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| Column | Value |
|---|---|
| Trial registration number | NCT05182515 |
|
Full text link
Last imported at : Jan. 12, 2022, 9 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Jan. 12, 2022, 9 a.m. Source : ClinicalTrials.gov |
|
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Contact
Last imported at : Jan. 12, 2022, 9 a.m. Source : ClinicalTrials.gov |
a.mazeraud@ghu-paris.fr |
|
Registration date
Last imported at : Jan. 12, 2022, 9 a.m. Source : ClinicalTrials.gov |
2022-01-10 |
|
Recruitment status
Last imported at : Jan. 12, 2022, 9 a.m. Source : ClinicalTrials.gov |
Recruiting |
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Study design
Last imported at : Jan. 12, 2022, 9 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Jan. 12, 2022, 9 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Jan. 12, 2022, 9 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Jan. 12, 2022, 9 a.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : Jan. 12, 2022, 9 a.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Jan. 12, 2022, 9 a.m. Source : ClinicalTrials.gov |
inclusion criteria: sars-cov-2 infection proven by pcr. positive detection of anti-interferon antibodies. patient, family or deferred consent (emergency clause). affiliation to a social security scheme (or exemption from affiliation). inclusions are possible also for protected patient (under guardianship and tutornship). |
|
Exclusion criteria
Last imported at : Jan. 12, 2022, 9 a.m. Source : ClinicalTrials.gov |
pregnant women, parturients and nursing mothers minor patient participation in another interventional trial in progress, with the objective, even secondary, of reducing mortality indication to ept for another associated pathology contra-indication to ept, known allergy to albumin 5%. persons under court protection, disturbance of the haemostasis balance (pt<50%, aptt>1.5 and fibrinogen <1g/l) patient presenting a hemorrhagic diathesis (intracranial or digestive bleeding or threatening the functional prognosis) any progressive and advanced pathology whose life expectancy is less than one month bacterial or viral infectious disease (hiv) explaining most of the aggravation |
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Number of arms
Last imported at : Jan. 12, 2022, 9 a.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : Jan. 12, 2022, 9 a.m. Source : ClinicalTrials.gov |
Centre Hospitalier St Anne |
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Inclusion age min
Last imported at : Jan. 12, 2022, 9 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Jan. 12, 2022, 9 a.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Jan. 12, 2022, 9 a.m. Source : ClinicalTrials.gov |
France |
|
Type of patients
Last imported at : Jan. 12, 2022, 9 a.m. Source : ClinicalTrials.gov |
Severe disease at enrollment |
|
Severity scale
Last imported at : Jan. 12, 2022, 9 a.m. Source : ClinicalTrials.gov |
6: Severe disease at enrollment |
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Total sample size
Last imported at : Jan. 12, 2022, 9 a.m. Source : ClinicalTrials.gov |
50 |
|
primary outcome
Last imported at : Jan. 12, 2022, 9 a.m. Source : ClinicalTrials.gov |
Survival at day 28 |
|
Notes
Last imported at : Jan. 12, 2022, 9 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Jan. 12, 2022, 9 a.m. Source : ClinicalTrials.gov |
Phase 3 |
|
Arms
Last imported at : Jan. 12, 2022, 9 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 1000, "treatment_name": "Plasma exchange", "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"}] |