| Trial registration number
|
NCT04374539 |
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
https://clinicaltrials.gov/show/NCT04374539
|
First author
Last imported at : April 6, 2022, 9 p.m.
Source : ClinicalTrials.gov
|
Not reported
|
Contact
Last imported at : April 6, 2022, 9 p.m.
Source : ClinicalTrials.gov
|
Not reported
|
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
2020-05-05
|
Recruitment status
Last imported at : April 6, 2022, 9 p.m.
Source : ClinicalTrials.gov
|
Terminated
|
Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
RCT
|
Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Randomized
|
Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Parallel
|
Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Open label
|
Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov
|
single-center
|
Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Treatment
|
Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
|
inclusion criteria:
male or female subject ≥18 years and < 80 years of age;
subjects with diagnosis of covid-19 disease by pcr in nasopharyngeal smear, sputum, or bronchial aspirates;
subjects admitted in icu with invasive mechanical ventilation;
informed consent granted via telephone by relatives or legal representative
|
Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
|
more than seven days with invasive mechanical ventilation
refractory shock (noradrenaline dose > 0.5 micrograms/ kg/minute)
decompensated cirrhosis
chronic kidney disease requiring hemodialysis
active neoplastic disease
severe chronic heart failure (nyha class iii or iv)
severe pulmonary disease (gold iii or iv)
hiv infection (aids criteria)
|
Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
2
|
Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Fundacion Clinic per a la Recerca Biomédica
|
Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
18
|
Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
80
|
Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Spain
|
Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Severe/critical disease at enrollment
|
Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
7: Severe/critical disease at enrollment
|
Total sample size
Last imported at : April 6, 2022, 9 p.m.
Source : ClinicalTrials.gov
|
36
|
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Impact of plasma exchange
|
Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
None
|
Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov
|
Phase 2
|
Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
[{"arm_notes": "", "treatment_id": 1653, "treatment_name": "Non convalescent plasma+polyclonal immunoglobulin", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]
|