SARS-Cov-2Phase 3NCT04391101
Convalescent Plasma for the Treatment of Severe SARS-CoV-2 (COVID-19)
A Phase 3 study testing Convalescent plasma in people with SARS-Cov-2, run by Hospital San Vicente Fundación at 1 site in Colombia.
Trial summary
Convalescent plasma has been used for over 100 years in the treatment of severe acute respiratory infections of viral origin. There are not pharmacological treatments for the actual outbreak for SARS-Cov-2 and it is necessary to evaluate the efficacy of treatment options, including convalescent plasma transfusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-Cov-2
- What is being tested?
- Convalescent plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 231 participants
- Where
- 1 siteColombia
- Study dates
- Jun 2020to Dec 2021
- Phase
- Phase 3
- 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
- For plasma donors:
- Over 18 years of age
- Men or nulliparous women with no history of recent abortions or transfusions SARS-CoV-2 infection by PCR in any sample or serological test with a maximum of 60 days from resolution of symptoms.
- If donation is done within 14 to 28 days after resolution of symptoms, the patient must have a negative PCR test for SARS-CoV-2. If donation is done after 28 days of resolving symptoms, no negative control test will be required.
- For plasma recipients:
- Over 18 years of age
- SARS-CoV-2 infection confirmed by PCR in any sample
- Hospitalized in the ICU due to shock or respiratory failure, with less than 24 hours after entering the ICU.
Who cannot join
- For plasma donors:
- Severe SARS-CoV-2 infections with an ICU requirement or those with asymptomatic infections will not be accepted as donors.
- Nor will a person who has received convalescent plasma as part of the COVID-19 treatment.
- For plasma receivers:
- Serious volume overload or other condition that contraindicates plasma transfusion.
- History of anaphylaxis or serious adverse reaction to plasma.
- Previous diagnosis of immunoglobulin A deficiency
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Hospital San Vicente Fundacion
Medellín, Antioquia
Oliver Perilla, Hematologist, 3136395608, gerardoperilla@gmail.com
Fabian Jaimes, Epidemiologi, 2192433, fabian.jaimes@udea.edu.co
About this study
Official title: Efficacy of Convalescent Plasma for the Treatment of Severe SARS-CoV-2 Infection: A Randomized, Open Label Clinical Trial
Convalescent plasma has been used for over 100 years in the treatment of severe acute respiratory infections of viral origin. There are not pharmacological treatments for the actual outbreak for SARS-Cov-2 and it is necessary to evaluate the efficacy of treatment options, including convalescent plasma transfusion. The hypothesis is that convalescent plasma is efficacious and safe for reducing mortality in patients with COVID-19 treated in ICU
Read the detailed description
Coronavirus infection has been declared by the World Health Organization as a pandemic. In addition to hemodynamic and ventilatory support in the intensive care unit, there is no treatment for COVID-19. Currently proposed treatments (chloroquine, antivirals, immunomodulators, among others) have low quality studies that do not prove efficacy.
Blood or plasma transfusion from convalescent patients (patients who have overcome the disease by generating a competent immune response) has been prescribed for over 100 years. In the last 15 years, convalescent plasma has been studied for the treatment of severe acute respiratory infections of viral origin, such as severe acute respiratory syndrome (SARS), avian influenza, and influenza A (H1N1). Suppressing viremia is one of the possible explanations for the efficacy of convalescent plasma treatment.
For the treatment of COVID-19, there are case series that show a clear improvement in severe patients after administration of convalescent plasma without significant adverse events. At the current crisis of the SARS-CoV-2 pandemic, in which there are no pharmacological treatments that have proven to have any therapeutic effect, it is imperative to assess the efficacy and safety of convalescent plasma transfusion in infected patients.
This is an open, randomized clinical trial with patient allocation in a 2 :1 ratio, plasma: standard management, for a superiority hypothesis. The main objective of this study is to determine the efficacy of convalescent plasma for the treatment of severe COVID-19 infection in terms of decreased in-hospital mortality.
