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Convalescent Plasma Therapy vs. SOC for the Treatment of COVID19 in Hospitalized Patients (ConPlas-19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04345523
Recruitment Status : Recruiting
First Posted : April 14, 2020
Last Update Posted : April 15, 2020
Sponsor:
Information provided by (Responsible Party):
Cristina Avendaño Solá, Puerta de Hierro University Hospital

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 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.


Condition or disease Intervention/treatment Phase
COVID-19 Other: Blood and derivatives. Drug: Standard of Care Phase 2

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 278 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1:1 ratio for CP: Control arm. Also, approximately 140-200 CP donors.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-center, Randomized Clinical Trial of Convalescent Plasma Therapy Versus Standard of Care for the Treatment of COVID-19 in Hospitalized Patients
Actual Study Start Date : April 3, 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Arm Intervention/treatment
Experimental: Treatment Arm
Pathogen-reduced CP from patients recovered from COVID-19, whom, for the purpose of this trial, are herein designated as donors.
Other: Blood and derivatives.
Administration of fresh plasma from donor immunized against COVID-19
Other Name: Convalescent Plasma from patients recovered from COVID-19

Active Comparator: Control Arm
Standard of Care (SOC) for COVID-19
Drug: Standard of Care
Standard of care for the treatment of COVID-19 in hospitalized patients
Other Name: SOC




Primary Outcome Measures :
  1. Category Changes in Ordinal Scale [ Time Frame: 15 days ]

    Proportion of patients in categories 5, 6 or 7 of the 7-point ordinal scale at day 15

    Ordinal scale:

    1. Not hospitalized, no limitations on activities.
    2. Not hospitalized, limitation on activities.
    3. Hospitalized, not requiring supplemental oxygen.
    4. Hospitalized, requiring supplemental oxygen.
    5. Hospitalized, on non-invasive ventilation or high flow oxygen devices.
    6. Hospitalized, on invasive mechanical ventilation or ECMO.
    7. Death.


Secondary Outcome Measures :
  1. Time to category 5, 6 or 7 of the ordinal scale [ Time Frame: 29 days ]
    Time to change from baseline category to worsening into 5,6 or 7 categories of the ordinal scale

  2. Mortality of any cause at 15 days [ Time Frame: 15 days ]
    Mortality

  3. Mortality of any cause at 29 days [ Time Frame: 29 days ]
    Mortality

  4. Oxygenation free days [ Time Frame: 29 days ]
    days free from oxygen supplementation

  5. Ventilator free days [ Time Frame: 29 days ]
    days free from mechanical ventilation

  6. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 29 days ]
    Infusion-related adverse events Cumulative incidence of serious adverse events (SAEs) Cumulative incidence of Grade 3 and 4 adverse events (AEs).

  7. Antibodies levels in CP donors recovered from COVID-19 [ Time Frame: 3 months ]
    Quantitative total antibodies and neutralizing antibody activity against SARSCoV-2 in the sera from donors and patients using viral pseudotypes

  8. Viral load [ Time Frame: Days 1,3,5,8,11 and 29 ]
    Change in PCR for SARS-CoV-2 in naso/oropharyngeal swabs and blood at baseline and on days 3, 5, 8, 11 (while hospitalized); and days 15 and 29 (if able to return to clinic or still hospitalized).


Other Outcome Measures:
  1. Change in biological parameters [ Time Frame: Days 1,3,5,8,11 and 29 ]
    Serum levels of CRP, lymphocyte count, LDH, D Dimer,IL-6, coagulation tests at baseline and days 3, 5, 8, 11, 15 and 29.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  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 12 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 12 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04345523


Contacts
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Contact: Cristina Avendaño Solá, MD, PhD +34 91 191 64 79 cavendano@salud.madrid.org

Locations
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Spain
Hospital Clínico Universitario Lozano Blesa Not yet recruiting
Zaragoza, Aragón, Spain, 50009
Contact: José Ramón Paño Pardo, MD, PhD         
Principal Investigator: José Ramón Paño Pardo, MD, PhD         
Principal Investigator: José Antonio Moreno Chulilla, MD, PhD         
Hospital Universitario Severo Ochoa Not yet recruiting
Leganés, Madrid, Spain, 28911
Contact: Miguel Cervero Jiménez, MD         
Principal Investigator: Miguel Cervero Jiménez, MD         
Principal Investigator: Margarita Barberana, MD         
Hospital Universitario Puerta de Hierro Majadahonda Recruiting
Majadahonda, Madrid, Spain, 28222
Contact: Elena Muñez, MD, PhD         
Principal Investigator: Elena Muñez, MD, PhD         
Principal Investigator: José Luis Bueno, MD         
Hospital Universitario Príncipe de Asturias Not yet recruiting
Meco, Madrid, Spain, 28805
Contact: Cristina Hernández Guitiérrez, MD         
Principal Investigator: Cristina Hernández Gutiérrez, MD         
Principal Investigator: Elena Flores Ballester, MD         
Hospital Universitario La Princesa Not yet recruiting
Madrid, Spain, 28006
Contact: Ignacio de Santos Gil, MD         
Principal Investigator: Ignacio de Santos Gil, MD         
Principal Investigator: Isabel Vicuña Andrés, MD         
Hospital General Universitario Gregorio Marañón Not yet recruiting
Madrid, Spain, 28009
Contact: Marina Machado, MD         
Principal Investigator: Marina Machado, MD         
Principal Investigator: Javier Anguita Velasco, MD         
Hospital Universitario Ramón y Cajal Not yet recruiting
Madrid, Spain, 28034
Contact: Javier Martínez Sanz, MD         
Principal Investigator: Javier Martínez Sanz, MD         
Principal Investigator: Gemma Moreno, MD         
Hospital Clínico San Carlos Not yet recruiting
Madrid, Spain, 28040
Contact: Vicente Estrada Pérez, MD         
Principal Investigator: Vicente Estrada Pérez, MD         
Principal Investigator: María Isabel Saez Serrano, MD         
Hospital Universitario 12 de Octubre Not yet recruiting
Madrid, Spain, 28041
Contact: Jaime Lora Tamayo, MD         
Principal Investigator: Jaime Lora Tamayo, MD         
Principal Investigator: María Liz Paciello, MD         
Sponsors and Collaborators
Cristina Avendaño Solá
Investigators
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Study Chair: Cristina Avendaño Solá, MD, PhD Hospital Universitario Puerta de Hierro Majadahonda
Study Chair: Rafael Duarte Palomino, MD, PhD Hospital Universitario Puerta de Hierro Majadahonda
Principal Investigator: Antonio Ramos, MD, PhD Hospital Universitario Puerta de Hierro Majadahonda
Principal Investigator: José Luis Bueno, MD Hospital Universitario Puerta de Hierro Majadahonda
Principal Investigator: Inmaculada Casas Flecha, PharmD, PhD Centro Nacional de Microbiología, Instituto de Salud Carlos III
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Responsible Party: Cristina Avendaño Solá, MD, PhD, Puerta de Hierro University Hospital
ClinicalTrials.gov Identifier: NCT04345523    
Other Study ID Numbers: ConPlas-19
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: April 15, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cristina Avendaño Solá, Puerta de Hierro University Hospital:
COVID-19
Coronavirus
SARS-CoV-2
Convalescent Plasma
SOC
CP