Convalescent Plasma Therapy vs. SOC for the Treatment of COVID-19 in Hospitalized Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-03

Study Completion Date

2021-04-05

Brief Summary

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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.

Detailed Description

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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.

Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1:1 ratio for CP: Control arm. Also, approximately 140-200 CP donors.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Arm

Pathogen-reduced CP from patients recovered from COVID-19, whom, for the purpose of this trial, are herein designated as donors.

Group Type EXPERIMENTAL

Blood and derivatives.

Intervention Type OTHER

Administration of fresh plasma from donor immunized against COVID-19

Control Arm

Standard of Care (SOC) for COVID-19

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type DRUG

Standard of care for the treatment of COVID-19 in hospitalized patients

Interventions

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Blood and derivatives.

Administration of fresh plasma from donor immunized against COVID-19

Intervention Type OTHER

Standard of Care

Standard of care for the treatment of COVID-19 in hospitalized patients

Intervention Type DRUG

Other Intervention Names

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Convalescent Plasma from patients recovered from COVID-19 SOC

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Cristina Avendaño Solá

MD, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Valladolid, , Spain

Site Status

Hospital Universitario Miguel Servet

Zaragoza, , Spain

Site Status

Countries

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Spain

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ConPlas-19

Identifier Type: -

Identifier Source: org_study_id

Convalescent Plasma Therapy vs. SOC for the Treatment of COVID-19 in Hospitalized Patients

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Treatment Arm

Blood and derivatives.

Control Arm

Standard of Care

Interventions

Blood and derivatives.

Standard of Care

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Instituto de Salud Carlos III

Cristina Avendaño Solá

Responsible Party

Cristina Avendaño Solá

Principal Investigators

Cristina Avendaño Solá, MD, PhD

Rafael Duarte Palomino, MD, PhD

Antonio Ramos, MD, PhD

José Luis Bueno, MD

Inmaculada Casas Flecha, PharmD, PhD

Locations

Hospital Clínico Universitario Lozano Blesa

Hospital Universitario Mútua Terrassa

Hospital Universitario Puerta de Hierro Majadahonda

Hospital General de Albacete

Hospital del Mar

Hospital General Universitario de Ciudad Real

Hospital Universitario Donostia

Hospital Doctor Josep Trueta

Hospital Doctor Negrín

Complejo Asistencial Universitario de León

Hospital Universitario Arnau de Vilanova

Hospital San Pedro

Hospital Universitario La Princesa

Hospital General Universitario Gregorio Marañón

Hospital Universitario Ramón y Cajal

Hospital Clínico San Carlos

Hospital Universitario 12 de Octubre

Hospital Universitario HM Sanchinarro

Hospital Sant Joan de Deu de Manresa. Fundación Althaia

Hospital Universitario de Asturias

Hospital Universitario Son Espases

Clínica Universidad de Navarra (CUN). Sedes Pamplona y Madrid

Complejo Hospitalario de Navarra

Hospital Universitario de Salamanca

Hospital Universitario Marqués de Valdecilla

Complejo Hospitalario de Toledo

Hospital General Universitario de Valencia

Hospital Clínico Universitario de Valladolid

Hospital Universitario Miguel Servet

Countries

References

Other Identifiers

ConPlas-19