- Conditions
- SARS-Cov-2
- Being tested
- Convalescent plasma
- Keywords
- Coronavirus, Covid-19, Convalescent plasma, Intensive Care Unit
- 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.
Convalescent plasmaDrug
Also called Plasma
400-500ml convalescent plasma
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Administration of two units of fresh frozen plasma (between 400 and 500 ml) obtained from convalescent patients from infection by SARS-CoV-2. Convalescent plasma is defined as the plasma of patients who had PCR confirmed SARS-CoV-2 infection, who have recovered clinically, and who have positive antibodies against SARS-CoV-2. Receives: Drug: Convalescent plasma |
| Control group | No intervention | Subjects assigned to the control group will receive support treatment in the intensive care unit based on institutional management guidelines. The use of antiviral, antimalarial or anti-inflammatory drugs is allowed in both groups according to the ICU protocols. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrahospital mortality from any cause
Proportion of patients who die while being hospitalized
Measured: Up to 28 days
Secondary outcomes (4)
Length of hospital stay
Number of days hospitalized
Measured: Up to 60 days
Free time for ventilatory support on day 60
Number of days without ventilatory support
Measured: Day 60
Overall survival at day 60 since hospitalization
Proportion of patients alive on day 60
Measured: Day 60
Cumulative incidence of adverse events: transfusion reactions (fever, flare), TRALI (transfusion-associated lung injury), TACO (transfusion-related circulatory overload), transfusion- related infections
Proportion of adverse events related with convalescent plasma
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study startJun 2020 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-Cov-2Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label, parallel, randomized clinical trial with stratified (center and age) patient allocation in a 2 :1 ratio (plasma: standard management) for a superiority hypothesis
- Masking
- None (open label)
- Enrolment
- 231 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital San Vicente Fundación
- Sponsor type
- University, hospital or other
- Collaborators
- Clínica León XIII, Grupo de Inmunodeficiencias primarias Universidad de Antioquia, Clínica Universitaria Bolivariana, Hospital Pablo Tobón Uribe, Clínica Rosario El Tesoro, Clínica Las Américas, Clínica Cardiovid
- Responsible party
- Sponsor
- Investigators
- Oliver Perilla Suarez, Hematologist, Principal investigator, Hospital San Vicente Fundación
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391101
- Sponsor's protocol ID
- 002
- Status last verified
- May 2020
- First submitted
- 8 May 2020
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Convalescent Plasma for the Treatment of Severe SARS-CoV-2 Infection: A Randomized, Open Label Clinical Trial
- ClinicalTrials.gov ID
- NCT04391101
- Acronym / sponsor ID
- 002
- Conditions
- SARS-Cov-2
- Keywords
- Coronavirus, Covid-19, Convalescent plasma, Intensive Care Unit
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 231 participants (estimated)
- Lead sponsor
- Hospital San Vicente FundaciónUniversity, hospital or other
- Collaborators
- Clínica León XIII, Grupo de Inmunodeficiencias primarias Universidad de Antioquia, Clínica Universitaria Bolivariana, Hospital Pablo Tobón Uribe, Clínica Rosario El Tesoro, Clínica Las Américas, Clínica Cardiovid
- Study start
- Jun 2020 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 18 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 has been used for over 100 years in the treatment of severe acute respiratory infections of viral origin. There are not pharmacological treatments for the actual outbreak for SARS-Cov-2 and it is necessary to evaluate the efficacy of treatment options, including convalescent plasma transfusion. The hypothesis is that convalescent plasma is efficacious and safe for reducing mortality in patients with COVID-19 treated in ICU
Detailed description
Coronavirus infection has been declared by the World Health Organization as a pandemic. In addition to hemodynamic and ventilatory support in the intensive care unit, there is no treatment for COVID-19. Currently proposed treatments (chloroquine, antivirals, immunomodulators, among others) have low quality studies that do not prove efficacy.
