Covid19NCT04803370
Efficacy of Reinforcing Standard Therapy in COVID-19 Patients With Repeated Transfusion of Convalescent Plasma
A study testing Convalescent Plasma with antibody against SARS-CoV-2. and Standard treatment for COVID-19 in people with Covid19, run by Hospital Son Llatzer at 1 site in Spain.
Trial summary
The coronavirus disease 2019 (COVID-19) was classified as a pandemic by the World Health Organization (WHO) in March 2020. The SARS-COV-2 virus is easily transmissible and there is currently no approved treatment with effective results. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Convalescent Plasma with antibody against SARS-CoV-2. and Standard treatment for COVID-19
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteSpain
- Study dates
- 8 Jul 2020to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Ability to understand the HIP and sign the study IC
- male or female =/> 18 years
- Patient hospitalized with a COVID-19 diagnosis by PCR on nasopharyngeal swabs or any other biological sample.
- Presence of respiratory symptoms and / or fever associated with COVID-19, with clinical evolution time for COVID-19 equal to or less than 7 days.
- Presence of pneumonia on chest X-ray and / or SatO2 <94% aa.
- Sequential Organ Failure Assessment (SOFA) score ≤ 6.
- Accept the condition of complying with the procedures established in the protocol.
Who cannot join
- Patients with a previous history of allergic transfusion reaction.
- Lactating or pregnant women and a positive pregnancy test.
- Patients who have been treated with plasma in the 21 days prior to the screening / baseline visit.
- Patients who are at the time of study, participating in another clinical trial.
- Patients who haven't completed all study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Efficacy of Reinforcing of the Standard Therapy in COVID-19 Patients With Repeated Transfusion of Immune Plasma From COVID-19 Convalescents vs Exclusive Standard Therapy in Hospitalized COVID-19 Patients
The coronavirus disease 2019 (COVID-19) was classified as a pandemic by the World Health Organization (WHO) in March 2020. The SARS-COV-2 virus is easily transmissible and there is currently no approved treatment with effective results. Although the main epidemiological parameters are currently being studied, apparently the speed of contagion, the incidence and the mortality rate in severe cases appear to be high. Therefore, there is an urgent need to find a viable therapeutic option. The present trial is a pilot study with an objective to determine the efficacy of standard treatment reinforced with two repeated doses in two consecutive days of plasma from former convalescent people of the COVID-19 disease already discharged and / or with results in negative COVID-19 screenings, transfused to hospitalized COVID-19 patients.
- Conditions
- Covid19
- Being tested
- Convalescent Plasma with antibody against SARS-CoV-2., Standard treatment for COVID-19
- Keywords
- COVID19, Immune Plasma
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Convalescent Plasma with antibody against SARS-CoV-2.Other
Convalescent plasma plus standard treatment for COVID-19. The convalescent plasma is from patients recovered from COVID-19 and negative viremia in the test detection COVID-19.
The infusions will be given on days 1 and 2, of the study, after the positive result for COVID-19 of the recipient patient.
Standard treatment for COVID-19Other
The patients will receive the standard treatment for COVID-19, according to guidelines for COVID-19 (retrovirals drugs, interferon-α / β, anti-Interleukin-6 monoclonal antibody, oxygen therapy, etc..)
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Standard treatment for COVID-19 (according to clinical guidelines for COVID-19). Receives: Other: Standard treatment for COVID-19 |
| Intervention group | Experimental | Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines). Receives: Other: Convalescent Plasma with antibody against SARS-CoV-2. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II
The scale provides a measure of COVID-19 severity based on the patient's physical situation, whose design was based on a blueprint of the WHO in treating COVID-19.
- 1= Death
- 2= Hospitalized. on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
- 3= Hospitalized. on non-invasive ventilation or high flow oxygen devices
- 4= Hospitalized. requiring supplemental oxygen
- 5= Hospitalized. not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise)
- 6= Hospitalized. not requiring supplemental oxygen - no longer requiring ongoing medical care.
- 7= Not hospitalized. limitation on activities and/or requiring home oxygen
- 8= Not hospitalized. no limitations on activities.
