COVID-19Phase 2ConPlas-19NCT04345523

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

A Phase 2 study testing Blood and derivatives. in people with COVID-19, run by Cristina Avendaño Solá at 29 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: COVID-19
What is being tested?: Blood and derivatives.
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 350 participants
Where: 29 sitesSpain
Study dates: 3 Apr 2020to 5 Apr 2021
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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).

Trial locations and contacts

29 sites in 1 country.

City, postcode or hospital

29 sites in 1 country

Spain29 sites

Hospital General de Albacete
Albacete, 02006
Hospital del Mar
Barcelona, 08003
Hospital General Universitario de Ciudad Real
Ciudad Real, 13005
Hospital Universitario Donostia
Donostia / San Sebastian, 20014
Hospital Doctor Josep Trueta
Girona, 17007
Hospital Doctor Negrín
Las Palmas, 35010
Complejo Asistencial Universitario de León
León, 24071
Hospital Universitario Arnau de Vilanova
Lleida, 25198
Hospital San Pedro
Logroño, 26006
Hospital Universitario La Princesa
Madrid, 28006
Hospital General Universitario Gregorio Marañón
Madrid, 28009
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Clínico San Carlos
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario HM Sanchinarro
Madrid, 28050
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222
Hospital Sant Joan de Deu de Manresa. Fundación Althaia
Manresa, 08243
Hospital Universitario de Asturias
Oviedo, 33011
Hospital Universitario Son Espases
Palma de Mallorca, 07120
Clínica Universidad de Navarra (CUN). Sedes Pamplona y Madrid
Pamplona, 31008
Complejo Hospitalario de Navarra
Pamplona, 31008
Hospital Universitario de Salamanca
Salamanca
Hospital Universitario Marqués de Valdecilla
Santander, 39008
Hospital Universitario Mútua Terrassa
Terrassa, Barcelona, 08221
Complejo Hospitalario de Toledo
Toledo, 45007
Hospital General Universitario de Valencia
Valencia, 46014
Hospital Clínico Universitario de Valladolid
Valladolid, 47003
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Aragon, 50009
Hospital Universitario Miguel Servet
Zaragoza, 50009

Other trials in Spain

About this study

Official title: Multi-center, Randomized Clinical Trial of Convalescent Plasma Therapy Versus Standard of Care for the Treatment of COVID-19 in Hospitalized Patients

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.

Read the 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.

Conditions: COVID-19
Being tested: Blood and derivatives., Standard of Care
Keywords: COVID-19, Coronavirus, SARS-CoV-2, Convalescent Plasma, SOC, CP
Medical subject headings: COVID-19, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Blood and derivatives.Other
Also called Convalescent Plasma from patients recovered from COVID-19
Administration of fresh plasma from donor immunized against COVID-19
Standard of CareDrug
Also called SOC
Standard of care for the treatment of COVID-19 in hospitalized patients

Study groups in NCT04345523
Study group	Role	What they receive
Treatment Arm	Experimental	Pathogen-reduced CP from patients recovered from COVID-19, whom, for the purpose of this trial, are herein designated as donors. Receives: Other: Blood and derivatives.
Control Arm	Active comparator	Standard of Care (SOC) for COVID-19 Receives: Drug: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 15 days

Secondary outcomes (22)

Status at day 30 in the "7-point ordinal scale"
Status at day 30 in the "7-point ordinal scale"
Measured: 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"
Measured: 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"
Measured: 29 days
Time to first deterioration
Time to first deterioration
Measured: 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
Measured: 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.
Measured: 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"
Measured: 30 days
Mortality of any cause at 15 days
Rate of mortality of any cause within first 15 days.
Measured: 15 days
Mortality of any cause at 28 days (day 29)
Rate of mortality of any cause within first 28 days.
Measured: 28 days (day 29)
Mortality of any cause at 60 days
Rate of mortality of any cause within first 60 days.
Measured: 60 days
Oxygenation free days
days free from oxygen supplementation
Measured: 29 days
Ventilator free days
days free from mechanical ventilation
Measured: 29 days
Duration of hospitalization (days)
days of hospitalization
Measured: 60 days
Incidence of thrombotic arterial events
incidence of thrombotic arterial events
Measured: 60 days
Incidence of thrombotic venous events
incidence of thrombotic venous events
Measured: 60 days
Status at day 30 in the "11-Ordinal scale"
Status at day 30 in the "11-Ordinal scale"
"11-Ordinal scale" :
1. Uninfected ; no viral RNA detected.
2. Asymptomatic; viral RNA detected, limitation on activities.
3. Symptomatic; independent
4. Symptomatic; assistance needed
5. Hospitalized, no oxygen therapy.
6. Hospitalized, oxygen by mask or nasal prongs
7. Oxygen by mask or nasal prongs
8. Intubation and mechanical ventilation, pO2/FiO2 ≥150 or SpO2/FiO2 ≥200
9. Mechanical ventilation pO2/FIO2 <150 (SpO2/FiO2 <200) or vasopressors
10. Mechanical ventilation pO2/FiO2 <150 and vasopressors, dialysis, or ECMO
11. Dead
Measured: 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).
Measured: 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).
Measured: 60 days
rate of rehospitalizations
rehospitalizations
Measured: 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
Measured: 3 months
Viral load
Change in PCR for SARS-CoV-2 in naso/oropharyngeal swabs at baseline and at discharge
Measured: 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
Measured: Days 1,3,5,8,11,15,29 and 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Apr 20205 Apr 2021

