PERUCONPLASMA: Evaluating the Use of Convalescent Plasma as Management of COVID-19

Study Overview
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Brief Summary
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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
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The study protocol can be found in: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05189-6

Official Title
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PERUCONPLASMA: Randomized Clinical Trial to Evaluate Safety and Efficacy of the Use of Convalescent Plasma in Hospitalized Patients With COVID-19

Conditions
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COVID-19

Intervention / Treatment
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* Biological: Convalescent plasma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Administration of 1 to 2 units of convalescent plasma (200 ml to 250 ml, each), within 48 hours, plus standard of care. | Biological: Convalescent plasma<br>* Administration of 1 to 2 units of convalescent plasma (200 ml to 250 ml, each), within 48 hours, plus standard of care.<br>|
| No Intervention: Control group<br>Standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transfusion-related Serious Adverse Events | Incidence of transfusion-related Serious Adverse Events, according to the Hemovigilance Module Surveillance Protocol v2.5.2 | 14 days after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause in-hospital mortality | Death during hospitalization within the first 30 days after enrollment | 30 days after randomization | 
| Length of hospital stay | Number of days from date of enrollment to date of discharge | 30 days after randomization or until hospital discharge, whatever comes first | 
| Length of ICU stay | Number of days from date of admission to the ICU to date of discharge from ICU | 30 days after randomization or until hospital discharge, whatever comes first | 
| Need of invasive mechanical ventilation | Requirement of invasive mechanical ventilation (Yes/No). Evaluated only for those participants that were on non-invasive ventilatory support at time of randomization | 30 days after randomization or until hospital discharge, whatever comes first | 
| Duration of mechanical ventilation | Number of days from date of intubation to date of successful extubation | 30 days after randomization or until hospital discharge, whatever comes first | 
| Clinical Improvement at 14 days | Improvement of 2 or more points in the WHO progression scale | At 3, 14 and 30 days after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Convalescent plasma