Status:
COMPLETED
Treatment of Patients With COVID-19 With Convalescent Plasma
Lead Sponsor:
University of Sao Paulo General Hospital
Collaborating Sponsors:
Ministério da Ciência, Tecnologia, Inovações e Comunicações
Faculty of Medicine of Ribeirão Preto (FMRP-USP)
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The COVID-19 pandemic has been spreading continuously, and in Brazil, until May 31, 2020, there have been more than 450.000 cases with more than 28.000 deaths, with daily increases. The present study ...
Detailed Description
Eligible patients will be randomized 1:1:1 into 3 treatment groups: A- standard (control); B- standard and convalescent plasma in a volume of 200ml (150-300ml); C- standard and convalescent plasma in ...
Eligibility Criteria
Inclusion
- Age = or \> than 18 years; .
- Laboratory-proven COVID-19 infection by RT-PCR in any clinical sample . Time since symptom onset less than 10 days at the time of screening; - . Presence of COVID-19 pneumonia, with a typical, indeterminate or atypical compatible image in a chest tomography exam (see definition below) -
- Presence of one of the following criteria:
- Need for\> 3L of O2 in the catheter / mask or\> 25% in the Venturi mask to maintain O2 saturation\> 92% B presence of respiratory distress syndrome with PaO2 / FiO2 \<300mmHg If intubated, within 48 hours of orotracheal intubation
- Absence of a history of serious adverse reactions to transfusion, for example, anaphylaxis; - .Participation approval by the research clinician
Exclusion
- Already enrolled in another clinical trial evaluating antiviral or immunobiological therapy for the treatment of COVID-19.
- IgA deficiency
- Presence of a clinical condition that does not allow infusion of 400 ml of volume at clinical discretion
- Pregnancy or breastfeeding
- Receipt of immunoglobulin in the last 30 days
- Presence of significant risk of death within the next 48 hours at clinical discretion.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2022
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT04415086
Start Date
June 1 2020
End Date
February 15 2022
Last Update
May 19 2022
Active Locations (1)
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1
University of Sao Paulo - General Hospital
São Paulo, São Paulo, Brazil, 01403-002