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Plasma turnover in patients with COVID-19 disease and invasive mechanical ventilatio

Phase 1
Conditions
coronavirus (covid-19) infection with respiratory failure requiring mechanical ventilation.
MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 21.1Level: PTClassification code 10067221Term: Mechanical ventilationSystem Organ Class: 10042613 - Surgical and medical procedures
Therapeutic area: Diseases [C] - Virus Diseases [C02]
Registration Number
EUCTR2020-001722-66-ES
Lead Sponsor
Fundació Clínic per a la recerca Biomèdica
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
116
Inclusion Criteria

1-Age 18-79 years;

2-Diagnosis of COVID-19 by PCR in nasopharyngeal, sputum or bronchial aspirate smears :

3-Admission to ICU with invasive mechanical ventilation;

4-Telephone informed consent granted by family members or legal representative.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 91
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

1-> 7 days of invasive mechanical ventilation, 2- Refractory shock (norepinephrine> 0.5 microg / Kg / min), 3- Decompensated liver cirrhosis 4- Chronic hemodialysis 5- Active neoplastic disease 6- Moderate or severe heart failure (NYHA III- IV), 7- Moderate-severe lung disease (GOLD III-IV), 8- HIV with AIDS criteria.

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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