Status:
COMPLETED
PERUCONPLASMA: Evaluating the Use of Convalescent Plasma as Management of COVID-19
Lead Sponsor:
Universidad Peruana Cayetano Heredia
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Open label controlled clinical trial to evaluate the safety and efficacy of the use of convalescent plasma in hospitalized patients with COVID-19 infection. This study will have two arms, one arm will...
Detailed Description
The study protocol can be found in: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05189-6
Eligibility Criteria
Inclusion
- Hospitalized 18 years old or older patient with COVID-19 disease, confirmed by a molecular test or a serologic test, along with a typical COVID-19 clinical presentation.
- Severe or critical disease caused by COVID-19 Severe disease is defined as 2 or more of the following criteria:
- Respiratory frequency \>22
- O2 saturation ≤93%
- PaO2 50mmHg
- PaO2/FiO2 \<300
- Or critical disease with one or more of the following criteria:
- Respiratory insufficiency with requirement of mechanical ventilation within the last 72hours
- Shock
- Inform consent signed by patient or direct family member.
Exclusion
- Contraindication for transfusion (history of TRALI or TACO, history of anaphylaxis to blood components
- Multiorgan failure, defined by a SOFA score of \>5
- hemodynamically unstable, with mean arterial pressure \<60 mmHg, refractory to vasopressors use
- Uncontrolled concomitant infection
- Disseminated intravascular coagulation
- Myocardial infarction
- Acute coronary disease
- Patient on dialysis
- Intracranial bleeding active within the last 7 days
- Pregnancy
Key Trial Info
Start Date :
September 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 17 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04497324
Start Date
September 21 2020
End Date
April 17 2021
Last Update
October 28 2021
Active Locations (2)
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1
Hospital Cayetano Heredia
Lima, Peru, 15102
2
Hospital Nacional Hipolito Unanue
Lima, Peru