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.
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.
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.
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.
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Tlalpan, Mexico
Investigator: Juan Sierra Madero, MD
Contact: +525556559675
jsmadero@yahoo.com
Juan G Sierra-Madero, MD
+52556559675
jsmadero@yahoo.com
Alvaro Lopez-Iñiguez, MD
Juan G Sierra-Madero, MD, Principal Investigator
Department of Infectious Diseases