Safety in Convalescent Plasma Transfusion to COVID-19

Study Overview
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Brief Summary
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There is currently no specific vaccine or treatment to treat critically ill patients with COVID-19. Different therapies are still under investigation and are use in different health institutions, however, a significant proportion of patients do not respond to these treatments, so it is important to seek new treatments. One of these alternatives is the use of convalescent plasma. The investigator will use plasma obtained from convalescent individuals with proven novel SARS-CoV-2 virus infection, diagnosed with coronavirus-19-induced disease and symptom-free for a period of not less than 10 days since they recovered from the disease. This plasma will be infused in patients affected by the same virus, but who have developed respiratory complications that have not responded favorably to usual treatment such as chloroquine, hydroxychloroquine, azithromycin, and other antivirals. The investigator will evaluate the safety of this procedure by accounting for any adverse event.

Detailed Description
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There is currently no specific vaccine or treatment to treat critically ill patients with COVID-19. Different therapies are still under investigation and are use in different health institutions, however, a significant proportion of patients do not respond to these treatments, so it is important to seek new treatments. One of these alternatives is the use of convalescent plasma. The investigator will use plasma obtained from convalescent individuals with proven novel SARS-CoV-2 virus infection, diagnosed with coronavirus-19-induced disease and symptom-free for a period of not less than 10 days since they recovered from the disease. Donors will be screened for infectious diseases including sARS-CoV-2 and will be programmed for apheresis the next day. The investigaotr will process one plasmatic volume per donor and this will be guarded in the blood bank until required by the principal investigator. Patients or receptors will be screened and selected by the research team according to eligibility criteria, including severe disease refractory to treatment such as chloroquine, hydroxychloroquine, azithromycin, and other antivirals. Plasma will be fractioned in 250ml. Infusion will start after a clinical evaluation and blood sampling. Patients will remain under careful observation. If no adverse event is present, infusion will be repeated after 24 hours and the investigator will evaluate patients again 48 hours after the second transfusion. A final evaluation will be performed at day 14. The investigator will evaluate the safety of this procedure by accounting for any adverse event.

Official Title
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Phase 1 Study to Evaluate the Safety of Convalescent Plasma as an Adjuvant Therapy in Patients With SARS-CoV-2 Infection

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 Patients 18 years and older Confirmed SARS-CoV-2 Infection by RT-PCR. Serious or life-threatening infection defined as: Serious: Dyspnea Respiratory rate greater than or equal to 30 cycles / minute. Blood oxygen saturation less than or equal to 93% with an oxygen supply greater than 60%. Partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300 A 50% increase in pulmonary infiltrates defined by computer tomography scans in 24 to 48 hours. Life-threatening infection: respiratory failure. septic shock. dysfunction or multiple organ failure. Refractory to treatment with azithromycin / hydroxychloroquine or chloroquine / ritonavir / lopinavir defined as: 48 hours with no improvement in the modified parameters such as serious or clinically imminent infection. Signed Informed consent by the patient or by the person responsible for the patient in the case of critically ill patients (spouse or parents). Exclusion Criteria: Patients with a history of allergic reaction to any type of previous transfusion. Heart failure patients at risk of volume overload. Patients with a history of chronic kidney failure in the dialysis phase. Patients with previous hematological diseases (anemia less than 10 grams of hemoglobin, platelets greater than 100,000 / µl). Any case where the investigator decides that the patient is not suitable for the protocol.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COVID-19 patients receiving Convalescent Plasma<br>Convalescent Plasma from patients who recently recover from COVID-19 | Biological: Convalescent Plasma<br>* Along with the administration of convalescent plasma, patients will continue to receive supportive standard care.<br>* Other names: Supportive standard care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects | Identify possible adverse effects after the administration of convalescent plasma | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Failure | Development of heart failure during convalescent plasma transfusion or after it. | 14 days | 
| Pulmonary Edema | Development of pulmonary edema during convalescent plasma transfusion or after it. | 14 days | 
| Allergic Reaction | Development of any allergic reaction during convalescent plasma transfusion or after it. | 14 days | 
| Viral load of SARS-CoV-2 | RT PCR SARS-CoV-2 | 48 hrs | 
| Viral load of SARS-CoV-2 | RT PCR SARS-CoV-2 | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, SARS-CoV-2, Convalescent plasma