spain
81	Hospital Universitario Ramon y Cajal	Madrid		Spain
82	Hospital Miguel Servet	Zaragoza		Spain
83	Lund University Hospital	Lund		Sweden
84	Karolinska University Hospital	Stockholm		Sweden
85	University Hospital, Basel, Switzerland	Basel		Switzerland
86	University of Bern	Bern		Switzerland
87	University Hospital, Geneva	Geneva		Switzerland
88	University of Lausanne Hospitals	Lausanne		Switzerland
89	Cardiocentro Ticino	Lugano		Switzerland
90	Klinik Hirslanden, Zurich	Zürich		Switzerland
91	University of Zurich	Zürich		Switzerland
92	Royal Brompton & Harefield NHS Foundation Trust	Brompton		United Kingdom
93	Paediatric Intensive Care Glasgow	Glasgow		United Kingdom
94	Leicester Children's Hospital	Leicester		United Kingdom
95	Great Ormond Street Hospital for Children NHS Foundation Trust	London		United Kingdom
96	Guy's and St Thomas' NHS Foundation Trust	London		United Kingdom
97	Newcastle-upon-Tyne Hospitals NHS Trust	Newcastle Upon Tyne		United Kingdom

Sponsors and Collaborators

• Maastricht University Medical Center
• 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
• IRCCS Policlinico S. Matteo
• 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
• Universitätsklinikum 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 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
• Universitätskliniken 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

Investigators

• Principal Investigator: Lorusso, Prof. Dr., Maastricht University Hospital

Study Documents (Full-Text)

None provided.

More Information

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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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;:.
• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Maastricht University Medical Center
• ClinicalTrials.gov Identifier: NCT04366921
• Other Study ID Numbers: METC 2020-1343
• First Posted: Apr 29, 2020
• Last Update Posted: Sep 5, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Respiratory Distress Syndrome; Shock, Cardiogenic; Shock; Hypoxia

Study Results

No Results Posted as of Sep 5, 2021