Measured: Day 7
Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II
The scale provides a measure of COVID-19 severity based on the patient's physical situation, whose design was based on a blueprint of the WHO in treating COVID-19.
- 1= Death
- 2= Hospitalized. on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
- 3= Hospitalized. on non-invasive ventilation or high flow oxygen devices
- 4= Hospitalized. requiring supplemental oxygen
- 5= Hospitalized. not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise)
- 6= Hospitalized. not requiring supplemental oxygen - no longer requiring ongoing medical care.
- 7= Not hospitalized. limitation on activities and/or requiring home oxygen
- 8= Not hospitalized. no limitations on activities.
Measured: Day 14
Secondary outcomes (26)
Anti-SARS-CoV-2 S IgG Serum Titer
The levels of Anti-SARS-CoV-2 S IgG serum
Measured: At inclusion, Day 21
Time of Hospitalization
time that the patients have passed in the hospital.
Measured: Day 21
Time to Negativization of RT-PCR
total time elapsed until negative RT-PCR test
Measured: Day 21
Diastolic Blood Pressure
the pressure of blood in the artery when the heart relaxes between beats.
Measured: At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21
Systolic Blood Pressure
The pressure of blood in the artery when the heart contracts. It is the high number in a blood pressure measurement.
Measured: At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21
Temperature
Measured: At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21
Cardiac Frequency
The number of heart contractions or beats per unit of time. The normal values in adults at rest range between 60 and 100 beats per minit.
Measured: At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21
Respiratory Frequency
Number of breaths the patient takes per minute.
Measured: At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21
Oxygen Saturation
blood oxygen percentage. A healthy percentage of oxygen in the blood is between 95% and 100%.
Measured: At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21
Hemoglobin
hemoglobin levels in the blood
Measured: At inclusion, Day 3, Day 7, Day 14, Day 21
Leucocytes
Leucocyte count a patient's blood.
Measured: At inclusion, Day 3, Day 7, Day 14, Day 21
Neutrophils
Neutrophils count a patient's blood.
Measured: At inclusion, Day 3, Day 7, Day 14, Day 21
Absolute Lymphocytes
lymphocyte count a patient's blood.
Measured: At inclusion, Day 3, Day 7, Day 14, Day 21
Activated Partial Thromboplastin Time
measurement of the number of seconds it takes for a clot to form in a patient's blood.
Measured: At inclusion, Day 3, Day 7, Day 14, Day 21
Fibrinogen Level
measurement of the level of fibrinogen in the blood (mg / dl), as a measure of assessing the severity of the disease.
Measured: At inclusion, Day 3, Day 7, Day 14, Day 21
Fragment D-dimer Assessment
Determination of the existence of the D-dimer fragment in blood as a measure of assessing the severity of the disease.
Measured: At inclusion, Day 3, Day 7, Day 14
Glomerular Filtration Rate Assessment
estimation of how much blood passes per minute through the glomerular filters of the kidneys (ml/min).
Measured: At inclusion, Day 3, Day 7, Day 14, Day 21
Troponin I Assessment
measurement of the levels of troponin I proteins in the blood (ng/mL), as a measure of assessing the severity of the disease.
Measured: At inclusion, Day 3, Day 7, Day 14, Day 21
Procalcitonin Assessment
measurement of the levels of procalcitonin in the blood (ng/L), as a measure of assessing the severity of the disease.
Measured: At inclusion, Day 3, Day 7, Day 14, Day 21
C-reactive Protein Assessment
measurement of the level of c-reactive protein in the blood (mg/dl), as a measure of a change in inflammation
Measured: At inclusion, Day 3, Day 7, Day 14, Day 21
Lactate Dehydrogenase (LDH) Assessment
measurement of the level of lactate dehydrogenase in the blood (U/L), as a measure of assessing the severity of the disease.
Measured: At inclusion, Day 3, Day 7, Day 14, Day 21
Interleukin-6 Assessment
measurement of serum levels Interleukin-6 in pg/mL, as a measure of assessing the severity of the disease.
Measured: At inclusion, Day 3, Day 7, Day 14, Day 21
Ferritin Blood Assessment
measurement of the amount of ferritin (blood protein) in ng/ml in the blood, as a measure of assessing the severity of the disease.
Measured: At inclusion, Day 3, Day 7, Day 14, Day 21
Percentage of Patients Requiring Admission to Intensive Care Units.
Percentage of patients requiring admission to intensive care units.
Measured: Day 21
Mortality Rate at 15 Days
number of dead participants through day 15
Measured: Day 15
Mortality Rate at 30 Days
number of dead participants through day 30
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start8 Jul 2020
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Son Llatzer
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació d'investigació Sanitària de les Illes Balears
- Responsible party
- Principal investigator, Maria Arrizabalaga Asenjo, Hospital Son Llatzer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803370
- Sponsor's protocol ID
- CO-PLASMA-2020
- Status last verified
- Sep 2025
- First submitted
- 9 Mar 2021
- Last updated
- 29 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bargay-Lleonart J, Sarubbo F, Arrizabalaga M, Guerra JM, Borras J, El Haji K, Flexas M, Perales J, Fernandez-Baca V, Gallegos C, Cruz MR, Velasco S, Lopez V, Cruz A, Bautista-Gili A, Jimenez-Marco T, Girona-Llobera E, Vilaplana L, Calonge L, Tena J, Galan MP, Payeras A. Reinforcement of the Standard Therapy with Two Infusions of Convalescent Plasma for Patients with COVID-19: A Randomized Clinical Trial. J Clin Med. 2022 May 27;11(11):3039. doi: 10.3390/jcm11113039.
PubMed 35683427
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Efficacy of Reinforcing of the Standard Therapy in COVID-19 Patients With Repeated Transfusion of Immune Plasma From COVID-19 Convalescents vs Exclusive Standard Therapy in Hospitalized COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04803370
- Acronym / sponsor ID
- CO-PLASMA-2020
- Conditions
- Covid19
- Keywords
- COVID19, Immune Plasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Hospital Son LlatzerUniversity, hospital or other
- Collaborators
- Fundació d'investigació Sanitària de les Illes Balears
- Study start
- 8 Jul 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 17 Mar 2021 (actual)
- Results
- Posted 26 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The coronavirus disease 2019 (COVID-19) was classified as a pandemic by the World Health Organization (WHO) in March 2020. The SARS-COV-2 virus is easily transmissible and there is currently no approved treatment with effective results. Although the main epidemiological parameters are currently being studied, apparently the speed of contagion, the incidence and the mortality rate in severe cases appear to be high. Therefore, there is an urgent need to find a viable therapeutic option. The present trial is a pilot study with an objective to determine the efficacy of standard treatment reinforced with two repeated doses in two consecutive days of plasma from former convalescent people of the COVID-19 disease already discharged and / or with results in negative COVID-19 screenings, transfused to hospitalized COVID-19 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: Standard treatment for COVID-19Standard treatment for COVID-19 (according to clinical guidelines for COVID-19). |
| Intervention group | Experimental | Other: Convalescent Plasma with antibody against SARS-CoV-2.Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ability to understand the HIP and sign the study IC
- male or female =/> 18 years
- Patient hospitalized with a COVID-19 diagnosis by PCR on nasopharyngeal swabs or any other biological sample.
- Presence of respiratory symptoms and / or fever associated with COVID-19, with clinical evolution time for COVID-19 equal to or less than 7 days.
- Presence of pneumonia on chest X-ray and / or SatO2 <94% aa.
Key exclusion criteria (5 listed)
- Patients with a previous history of allergic transfusion reaction.
- Lactating or pregnant women and a positive pregnancy test.
- Patients who have been treated with plasma in the 21 days prior to the screening / baseline visit.
- Patients who are at the time of study, participating in another clinical trial.
- Patients who haven't completed all study procedures.
