Effectiveness and Safety of Convalescent Plasma in Patients With High-risk COVID-19
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- COVID-19
- SARS COV2
- Type
- Interventional
- Phase
- Phase 2Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a Phase II/III randomized clinical trial to assess the effectiveness and safety of anti-SARS-CoV-2 convalescent plasma in i) hospitalized adult patients with high-risk of progression SARS-CoV-2 infection and ii) patients in Intensive Care Unit (ICU). Compatible ABO plasma from convalescent p...
This is a Phase II/III randomized clinical trial to assess the effectiveness and safety of anti-SARS-CoV-2 convalescent plasma in i) hospitalized adult patients with high-risk of progression SARS-CoV-2 infection and ii) patients in Intensive Care Unit (ICU). Compatible ABO plasma from convalescent patients will be administered at a dose of 400 ml divided into two doses intravenously. Outcomes will be measured as follows: * Group of patients with critical illness: Primary outcomes (Effectiveness and safety): Mortality Safety: Presence of adverse events Secondary outcomes: Intensive care unit length of stay Evolution of clinical and paraclinical aspects. Group of patients at high risk of progression: Primary outcomes (Effectiveness and safety): Mortality Safety: Presence of adverse events Admission to ICU in 30 days Mechanical ventilation requirement Secondary outcomes: Hospital/Intensive care unit length of stay Evolution of clinical and paraclinical aspects.
Tracking Information
- NCT #
- NCT04425837
- Collaborators
- Not Provided
- Investigators
- Not Provided
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