Safety and Efficacy of Convalescent Plasma Transfusion for Patients With COVID-19

NCT ID: NCT04388410

Last Updated: 2020-08-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 410 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-25
• Study Completion Date: 2020-12-31

Brief 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. 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:

1. Adults older than 18 years.

2. Confirmed SARS-CoV2 infection

3. Patient hospitalized for COVID 19

4. Severe disease or risk for severe disease

5. Informed consent from patient or responsible person.

Exclusion criteria

1. History of allergic reactions to blood products

2. SOFA scale >12 points

3. Absolute contraindication for administration of plasma

4. Participation in other blinded clinical trial

5. Projected life expectancy less than 3 months

6. Any condition perceived by the investigator as not appropriate for participation of the patient in the trial.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

convalescent plasma

Convalescent plasma obtained from volunteers who have recovered from COVID 19. Enclosed with a similar material as the control

Group Type: EXPERIMENTAL

convalescent plasma

Intervention Type: BIOLOGICAL

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.

Normal saline

Normal saline solution in 200 ml plasma bags enclosed with with a similar material as the plasma

Group Type: PLACEBO_COMPARATOR

convalescent plasma

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Adults 18 years of age and older.

2. Confirmed SARS-CoV2 infection

3. Hospitalized for COVID 19

4. Severe disease or risk for severe disease

5. Informed consent from patient or responsible person.

Exclusion Criteria

1. History of allergic reactions to blood products

2. SOFA scale >12 points

3. Absolute contraindication for administration of plasma

4. Participation in other blinded clinical trial

5. Projected life expectancy less than 3 months

6. Any condition perceived by the investigator as not appropriate for participation of the patient in the trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TecSalud Investigación Clínica

OTHER

Sponsor Role: collaborator

Instituto Nacional de Enfermedades Respiratorias

OTHER_GOV

Sponsor Role: collaborator

Instituto Nacional de Cardiologia Ignacio Chavez

OTHER

Sponsor Role: collaborator

Hospital General Dr. Manuel Gea González

OTHER_GOV

Sponsor Role: collaborator

Hospital Regional de Alta Especialidad del Bajio

OTHER

Sponsor Role: collaborator

Instituto Nacional de Cancerologia de Mexico

OTHER

Sponsor Role: collaborator

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

OTHER

Sponsor Role: lead

Responsible Party

Juan G. Sierra Madero

Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juan G Sierra-Madero, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Infectious Diseases

Locations

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, Tlalpan, Mexico

Site Status: RECRUITING

Countries

Mexico

Central Contacts

Juan G Sierra-Madero, MD

Role: CONTACT

jsmadero@yahoo.com

+52556559675

Alvaro Lopez-Iñiguez, MD

Role: CONTACT

Facility Contacts

Juan Sierra Madero, MD

Role: primary

jsmadero@yahoo.com

+525556559675

Other Identifiers

3380

Identifier Type: -

Identifier Source: org_study_id