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

NCT04345523 | Completed Phase 2 DMC

• 1 other identifier: ConPlas-19
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 29

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.

Conditions

COVID-19

Keywords

COVID-19; Coronavirus; SARS-CoV-2; Convalescent Plasma; SOC; CP

Outcome Measures

Primary Outcomes (1)

• 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: 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.

  15 days

Secondary Outcomes (22)

• Status at day 30 in the "7-point ordinal scale"

  30 days

• Time to category 5, 6 or 7 of the " 7-Ordinal scale"

  29 days

• Time to an improvement of one category from admission in the "7-Ordinal scale"

  29 days

• Time to first deterioration

  60 days

• Mean change in the ranking in the "7-Ordinal scale" from baseline to days 3,5,8,11,15,29 and 60

  60 days

Study Arms (2)

Treatment Arm

EXPERIMENTAL

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.

Control Arm

ACTIVE COMPARATOR

Standard of Care (SOC) for COVID-19

Drug: Standard of Care

Interventions

Blood and derivatives. OTHER

Administration of fresh plasma from donor immunized against COVID-19

Also known as: Convalescent Plasma from patients recovered from COVID-19

Treatment Arm

Standard of Care DRUG

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

Also known as: SOC

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cristina Avendaño Solá: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (29)

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Aragon, 50009, Spain

Location

Hospital Universitario Mútua Terrassa

Terrassa, Barcelona, 08221, Spain

Location

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, 28222, Spain

Location

Hospital General de Albacete

Albacete, 02006, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital General Universitario de Ciudad Real

Ciudad Real, 13005, Spain

Location

Hospital Universitario Donostia

Donostia / San Sebastian, 20014, Spain

Location

Hospital Doctor Josep Trueta

Girona, 17007, Spain

Location

Hospital Doctor Negrín

Las Palmas, 35010, Spain

Location

Complejo Asistencial Universitario de León

León, 24071, Spain

Location

Hospital Universitario Arnau de Vilanova

Lleida, 25198, Spain

Location

Hospital San Pedro

Logroño, 26006, Spain

Location

Hospital Universitario La Princesa

Madrid, 28006, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28009, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario HM Sanchinarro

Madrid, 28050, Spain

Location

Hospital Sant Joan de Deu de Manresa. Fundación Althaia

Manresa, 08243, Spain

Location

Hospital Universitario de Asturias

Oviedo, 33011, Spain

Location

Hospital Universitario Son Espases

Palma de Mallorca, 07120, Spain

Location

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

Pamplona, 31008, Spain

Location

Complejo Hospitalario de Navarra

Pamplona, 31008, Spain

Location

Hospital Universitario de Salamanca

Salamanca, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, 39008, Spain

Location

Complejo Hospitalario de Toledo

Toledo, 45007, Spain

Location

Hospital General Universitario de Valencia

Valencia, 46014, Spain

Location

Hospital Clínico Universitario de Valladolid

Valladolid, 47003, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Related Publications (5)

• Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub6.

  PMID: 37162745 DERIVED

• Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 Feb 1;2(2):CD013600. doi: 10.1002/14651858.CD013600.pub5.

  PMID: 36734509 DERIVED

• 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.

  PMID: 34473652 DERIVED

• 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.

  PMID: 34013969 DERIVED

• 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.

  PMID: 33472681 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

Blood Specimen Collection; Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Cristina Avendaño Solá, MD, PhD

  Hospital Universitario Puerta de Hierro Majadahonda

  STUDY CHAIR

• Rafael Duarte Palomino, MD, PhD

  Hospital Universitario Puerta de Hierro Majadahonda

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

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

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: April 14, 2020
• Study Start: April 3, 2020
• Primary Completion: February 5, 2021
• Study Completion: April 5, 2021
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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
• Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request.

Locations

ES (29)