COVID-19Phase 2NCT04547127
A Study to Evaluate Safety and Efficacy of Convalescent Methylene Blue Treated (MBT) Plasma From Donors Recovered From Coronavirus Disease 2019 (COVID-19)
A Phase 2 study testing Convalescent anti-SARS-CoV-2 MBT Plasma and Standard Medical Treatment in people with COVID-19, run by Instituto Grifols, S.A. at 12 sites in Spain.
Trial summary
The purpose of the study is to determine if Convalescent anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Methylene Blue Treated (MBT) plasma plus Standard Medical Treatment (SMT) can reduce all-cause mortality versus SMT alone in hospitalized participants with COVID-19 requiring admission to the… 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?
- Convalescent anti-SARS-CoV-2 MBT Plasma and Standard Medical Treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 12 sitesSpain
- Study dates
- 29 Apr 2020to 4 Feb 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
- Hospitalized male or female subjects of ≥ 18 years of age at time of Screening who are being treated in the intensive care unit (ICU) for COVID-19 for not longer than 48 hours or for whom a decision has been made that COVID-19 disease severity warrants ICU admission.
- Subject (or a legal representative or a nearest relative or a relative by marriage, as appropriate) provides informed consent (ICF) prior to initiation of any study procedures.
- Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by qualitative Polymerase Chain Reaction (PCR) (reverse transcriptase [RT]-PCR), or other commercial or public health assay in any specimen during the current hospital admission prior to randomization.
- Illness (symptoms) of any duration, and the following:
- Radiographic infiltrates by imaging (chest x-ray, computerized tomography [CT] scan, etc.), and
- Requiring mechanical ventilation and/or supplemental oxygen
- Subjects with no limitation of therapeutic effort (decision on the status and future of the subject).
- Female subjects of child-bearing potential must have a negative test for pregnancy blood or urine human chorionic gonadotropin (HCG)-based assay at Screening/Baseline Visit.
Who cannot join
- Clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may place the subject at undue medical risk.
- The subject has had a known serious anaphylactic reaction to blood, any blood-derived or plasma product or methylene blue.
- A medical condition in which the infusion of additional fluid is contraindicated.
- Shock unresponsive to fluid challenge and/or multiple vasopressors and accompanied by multiorgan failure considered by the Principal Investigator not able to be reversed.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Spain12 sites
Hospital General Universitario de Alicante
Alicante
Hospital Universitari Vall d'Hebron
Barcelona
Hospital Universitari de Girona Doctor Josep Trueta
Girona
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat
Hospital Universitari Arnau de Vilanova
Lleida
Fundación Jimenez Diaz
Madrid
Hospital Clínico San Carlos
Madrid
Hospital Universitario La Paz
Madrid
Hospital Universitario La Princesa
Madrid
Complejo Hospitalario Universitario de Canarias
Santa Cruz de Tenerife
Hospital Clínico Universitario de Santiago -CHUS
Santiago
Hospital Universitari Joan XXIII
Tarragona
About this study
Official title: A Multicenter, Randomized, Open-label, Parallel Group Pilot Study to Evaluate Safety and Efficacy of Convalescent Methylene Blue Treated (MBT) Plasma From Donors Recovered From Coronavirus Disease 2019 (COVID-19) With Standard Medical Treatment (SMT) Versus SMT Alone in Subjects With COVID-19 Requiring Admission to the Intensive Care Unit (ICU)
The purpose of the study is to determine if Convalescent anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Methylene Blue Treated (MBT) plasma plus Standard Medical Treatment (SMT) can reduce all-cause mortality versus SMT alone in hospitalized participants with COVID-19 requiring admission to the intensive care unit (ICU) through Day 29.
- Conditions
- COVID-19
- Being tested
- Convalescent anti-SARS-CoV-2 MBT Plasma, Standard Medical Treatment
- Keywords
- Coronavirus Disease, Severe acute respiratory syndrome coronavirus 2, SARS-CoV-2
- 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 anti-SARS-CoV-2 MBT PlasmaBiological
Intravenous infusion.