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 |
|---|---|---|
| Convalescent Plasma with antibody against SARS-CoV-2.Convalescent plasma plus standard treatment for COVID-19. The convalescent plasma is from patients recovered from COVID-19 and negative viremia in the test detection COVID-19. The infusions will be given on days 1 and 2, of the study, after the positive result for COVID-19 of the recipient patient. | Other | Intervention group |
| Standard treatment for COVID-19The patients will receive the standard treatment for COVID-19, according to guidelines for COVID-19 (retrovirals drugs, interferon-α / β, anti-Interleukin-6 monoclonal antibody, oxygen therapy, etc..) | Other | Control group |
Primary outcome
Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II
Time frame: Day 7
The scale provides a measure of COVID-19 severity based on the patient's physical situation, whose design was based on a blueprint of the WHO in treating COVID-19. * 1= Death * 2= Hospitalized. on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) * 3= Hospitalized. on non-invasive ventilation or high flow oxygen devices * 4= Hospitalized. requiring supplemental oxygen * 5= Hospitalized. not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) * 6= Hospitalized. not requiring supplemental oxygen - no longer requiring ongoing medical care. * 7= Not hospitalized. limitation on activities and/or requiring home oxygen * 8= Not hospitalized. no limitations on activities.
Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II
Time frame: Day 14
The scale provides a measure of COVID-19 severity based on the patient's physical situation, whose design was based on a blueprint of the WHO in treating COVID-19. * 1= Death * 2= Hospitalized. on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) * 3= Hospitalized. on non-invasive ventilation or high flow oxygen devices * 4= Hospitalized. requiring supplemental oxygen * 5= Hospitalized. not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) * 6= Hospitalized. not requiring supplemental oxygen - no longer requiring ongoing medical care. * 7= Not hospitalized. limitation on activities and/or requiring home oxygen * 8= Not hospitalized. no limitations on activities.
26 secondary outcomes
Anti-SARS-CoV-2 S IgG Serum Titer
Time frame: At inclusion, Day 21
Time of Hospitalization
Time frame: Day 21
Time to Negativization of RT-PCR
Time frame: Day 21
Diastolic Blood Pressure
Time frame: At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21
Systolic Blood Pressure
Time frame: At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21
Temperature
Time frame: At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21
Cardiac Frequency
Time frame: At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21
Respiratory Frequency
Time frame: At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21
Oxygen Saturation
Time frame: At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21
Hemoglobin
Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21
Leucocytes
Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21
Neutrophils
Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21
Absolute Lymphocytes
Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21
Activated Partial Thromboplastin Time
Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21
Fibrinogen Level
Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21
Fragment D-dimer Assessment
Time frame: At inclusion, Day 3, Day 7, Day 14
Glomerular Filtration Rate Assessment
Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21
Troponin I Assessment
Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21
Procalcitonin Assessment
Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21
C-reactive Protein Assessment
Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21
Lactate Dehydrogenase (LDH) Assessment
Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21
Interleukin-6 Assessment
Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21
Ferritin Blood Assessment
Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21
Percentage of Patients Requiring Admission to Intensive Care Units.
Time frame: Day 21
Mortality Rate at 15 Days
Time frame: Day 15
Mortality Rate at 30 Days
Time frame: Day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 35683427Bargay-Lleonart J, Sarubbo F, Arrizabalaga M, Guerra JM, Borras J, El Haji K, Flexas M, Perales J, Fernandez-Baca V, Gallegos C, Cruz MR, Velasco S, Lopez V, Cruz A, Bautista-Gili A, Jimenez-Marco T, Girona-Llobera E, Vilaplana L, Calonge L, Tena J, Galan MP, Payeras A. Reinforcement of the Standard Therapy with Two Infusions of Convalescent Plasma for Patients with COVID-19: A Randomized Clinical Trial. J Clin Med. 2022 May 27;11(11):3039. doi: 10.3390/jcm11113039.
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Convalescent Plasma with antibody against SARS-CoV-2. and Standard treatment for COVID-19 in people with Covid19, run by Hospital Son Llatzer at 1 site 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 5 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 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II (time frame: Day 7). The study lists 2 primary outcomes in all. 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 NCT04803370, which also lists 1 linked publication.
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 29 Sep 2025.