Sars-CoV2Phase 2/3NCT04425837
Effectiveness and Safety of Convalescent Plasma in Patients With High-risk COVID-19
A Phase 2/3 study testing SARS-CoV-2 convalescent plasma treatment in people with Sars-CoV2 and Covid-19, run by Fundación Santa Fe de Bogota at 1 site in Colombia.
Trial summary
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has affected the global population with significant morbidity and mortality. One of the main concerns is the management of the patients since there is no specific treatment for this condition. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- SARS-CoV-2 convalescent plasma treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteColombia
- Study dates
- Jul 2020to Feb 2021
- Phase
- Phase 2/3
- 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
- All patients
- Patients diagnosed with COVID-19 infection by RT-PCR technique
- Patients ≥ 18 years of age
- Patients in standard care according to the national guide
- Onset of symptoms ≤ 14 days
- Signature of informed consent report
Show all 15Show fewer
- Patients at high risk of progression, defined by all of the following:
- Score greater than 9 on the CALL scale
- Pao2 / Fio2 ≤ 200 (parameters adjusted to the height of Bogotá, Colombia)
- X-ray or CT compatible with pneumonia
- Hospitalized patients
- Critically ill patients, defined by any of the following:
- Mechanical ventilation requeriment
- Patients in Intensive Care Unit or Intermediate Care Unit
- Ventilatory failure, septic shock, dysfunction or multi-organ failure
Who cannot join
- Negative RT-PCR result from secretion 48 hours prior to study recruitment
- History of allergic reaction to blood or plasma in patients with a known history of IgA deficiency
- Patients participating in other clinical trial
- History of allergy to blood products
- History of confirmed infection and that required antibiotic or antifungal treatment 30 days prior to recruitment
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Fundación Santa Fe de Bogotá
Bogotá, Cundinamarca, 110111
José De la Hoz, Epidemiologist, 5716030303 ext. 1127, jose.delahoz@fsfb.org.co
About this study
Official title: Effectiveness and Safety of Convalescent Plasma in Patients With High-risk COVID-19: A Randomized, Controlled Study CRI-CP (Coronavirus Investigation - Convalescent Plasma)
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has affected the global population with significant morbidity and mortality. One of the main concerns is the management of the patients since there is no specific treatment for this condition. Therefore, in SARS-CoV-2 patients the compassionate use of off-label therapies has been initiated; such as the use of plasma from convalescent patients. This treatment has been used in other pandemics like SARS-CoV-1, H5N1, H1N1, Ebola, among others. This study is a phase II/III randomized clinical trial to assess the effectiveness and safety of convalescent plasma administration in patients with high-risk SARS-CoV-2.
Read the detailed description
This is a Phase II/III randomized clinical trial to assess the effectiveness and safety of anti-SARS-CoV-2 convalescent plasma in i) hospitalized adult patients with high-risk of progression SARS-CoV-2 infection and ii) patients in Intensive Care Unit (ICU).
Compatible ABO plasma from convalescent patients will be administered at a dose of 400 ml divided into two doses intravenously. Outcomes will be measured as follows:
- Group of patients with critical illness:
Primary outcomes (Effectiveness and safety):
- Mortality
- Safety: Presence of adverse events
Secondary outcomes:
- Intensive care unit length of stay
- Evolution of clinical and paraclinical aspects.
- Group of patients at high risk of progression:
Primary outcomes (Effectiveness and safety):
- Mortality
- Safety: Presence of adverse events
- Admission to ICU in 30 days
- Mechanical ventilation requirement
Secondary outcomes:
- Hospital/Intensive care unit length of stay
- Evolution of clinical and paraclinical aspects.
