PERUCONPLASMA: Evaluating the Use of Convalescent Plasma as Management of COVID-19
- Conditions
- COVID-19
- Interventions
- Biological: Convalescent plasma
- Registration Number
- NCT04497324
- Lead Sponsor
- Universidad Peruana Cayetano Heredia
- 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 receive convalescent plasma plus standard of care, and the other arm will receive standard of care only. Adults older than 18 years old, hospitalized with diagnosis of COVID-19 confirmed by a laboratory test (molecular or serology), with severe or life-threatening disease, will be included to the study after obtaining inform consent by the patient of a direct family member. Participants will be then randomized 1:1 to the experimental and the control groups.
Participants at the experimental group will receive 1 to 2 units of ABO compatible COVID-19 convalescent plasma (200 ml to 250 ml each) within 48 hours, in addition to the standard of care. Participants at the control group will receive standard of care. Safety of convalescent plasma administration will be evaluated, as well as other indicators of clinical efficacy.
- Detailed Description
The study protocol can be found in:
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05189-6
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
-
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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group Convalescent plasma Administration of 1 to 2 units of convalescent plasma (200 ml to 250 ml, each), within 48 hours, plus standard of care.
- Primary Outcome Measures
Name Time Method Transfusion-related Serious Adverse Events 14 days after randomization Incidence of transfusion-related Serious Adverse Events, according to the Hemovigilance Module Surveillance Protocol v2.5.2
- Secondary Outcome Measures
Name Time Method All-cause in-hospital mortality 30 days after randomization Death during hospitalization within the first 30 days after enrollment
Length of hospital stay 30 days after randomization or until hospital discharge, whatever comes first Number of days from date of enrollment to date of discharge
Length of ICU stay 30 days after randomization or until hospital discharge, whatever comes first Number of days from date of admission to the ICU to date of discharge from ICU
Clinical Improvement at 14 days At 3, 14 and 30 days after randomization Improvement of 2 or more points in the WHO progression scale
Duration of mechanical ventilation 30 days after randomization or until hospital discharge, whatever comes first Number of days from date of intubation to date of successful extubation
Need of invasive mechanical ventilation 30 days after randomization or until hospital discharge, whatever comes first Requirement of invasive mechanical ventilation (Yes/No). Evaluated only for those participants that were on non-invasive ventilatory support at time of randomization
Trial Locations
- Locations (2)
Hospital Nacional Hipolito Unanue
🇵🇪Lima, Peru
Hospital Cayetano Heredia
🇵🇪Lima, Peru