v3.0.7
Please consider this website is continuously evolving and still under development
to harmonize automatic data extraction and integrate manual data annotation.
| Column | Value |
|---|---|
| Trial registration number | NCT05247307 |
|
Full text link
Last imported at : Feb. 19, 2022, 5 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Feb. 19, 2022, 5 p.m. Source : ClinicalTrials.gov |
|
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Contact
Last imported at : Feb. 19, 2022, 5 p.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : Feb. 19, 2022, 5 p.m. Source : ClinicalTrials.gov |
2022-02-18 |
|
Recruitment status
Last imported at : Feb. 19, 2022, 5 p.m. Source : ClinicalTrials.gov |
Terminated |
|
Study design
Last imported at : Feb. 19, 2022, 5 p.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Feb. 19, 2022, 5 p.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : Feb. 19, 2022, 5 p.m. Source : ClinicalTrials.gov |
Adaptive |
|
Masking
Last imported at : Feb. 19, 2022, 5 p.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : Feb. 19, 2022, 5 p.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Feb. 19, 2022, 5 p.m. Source : ClinicalTrials.gov |
inclusion criteria: sars cov 2 infection, confirmed by pcr or technique of similar specificity. symptom onset, or positive pcr (whichever comes first) within 7 days (168 hours) prior to planned plasma infusion. 65 years of age or older. all patients, or the guardian appointed by the judge, in the case of recognized judicial incapacity, must sign the informed consent document. |
|
Exclusion criteria
Last imported at : Feb. 19, 2022, 5 p.m. Source : ClinicalTrials.gov |
less than 65 years of age symptom onset, or positive pcr (whichever comes first), more than 7 days (168 hours) prior to planned plasma infusion. severe dementia, or other significant comorbidity, that generates a serious deterioration of the baseline functional status, with a life expectancy of less than 6 months. participation in another clinical trial or study. history of allergy to amotosalen or psoralens |
|
Number of arms
Last imported at : Feb. 19, 2022, 5 p.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : Feb. 19, 2022, 5 p.m. Source : ClinicalTrials.gov |
Hospital Galdakao-Usansolo |
|
Inclusion age min
Last imported at : Feb. 19, 2022, 5 p.m. Source : ClinicalTrials.gov |
65 |
|
Inclusion age max
Last imported at : Feb. 19, 2022, 5 p.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Feb. 19, 2022, 5 p.m. Source : ClinicalTrials.gov |
Spain |
|
Type of patients
Last imported at : Feb. 19, 2022, 5 p.m. Source : ClinicalTrials.gov |
No restriction on type of patients |
|
Severity scale
Last imported at : Feb. 19, 2022, 5 p.m. Source : ClinicalTrials.gov |
0: No restriction on type of patients |
|
Total sample size
Last imported at : Feb. 19, 2022, 5 p.m. Source : ClinicalTrials.gov |
93 |
|
primary outcome
Last imported at : March 8, 2022, 10:30 p.m. Source : ClinicalTrials.gov |
Rate of complications;Rate of hospital admission;Rate of of deaths;Rate of severity of the disease |
|
Notes
Last imported at : Feb. 19, 2022, 5 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Feb. 19, 2022, 5 p.m. Source : ClinicalTrials.gov |
Phase 3 |
|
Arms
Last imported at : Feb. 19, 2022, 5 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 999, "treatment_name": "Plasma", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}] |