- Being tested
- SARS-CoV-2 convalescent plasma treatment, Standard care
- Keywords
- COVID-19 serotherapy, Mortality, Safety
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2 convalescent plasma treatmentBiological
Plasma transfusion of convalescent patients from COVID-19 with negative RT-PCR, and antibody titers of 1:160 or greater at a dose of 400ml distributed in two doses administered on the same day intravenous administration
Standard careOther
Standard care according to guidelines and national regulations
| Study group | Role | What they receive |
|---|---|---|
| Standard care alone | Active comparator | Not described Receives: Other: Standard care |
| SARS-CoV-2 convalescent plasma treatment plus standard care | Experimental | Not described Receives: Biological: SARS-CoV-2 convalescent plasma treatment; Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Death of the patient (yes/no)
Measured: Up to 30 days after the study enrollment
Adverse events
Presence of any of the following adverse events (yes/no):
- Nonhemolytic febrile reactions
- Allergic reactions
- Acute hemolytic reactions
- Non-immune hemolysis
- Acute transfusion-related lung damage
- Transfusion-related circulatory overload
- Metabolic reactions
- Hypotensive reactions
- Delayed hemolytic reactions
- Post transfusion purple
- Graft versus host disease
- Bacterial contamination of blood components
- Viral infections
- Other infections (syphilis, prions, malaria, Chagas, yellow fever, dengue)
Measured: Up to 30 days after the study enrollment
ICU admission
Admitted to intensive care units (ICUs) (yes/no)
Measured: Up to 30 days after the study enrollment
Mechanical ventilation
Mechanical ventilation requirement (yes/no)
Measured: Up to 30 days after the study enrollment
Secondary outcomes (12)
ICU length
Intensive care unit length of stay
Measured: Up to 30 days after the study enrollment
Reduction of D Dimer
D dimer reduction below 1mcg / ml
Measured: Assessment at day 30 after study enrollment
LDH reduction
Reduction of LDH below 350 IU / L
Measured: Assessment at day 30 after study enrollment
Reduction of Troponin level
Reduction of troponin level to than 8 pg / mL
Measured: Assessment at day 30 after study enrollment
Decrease in ferritin level
Decrease in ferritin level below 1025 mcg / L
Measured: Assessment at day 30 after study enrollment
Decrease in procalcitonin level
Decrease in procalcitonin level below 0.1ng / ml
Measured: Assessment at day 30 after study enrollment
Decrease in CRP
Decrease in CRP level bellow <8 mg / L
Measured: Assessment at day 30 after study enrollment
Increase in lymphocyte count
Increase in lymphocyte count greater than 0.6 x 10-9 / L
Measured: Assessment at day 30 after study enrollment
Increase in PaO2 / Fio2
Increase in PaO2 / Fio2 greater than 200
Measured: Assessment at day 30 after study enrollment
Decrease in Sequential Organ failure assessment (SOFA ) score
Scale of 24 points, greater number indicates worst outcome
Measured: Assessment at day 30 after study enrollment
Extracorporeal membrane oxygenation (ECMO)
Extracorporeal membrane oxygenation requirement (ECMO)
Measured: Assessment at day 30 after study enrollment
Lung infiltration
Decrease in the percentage of lung infiltration
Measured: Assessment at day 30 after study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study startJul 2020 (estimated)
- Primary completionFeb 2021 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sars-CoV2Studies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Santa Fe de Bogota
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillermo Enrique Quintero-Vega, Fundación Santa Fe de Bogota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425837
- Sponsor's protocol ID
- PLASMA COVID-19
- Status last verified
- Jun 2020
- First submitted
- 29 May 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Convalescent Plasma in Patients With High-risk COVID-19: A Randomized, Controlled Study CRI-CP (Coronavirus Investigation - Convalescent Plasma)
- ClinicalTrials.gov ID
- NCT04425837
- Acronym / sponsor ID
- PLASMA COVID-19
- Keywords
- COVID-19 serotherapy, Mortality, Safety
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Fundación Santa Fe de BogotaUniversity, hospital or other
- Study start
- Jul 2020 (estimated)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 11 Jun 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.
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has affected the global population with significant morbidity and mortality. One of the main concerns is the management of the patients since there is no specific treatment for this condition. Therefore, in SARS-CoV-2 patients the compassionate use of off-label therapies has been initiated; such as the use of plasma from convalescent patients. This treatment has been used in other pandemics like SARS-CoV-1, H5N1, H1N1, Ebola, among others. This study is a phase II/III randomized clinical trial to assess the effectiveness and safety of convalescent plasma administration in patients with high-risk SARS-CoV-2.
Detailed description
This is a Phase II/III randomized clinical trial to assess the effectiveness and safety of anti-SARS-CoV-2 convalescent plasma in i) hospitalized adult patients with high-risk of progression SARS-CoV-2 infection and ii) patients in Intensive Care Unit (ICU).
