Anti COVID-19 Convalescent Plasma Therapy

Orthosera Kft.

Status and phase: Unknown; Early Phase 1

Conditions: COVID 19

Treatments: Biological: anti-SARS-CoV-2 convalescent plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT04345679

AntiCOVID19ORT

Details and patient eligibility

About

Why is the research needed? The pandemic known as COVID-19 is now spreading across the world with currently (April 10, 2020) more than 1 115 530 active cases and 96 791 deaths. In most affected countries the current goal is to 'flatten the curve' of the epidemic since there is no health care system that is able to treat an extremely high volume of patients all at once. There is a need for immediately applicable treatments for the patients at highest risk, which gains time until targeted therapies become available. A key feature in the pathomechanism of the disease is that the virus elicits an immunological over-reaction in the human body termed 'cytokine storm'. In susceptible patients this hyper-inflammation itself is a significant burden and may even inhibit the body to generate antibodies against the virus in adequate quantities. Therefore, identifying the subset of patients with excess cytokine response and supplementing them with convalescent plasma from recovered donors may be a life-saving treatment option.

What is our study about? In light of recent promising data on plasma therapy in the treatment of COVID-19 and other viral epidemics, there is a need for better understanding the cytokine response to the virus in order to better characterize the target population for convalescent plasma therapy.

Our hypothesis is that convalescent plasma transfusion from healthy donors who recovered from SARS CoV-2 is able to reduce the cytokine storm in addition to replenish the patient's own antibodies in the acutely infected phase of the disease.

A plasmapheresis donation of 400ml will be performed in subjects who recovered from COVID-19 and who are otherwise eligible for plasma donation. The sample will be tested for anti-SARS CoV-2 neutralizing antibody titers and those that reach the level of 1:320 will be processed for transfusion at the Hungarian National Transfusion Service.

Recipients will be COVID-19 patients requiring hospitalization regardless of the severity of the disease or other co-morbidities. A blood-type matched transfusion of 200 ml convalescent plasma will be infused in a single sitting through an iv. infusion of 4 hours.

Recipients will be followed up at days 1, 3,7,12, 17, 28 for clinical symptoms, antibody levels and cytokine response.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria for blood donors :

• age : >18 and <60 years
• body weight : >50 kg
• confirmed previous SARS CoV-2 infection
• 2 negative SARS CoV-2 test result
• written informed consent
• neutralizing antibody titer min. 1 : 120

Exclusion criteria for blood donors :

• age : <18 or >60 years
• female subjects who are pregnant
• HIV1,2 hepatitis B,C or syphilis infection

to minimize the transfusional side effects our aim is to include mostly male donors.

Inclusion criteria for patients/recipients :

• age : >18 years
• admitted to hospital due to SARS CoV-2 infection
• written informed consent

Exclusion criteria for patients/recipients :

• age : <18 years
• female subjects who are pregnant or breastfeeding
• patients with prior allergic reaction to transfusion
• patients who received in the past 30 days immunoglobulin therapy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Hospitalized patients with SARS CoV-2 infection

Experimental group

Treatment:

Biological: anti-SARS-CoV-2 convalescent plasma