COVID-19Phase 2/3EPCOvid-1NCT04388410
Safety and Efficacy of Convalescent Plasma Transfusion for Patients With COVID-19
A Phase 2/3 study testing convalescent plasma in people with COVID-19, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial summary
This is a multicenter double blinded study to evaluate the efficacy and safety of convalescent plasma from COVID-19 recovered individuals to treat hospitalized patients with severe COVID-19 disease. 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 plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 410 participants
- Where
- 1 siteMexico
- Study dates
- 25 Aug 2020to 31 Dec 2020
- 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
- Adults 18 years of age and older.
- Confirmed SARS-CoV2 infection
- Hospitalized for COVID 19
- Severe disease or risk for severe disease
- Informed consent from patient or responsible person.
Who cannot join
- History of allergic reactions to blood products
- SOFA scale >12 points
- Absolute contraindication for administration of plasma
- Participation in other blinded clinical trial
- Projected life expectancy less than 3 months
- Any condition perceived by the investigator as not appropriate for participation of the patient in the trial.
Trial locations and contacts
1 site in 1 country.
Alvaro Lopez-Iñiguez, MD contact
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Tlalpan, 14000
Juan Sierra Madero, MD, +525556559675, jsmadero@yahoo.com
About this study
Official title: Phase 2b/3 Trial to Evaluate the Safety and Efficacy of Plasma Transfusion From Convalescent Patients With SARS-CoV-2 Infection on Severity and Mortality of COVID-19 in Hospitalized Patients.
This is a multicenter double blinded study to evaluate the efficacy and safety of convalescent plasma from COVID-19 recovered individuals to treat hospitalized patients with severe COVID-19 disease. The study will enroll 410 subjects who will be randomized 1:1 to receive convalescent plasma or normal saline solution in a blinded manner. The primary endpoint will be improvement on the 8 point WHO scale over 28 days. Mortality at day 28 will be a secondary endpoint. An interim analysis will be done when 224 patients have completed their follow up to assess safety and to indicate continuation or stopping of the study, based on safety and efficacy observed.
Read the detailed description
A total of 410 patients with COVID 19 who fulfill inclusion criteria will be invited to receive:
Human convalescent plasma from recovered patients in two infusions of 200 ml separated with 24 to 72 hours or Normal saline solution in a similar plasma bag. Both products will be covered in an identical material to avoid identification of the infused product.
Primary endpoint:
Improvement on the 8 point WHO scale over 28 days.
Secondary endpoints.
Mortality at day 28
- Presence of antibodies against SARS-CoV-2 in serum on days 0, 3, 7, 14, 21 y 28 after plasma administration, as long as the patient remains in the hospital.
- Disease progression to a worse stage compared to the baseline on admission to the study according to SOFA scale.
- Disease progression to a worse stage defined as worsening in at least two categories in the OMS disease scale on different timelines in comparison to baseline on admission to the study
- Number of hours on mechanical ventilation in those who enter the study on mechanical ventilation.
- Number of days with fever defined as temperature >38°C on at least one occasion during the day
Inclusion criteria:
- Adults older than 18 years.
- Confirmed SARS-CoV2 infection
- Patient hospitalized for COVID 19
- Severe disease or risk for severe disease
- Informed consent from patient or responsible person.
Exclusion criteria
- History of allergic reactions to blood products
- SOFA scale >12 points
- Absolute contraindication for administration of plasma
- Participation in other blinded clinical trial
- Projected life expectancy less than 3 months
- Any condition perceived by the investigator as not appropriate for participation of the patient in the trial.
- Conditions
- COVID-19
- Being tested
- convalescent plasma
- Keywords
- SARS-CoV-2, convalescent plasma, randomized clinical trial
- 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 plasmaBiological
Plasma obtained from volunteers who have recovered from SARS-Cov-2 infection. Two 200 ml infusions will be administered with 24-72 hours in between.
| Study group | Role | What they receive |
|---|---|---|
| convalescent plasma | Experimental | Convalescent plasma obtained from volunteers who have recovered from COVID 19. Enclosed with a similar material as the control Receives: Biological: convalescent plasma |
| Normal saline | Placebo comparator | Normal saline solution in 200 ml plasma bags enclosed with with a similar material as the plasma Receives: Biological: convalescent plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity and death
Ordinal 8-point severity outcome scale: 1 Death, 2 Hospitalized, intubated and receiving mechanical ventilation and additional organ support (eg. renal replacement therapy, vasopressors, extracorporeal membrane oxygenation), 3 Hospitalized, intubated and receiving mechanical ventilation but no additional organ support, 4 Hospitalized receiving non-invasive ventilation of high-flow oxygen, 5 Hospitalized, receiving supplementary oxygen by mask or nasal prongs, 6 Hospitalized, no oxygen therapy needed, 7 Not-hospitalized (ambulatory) with limited activity, 8 Not-hospitalized (ambulatory) with no limitation of activities.
