Study on the Safety and Efficacy of Convalescent Plasma in Patients With Severe COVID-19 Disease

Study Overview
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Brief Summary
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Currently, there is no specific treatment or vaccine for SARS-CoV-2 available, some drugs are being investigated as treatment, but the effect is unknown. A strategy and other method used before, in coronavirus pandemic (SARS-CoV in 2003 and MERS-CoV in 2012), was the use of immune (convalescent) plasma. Passive administration of antibodies through convalescent plasma transfusion may offer the only short-term strategy available to confer immediate immunity and being a relative immediately resource available for treat COVID-19 disease. This research proposes the passive administration of antibodies through the transfusion of convalescent plasma, in patients with severe COVID-19 disease.

Detailed Description
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A randomized clinical trial comparing administration convalescent plasma to standard therapy for severe COVID-19 disease. Patients will be randomized 1:1 in a single blind study. The patients with SARS-CoV-2 PCR confirmed infection with pulmonary infiltrates and hypoxemia will be screened and invited to participate. Our primary outcomes will be disease progression and mortality, evaluate of ordinal Scale for Clinical Improvement and. (WHO)

Official Title
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Convalescent Plasma as a Treatment for Patients With Severe COVID-19 Disease

Conditions
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Severe COVID-19 Disease

Intervention / Treatment
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* Biological: Biological


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: O2 saturation <93% Radiographic evidence of moderate pneumonia according to Rale's classification. Acute respiratory distress syndrome (PaO2 / FiO2 <300 or SpO2 / FiO2 ≤ 315) Authorization to participate in the study and have informed consent letter, signed by the patient or the person responsible for the patient in case of critical patients (intubated) Exclusion Criteria: Pregnant patients History of transfusion reactions Patients with congestive heart failure Patients with a history of chronic kidney failure on dialysis Patients with multiple organ failure Patients who does not accept or agree with the treatment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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
Interventional Model Description: The PC-COVID-HCM clinical trial is a randomized, controlled, single-blind study .
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>They will receive the standard care for critically ill inpatients. | |
| Experimental: Convalescent plasma group.<br>They will receive standard care for patients with severe COVID-19 disease and convalescent plasma disease. | Biological: Biological<br>* An administration unit of 200 ml convalescent plasma intravenous infusion every 24 hours for two doses. If a third dose of convalescent plasma is necessary, it may be used, as long as an evaluation of the research team is carried out.<br>* Other names: Convalescent plasma;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease progression | Change in ordinal Scale for Clinical Improvement (WHO). The progression disease, its the change in the severity score; a bigger number to the obtained after randomization | Up to 30 days later from study entry | 
| Side effects | Side effects associated with the administration of convalescent plasma | Up to 30 days later from study entry | 
| Mortality | Any cause of death | Up to 30 days later from study entry | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory improvement | Change in partial pressure of arterial Oxygen to Fraction of inspired Oxygen ratio (PaO2/FiO2) | 10 days | 
| Clinical improvement | Change in oxygen saturation levels | 10 days | 
| Acute adverse events (AAE) | Transfusion reactions during transfusion. | After receiving intervention, an average time one hour, until 24 hours after administration. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV2, Convalescent Plasma, Severe Acute Respiratory Syndrome