Status:
COMPLETED
Convalescent Plasma Therapy vs. SOC for the Treatment of COVID-19 in Hospitalized Patients
Lead Sponsor:
Cristina Avendaño Solá
Collaborating Sponsors:
Instituto de Salud Carlos III
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A total of 278 patients are planned. All patients will be in an early-stage of COVID-19. They must be adults and hospitalized. In this study, all participating patients will receive the standard tre...
Detailed Description
A multi-center, randomized, clinical trial with two arms to study the efficacy and safety of passive immunotherapy with CP compared to a control of standard of care (SOC). All trial participants will...
Eligibility Criteria
Inclusion
- Written informed consent prior to performing study procedures. Witnessed oral consent will be accepted in order to avoid paper handling. Written consent by patient or representatives will be obtained as soon as possible.
- Male or female adult patient ≥18 years of age at time of enrolment.
- Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR in naso/oropharyngeal swabs or any other relevant specimen in the ongoing COVID-19 symptomatic period. Alternative test (i.e antigenic tests) are also acceptable as laboratory confirmation if their adequate specificity has been accepted by the sponsor.
- Patients requiring hospitalization for COVID-19 without mechanical ventilation (invasive or non-invasive) or high flow oxygen devices and at least one of the following:
- Radiographic evidence of pulmonary infiltrates by imaging (chest x-ray, CT scan, etc.), OR
- Clinical assessment (evidence of rales/crackles on exam) AND SpO2 ≤ 94% on room air that requires supplemental oxygen.
- No more than 7 days between the onset of symptoms (fever or cough) and treatment administration day.
Exclusion
- Requiring mechanical ventilation (invasive or non-invasive) or high flow oxygen devices.
- More than 7 days since symptoms (fever or cough).
- Participation in any other clinical trial of an experimental treatment for COVID-19.
- In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
- Any incompatibility or allergy to the administration of human plasma.
- Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR \<30).
Key Trial Info
Start Date :
April 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 5 2021
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT04345523
Start Date
April 3 2020
End Date
April 5 2021
Last Update
December 2 2024
Active Locations (29)
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1
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Aragon, Spain, 50009
2
Hospital Universitario Mútua Terrassa
Terrassa, Barcelona, Spain, 08221
3
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain, 28222
4
Hospital General de Albacete
Albacete, Spain, 02006