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
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||278 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||1:1 ratio for CP: Control arm. Also, approximately 140-200 CP donors.|
|Masking:||None (Open Label)|
|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|
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
- 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
- Not hospitalized, no limitations on activities.
- Not hospitalized, limitation on activities.
- Hospitalized, not requiring supplemental oxygen.
- Hospitalized, requiring supplemental oxygen.
- Hospitalized, on non-invasive ventilation or high flow oxygen devices.
- Hospitalized, on invasive mechanical ventilation or ECMO.
- 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
- Mortality of any cause at 15 days [ Time Frame: 15 days ]Mortality
- Mortality of any cause at 29 days [ Time Frame: 29 days ]Mortality
- Oxygenation free days [ Time Frame: 29 days ]days free from oxygen supplementation
- Ventilator free days [ Time Frame: 29 days ]days free from mechanical ventilation
- 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).
- 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
- 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).
- 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.
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
|Contact: Cristina Avendaño Solá, MD, PhD||+34 91 191 64 firstname.lastname@example.org|
|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|
|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|