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

September 3, 2021 updated by: Maastricht University Medical Center

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.

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 Overview

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Innsbruck, Austria
        • Recruiting
        • Universitätskliniken Innsbruck
        • Contact:
          • Nikolaos Bonaros, Prof.
        • Contact:
          • Christoph Krapf, Dr.
      • St.Pölten, Austria
        • Recruiting
        • Landesklinikum Sankt Pölten
        • Contact:
          • Nikolaos Bonaros, Prof.
      • Vienna, Austria
        • Recruiting
        • Medical University of Vienna
        • Contact:
          • Peter Schellongowski, Dr.
      • Aalst, Belgium
        • Recruiting
        • Onze Lieve Vrouwziekenhuis Aalst
        • Contact:
          • Bernard Stockman, Dr.
      • Antwerp, Belgium
        • Recruiting
        • University Hospital, Antwerp
        • Contact:
          • Gerdy Debeuckelaere
      • Brussel, Belgium
        • Recruiting
        • Erasme University Hospital
        • Contact:
          • Fabio Taccone, Prof.
      • Brussel, Belgium
        • Recruiting
        • Universitair Ziekenhuis Brussel
        • Contact:
          • Dimitri Vandeweghe
      • Brussels, Belgium
        • Recruiting
        • Centre Hospitalier Universitaire Saint Pierre
        • Contact:
          • Olivier Germay
      • Brussels, Belgium
        • Recruiting
        • CHIREC
        • Contact:
          • Daniel De Backer, Dr.
      • Charleroi, Belgium
        • Recruiting
        • Hôpital Civil Marie Curie de Charleroi
        • Contact:
          • Patrick Biston, Dr.
        • Contact:
          • Michael Piagnerelli
      • Ghent, Belgium
        • Recruiting
        • University Hospital, Ghent
        • Contact:
          • Harlinde Peperstraete
      • La Louvière, Belgium
        • Recruiting
        • La Louvière Hopital
        • Contact:
          • Romain Courcelle
      • Leuven, Belgium
        • Recruiting
        • Universitaire Ziekenhuizen Leuven
        • Contact:
          • Leen Vercaemst, Dr.
      • Liège, Belgium
        • Recruiting
        • CHU de Liege
        • Contact:
          • Marc Lagny
      • Praha, Czechia
        • Recruiting
        • Charles University, Czech Republic
        • Contact:
          • Vaclav Vobruba
      • Praha, Czechia
        • Recruiting
        • General University Hospital, Prague
        • Contact:
          • Jan Belohlavek, Prof.
      • Copenhagen, Denmark
        • Recruiting
        • Copenhagen University Hospital at Herlev
        • Contact:
          • Finn Moeller Pedersen, Dr.
      • Bourdeaux, France
        • Recruiting
        • University Hospital, Bordeaux
        • Contact:
          • Olivier Brissaud
      • Lyon, France
        • Recruiting
        • Hospices Civils de Lyon
        • Contact:
          • Matteo Pozzi, Dr.
      • Montpellier, France
        • Recruiting
        • University Hospital, Montpellier
        • Contact:
          • Phillipe Gaudard
      • Paris, France
        • Recruiting
        • Pitie-Salpêtrière Hospital
        • Contact:
          • Alain Combes, Prof.
        • Contact:
          • Thierry Folliguet, Prof.
      • Paris, France
        • Recruiting
        • Henri Mondor University Hospital
        • Contact:
          • Gabriel Saiydoun, Dr.
      • Paris, France
        • Recruiting
        • Paris South University Hospitals
        • Contact:
          • Pierre Tissieres
      • Rennes, France
        • Recruiting
        • Rennes University Hospital
        • Contact:
          • Alessandro Paradiso, Dr.
      • Aachen, Germany
        • Recruiting
        • University Hospital, Aachen
        • Contact:
          • Alexander Kersten, Dr.
      • Berlin, Germany
        • Recruiting
        • German Heart Center
        • Contact:
          • Felix Hennig, Dr.
      • Düsseldorf, Germany
        • Recruiting
        • Universitätsklinikum Düsseldorf
        • Contact:
          • Udo Boeken, Prof.
      • Essen, Germany
        • Recruiting
        • Children's Medical Hospital, University of Essen, Essen, Germany
        • Contact:
          • Malaika Mendoca
      • Essen, Germany
        • Recruiting
        • University Hospital, Essen
        • Contact:
          • Matthias Thielman, Prof.
      • Freiburg, Germany
        • Recruiting
        • University Heart Center Freiburg - Bad Krozingen
        • Contact:
          • David Schibilsky, Dr.
        • Contact:
          • Sven Maier, Dr.
      • Hannover, Germany
        • Recruiting
        • Hannover Medical School
        • Contact:
          • Jan Schmitto, Prof.
        • Contact:
          • Christian Napp, Dr.
      • Kassel, Germany
        • Recruiting
        • Klinikum Kassel
        • Contact:
          • Ralf Muellenbach, Prof
        • Contact:
          • Torje Iuliu, Dr.
      • Köln, Germany
        • Recruiting
        • Universitätsklinikum Köln
        • Contact:
          • Simone Schafer, Dr.
      • Leipzig, Germany
        • Recruiting
        • Heart Center Leipzig - University Hospital
        • Contact:
          • Diyar Saeed, Prof.
      • Nürnberg, Germany
        • Recruiting
        • Klinikum Nürnberg
        • Contact:
          • Justyna Swol, Dr.
      • Regensburg, Germany
        • Recruiting
        • University Hospital Regensburg
        • Contact:
          • Maximillian Malfertheiner, Dr.
        • Contact:
          • Esther Dreier, Dr.
      • Tuebingen, Germany
        • Recruiting
        • University Hospital Tuebingen
        • Contact:
          • Philipp Hen, Dr.
        • Contact:
          • Aron Frederik Popov, Prof.
      • Alexandroupolis, Greece
        • Recruiting
        • University Hospital, Alexandroupolis
        • Contact:
          • Dimitrios Soufleris
      • Budapest, Hungary
        • Recruiting
        • Heim Pal Children's Hospital
        • Contact:
          • Veronika Maraczi
      • Jerusalem, Israel
        • Recruiting
        • ECMO Centers Israel
        • Contact:
          • Maged Makhoul, Dr.
        • Contact:
          • Gil Bolotin, Dr.
      • Alessandria, Italy
        • Recruiting
        • San Giorgio Clinic
        • Contact:
          • Sandrelli Luca, Dr.
      • Ancona, Italy
        • Recruiting
        • Ospedali Riuniti Ancona
        • Contact:
          • Roberto Carozza
      • Bergamo, Italy
        • Recruiting
        • Papa Giovanni XXIII Hospital
        • Contact:
          • Davide Ghitti, Dr.
      • Bologna, Italy
        • Recruiting
        • St. Orsola Hospital
        • Contact:
          • Antonio Loforte, Dr.
      • Brescia, Italy
        • Recruiting
        • Azienda Ospedaliera Spedali Civili di Brescia
        • Contact:
          • Giovanni Chiarini, Dr.
      • Cesena, Italy
        • Recruiting
        • Ospedale Maurizio Bufalini
        • Contact:
          • Allesandro Circelli, Dr.
      • Genua, Italy
        • Recruiting
        • Gaslini Children's Hospital
        • Contact:
          • Andrea Moscatelli
      • Massa, Italy
        • Recruiting
        • G. Pasquinucci Heart Hospital, Massa
        • Contact:
          • Paolo Del Sarto
      • Milan, Italy
        • Recruiting
        • Niguarda Hospital
        • Contact:
          • Paolof Meani, Dr.
        • Contact:
          • Antioco Cappai, Dr.
      • Milan, Italy
        • Recruiting
        • Ospedale San Donato
        • Contact:
          • Dario Fina, Dr.
        • Contact:
          • Marco Ranucci, Dr.
      • Milan, Italy
        • Recruiting
        • San Raffaele University Hospital, Italy
        • Contact:
          • Giovenni Landoni
        • Contact:
          • Mara Scandroglio
      • Milano, Italy
        • Recruiting
        • Policlinico Hospital Milan
        • Contact:
          • Giacomo Cavallaro
      • Monza, Italy
        • Recruiting
        • San Gerardo Hospital
        • Contact:
          • Marco Giani, Dr.
        • Contact:
          • Roberto Rona, Dr.
      • Pavia, Italy
        • Recruiting
        • IRCCS Policlinico S. Matteo
        • Contact:
          • Mirko Belliato, Dr.
        • Contact:
          • Antonella Degani
      • Puglia, Italy
        • Recruiting
        • GVM Care & Research
        • Contact:
          • Ignazio Condello
        • Contact:
          • Marco Moscarelli, Dr.
      • Roma, Italy
        • Recruiting
        • Bambino Gesù Hospital and Research Institute
        • Contact:
          • Matteo Di Nardo
      • Roma, Italy
        • Recruiting
        • San Camillo Hospital, Rome
        • Contact:
          • Andrea Montalto, Dr.
      • Turin, Italy
        • Recruiting
        • A.O.U. Città della Salute e della Scienza - Molinette Hospital
        • Contact:
          • Vito Fanelli, Dr.
      • Turin, Italy
        • Recruiting
        • Mauriziano Umberto I Hospital
        • Contact:
          • Maria Elena De Piero, Dr.
      • Turin, Italy
        • Recruiting
        • Ospedale S. Giovanni Bosco
        • Contact:
          • Maria Elena De Piero, Dr.
      • Udine, Italy
        • Recruiting
        • University Hospital, Udine, Italy
        • Contact:
          • Sandro Sponga, Dr.
      • Venice, Italy
        • Recruiting
        • Ospedale dell'Angelo, Venezia-Mestre
        • Contact:
          • Reina Gianfranco, Dr.
      • Vicenza, Italy
        • Recruiting
        • Ospedale San Bortolo di Vicenza
        • Contact:
          • Marco Piccichè
      • Vilnius, Lithuania
        • Recruiting
        • Vilnius University hospital Santaros klinikos
        • Contact:
          • Robertas Samalavicius, Dr.
      • Groningen, Netherlands
        • Recruiting
        • University of Groningen
        • Contact:
          • Martin Kneyber
      • Leiden, Netherlands
