Safety and Efficacy of Convalescent Plasma Transfusion for Patients With COVID-19 (EPCOvid-1)
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ClinicalTrials.gov Identifier: NCT04388410 |
Recruitment Status : Unknown
Verified August 2020 by Juan G. Sierra Madero, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran.
Recruitment status was: Recruiting
First Posted : May 14, 2020
Last Update Posted : August 26, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID-19 | Biological: convalescent plasma | Phase 2 Phase 3 |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 410 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Randomized, double-blinded, multicenter, placebo-controlled study |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | Encasement of plasma and saline bags with an identical material will be done in Blood bank |
Primary Purpose: | Treatment |
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. |
Actual Study Start Date : | August 25, 2020 |
Estimated Primary Completion Date : | November 30, 2020 |
Estimated Study Completion Date : | December 31, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: convalescent plasma
Convalescent plasma obtained from volunteers who have recovered from COVID 19. Enclosed with a similar material as the control
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Biological: convalescent plasma
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. |
Placebo Comparator: Normal saline
Normal saline solution in 200 ml plasma bags enclosed with with a similar material as the plasma
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Biological: convalescent plasma
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. |
- 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
- Time to clinical improvement [ Time Frame: 28 days ]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.
- Severity and death [ Time Frame: Days 1, 3, 5, 7, 12, 14, and 21. ]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.
- Antibodies against SARS-CoV-2 [ Time Frame: Days 0, 3, 7, 14, 21, 28 ]Antibody titers on serum/plasma as long as the patient remains in the hospital.
- Disease progression 1 [ Time Frame: 28 days ]Changes in SOFA scale during hospitalization compared to the baseline
- Disease progression 2 [ Time Frame: Days 7,14, 21, 28 ]Changes in at least two categories in the 8-point ordinal severity scale in comparison to baseline on admission to the study
- Time on mechanical ventilation [ Time Frame: 28 days ]Time (in hours) spent receiving invasive mechanical ventilation in those who enter the study on mechanical ventilation.
- Number of days with fever [ Time Frame: 28 days ]Temperature >=38°C on at least one measurement during the day
- Adverse events attributed to the study intervention [ Time Frame: 28 days ]Any unfavorable and unintended symptom or sign (including an abnormal laboratory finding) temporally associated with the study intervention and considered related to the intervention.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04388410
Contact: Juan G Sierra-Madero, MD | +52556559675 | jsmadero@yahoo.com | |
Contact: Alvaro Lopez-Iñiguez, MD |
Mexico | |
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | Recruiting |
Mexico City, Tlalpan, Mexico, 14000 | |
Contact: Juan Sierra Madero, MD +525556559675 jsmadero@yahoo.com |
Principal Investigator: | Juan G Sierra-Madero, MD | Department of Infectious Diseases |
Responsible Party: | Juan G. Sierra Madero, Investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
ClinicalTrials.gov Identifier: | NCT04388410 |
Other Study ID Numbers: |
3380 |
First Posted: | May 14, 2020 Key Record Dates |
Last Update Posted: | August 26, 2020 |
Last Verified: | August 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Plan to make IPD still not decided and would need approval by regulatory authorities |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
SARS-CoV-2 convalescent plasma randomized clinical trial |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |