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 treatment provided according to the current treatment protocols for coronavirus disease. In addition to this treatment, each patient will be randomly assigned to receive additional treatment with convalescent plasma transfusion (CP; blood plasma from patients who have been cured of coronavirus), or continue with standard treatment but without adding transfusion. 50% of the chances of additional treatment with CP, and 50% of the chances of receiving only the standard treatment for coronavirus. The duration of the study shall be one month from the assignment of the treatment. The patient and the doctor will know the treatment assigned.
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 receive SOC:
- Treatment arm: Pathogen-reduced CP from patients recovered from COVID-19, whom, for the
purpose of this trial, are herein designated as donors.
- Control arm: SOC for COVID-19.
Randomization among the two arms will be 1:1 and will be stratified per center. Of note, in
the current status of a worldwide pandemic for which we have no approved vaccines or drugs,
for the purpose of this trial SOC would also accept any drugs that are being used in clinical
practice (e.g. lopinavir/ritonavir; darunavir/cobicistat; hydroxy/chloroquine, tocilizumab,
etc.), other than those used as part of another clinical trial.
The study is planned with a sequential design. Interim analyses: comprehensive safety data
monitoring analyses will be conducted when 20%, 40%, 60% and 80% of patients, or at the
discretionary DSMB criteria when needed. A DSMB charter will be set before the trial
initiation where criteria for prematurely stopping the trial due to safety issues will be
set. Interim analyses will be predefined upfront based on the DSMB recommendations.
Other: Blood and derivatives.
Administration of fresh plasma from donor immunized against COVID-19
Other Name: Convalescent Plasma from patients recovered from COVID-19
Drug: Standard of Care
Standard of care for the treatment of COVID-19 in hospitalized patients
Other Name: SOC
Inclusion Criteria:
1. 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.
2. Male or female adult patient ≥18 years of age at time of enrolment.
3. 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.
4. 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.
5. No more than 7 days between the onset of symptoms (fever or cough) and treatment
administration day.
Exclusion Criteria:
1. Requiring mechanical ventilation (invasive or non-invasive) or high flow oxygen
devices.
2. More than 7 days since symptoms (fever or cough).
3. Participation in any other clinical trial of an experimental treatment for COVID-19.
4. 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.
5. Any incompatibility or allergy to the administration of human plasma.
6. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR <30).
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Aragón, Spain
Hospital Universitario Mútua Terrassa
Terrassa, Barcelona, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain
Hospital General de Albacete
Albacete, Spain
Hospital del Mar
Barcelona, Spain
Hospital General Universitario de Ciudad Real
Ciudad Real, Spain
Hospital Universitario Donostia
Donostia, Spain
Hospital Doctor Josep Trueta
Girona, Spain
Hospital Doctor Negrín
Las Palmas, Spain
Complejo Asistencial Universitario de León
León, Spain
Hospital Universitario Arnau de Vilanova
Lleida, Spain
Hospital San Pedro
Logroño, Spain
Hospital Universitario La Princesa
Madrid, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario HM Sanchinarro
Madrid, Spain
Hospital Sant Joan de Deu de Manresa. Fundación Althaia
Manresa, Spain
Hospital Universitario de Asturias
Oviedo, Spain
Hospital Universitario Son Espases
Palma De Mallorca, Spain
Clínica Universidad de Navarra (CUN). Sedes Pamplona y Madrid
Pamplona, Spain
Complejo Hospitalario de Navarra
Pamplona, Spain
Hospital Universitario de Salamanca
Salamanca, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Spain
Complejo Hospitalario de Toledo
Toledo, Spain
Hospital General Universitario de Valencia
Valencia, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain