Infections, CoronavirusPhase 2NCT04385186
Inactivated Convalescent Plasma as a Therapeutic Alternative in Patients CoViD-19
A Phase 2 study testing Inactivated convalescent plasma and Support treatment in people with Infections, Coronavirus, run by National Blood Center Foundation, Hemolife at 10 sites in Colombia.
Trial summary
Convalescent plasma is a way to provide passive immunity to a person exposed to an infectious agent. It has been used as a therapeutic tool for emerging viral infections without specific treatment and with high morbidity and mortality, such as Influenza H1N1, H5N1, H7N9, Ebola, MERS, SARS-CoV1, and even SARS-Cov2… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infections, Coronavirus
- What is being tested?
- Inactivated convalescent plasma and Support treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 10 sitesColombia
- Study dates
- 20 Jun 2020to 30 Dec 2020
- 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
- Over 18 years old
- Confirmed laboratory diagnosis for qRT-PCR to SARS-CoV-2
- Meet any of the following medical criteria (Defined by WHO): Be currently hospitalized with: Pneumonia, Severe pneumonia, Acute Respiratory Distress Syndrome (moderate or severe), Sepsis or Septic shock
- The patient, or his representative, must sign an informed consent
Who cannot join
- Participate in another clinical trial for CoViD- 19
- History of acute allergic transfusion reactions due to transfusion of blood or other components, especially plasma components (fresh frozen plasma, cryoprecipitate and platelets),
- History of allergic reaction due to IgA deficiency
- Allergic reaction to sodium citrate or riboflavin (vitamin B2)
- History of immunosuppression
Trial locations and contacts
10 sites in 1 country.
Ana L Muñoz, MSc, PhD contact
10 sites in 1 country
Colombia10 sites
National Blood Center Foundation, Hemolife/Fundación Banco Nacional de Sangre Hemolife
Bogotá, Cundinamarca, 1101
Ana L Muñoz, MSc, PhD, +573128879089, ana.munoz@hemolifeamerica.org
Ana L Muñoz, MSc, PhD
Clínica Corpas
Bogotá
Clinica Nuestra
Cali, Valle del Cauca Department
Diego Gómez, MD, Msc, diego.gomez@clinicanuestra.com
E.S.E Hospital San Rafael Facatativa
Facatativá
Fernando J Charries, MD, MSc
José R Almarales, MD, MSc
Clínica Antioquía
Medellín, Antioquía, 0500
Diego Gómez, MD. MSc, diego.gomez@clinicanuestra.com
Clínica Sagrado Corazón
Medellín, Antioquía, 0500
IPS Universitaria
Medellín, Antioquía, 0500
Universidad de Antioquía
Medellín, Antioquía, 0500
Andrés F Zuluaga, MD, MSc, MeH, 3014020291, andres.zuluaga@udea.edu.co
Amanda E Maestre, MD, PhD
Clínica Rosales
Pereira, Risaralda Department
Diego Gómez, MD, MSc, diego.gomez@clinicanuestra.com
Clínica la Estancia
Popayán
Diego Gómez, MD, MSc, diego.gomez@clinicanuestra.com
About this study
Official title: Inactivated Convalescent Plasma as a Therapeutic Alternative in Hospitalized Patients CoViD-19
Convalescent plasma is a way to provide passive immunity to a person exposed to an infectious agent. It has been used as a therapeutic tool for emerging viral infections without specific treatment and with high morbidity and mortality, such as Influenza H1N1, H5N1, H7N9, Ebola, MERS, SARS-CoV1, and even SARS-Cov2, with satisfactory results regarding evolution clinic of patients treated and without significant adverse events reported. One of its main advantages of convalescent plasma is to generate a rapid immune response (even faster than a vaccine), against a pathogen that circulates in a specific geographic area, probably common for both donor and recipient.
Read the detailed description
This study consists of obtaining convalescent plasma by means of apheresis, from recovered donors, who meet the eligibility criteria to donate. Then this plasma will be inactivated by riboflavin and UV based photochemical treatment (Mirasol technology - Terumo BCT®), in order to add more transfusion security to the procedure. Finally, it will be transfused to CoViD-19 patients hospitalized in any of the participating clinics. There are currently no reported significant adverse events associated with this therapy. Have been published two serial cases reports,more evidence is necessary to standardize the treatment.
- Conditions
- Infections, Coronavirus
- Being tested
- Inactivated convalescent plasma, Support treatment
- Keywords
- CoViD-19, Pathogen inactivation, Apheresis, Convalescent plasma
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inactivated convalescent plasmaDrug
Also called Inactivated convalescent plasma SARS-Cov-2 + Support treatment
Day 0: Transfusion of 200mL of ABO -Rh compatible inactivated convalescent plasma, Start of support treatment selected by medical staff according to each institutional protocol
Day 1: Transfusion of 200mL of ABO -Rh compatible inactivated convalescent plasma
Support treatmentDrug
Also called Support treatment under medical decision
Day 0: Start of support treatment selected by medical staff according to each each institutional protocol
| Study group | Role | What they receive |
|---|---|---|
| Convalescent plasma+Support treatment selected by the hospital | Experimental | Participants will receive two doses of ABO - Rh compatible inactivated convalescent plasma, each one of 200 mililiters (mL), with a 24-hour interval via transfusion, for a final volume of 400 mL, meanwhile they continue to receive the supportive treatment chosen by the hospitals, according to each institutional protocol. Receives: Drug: Inactivated convalescent plasma; Drug: Support treatment |
| Support treatment selected by the hospital | Active comparator | The best support treatment selected by the hospital, according to each institutional protocol. Due to the ongoing development of knowledge of pathophysiology and scientific evidence of the available alternatives, it will be selected at the time of treatment. Receives: Drug: Support treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality reduction in CoViD-19 patients treated with inactivated convalescent plasma + support treatment
To assess the efficacy in reducing mortality in CoViD-19 patients treated with inactivated convalescent plasma together with the support treatment selected by the respective hospital
Measured: Over a period of 28 days
Secondary outcomes (25)
Clinical evolution
Number of Participants with resolution of fever (<38ºC temperature)
Measured: Over a period of 28 days
Clinical evolution by seven-parameter ordinal scale
The clinical improvement will be established with a two-point improvement within this seven categories (recommended by World Organization Health-WHO): 1) Not hospitalized, with resumption of normal activities 2) Not hospitalized, but unable to resume normal activities 3) Hospitalized that does not require supplemental oxygen 4) Hospitalized requiring supplemental oxygen 5) Hospitalized requiring high-flow nasal oxygen therapy, non-invasive mechanical ventilation, or both 6) Hospitalized requiring extracorporeal membrane oxygenation, invasive mechanical ventilation, or both 7) death
Measured: 3, 7, 14 and 28 days
Multi-organ failure progression
Evolution by SOFA (Sequential Organ Failure Assessment), The range is between 0 and 24 points, with the highest scores being indicators of a more serious illness
Measured: 3, 7, 14 and 28 days
Change in hemoglobin concentration
Compare the change in hemoglobin concentration at 3, 7, 14 and 28 days after treatment
Measured: 3, 7, 14 and 28 days
Change in blood cell count
Compare the change in blood cell count at 3, 7, 14 and 28 days after treatment
Measured: 3, 7, 14 and 28 days
Change in serum creatinine level
Compare the change in Serum creatinine concentration at 3, 7, 14 and 28 days after treatment
Measured: 3, 7, 14 and 28 days
Change in aspartate aminotransferase level
Compare the change in aspartate aminotransferase level at 3, 7, 14 and 28 days after treatment
Measured: 3, 7, 14 and 28 days
Change in alanin aminotransferase level
Compare the change in Alanine aminotransferase levels at 3, 7, 14 and 28 days after treatment
Measured: 3, 7, 14 and 28 days
Change in bilirubin level
Compare the change in bilirubin levels at 3, 7, 14 and 28 days after treatment
Measured: 3, 7, 14 and 28 days
Change in lactate dehydrogenase level
Compare the change in lactate dehydrogenase levels at 3, 7, 14 and 28 days after treatment
Measured: 3, 7, 14 and 28 days
Change in creatine kinase level
Compare the change in creatine kinase levels at 3, 7, 14 and 28 days after treatment
Measured: 3, 7, 14 and 28 days
Change in creatine kinase MB level
Compare the change in creatine kinase MB levels at 3, 7, 14 and 28 days after treatment
Measured: 3, 7, 14 and 28 days
Change in C reactive protein concentration
Compare the change in C reactive protein concentration at 3, 7, 14 and 28 days after treatment, in mg/L
Measured: 3, 7, 14 and 28 days
Change in D Dimer concentration
Compare the change in D Dimer concentration at 3, 7, 14 and 28 days after treatment
Measured: 3, 7, 14 and 28 days
Change in Procalcitonin concentration
Compare the change in procalcitonin concentration at 3, 7, 14 and 28 days after treatment
Measured: 3, 7, 14 and 28 days
Change in IL6 level
Compare the change in IL6 level at 3, 7, 14 and 28 days after treatment
Measured: 3, 7, 14 and 28 days
Radiography imaging
Resolution of chest radiography imaging findings (example, bilateral, peripheral and basal predominant ground-glass opacity, consolidation, or both)
Measured: Over a period of 60 days
Tomography imaging
Resolution of tomography imaging (example, patches located in the subpleural regions of the lung)
Measured: Over a period of 60 days
Assessment of oxygenation
Arterial oxygen partial pressure (PaO2) in mmHg / Inspired fraction of oxygen (FIO2) ratio
Measured: 3, 7, 14 and 28 days
Viral Load
Viral Load Quantification
Measured: 0, 3, 7 days and until hospital discharge or a maximum of 60 days whichever comes first
Antibody titer
Neutralizing antibody anti SARS-CoV-2 titer evolution
Measured: Day 0, Day 3 and Day 7
Oxygen-free days through Day 60
Number of days without use of Oxygen
Measured: Until hospital discharge or a maximum of 60 days whichever comes first
Mechanical ventilation-free days through Day 28
Number of days without use of mechanical ventilation
Measured: Until hospital discharge or a maximum of 28 days whichever comes first
Intensive Care Unit (ICU)-free days through Day 28
Time outside of ICU, in days
Measured: Until hospital discharge or a maximum of 28 days whichever comes first
Hospital-free days through Day 60
Time outside of the hospital, in days
Measured: Until hospital discharge or a maximum of 60 days whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start20 Jun 2020 (estimated)
- Primary completion30 Nov 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Infections, CoronavirusStudies 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
- MULTICENTER, CONTROLLED, RANDOMIZED, SIMPLE BLIND, CLINICAL TRIAL
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Blood Center Foundation, Hemolife
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrés F Zuluaga, MD, MSc, MeH, Principal investigator, Universidad de Antioquia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385186
- Sponsor's protocol ID
- CT01
- Status last verified
- May 2020
- First submitted
- 6 May 2020
- Last updated
- 2 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Epstein J, Burnouf T. Points to consider in the preparation and transfusion of COVID-19 convalescent plasma. Vox Sang. 2020 Aug;115(6):485-487. doi: 10.1111/vox.12939. Epub 2020 May 14. No abstract available.
PubMed 32319102Shen C, Wang Z, Zhao F, Yang Y, Li J, Yuan J, Wang F, Li D, Yang M, Xing L, Wei J, Xiao H, Yang Y, Qu J, Qing L, Chen L, Xu Z, Peng L, Li Y, Zheng H, Chen F, Huang K, Jiang Y, Liu D, Zhang Z, Liu Y, Liu L. Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma. JAMA. 2020 Apr 28;323(16):1582-1589. doi: 10.1001/jama.2020.4783.
PubMed 32219428Casadevall A, Pirofski LA. The convalescent sera option for containing COVID-19. J Clin Invest. 2020 Apr 1;130(4):1545-1548. doi: 10.1172/JCI138003. No abstract available.
PubMed 32167489
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inactivated Convalescent Plasma as a Therapeutic Alternative in Hospitalized Patients CoViD-19
- ClinicalTrials.gov ID
- NCT04385186
- Acronym / sponsor ID
- CT01
- Conditions
- Infections, Coronavirus
- Keywords
- CoViD-19, Pathogen inactivation, Apheresis, Convalescent plasma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Blood Center Foundation, HemolifeUniversity, hospital or other
- Study start
- 20 Jun 2020 (estimated)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 12 May 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.
Convalescent plasma is a way to provide passive immunity to a person exposed to an infectious agent. It has been used as a therapeutic tool for emerging viral infections without specific treatment and with high morbidity and mortality, such as Influenza H1N1, H5N1, H7N9, Ebola, MERS, SARS-CoV1, and even SARS-Cov2, with satisfactory results regarding evolution clinic of patients treated and without significant adverse events reported. One of its main advantages of convalescent plasma is to generate a rapid immune response (even faster than a vaccine), against a pathogen that circulates in a specific geographic area, probably common for both donor and recipient.
Detailed description
This study consists of obtaining convalescent plasma by means of apheresis, from recovered donors, who meet the eligibility criteria to donate. Then this plasma will be inactivated by riboflavin and UV based photochemical treatment (Mirasol technology - Terumo BCT®), in order to add more transfusion security to the procedure. Finally, it will be transfused to CoViD-19 patients hospitalized in any of the participating clinics. There are currently no reported significant adverse events associated with this therapy. Have been published two serial cases reports,more evidence is necessary to standardize the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- MULTICENTER, CONTROLLED, RANDOMIZED, SIMPLE BLIND, CLINICAL TRIAL
| Arm | Type | Receives |
|---|---|---|
| Convalescent plasma+Support treatment selected by the hospital | Experimental | Drug: Inactivated convalescent plasma, Drug: Support treatmentParticipants will receive two doses of ABO - Rh compatible inactivated convalescent plasma, each one of 200 mililiters (mL), with a 24-hour interval via transfusion, for a final volume of 400 mL, meanwhile they continue to receive the supportive treatment chosen by the hospitals, according to each institutional protocol. |
| Support treatment selected by the hospital | Active comparator | Drug: Support treatmentThe best support treatment selected by the hospital, according to each institutional protocol. Due to the ongoing development of knowledge of pathophysiology and scientific evidence of the available alternatives, it will be selected at the time of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 18 years old
- Confirmed laboratory diagnosis for qRT-PCR to SARS-CoV-2
- Meet any of the following medical criteria (Defined by WHO): Be currently hospitalized with: Pneumonia, Severe pneumonia, Acute Respiratory Distress Syndrome (moderate or severe), Sepsis or Septic shock
- The patient, or his representative, must sign an informed consent
Key exclusion criteria (5 listed)
- Participate in another clinical trial for CoViD- 19
- History of acute allergic transfusion reactions due to transfusion of blood or other components, especially plasma components (fresh frozen plasma, cryoprecipitate and platelets),
- History of allergic reaction due to IgA deficiency
- Allergic reaction to sodium citrate or riboflavin (vitamin B2)
- History of immunosuppression
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 |
|---|---|---|
| Inactivated convalescent plasmaAlso: Inactivated convalescent plasma SARS-Cov-2 + Support treatmentDay 0: Transfusion of 200mL of ABO -Rh compatible inactivated convalescent plasma, Start of support treatment selected by medical staff according to each institutional protocol Day 1: Transfusion of 200mL of ABO -Rh compatible inactivated convalescent plasma | Drug | Convalescent plasma+Support treatment selected by the hospital |
| Support treatmentAlso: Support treatment under medical decisionDay 0: Start of support treatment selected by medical staff according to each each institutional protocol | Drug | Convalescent plasma+Support treatment selected by the hospital, Support treatment selected by the hospital |
