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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
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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.
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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | Pathogen-reduced CP from patients recovered from COVID-19, whom, for the purpose of this trial, are herein designated as donors. |
|
| Control Arm | Active Comparator | Standard of Care (SOC) for COVID-19 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood and derivatives. | Other | Administration of fresh plasma from donor immunized against COVID-19 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Status at day 30 in the "7-point ordinal scale" | Status at day 30 in the "7-point ordinal scale" | 30 days |
| 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" |
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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:
No more than 7 days between the onset of symptoms (fever or cough) and treatment administration day.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínico Universitario Lozano Blesa | Zaragoza | Aragon | 50009 | Spain | ||
| Hospital Universitario Mútua Terrassa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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 May 10;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub6. | |
| 36734509 |
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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.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research
The investigator who proposed to use the data will have access to the data upon reasonable request.
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1:1 ratio for CP: Control arm. Also, approximately 140-200 CP donors.
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| Standard of Care | Drug | Standard of care for the treatment of COVID-19 in hospitalized patients |
|
|
| 29 days |
| 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" | 29 days |
| Time to first deterioration | 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 | Mean change in the ranking in the "7-Ordinal Scale" from baseline to days 3,5,8,11,15,29 and 60 | 60 days |
| 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. | 60 days |
| 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" | 30 days |
| Mortality of any cause at 15 days | Rate of mortality of any cause within first 15 days. | 15 days |
| Mortality of any cause at 28 days (day 29) | Rate of mortality of any cause within first 28 days. | 28 days (day 29) |
| Mortality of any cause at 60 days | Rate of mortality of any cause within first 60 days. | 60 days |
| Oxygenation free days | days free from oxygen supplementation | 29 days |
| Ventilator free days | days free from mechanical ventilation | 29 days |
| Duration of hospitalization (days) | days of hospitalization | 60 days |
| Incidence of thrombotic arterial events | incidence of thrombotic arterial events | 60 days |
| Incidence of thrombotic venous events | incidence of thrombotic venous events | 60 days |
| 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.
| 30 days |
| 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). | 60 days |
| 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). | 60 days |
| rate of rehospitalizations | rehospitalizations | 60 days |
| 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 | 3 months |
| Viral load | Change in PCR for SARS-CoV-2 in naso/oropharyngeal swabs at baseline and at discharge | Days 1,3,5,8,11,15, 29 and 60 |
| 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 | Days 1,3,5,8,11,15,29 and 60 |
| Terrassa |
| Barcelona |
| 08221 |
| Spain |
| Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda | Madrid | 28222 | Spain |
| Hospital General de Albacete | Albacete | 02006 | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital General Universitario de Ciudad Real | Ciudad Real | 13005 | Spain |
| Hospital Universitario Donostia | Donostia / San Sebastian | 20014 | Spain |
| Hospital Doctor Josep Trueta | Girona | 17007 | Spain |
| Hospital Doctor Negrín | Las Palmas | 35010 | Spain |
| Complejo Asistencial Universitario de León | León | 24071 | Spain |
| Hospital Universitario Arnau de Vilanova | Lleida | 25198 | Spain |
| Hospital San Pedro | Logroño | 26006 | Spain |
| Hospital Universitario La Princesa | Madrid | 28006 | Spain |
| Hospital General Universitario Gregorio Marañón | Madrid | 28009 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital Clínico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario HM Sanchinarro | Madrid | 28050 | Spain |
| Hospital Sant Joan de Deu de Manresa. Fundación Althaia | Manresa | 08243 | Spain |
| Hospital Universitario de Asturias | Oviedo | 33011 | Spain |
| Hospital Universitario Son Espases | Palma de Mallorca | 07120 | Spain |
| Clínica Universidad de Navarra (CUN). Sedes Pamplona y Madrid | Pamplona | 31008 | Spain |
| Complejo Hospitalario de Navarra | Pamplona | 31008 | Spain |
| Hospital Universitario de Salamanca | Salamanca | Spain |
| Hospital Universitario Marqués de Valdecilla | Santander | 39008 | Spain |
| Complejo Hospitalario de Toledo | Toledo | 45007 | Spain |
| Hospital General Universitario de Valencia | Valencia | 46014 | Spain |
| Hospital Clínico Universitario de Valladolid | Valladolid | 47003 | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | 50009 | Spain |
| 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. |
| 34473652 | 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. |
| 34013969 | 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. |
| 33472681 | 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. |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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