        • Recruiting
        • Leiden University Medical Center
        • Contact:
          • Dario Candura, Dr.
        • Contact:
          • Jacinta Maas, Dr.
      • Maastricht, Netherlands
        • Recruiting
        • Maastricht University Medical Center
        • Contact:
          • Lorusso, Prof. Dr.
        • Sub-Investigator:
          • Lo Coco, Drs.
        • Sub-Investigator:
          • De Piero, Drs.
      • Rotterdam, Netherlands
        • Recruiting
        • Erasmus Medical Center
        • Contact:
          • Dinis Reis Miranda, Dr.
      • Utrecht, Netherlands
        • Recruiting
        • UMC Utrecht
        • Contact:
          • J.J. van der Heijden, Dr.
      • Warsaw, Poland
        • Recruiting
        • Medical University of Warsaw
        • Contact:
          • Mariusz Kowaleswsky, Dr.
      • Porto, Portugal
        • Recruiting
        • Hospital Sao Joao
        • Contact:
          • Luis Filipe Pinto, Dr.
      • Chelyabinsk, Russian Federation
        • Recruiting
        • Chelyabinsk Regional Clinical Hospital
        • Contact:
          • Alexandr Turchaninov
      • Ekaterinburg, Russian Federation
        • Recruiting
        • City Hospital No 41, Ekaterinburg, Russia
        • Contact:
          • Alexandr Turchaninov
      • Kemerovo, Russian Federation
        • Recruiting
        • Kemerovo Regional Clinical Cardiological Center named after academician L.S. Barbarash
        • Contact:
          • Roman Komelyuk
      • Krasnodar, Russian Federation
        • Recruiting
        • Krasnodar Regional Hospital no 1
        • Contact:
          • Alexander Skopets
      • Moscow, Russian Federation
        • Recruiting
        • City Clinical Hospital No. 67, Moscow, Russia
        • Contact:
          • Ivan Akufov
        • Contact:
          • Alexandra Shilova
      • Novosibirsk, Russian Federation
        • Recruiting
        • Novosibirsk City Hospital #2
        • Contact:
          • Igor Komilov
      • Saint Petersburg, Russian Federation
        • Recruiting
        • City Hospital No 40, Saint Petersburg, Russia
        • Contact:
          • Daniil Shelukhin
        • Contact:
          • Sergei Minin
      • Barcelona, Spain
        • Recruiting
        • Hospital Sant Joan de Deu
        • Contact:
          • Susana Segura Matute
      • Barcelona, Spain
        • Recruiting
        • Hospital Vall d'Hebron
        • Contact:
          • Jordi Riero del Brio, Dr.
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Ramon y Cajal
        • Contact:
          • Aaron Blandino, Ortiz
      • Zaragoza, Spain
        • Recruiting
        • Hospital Miguel Servet
        • Contact:
          • Pablo Ruiz, Dr.
      • Lund, Sweden
        • Recruiting
        • Lund University Hospital
        • Contact:
          • Edgars Grins
      • Stockholm, Sweden
        • Recruiting
        • Karolinska University Hospital
        • Contact:
          • Lars Broman, Dr.
      • Basel, Switzerland
        • Recruiting
        • University Hospital, Basel, Switzerland
        • Contact:
          • Thomas Doebele
      • Bern, Switzerland
        • Recruiting
        • University of Bern
        • Contact:
          • Jolanda Consiglio
        • Contact:
          • Jenni Hansjoerg
      • Geneva, Switzerland
        • Recruiting
        • University Hospital, Geneva
        • Contact:
          • Angelo Polito
      • Lausanne, Switzerland
        • Recruiting
        • University of Lausanne Hospitals
        • Contact:
          • Xavier Bechtold
      • Lugano, Switzerland
        • Recruiting
        • Cardiocentro Ticino
        • Contact:
          • Gianluca Agus, Dr.
      • Zürich, Switzerland
        • Recruiting
        • Klinik Hirslanden, Zurich
        • Contact:
          • Halbe Maximillian, Dr.
      • Zürich, Switzerland
        • Recruiting
        • University of Zurich
        • Contact:
          • Alberto Weber, Prof. Dr.
        • Contact:
          • Grünenfelder Jürg, Prof. Dr.
      • Brompton, United Kingdom
        • Recruiting
        • Royal Brompton & Harefield NHS Foundation Trust
        • Contact:
          • Verna Aquino
      • Glasgow, United Kingdom
        • Recruiting
        • Paediatric Intensive Care Glasgow
        • Contact:
          • Mark Davidson
      • Leicester, United Kingdom
        • Recruiting
        • Leicester Children's Hospital
        • Contact:
          • Claire Westrope
      • London, United Kingdom
        • Recruiting
        • Guy's and St Thomas' NHS Foundation Trust
        • Contact:
          • Nicholas Bartlett, Dr.
      • London, United Kingdom
        • Recruiting
        • Great Ormond Street Hospital For Children NHS Foundation Trust
        • Contact:
          • Katherine Brown
      • Newcastle Upon Tyne, United Kingdom
        • Recruiting
        • Newcastle-upon-Tyne Hospitals NHS Trust
        • Contact:
          • Judit Llevadias