Standard Medical TreatmentDrug
SMT
| Study group | Role | What they receive |
|---|---|---|
| Convalescent anti-SARS-CoV-2 MBT Plasma + SMT | Experimental | Participants will receive 2 consecutive transfusions of 200 to 250 milliliters (ml) of ABO-compatible convalescent plasma with each unit of plasma, obtained from the same convalescent donor, which will be administered on Day 1 using standard procedures for administration of fresh frozen plasma. Participants weighing less than 45 kilograms (kg) will receive two transfusions of 10 ml of convalescent plasma per kilogram of body weight with each unit of plasma obtained from the same convalescent donor. Participants will also receive all standard of care interventions while hospitalized, from Day 1 to Day 29. Receives: Biological: Convalescent anti-SARS-CoV-2 MBT Plasma; Drug: Standard Medical Treatment |
| Standard Medical Treatment | Active comparator | Participants will receive all standard of care interventions required throughout the participant's hospitalization, from Day 1 to Day 29. Receives: Drug: Standard Medical Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-Cause Mortality Rate
Measured: Up to Day 29
Secondary outcomes (9)
Change from Baseline in National Early Warning Score (NEWS)
Measured: Day 1 through Day 29
Time to Clinical Response as Assessed by NEWS ≤ 2 Maintained for 24 hours
Measured: Day 1 through Day 29
Time to Hospital Discharge
Measured: Day 1 through Day 29
Time to ICU Discharge
Measured: Day 1 through Day 29
Duration of All Oxygen Use
Measured: Day 1 through Day 29
Duration of Mechanical Ventilation
Measured: Day 1 through Day 29
Absolute Value Change from Baseline in Ordinal Scale
Measured: Day 1 through Day 29
Mean Change from Baseline in Ordinal Scale
Measured: Day 1 through Day 29
Percentage of Participants in Each Severity Category of the 7-Point Ordinal Scale
Measured: Day 15 and Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start29 Apr 2020
- Primary completion4 Feb 2021
- Study completion4 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Grifols, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04547127
- Sponsor's protocol ID
- GC2003
- Other IDs
- 2020-001299-14
- Status last verified
- Mar 2021
- First submitted
- 10 Sep 2020
- Last updated
- 3 Mar 2021
- 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 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-label, Parallel Group Pilot Study to Evaluate Safety and Efficacy of Convalescent Methylene Blue Treated (MBT) Plasma From Donors Recovered From Coronavirus Disease 2019 (COVID-19) With Standard Medical Treatment (SMT) Versus SMT Alone in Subjects With COVID-19 Requiring Admission to the Intensive Care Unit (ICU)
- ClinicalTrials.gov ID
- NCT04547127
- Acronym / sponsor ID
- GC2003
- Conditions
- COVID-19
- Keywords
- Coronavirus Disease, Severe acute respiratory syndrome coronavirus 2, SARS-CoV-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Instituto Grifols, S.A.Industry (pharma, biotech, devices)
- Study start
- 29 Apr 2020 (actual)
- Primary completion
- 4 Feb 2021 (actual)
- Study completion
- 4 Feb 2021 (actual)
- First posted
- 14 Sep 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 purpose of the study is to determine if Convalescent anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Methylene Blue Treated (MBT) plasma plus Standard Medical Treatment (SMT) can reduce all-cause mortality versus SMT alone in hospitalized participants with COVID-19 requiring admission to the intensive care unit (ICU) through Day 29.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Convalescent anti-SARS-CoV-2 MBT Plasma + SMT | Experimental | Biological: Convalescent anti-SARS-CoV-2 MBT Plasma, Drug: Standard Medical TreatmentParticipants will receive 2 consecutive transfusions of 200 to 250 milliliters (ml) of ABO-compatible convalescent plasma with each unit of plasma, obtained from the same convalescent donor, which will be administered on Day 1 using standard procedures for administration of fresh frozen plasma. Participants weighing less than 45 kilograms (kg) will receive two transfusions of 10 ml of convalescent plasma per kilogram of body weight with each unit of plasma obtained from the same convalescent donor. Participants will also receive all standard of care interventions while hospitalized, from Day 1 to Day 29. |
| Standard Medical Treatment | Active comparator | Drug: Standard Medical TreatmentParticipants will receive all standard of care interventions required throughout the participant's hospitalization, from Day 1 to Day 29. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Hospitalized male or female subjects of ≥ 18 years of age at time of Screening who are being treated in the intensive care unit (ICU) for COVID-19 for not longer than 48 hours or for whom a decision has been made that COVID-19 disease severity warrants ICU admission.
- Subject (or a legal representative or a nearest relative or a relative by marriage, as appropriate) provides informed consent (ICF) prior to initiation of any study procedures.
- Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by qualitative Polymerase Chain Reaction (PCR) (reverse transcriptase [RT]-PCR), or other commercial or public health assay in any specimen during the current hospital admission prior to randomization.
- Illness (symptoms) of any duration, and the following:
- Subjects with no limitation of therapeutic effort (decision on the status and future of the subject).
Key exclusion criteria (4 listed)
- Clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may place the subject at undue medical risk.
- The subject has had a known serious anaphylactic reaction to blood, any blood-derived or plasma product or methylene blue.
- A medical condition in which the infusion of additional fluid is contraindicated.
- Shock unresponsive to fluid challenge and/or multiple vasopressors and accompanied by multiorgan failure considered by the Principal Investigator not able to be reversed.
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 anti-SARS-CoV-2 MBT PlasmaIntravenous infusion. | Biological | Convalescent anti-SARS-CoV-2 MBT Plasma + SMT |
| Standard Medical TreatmentSMT | Drug | Convalescent anti-SARS-CoV-2 MBT Plasma + SMT, Standard Medical Treatment |
Primary outcome
All-Cause Mortality Rate
Time frame: Up to Day 29
9 secondary outcomes
Change from Baseline in National Early Warning Score (NEWS)
Time frame: Day 1 through Day 29
Time to Clinical Response as Assessed by NEWS ≤ 2 Maintained for 24 hours
Time frame: Day 1 through Day 29
Time to Hospital Discharge
Time frame: Day 1 through Day 29
Time to ICU Discharge
Time frame: Day 1 through Day 29
Duration of All Oxygen Use
Time frame: Day 1 through Day 29
Duration of Mechanical Ventilation
Time frame: Day 1 through Day 29
Absolute Value Change from Baseline in Ordinal Scale
Time frame: Day 1 through Day 29
Mean Change from Baseline in Ordinal Scale
Time frame: Day 1 through Day 29
Percentage of Participants in Each Severity Category of the 7-Point Ordinal Scale
Time frame: Day 15 and Day 29
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 3 Mar 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
12 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 Convalescent anti-SARS-CoV-2 MBT Plasma and Standard Medical Treatment in people with COVID-19, run by Instituto Grifols, S.A. at 12 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 8 inclusion and 4 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 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
All-Cause Mortality Rate (time frame: Up to Day 29). 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 3 Mar 2021.