Clinical trial NCT04345679: Anti COVID-19 Convalescent Plasma Therapy
Official title: Anti COVID-19 Convalescent Plasma Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: COVID 19
Keywords: COVID-19
convalescent plasma
serum therapy
Lead sponsor: Orthosera Kft.
Sponsor class: OTHER
Collaborators: name: Semmelweis University
name: University of Pecs
name: Hungarian National Blood Service
name: Humán Bioplazma Kft - Kedrion
First posted: 2020-04-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Changing of viral load of SARS-CoV2
timeFrame: Day 1,3, 7, 12
Secondary outcomes:
measure: Changes in immunglobulin G COVID-19 antibody titer
timeFrame: 12 days
measure: Changes at the cytokine pattern
timeFrame: 12 days
measure: Intensive Care Unit Admission
timeFrame: Day 7,12,28
measure: Length of hospital stay
timeFrame: Day 7, 12, 28
measure: Duration of mechanical ventilation
timeFrame: Day 7, 12, 28
measure: Clinical Status
timeFrame: Day 7, 12, 28
measure: Mortality
timeFrame: Day 7, 12, 28
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University's Department of Pulmonology
Study officials:
affiliation: Semmelweis University
name: Veronika Müller, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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