Compatible ABO plasma from convalescent patients will be administered at a dose of 400 ml divided into two doses intravenously. Outcomes will be measured as follows:
- Group of patients with critical illness:
Primary outcomes (Effectiveness and safety):
- Mortality
- Safety: Presence of adverse events
Secondary outcomes:
- Intensive care unit length of stay
- Evolution of clinical and paraclinical aspects.
- Group of patients at high risk of progression:
Primary outcomes (Effectiveness and safety):
- Mortality
- Safety: Presence of adverse events
- Admission to ICU in 30 days
- Mechanical ventilation requirement
Secondary outcomes:
- Hospital/Intensive care unit length of stay
- Evolution of clinical and paraclinical aspects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care alone | Active comparator | Other: Standard care |
| SARS-CoV-2 convalescent plasma treatment plus standard care | Experimental | Biological: SARS-CoV-2 convalescent plasma treatment, Other: Standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- All patients
- Patients diagnosed with COVID-19 infection by RT-PCR technique
- Patients ≥ 18 years of age
- Patients in standard care according to the national guide
- Onset of symptoms ≤ 14 days
Key exclusion criteria (6 listed)
- Negative RT-PCR result from secretion 48 hours prior to study recruitment
- History of allergic reaction to blood or plasma in patients with a known history of IgA deficiency
- Patients participating in other clinical trial
- History of allergy to blood products
- History of confirmed infection and that required antibiotic or antifungal treatment 30 days prior to recruitment
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 |
|---|---|---|
| SARS-CoV-2 convalescent plasma treatmentPlasma transfusion of convalescent patients from COVID-19 with negative RT-PCR, and antibody titers of 1:160 or greater at a dose of 400ml distributed in two doses administered on the same day intravenous administration | Biological | SARS-CoV-2 convalescent plasma treatment plus standard care |
| Standard careStandard care according to guidelines and national regulations | Other | SARS-CoV-2 convalescent plasma treatment plus standard care, Standard care alone |
Primary outcome
Mortality
Time frame: Up to 30 days after the study enrollment
Death of the patient (yes/no)
Adverse events
Time frame: Up to 30 days after the study enrollment
Presence of any of the following adverse events (yes/no): 1. Nonhemolytic febrile reactions 2. Allergic reactions 3. Acute hemolytic reactions 4. Non-immune hemolysis 5. Acute transfusion-related lung damage 6. Transfusion-related circulatory overload 7. Metabolic reactions 8. Hypotensive reactions 9. Delayed hemolytic reactions 10. Post transfusion purple 11. Graft versus host disease 12. Bacterial contamination of blood components 13. Viral infections 14. Other infections (syphilis, prions, malaria, Chagas, yellow fever, dengue)
ICU admission
Time frame: Up to 30 days after the study enrollment
Admitted to intensive care units (ICUs) (yes/no)
Mechanical ventilation
Time frame: Up to 30 days after the study enrollment
Mechanical ventilation requirement (yes/no)
12 secondary outcomes
ICU length
Time frame: Up to 30 days after the study enrollment
Reduction of D Dimer
Time frame: Assessment at day 30 after study enrollment
LDH reduction
Time frame: Assessment at day 30 after study enrollment
Reduction of Troponin level
Time frame: Assessment at day 30 after study enrollment
Decrease in ferritin level
Time frame: Assessment at day 30 after study enrollment
Decrease in procalcitonin level
Time frame: Assessment at day 30 after study enrollment
Decrease in CRP
Time frame: Assessment at day 30 after study enrollment
Increase in lymphocyte count
Time frame: Assessment at day 30 after study enrollment
Increase in PaO2 / Fio2
Time frame: Assessment at day 30 after study enrollment
Decrease in Sequential Organ failure assessment (SOFA ) score
Time frame: Assessment at day 30 after study enrollment
Extracorporeal membrane oxygenation (ECMO)
Time frame: Assessment at day 30 after study enrollment
Lung infiltration
Time frame: Assessment at day 30 after study enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing SARS-CoV-2 convalescent plasma treatment in people with Sars-CoV2 and Covid-19, run by Fundación Santa Fe de Bogota 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 15 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: status not confirmed, as of the sponsor's last update on 11 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 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 combined 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.
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 Guillermo E Quintero, Hematologist (5716030303 ext. 1221, quiquequintero@yahoo.com.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Up to 30 days after the study enrollment). The study lists 4 primary outcomes in all. 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 11 Jun 2020.