Status:
COMPLETED
Clinical Trial to Evaluate the Efficacy of Treatment With Hyperimmune Plasma Obtained From Convalescent Antibodies of COVID-19 Infection
Lead Sponsor:
Andalusian Network for Design and Translation of Advanced Therapies
Conditions:
SARS-CoV 2
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
Phase I / II multicentre, randomized and controlled clinical trial to evaluate the efficacy of treatment with hyperimmune plasma obtained from convalescent antibodies of COVID-19 infection.
Eligibility Criteria
Inclusion
- Informed consent prior to performing procedures. the oral consent be accepted testified to prevent paper handling.
- Patient of both sexes, and ≥18 years.
- SARS-CoV-2 infection determined by PCR in a sample of naso-oropharyngeal exudate or other respiratory specimen or determination of specific positive IgM antibodies, in \<72 hours before randomization.
- Patients requiring hospitalization for pneumonia COVID-19 without need until randomization of mechanical ventilation (invasive or non-invasive), and at least one of the following:
- O2 saturation ≤ 94% in ambient air, or PaO2 / FiO2 ≤ 300 mm Hg.
- Age\> 65 years.
- Presence of: high blood pressure, chronic heart failure, chronic obstructive pulmonary disease, liver cirrhosis, or other chronic pulmonary and cardiovascular diseases, diabetes, or obesity
Exclusion
- Requirement before randomization of mechanical ventilation (invasive or non-invasive).
- Any of the following analytical data before randomization: IL-6\> 80 pg / mL, D-dimer\> 10 times ULN, ferritin\> 1000ng / mL.
- Participation in another clinical trial or experimental treatment for COVID-19.
- In the opinion of the clinical team, progression to death or mechanical ventilation is highly probable within 24 hours, regardless of treatment provision.
- Incompatibility or allergy to the administration of human plasma.
- Severe chronic kidney disease grade 4 or requiring dialysis (ie eGFR \<30)
- Pregnant, lactating, or fertile women who are not using an effective method of contraception. It is considered a woman of childbearing age all women from 18 years and up to a year after the last menstrual period in the case of menopausal women
Key Trial Info
Start Date :
April 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2020
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04366245
Start Date
April 23 2020
End Date
December 30 2020
Last Update
April 6 2022
Active Locations (14)
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1
Hospital U. Jerez de la Frontera
Jerez de la Frontera, Cádiz, Spain, 11407
2
Hospital U. Puerto Real
Puerto Real, Cádiz, Spain, 11510
3
Hospital Costa del Sol
Marbella, Málaga, Spain, 29603
4
Hospital U. Torrecárdenas
Almería, Spain, 04009