Status:
UNKNOWN
Effectiveness and Safety of Convalescent Plasma in Patients With High-risk COVID-19
Lead Sponsor:
Fundación Santa Fe de Bogota
Conditions:
Sars-CoV2
Covid-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has affected the global population with significant morbidity and mortality. One of the main concerns is the management of the patients...
Detailed 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-...
Eligibility Criteria
Inclusion
- All patients
- Patients diagnosed with COVID-19 infection by RT-PCR technique
- Patients ≥ 18 years of age
- Patients in standard care according to the national guide
- Onset of symptoms ≤ 14 days
- Signature of informed consent report
- Patients at high risk of progression, defined by all of the following:
- Score greater than 9 on the CALL scale
- Pao2 / Fio2 ≤ 200 (parameters adjusted to the height of Bogotá, Colombia)
- X-ray or CT compatible with pneumonia
- Hospitalized patients
- Critically ill patients, defined by any of the following:
- Mechanical ventilation requeriment
- Patients in Intensive Care Unit or Intermediate Care Unit
- Ventilatory failure, septic shock, dysfunction or multi-organ failure
Exclusion
- Negative RT-PCR result from secretion 48 hours prior to study recruitment
- History of allergic reaction to blood or plasma in patients with a known history of IgA deficiency
- Patients participating in other clinical trial
- History of allergy to blood products
- History of confirmed infection and that required antibiotic or antifungal treatment 30 days prior to recruitment
- Pregnant women
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2021
Estimated Enrollment :
236 Patients enrolled
Trial Details
Trial ID
NCT04425837
Start Date
July 1 2020
End Date
February 1 2021
Last Update
June 11 2020
Active Locations (1)
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1
Fundación Santa Fe de Bogotá
Bogotá, Cundinamarca, Colombia, 110111