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with confirmed COVID-19 infection who require ECMO support

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Age
Time Frame: at baseline
age in years
at baseline
Gender
Time Frame: at baseline
male/female
at baseline
Weight
Time Frame: at baseline
in kilograms
at baseline
Height
Time Frame: at baseline
in meters
at baseline
BMI
Time Frame: at baseline
weight and height combined to calculate BMI in kg/m^2
at baseline
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
at baseline
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
at baseline
Date of signs of COVID-19 infection
Time Frame: at baseline or date of occurence
in dd-mm-yyyy or mm-dd-yyyy
at baseline or date of occurence
Date of positive swab
Time Frame: at baseline or date of occurence
in dd-mm-yyyy or mm-dd-yyyy
at baseline or date of occurence
Pre-ECMO length of hospital stay
Time Frame: at or during ECMO-implant
in days
at or during ECMO-implant
Pre-ECMO length of ICU stay
Time Frame: at or during ECMO-implant
in days
at or during ECMO-implant
Pre-ECMO length of mechanical ventilation days
Time Frame: at or during ECMO-implant
in days
at or during ECMO-implant
Use of antibiotics
Time Frame: up to 6 months
y/n, what kind
up to 6 months
Use of anti-viral treatment
Time Frame: up to 6 months
y/n, what kind
up to 6 months
Use of second line treatment
Time Frame: up to 6 months
y/n, what kind (eg prone-position, recruitment manoeuvers, neuromuscular blockade etc)
up to 6 months
Indications for ECMO-implant
Time Frame: at ECMO-implant
respiratory or cardiac
at ECMO-implant
Type of ECMO-implant
Time Frame: at ECMO-implant
veno-venous, veno-arterial or veno-venoarterial
at ECMO-implant
Type of access
Time Frame: at ECMO-implant
peripheral or central
at ECMO-implant
Date of ECMO implant
Time Frame: at ECMO-implant
in dd-mm-yyyy or mm-dd-yyyy
at ECMO-implant
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
from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months
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
from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months
ECMO configuration change
Time Frame: up to 6 months
y/n
up to 6 months
Date of ECMO configuration change
Time Frame: up to 6 months
in dd-mm-yyyy or mm-dd-yyyy
up to 6 months
New ECMO configuration
Time Frame: up to 6 months
veno-venous, veno-arterial, veno-venoarterial, other
up to 6 months
Indications for ECMO configuration change
Time Frame: up to 6 months
right ventricular failure, left ventricular failure, refractory hypoxemia
up to 6 months
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
from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months
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
from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months
Frequency of ECMO circuit change
Time Frame: up to 6 months
amount of ECMO circuit changes (1, 2, 3 etc.)
up to 6 months
ECMO complications
Time Frame: up to 6 months
Hemorrhagic, infection, other complications
up to 6 months
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
from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months
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
from day of ICU-admission for every 24 hours until date of discharge or death, up to 6 months
Main cause of death
Time Frame: 6 months
6 months
Type of discharge
Time Frame: up to 6 months
Ward, another ICU, rehabilitation center, home
up to 6 months
Alive/deceased
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2020

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

April 17, 2020

First Submitted That Met QC Criteria

April 28, 2020

First Posted (Actual)

April 29, 2020

Study Record Updates

Last Update Posted (Actual)

September 5, 2021

Last Update Submitted That Met QC Criteria

September 3, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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