Measured: 28 days
Adverse events that require study treatment interruption
Any unfavorable and unintended symptom or sign (including an abnormal laboratory finding) temporally associated with the study intervention and considered related to the intervention that require interruption of study treatment. Including but not limited to: Severe allergic reactions (rash and fever), transfusion-associated lung injury (TRALI), transfusion-associated circulatory overload (TACO), and other severe unexpected events
Measured: During the 28 day of follow up
Secondary outcomes (8)
Time to clinical improvement
Time (in days) to improvement in at least two categories in the 8-point ordinal severity scale in comparison to baseline on admission to the study.
Measured: 28 days
Severity and death
Ordinal 8-point severity outcome scale: 1 Death, 2 Hospitalized, intubated and receiving mechanical ventilation and additional organ support (eg. renal replacement therapy, vasopressors, extracorporeal membrane oxygenation), 3 Hospitalized, intubated and receiving mechanical ventilation but no additional organ support, 4 Hospitalized receiving non-invasive ventilation of high-flow oxygen, 5 Hospitalized, receiving supplementary oxygen by mask or nasal prongs, 6 Hospitalized, no oxygen therapy needed, 7 Not-hospitalized (ambulatory) with limited activity, 8 Not-hospitalized (ambulatory) with no limitation of activities.
Measured: Days 1, 3, 5, 7, 12, 14, and 21.
Antibodies against SARS-CoV-2
Antibody titers on serum/plasma as long as the patient remains in the hospital.
Measured: Days 0, 3, 7, 14, 21, 28
Disease progression 1
Changes in SOFA scale during hospitalization compared to the baseline
Measured: 28 days
Disease progression 2
Changes in at least two categories in the 8-point ordinal severity scale in comparison to baseline on admission to the study
Measured: Days 7,14, 21, 28
Time on mechanical ventilation
Time (in hours) spent receiving invasive mechanical ventilation in those who enter the study on mechanical ventilation.
Measured: 28 days
Number of days with fever
Temperature >=38°C on at least one measurement during the day
Measured: 28 days
Adverse events attributed to the study intervention
Any unfavorable and unintended symptom or sign (including an abnormal laboratory finding) temporally associated with the study intervention and considered related to the intervention.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start25 Aug 2020
- Primary completion30 Nov 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blinded, multicenter, placebo-controlled study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Collaborators
- TecSalud Investigación Clínica, Instituto Nacional de Enfermedades Respiratorias, Instituto Nacional de Cardiologia Ignacio Chavez, Hospital General Dr. Manuel Gea González, Hospital Regional de Alta Especialidad del Bajio, Instituto Nacional de Cancerologia de Mexico
- Responsible party
- Principal investigator, Juan G. Sierra Madero, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Investigators
- Juan G Sierra-Madero, MD, Principal investigator, Department of Infectious Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04388410
- Sponsor's protocol ID
- 3380
- Acronym
- EPCOvid-1
- Status last verified
- Aug 2020
- First submitted
- 12 May 2020
- Last updated
- 26 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Plan to make IPD still not decided and would need approval by regulatory authorities
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2b/3 Trial to Evaluate the Safety and Efficacy of Plasma Transfusion From Convalescent Patients With SARS-CoV-2 Infection on Severity and Mortality of COVID-19 in Hospitalized Patients.
- ClinicalTrials.gov ID
- NCT04388410
- Acronym / sponsor ID
- EPCOvid-1 / 3380
- Conditions
- COVID-19
- Keywords
- SARS-CoV-2, convalescent plasma, randomized clinical trial
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Collaborators
- TecSalud Investigación Clínica, Instituto Nacional de Enfermedades Respiratorias, Instituto Nacional de Cardiologia Ignacio Chavez, Hospital General Dr. Manuel Gea González, Hospital Regional de Alta Especialidad del Bajio, Instituto Nacional de Cancerologia de Mexico
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 14 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.
This is a multicenter double blinded study to evaluate the efficacy and safety of convalescent plasma from COVID-19 recovered individuals to treat hospitalized patients with severe COVID-19 disease. The study will enroll 410 subjects who will be randomized 1:1 to receive convalescent plasma or normal saline solution in a blinded manner. The primary endpoint will be improvement on the 8 point WHO scale over 28 days. Mortality at day 28 will be a secondary endpoint. An interim analysis will be done when 224 patients have completed their follow up to assess safety and to indicate continuation or stopping of the study, based on safety and efficacy observed.
