Status:
TERMINATED
Efficacy of the Infusion of Donor Plasma in COVID-19 Infection
Lead Sponsor:
Hospital Galdakao-Usansolo
Conditions:
COVID-19
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief Summary
Objectives Primary objectives To assess the superiority or not of the infusion of anti-COVID immune plasma infusion versus a placebo (non-immune plasma) to patients over 65 years of age recently infec...
Detailed Description
Objectives Primary objectives To assess the superiority or not of the infusion of anti-COVID immune plasma infusion versus a placebo (non-immune plasma) to patients over 65 years of age recently infec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT05247307
Start Date
March 31 2020
End Date
December 31 2021
Last Update
March 7 2022
Active Locations (1)
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1
Hospital Galdakao-Usansolo
Galdakao, Bizkaia, Spain, 48960