Last updated: December 15, 2021
Sponsor: ExThera Medical Europe BV
Overall Status: Active - Recruiting
Phase
N/A
Condition
Covid-19
Treatment
N/AClinical Study ID
NCT04547257
CP022
Ages 18-90 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Subjects with confirmed SARS-CoV-2 infection
- Be ≥ 18 years old and ≤90 years old
- Acute respiratory distress syndrome assessed by a modified Sequential Organ FailureAssessment score of at least 2 points
- At least one additional organ dysfunction assessed by a modified Sequential OrganFailure Assessment score of at least 1 point
- Written or electronic consent of the subjects who are legally competent and have thecapacity to give consent
Exclusion
Exclusion Criteria:
- Subject is currently participating in another clinical investigation
- Pregnant or nursing subjects and those who plan pregnancy during the clinicalinvestigation follow-up period
- Presence of comorbid conditions, or other medical, social, or psychological conditionsthat, in the investigator's opinion, could limit the subject's ability to participatein the clinical investigation or to comply with follow-up requirements, or impact thescientific soundness of the clinical investigation results
- Have Child-Pugh Class C cirrhosis
- Have platelet count <30.000/uL
- Contraindications for heparin sodium for injection
- Subjects demonstrating any contraindication for this treatment as described in the IFU
- Subjects with known allergy of polyethylene and copolyester
- Subjects with hospital-acquired SARS-CoV-2 infections
- Subject is held in an institution by court or official order
- Subject is dependent on the sponsor or investigator so that consent can no longer beconsidered voluntary
Study Design
Total Participants: 42
Study Start date:
May 04, 2021
Estimated Completion Date:
December 31, 2022
Study Description
Connect with a study center
Klinikum Aschaffenburg-Alzenau
Aschaffenburg, 63739
GermanyActive - Recruiting
Vivantes Klinikum Neukölln
Berlin, 12351
GermanySite Not Available
Universitätsklinikum Essen
Essen, 45147
GermanySite Not Available
Carla Kikken-Jussen
Vaals, Limburg
NetherlandsSite Not Available
Hospital Universitari Vall d'Hebron
Barcelona, 08035
SpainActive - Recruiting
Hospital Clinico San Carlos
Madrid, 28040
SpainSite Not Available
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