Detailed description
A total of 410 patients with COVID 19 who fulfill inclusion criteria will be invited to receive:
Human convalescent plasma from recovered patients in two infusions of 200 ml separated with 24 to 72 hours or Normal saline solution in a similar plasma bag. Both products will be covered in an identical material to avoid identification of the infused product.
Primary endpoint:
Improvement on the 8 point WHO scale over 28 days.
Secondary endpoints.
Mortality at day 28
- Presence of antibodies against SARS-CoV-2 in serum on days 0, 3, 7, 14, 21 y 28 after plasma administration, as long as the patient remains in the hospital.
- Disease progression to a worse stage compared to the baseline on admission to the study according to SOFA scale.
- Disease progression to a worse stage defined as worsening in at least two categories in the OMS disease scale on different timelines in comparison to baseline on admission to the study
- Number of hours on mechanical ventilation in those who enter the study on mechanical ventilation.
- Number of days with fever defined as temperature >38°C on at least one occasion during the day
Inclusion criteria:
- Adults older than 18 years.
- Confirmed SARS-CoV2 infection
- Patient hospitalized for COVID 19
- Severe disease or risk for severe disease
- Informed consent from patient or responsible person.
Exclusion criteria
- History of allergic reactions to blood products
- SOFA scale >12 points
- Absolute contraindication for administration of plasma
- Participation in other blinded clinical trial
- Projected life expectancy less than 3 months
- Any condition perceived by the investigator as not appropriate for participation of the patient in the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blinded, multicenter, placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| convalescent plasma | Experimental | Biological: convalescent plasmaConvalescent plasma obtained from volunteers who have recovered from COVID 19. Enclosed with a similar material as the control |
| Normal saline | Placebo comparator | Biological: convalescent plasmaNormal saline solution in 200 ml plasma bags enclosed with with a similar material as the plasma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults 18 years of age and older.
- Confirmed SARS-CoV2 infection
- Hospitalized for COVID 19
- Severe disease or risk for severe disease
- Informed consent from patient or responsible person.
Key exclusion criteria (6 listed)
- History of allergic reactions to blood products
- SOFA scale >12 points
- Absolute contraindication for administration of plasma
- Participation in other blinded clinical trial
- Projected life expectancy less than 3 months
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 plasmaPlasma obtained from volunteers who have recovered from SARS-Cov-2 infection. Two 200 ml infusions will be administered with 24-72 hours in between. | Biological | Normal saline, convalescent plasma |
Primary outcome
Severity and death
Time frame: 28 days
Ordinal 8-point severity outcome scale: 1 Death, 2 Hospitalized, intubated and receiving mechanical ventilation and additional organ support (eg. renal replacement therapy, vasopressors, extracorporeal membrane oxygenation), 3 Hospitalized, intubated and receiving mechanical ventilation but no additional organ support, 4 Hospitalized receiving non-invasive ventilation of high-flow oxygen, 5 Hospitalized, receiving supplementary oxygen by mask or nasal prongs, 6 Hospitalized, no oxygen therapy needed, 7 Not-hospitalized (ambulatory) with limited activity, 8 Not-hospitalized (ambulatory) with no limitation of activities.
Adverse events that require study treatment interruption
Time frame: During the 28 day of follow up
Any unfavorable and unintended symptom or sign (including an abnormal laboratory finding) temporally associated with the study intervention and considered related to the intervention that require interruption of study treatment. Including but not limited to: Severe allergic reactions (rash and fever), transfusion-associated lung injury (TRALI), transfusion-associated circulatory overload (TACO), and other severe unexpected events
8 secondary outcomes
Time to clinical improvement
Time frame: 28 days
Severity and death
Time frame: Days 1, 3, 5, 7, 12, 14, and 21.
Antibodies against SARS-CoV-2
Time frame: Days 0, 3, 7, 14, 21, 28
Disease progression 1
Time frame: 28 days
Disease progression 2
Time frame: Days 7,14, 21, 28
Time on mechanical ventilation
Time frame: 28 days
Number of days with fever
Time frame: 28 days
Adverse events attributed to the study intervention
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
- Individual participant dataSharing planned: No. Plan to make IPD still not decided and would need approval by regulatory authorities
Related trials for COVID-19
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.
Alvaro Lopez-Iñiguez, MD contact
Juan G Sierra-Madero, MD principal investigator
Department of Infectious Diseases
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 convalescent plasma in people with COVID-19, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
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 5 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 26 Aug 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 Mexico. 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. Some participants in this study may receive a placebo. 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 Juan G Sierra-Madero, MD (+52556559675, jsmadero@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity and death (time frame: 28 days). 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?
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 26 Aug 2020.