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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT04716556 |
|
Full text link
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
2021-01-20 |
|
Recruitment status
Last imported at : Aug. 27, 2021, 8 p.m. Source : ClinicalTrials.gov |
Completed |
|
Study design
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Open label |
|
Center
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
multi-center |
|
Study aim
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
inclusion criteria: - age ≥ 18 years old - adult patients with positive rt-pcr test for sars-cov2 (nasal swabs or lower respiratory tract sample), diagnosed with pneumonia (<= 10 days) according to the following definitions: - suggestive radiological imaging (ct, rx, ultrasound); - respiratory failure not fully explained by heart failure or fluid overload; - pao2/fio2 200-350 mmhg; - signed informed consent |
|
Exclusion criteria
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
- need of non invasive or invasive mechanical ventilation at the time of randomization; - pao2/fio2 <200; - patients with hypersensitivity or allergic reaction to blood products or immunoglobulins; - patients who expressly refuse to adhere the clinical study; - use of il-6 receptor inhibitors, il-1 inhibitors, jak inhibitors, tnf inhibitors; - patients participating to other clinical trial. |
|
Number of arms
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Istituto Superiore di Sanità |
|
Inclusion age min
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Italy |
|
Type of patients
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Moderate/severe disease at enrollment |
|
Severity scale
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
4: Moderate/severe disease at enrollment |
|
Total sample size
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
474 |
|
primary outcome
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Number of patients who meet invasive mechanical ventilation or death |
|
Notes
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
Not reported |
|
Arms
Last imported at : April 13, 2022, 11:30 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "nan", "treatment_id": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "nan", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |