Back to resultsConvalescent Plasma Therapy vs. SOC for the Treatment of COVID-19 in Hospitalized Patients (ConPlas-19)
Primary Purpose
COVID-19
Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Blood and derivatives.
Standard of Care
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, Coronavirus, SARS-CoV-2, Convalescent Plasma, SOC, CP
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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).
Sites / 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
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment Arm
Control Arm
Arm Description
Pathogen-reduced CP from patients recovered from COVID-19, whom, for the purpose of this trial, are herein designated as donors.
Standard of Care (SOC) for COVID-19
Outcomes
Primary Outcome Measures
Category Changes in the "7-Ordinal Scale"
Proportion of patients in categories 5, 6 or 7 of the 7-point ordinal scale at day 15 7- Ordinal scale:
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.
Death.
Secondary Outcome Measures
Time to category 5, 6 or 7 of the " 7-Ordinal scale"
Time to change from baseline category to worsening into 5,6 or 7 categories of the "7-Ordinal scale"
Time to an improvement of one category from admission in the "7-Ordinal scale"
Time to an improvement of one category from admission in the "7-Ordinal scale"
Status at day 30 in the "11-Ordinal scale"
Status at day 30 in the "11-Ordinal scale"
"11-Ordinal scale" :
0. Uninfected ; no viral RNA detected.
Asymptomatic; viral RNA detected, limitation on activities.
Symptomatic; independent
Symptomatic; assistance needed
Hospitalized, no oxygen therapy.
Hospitalized, oxygen by mask or nasal prongs
Oxygen by mask or nasal prongs
Intubation and mechanical ventilation, pO2/FiO2 ≥150 or SpO2/FiO2 ≥200
Mechanical ventilation pO2/FIO2 <150 (SpO2/FiO2 <200) or vasopressors
Mechanical ventilation pO2/FiO2 <150 and vasopressors, dialysis, or ECMO
Dead
Status at day 15 and 30 in the "11-Ordinal scale"
Status at day 15 and 30 in the "11-Ordinal scale"
Status at day 15 and 30 in the "11-Ordinal scale"
Time to first deterioration
Time to first deterioration
Mean change in the ranking in the "7-Ordinal scale" from baseline to days 3,5,8,11,15,29 and 60
Mean change in the ranking in the "7-Ordinal Scale" from baseline to days 3,5,8,11,15,29 and 60
Mean change in the ranking in the "11-Ordinal scale from baseline to days 3,5,8,11,15,29 and 60.
Mean change in the ranking in the "11- Ordinal scale" from baseline to days 3,5,8,11,15,29 and 60.
Mortality of any cause at 15 days
Rate of mortality of any cause within first 15 days.
Mortality of any cause at 28 days (day 29)
Rate of mortality of any cause within first 28 days.
Mortality of any cause at 60 days
Rate of mortality of any cause within first 60 days.
Oxygenation free days
days free from oxygen supplementation
Ventilator free days
days free from mechanical ventilation
Duration of hospitalization (days)
days of hospitalization
Infusion-related adverse events
Infusion-related adverse events Cumulative incidence of serious adverse events (SAEs) Cumulative incidence of Grade 3 and 4 adverse events (AEs).
Incidence of Treatment-Emergent Adverse Events
cumulative incidence of Grade 3 and 4 adverse events (AEs) 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
Quantitative total antibodies and neutralizing antibody activity against SARSCoV-2 in the sera from donors and patients using viral pseudotypes
Viral load
Change in PCR for SARS-CoV-2 in naso/oropharyngeal swabs at baseline and at discharge
Viral load
Change in PCR for SARS-CoV-2 in blood on Days 3,5,8,11,15,29 and 60 (while hospitalized) until two of them are negative consecutively
Incidence of thrombotic arterial events
incidence of thrombotic arterial events
Incidence of thrombotic venous events
incidence of thrombotic venous events
rate of rehospitalizations
rehospitalizations
Full Information
NCT ID
NCT04345523
First Posted
April 2, 2020
Last Updated
May 12, 2021
Sponsor
Cristina Avendaño Solá
Collaborators
Instituto de Salud Carlos III
1. Study Identification
Unique Protocol Identification Number
NCT04345523
Brief Title
Convalescent Plasma Therapy vs. SOC for the Treatment of COVID-19 in Hospitalized Patients
Acronym
ConPlas-19
Official Title
Multi-center, Randomized Clinical Trial of Convalescent Plasma Therapy Versus Standard of Care for the Treatment of COVID-19 in Hospitalized Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
April 3, 2020 (Actual)
Primary Completion Date
February 5, 2021 (Actual)
Study Completion Date
April 5, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Cristina Avendaño Solá
Collaborators
Instituto de Salud Carlos III
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, Coronavirus, SARS-CoV-2, Convalescent Plasma, SOC, CP
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
1:1 ratio for CP: Control arm. Also, approximately 140-200 CP donors.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Pathogen-reduced CP from patients recovered from COVID-19, whom, for the purpose of this trial, are herein designated as donors.
Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
Standard of Care (SOC) for COVID-19
Intervention Type
Other
Intervention Name(s)
Blood and derivatives.
Other Intervention Name(s)
Convalescent Plasma from patients recovered from COVID-19
Intervention Description
Administration of fresh plasma from donor immunized against COVID-19
Intervention Type
Drug
Intervention Name(s)
Standard of Care
Other Intervention Name(s)
SOC
Intervention Description
Standard of care for the treatment of COVID-19 in hospitalized patients
Primary Outcome Measure Information:
Title
Category Changes in the "7-Ordinal Scale"
Description
Proportion of patients in categories 5, 6 or 7 of the 7-point ordinal scale at day 15 7- Ordinal scale:
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.
Death.
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Time to category 5, 6 or 7 of the " 7-Ordinal scale"
Description
Time to change from baseline category to worsening into 5,6 or 7 categories of the "7-Ordinal scale"
Time Frame
29 days
Title
Time to an improvement of one category from admission in the "7-Ordinal scale"
Description
Time to an improvement of one category from admission in the "7-Ordinal scale"
Time Frame
29 days
Title
Status at day 30 in the "11-Ordinal scale"
Description
Status at day 30 in the "11-Ordinal scale"
"11-Ordinal scale" :
0. Uninfected ; no viral RNA detected.
Asymptomatic; viral RNA detected, limitation on activities.
Symptomatic; independent
Symptomatic; assistance needed
Hospitalized, no oxygen therapy.
Hospitalized, oxygen by mask or nasal prongs
Oxygen by mask or nasal prongs
Intubation and mechanical ventilation, pO2/FiO2 ≥150 or SpO2/FiO2 ≥200
Mechanical ventilation pO2/FIO2 <150 (SpO2/FiO2 <200) or vasopressors
Mechanical ventilation pO2/FiO2 <150 and vasopressors, dialysis, or ECMO
Dead
Time Frame
30 days
Title
Status at day 15 and 30 in the "11-Ordinal scale"
Description
Status at day 15 and 30 in the "11-Ordinal scale"
Status at day 15 and 30 in the "11-Ordinal scale"
Time Frame
30 days
Title
Time to first deterioration
Description
Time to first deterioration
Time Frame
60 days
Title
Mean change in the ranking in the "7-Ordinal scale" from baseline to days 3,5,8,11,15,29 and 60
Description
Mean change in the ranking in the "7-Ordinal Scale" from baseline to days 3,5,8,11,15,29 and 60
Time Frame
60 days
Title
Mean change in the ranking in the "11-Ordinal scale from baseline to days 3,5,8,11,15,29 and 60.
Description
Mean change in the ranking in the "11- Ordinal scale" from baseline to days 3,5,8,11,15,29 and 60.
Time Frame
60 days
Title
Mortality of any cause at 15 days
Description
Rate of mortality of any cause within first 15 days.
Time Frame
15 days
Title
Mortality of any cause at 28 days (day 29)
Description
Rate of mortality of any cause within first 28 days.
Time Frame
28 days (day 29)
Title
Mortality of any cause at 60 days
Description
Rate of mortality of any cause within first 60 days.
Time Frame
60 days
Title
Oxygenation free days
Description
days free from oxygen supplementation
Time Frame
29 days
Title
Ventilator free days
Description
days free from mechanical ventilation
Time Frame
29 days
Title
Duration of hospitalization (days)
Description
days of hospitalization
Time Frame
60 days
Title
Infusion-related adverse events
Description
Infusion-related adverse events Cumulative incidence of serious adverse events (SAEs) Cumulative incidence of Grade 3 and 4 adverse events (AEs).
Time Frame
60 days
Title
Incidence of Treatment-Emergent Adverse Events
Description
cumulative incidence of Grade 3 and 4 adverse events (AEs) Cumulative incidence of serious adverse events (SAEs) Cumulative incidence of Grade 3 and 4 adverse events (AEs).
Time Frame
60 days
Title
Antibodies levels in CP donors recovered from COVID-19
Description
Quantitative total antibodies and neutralizing antibody activity against SARSCoV-2 in the sera from donors and patients using viral pseudotypes
Time Frame
3 months
Title
Viral load
Description
Change in PCR for SARS-CoV-2 in naso/oropharyngeal swabs at baseline and at discharge
Time Frame
Days 1,3,5,8,11,15, 29 and 60
Title
Viral load
Description
Change in PCR for SARS-CoV-2 in blood on Days 3,5,8,11,15,29 and 60 (while hospitalized) until two of them are negative consecutively
Time Frame
Days 1,3,5,8,11,15,29 and 60
Title
Incidence of thrombotic arterial events
Description
incidence of thrombotic arterial events
Time Frame
60 days
Title
Incidence of thrombotic venous events
Description
incidence of thrombotic venous events
Time Frame
60 days
Title
rate of rehospitalizations
Description
rehospitalizations
Time Frame
60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristina Avendaño Solá, MD, PhD
Organizational Affiliation
Hospital Universitario Puerta de Hierro Majadahonda
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rafael Duarte Palomino, MD, PhD
Organizational Affiliation
Hospital Universitario Puerta de Hierro Majadahonda
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Antonio Ramos, MD, PhD
Organizational Affiliation
Hospital Universitario Puerta de Hierro Majadahonda
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
José Luis Bueno, MD
Organizational Affiliation
Hospital Universitario Puerta de Hierro Majadahonda
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Inmaculada Casas Flecha, PharmD, PhD
Organizational Affiliation
Centro Nacional de Microbiología, Instituto de Salud Carlos III
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínico Universitario Lozano Blesa
City
Zaragoza
State/Province
Aragón
ZIP/Postal Code
50009
Country
Spain
Facility Name
Hospital Universitario Mútua Terrassa
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08221
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital General de Albacete
City
Albacete
ZIP/Postal Code
02006
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital General Universitario de Ciudad Real
City
Ciudad Real
ZIP/Postal Code
13005
Country
Spain
Facility Name
Hospital Universitario Donostia
City
Donostia
ZIP/Postal Code
20014
Country
Spain
Facility Name
Hospital Doctor Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital Doctor Negrín
City
Las Palmas
ZIP/Postal Code
35010
Country
Spain
Facility Name
Complejo Asistencial Universitario de León
City
León
ZIP/Postal Code
24071
Country
Spain
Facility Name
Hospital Universitario Arnau de Vilanova
City
Lleida
ZIP/Postal Code
25198
Country
Spain
Facility Name
Hospital San Pedro
City
Logroño
ZIP/Postal Code
26006
Country
Spain
Facility Name
Hospital Universitario La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario HM Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Sant Joan de Deu de Manresa. Fundación Althaia
City
Manresa
ZIP/Postal Code
08243
Country
Spain
Facility Name
Hospital Universitario de Asturias
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Facility Name
Hospital Universitario Son Espases
City
Palma De Mallorca
ZIP/Postal Code
07120
Country
Spain
Facility Name
Clínica Universidad de Navarra (CUN). Sedes Pamplona y Madrid
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Complejo Hospitalario de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
Country
Spain
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Complejo Hospitalario de Toledo
City
Toledo
ZIP/Postal Code
45007
Country
Spain
Facility Name
Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Hospital Clínico Universitario de Valladolid
City
Valladolid
ZIP/Postal Code
47003
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
PD that underlie the results reported in this article, after deidenficiation (text, tables, figures, and appendices) will be shared. The data will be available after main report is published.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research
IPD Sharing Access Criteria
The investigator who proposed to use the data will have access to the data upon reasonable request.
Citations:
PubMed Identifier
34473652
Citation
Avendano-Sola C, Ramos-Martinez A, Munez-Rubio E, Ruiz-Antoran B, Malo de Molina R, Torres F, Fernandez-Cruz A, Calderon-Parra J, Payares-Herrera C, Diaz de Santiago A, Romera-Martinez I, Pintos I, Lora-Tamayo J, Mancheno-Losa M, Paciello ML, Martinez-Gonzalez AL, Vidan-Estevez J, Nunez-Orantos MJ, Saez-Serrano MI, Porras-Leal ML, Jarilla-Fernandez MC, Villares P, de Oteyza JP, Ramos-Garrido A, Blanco L, Madrigal-Sanchez ME, Rubio-Batlles M, Velasco-Iglesias A, Pano-Pardo JR, Moreno-Chulilla JA, Muniz-Diaz E, Casas-Flecha I, Perez-Olmeda M, Garcia-Perez J, Alcami J, Bueno JL, Duarte RF; ConPlas-19 Study Group. A multicenter randomized open-label clinical trial for convalescent plasma in patients hospitalized with COVID-19 pneumonia. J Clin Invest. 2021 Oct 15;131(20):e152740. doi: 10.1172/JCI152740.
Results Reference
derived
PubMed Identifier
34013969
Citation
Piechotta V, Iannizzi C, Chai KL, Valk SJ, Kimber C, Dorando E, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 20;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub4.
Results Reference
derived
PubMed Identifier
33472681
Citation
Diago-Sempere E, Bueno JL, Sancho-Lopez A, Rubio EM, Torres F, de Molina RM, Fernandez-Cruz A, de Diego IS, Velasco-Iglesias A, Payares-Herrera C, Flecha IC, Avendano-Sola C, Palomino RD, Ramos-Martinez A, Ruiz-Antoran B. Evaluation of convalescent plasma versus standard of care for the treatment of COVID-19 in hospitalized patients: study protocol for a phase 2 randomized, open-label, controlled, multicenter trial. Trials. 2021 Jan 20;22(1):70. doi: 10.1186/s13063-020-05011-9.
Results Reference
derived
Learn more about this trial
Convalescent Plasma Therapy vs. SOC for the Treatment of COVID-19 in Hospitalized Patients
We'll reach out to this number within 24 hrs