First posted14 Apr 2020
Study start3 Apr 2020
Primary completion5 Feb 2021
Study completion5 Apr 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 1:1 ratio for CP: Control arm. Also, approximately 140-200 CP donors.
Masking: None (open label)
Enrolment: 350 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04345523
Sponsor's protocol ID: ConPlas-19
Acronym: ConPlas-19
Status last verified: Nov 2024
First submitted: 2 Apr 2020
Last updated: 2 Dec 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

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.
PubMed 37162745
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.
PubMed 36734509
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.
PubMed 34473652
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.
PubMed 34013969
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.
PubMed 33472681

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multi-center, Randomized Clinical Trial of Convalescent Plasma Therapy Versus Standard of Care for the Treatment of COVID-19 in Hospitalized Patients
ClinicalTrials.gov ID: NCT04345523
Acronym / sponsor ID: ConPlas-19 / ConPlas-19
Conditions: COVID-19
Keywords: COVID-19, Coronavirus, SARS-CoV-2, Convalescent Plasma, SOC, CP
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 350 participants (actual)
Lead sponsor: Cristina Avendaño SoláUniversity, hospital or other
Collaborators: Instituto de Salud Carlos III
Study start: 3 Apr 2020 (actual)
Primary completion: 5 Feb 2021 (actual)
Study completion: 5 Apr 2021 (actual)
First posted: 14 Apr 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A total of 278 patients are planned.

All patients will be in an early-stage of COVID-19. They must be adults and hospitalized.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: 1:1 ratio for CP: Control arm. Also, approximately 140-200 CP donors.

Arm	Type	Receives
Treatment Arm	Experimental	Other: Blood and derivatives.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	Drug: Standard of CareStandard of Care (SOC) for COVID-19

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Blood and derivatives.Also: Convalescent Plasma from patients recovered from COVID-19Administration of fresh plasma from donor immunized against COVID-19	Other	Treatment Arm
Standard of CareAlso: SOCStandard of care for the treatment of COVID-19 in hospitalized patients	Drug	Control Arm

Primary outcome

Category Changes in the "7-Ordinal Scale"
Time frame: 15 days
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.

22 secondary outcomes

Status at day 30 in the "7-point ordinal scale"
Time frame: 30 days
Time to category 5, 6 or 7 of the " 7-Ordinal scale"
Time frame: 29 days
Time to an improvement of one category from admission in the "7-Ordinal scale"
Time frame: 29 days
Time to first deterioration
Time frame: 60 days
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
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
Status at day 15 and 30 in the "11-Ordinal scale"
Time frame: 30 days
Mortality of any cause at 15 days
Time frame: 15 days
Mortality of any cause at 28 days (day 29)
Time frame: 28 days (day 29)
Mortality of any cause at 60 days
Time frame: 60 days
Oxygenation free days
Time frame: 29 days
Ventilator free days
Time frame: 29 days
Duration of hospitalization (days)
Time frame: 60 days
Incidence of thrombotic arterial events
Time frame: 60 days
Incidence of thrombotic venous events
Time frame: 60 days
Status at day 30 in the "11-Ordinal scale"
Time frame: 30 days
Infusion-related adverse events
Time frame: 60 days
Incidence of Treatment-Emergent Adverse Events
Time frame: 60 days
rate of rehospitalizations
Time frame: 60 days
Antibodies levels in CP donors recovered from COVID-19
Time frame: 3 months
Viral load
Time frame: Days 1,3,5,8,11,15, 29 and 60
Viral load
Time frame: Days 1,3,5,8,11,15,29 and 60

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
Derived from this study: PubMed 37162745Iannizzi 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.
Derived from this study: PubMed 36734509Iannizzi 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.
Derived from this study: PubMed 34473652Avendano-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.
Derived from this study: PubMed 34013969Piechotta 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.
Derived from this study: PubMed 33472681Diago-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.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Cristina Avendaño Solá, MD, PhD study chair

Hospital Universitario Puerta de Hierro Majadahonda

Rafael Duarte Palomino, MD, PhD study chair

Hospital Universitario Puerta de Hierro Majadahonda

Antonio Ramos, MD, PhD principal investigator

Hospital Universitario Puerta de Hierro Majadahonda

29 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Blood and derivatives. in people with COVID-19, run by Cristina Avendaño Solá at 29 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Category Changes in the "7-Ordinal Scale" (time frame: 15 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04345523, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.