Primary outcome
Mortality reduction in CoViD-19 patients treated with inactivated convalescent plasma + support treatment
Time frame: Over a period of 28 days
To assess the efficacy in reducing mortality in CoViD-19 patients treated with inactivated convalescent plasma together with the support treatment selected by the respective hospital
25 secondary outcomes
Clinical evolution
Time frame: Over a period of 28 days
Clinical evolution by seven-parameter ordinal scale
Time frame: 3, 7, 14 and 28 days
Multi-organ failure progression
Time frame: 3, 7, 14 and 28 days
Change in hemoglobin concentration
Time frame: 3, 7, 14 and 28 days
Change in blood cell count
Time frame: 3, 7, 14 and 28 days
Change in serum creatinine level
Time frame: 3, 7, 14 and 28 days
Change in aspartate aminotransferase level
Time frame: 3, 7, 14 and 28 days
Change in alanin aminotransferase level
Time frame: 3, 7, 14 and 28 days
Change in bilirubin level
Time frame: 3, 7, 14 and 28 days
Change in lactate dehydrogenase level
Time frame: 3, 7, 14 and 28 days
Change in creatine kinase level
Time frame: 3, 7, 14 and 28 days
Change in creatine kinase MB level
Time frame: 3, 7, 14 and 28 days
Change in C reactive protein concentration
Time frame: 3, 7, 14 and 28 days
Change in D Dimer concentration
Time frame: 3, 7, 14 and 28 days
Change in Procalcitonin concentration
Time frame: 3, 7, 14 and 28 days
Change in IL6 level
Time frame: 3, 7, 14 and 28 days
Radiography imaging
Time frame: Over a period of 60 days
Tomography imaging
Time frame: Over a period of 60 days
Assessment of oxygenation
Time frame: 3, 7, 14 and 28 days
Viral Load
Time frame: 0, 3, 7 days and until hospital discharge or a maximum of 60 days whichever comes first
Antibody titer
Time frame: Day 0, Day 3 and Day 7
Oxygen-free days through Day 60
Time frame: Until hospital discharge or a maximum of 60 days whichever comes first
Mechanical ventilation-free days through Day 28
Time frame: Until hospital discharge or a maximum of 28 days whichever comes first
Intensive Care Unit (ICU)-free days through Day 28
Time frame: Until hospital discharge or a maximum of 28 days whichever comes first
Hospital-free days through Day 60
Time frame: Until hospital discharge or a maximum of 60 days whichever comes first
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
- Background: PubMed 32319102Epstein J, Burnouf T. Points to consider in the preparation and transfusion of COVID-19 convalescent plasma. Vox Sang. 2020 Aug;115(6):485-487. doi: 10.1111/vox.12939. Epub 2020 May 14. No abstract available.
- Background: PubMed 32219428Shen C, Wang Z, Zhao F, Yang Y, Li J, Yuan J, Wang F, Li D, Yang M, Xing L, Wei J, Xiao H, Yang Y, Qu J, Qing L, Chen L, Xu Z, Peng L, Li Y, Zheng H, Chen F, Huang K, Jiang Y, Liu D, Zhang Z, Liu Y, Liu L. Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma. JAMA. 2020 Apr 28;323(16):1582-1589. doi: 10.1001/jama.2020.4783.
- Background: PubMed 32167489Casadevall A, Pirofski LA. The convalescent sera option for containing COVID-19. J Clin Invest. 2020 Apr 1;130(4):1545-1548. doi: 10.1172/JCI138003. No abstract available.
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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.
Ana L Muñoz, MSc, PhD contact
Andrés F Zuluaga, MD, MSc, MeH principal investigator
Universidad de Antioquia
10 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 Inactivated convalescent plasma and Support treatment in people with Infections, Coronavirus, run by National Blood Center Foundation, Hemolife at 10 sites in Colombia.
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 4 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: status not confirmed, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Colombia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrés F Zuluaga, MD, MSc, MeH (3014020291, andres.zuluaga@udea.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality reduction in CoViD-19 patients treated with inactivated convalescent plasma + support treatment (time frame: Over a period of 28 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 NCT04385186, which also lists 3 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 Jun 2020.