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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.
Full 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
Inclusion criteria:
Exclusion criteria
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Primary purpose
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Interventional model
Masking
410 participants in 2 patient groups, including a placebo group
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Central trial contact
Alvaro Lopez-Iñiguez, MD; Juan G Sierra-Madero, MD
Data sourced from clinicaltrials.gov
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