Blood or plasma transfusion from convalescent patients (patients who have overcome the disease by generating a competent immune response) has been prescribed for over 100 years. In the last 15 years, convalescent plasma has been studied for the treatment of severe acute respiratory infections of viral origin, such as severe acute respiratory syndrome (SARS), avian influenza, and influenza A (H1N1). Suppressing viremia is one of the possible explanations for the efficacy of convalescent plasma treatment.
For the treatment of COVID-19, there are case series that show a clear improvement in severe patients after administration of convalescent plasma without significant adverse events. At the current crisis of the SARS-CoV-2 pandemic, in which there are no pharmacological treatments that have proven to have any therapeutic effect, it is imperative to assess the efficacy and safety of convalescent plasma transfusion in infected patients.
This is an open, randomized clinical trial with patient allocation in a 2 :1 ratio, plasma: standard management, for a superiority hypothesis. The main objective of this study is to determine the efficacy of convalescent plasma for the treatment of severe COVID-19 infection in terms of decreased in-hospital mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label, parallel, randomized clinical trial with stratified (center and age) patient allocation in a 2 :1 ratio (plasma: standard management) for a superiority hypothesis
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Convalescent plasmaAdministration of two units of fresh frozen plasma (between 400 and 500 ml) obtained from convalescent patients from infection by SARS-CoV-2. Convalescent plasma is defined as the plasma of patients who had PCR confirmed SARS-CoV-2 infection, who have recovered clinically, and who have positive antibodies against SARS-CoV-2. |
| Control group | No intervention | –Subjects assigned to the control group will receive support treatment in the intensive care unit based on institutional management guidelines. The use of antiviral, antimalarial or anti-inflammatory drugs is allowed in both groups according to the ICU protocols. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Over 18 years of age
- Men or nulliparous women with no history of recent abortions or transfusions SARS-CoV-2 infection by PCR in any sample or serological test with a maximum of 60 days from resolution of symptoms.
- If donation is done within 14 to 28 days after resolution of symptoms, the patient must have a negative PCR test for SARS-CoV-2. If donation is done after 28 days of resolving symptoms, no negative control test will be required.
- Over 18 years of age
- SARS-CoV-2 infection confirmed by PCR in any sample
Key exclusion criteria (7 listed)
- Severe SARS-CoV-2 infections with an ICU requirement or those with asymptomatic infections will not be accepted as donors.
- Nor will a person who has received convalescent plasma as part of the COVID-19 treatment.
- Serious volume overload or other condition that contraindicates plasma transfusion.
- History of anaphylaxis or serious adverse reaction to plasma.
- Previous diagnosis of immunoglobulin A deficiency
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 plasmaAlso: Plasma400-500ml convalescent plasma | Drug | Intervention group |
Primary outcome
Intrahospital mortality from any cause
Time frame: Up to 28 days
Proportion of patients who die while being hospitalized
4 secondary outcomes
Length of hospital stay
Time frame: Up to 60 days
Free time for ventilatory support on day 60
Time frame: Day 60
Overall survival at day 60 since hospitalization
Time frame: Day 60
Cumulative incidence of adverse events: transfusion reactions (fever, flare), TRALI (transfusion-associated lung injury), TACO (transfusion-related circulatory overload), transfusion- related infections
Time frame: Up to 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
- Individual participant dataSharing planned: No
Related trials for SARS-Cov-2
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
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
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.
Oliver Perilla Suarez, Hematologist principal investigator
Hospital San Vicente Fundación
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Convalescent plasma in people with SARS-Cov-2, run by Hospital San Vicente Fundación at 1 site 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 8 inclusion and 7 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 20 May 2020. 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Oliver G Perilla Suarez, Hematologist (+573136395608, gerardoperilla@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intrahospital mortality from any cause (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2020.