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Anti COVID-19 Convalescent Plasma Therapy

Anti COVID-19 Convalescent Plasma Therapy

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04345679
Enrollment
20
Registered
2020-04-14
Start date
2020-04-14
Completion date
2021-09-01
Last updated
2021-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID 19

Keywords

COVID-19, convalescent plasma, serum therapy

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.

Interventions

Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \ 200 mL over 4 hours

Sponsors

Semmelweis University
CollaboratorOTHER
University of Pecs
CollaboratorOTHER
Hungarian National Blood Service
CollaboratorUNKNOWN
Humán Bioplazma Kft - Kedrion
CollaboratorUNKNOWN
Orthosera Kft.
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Changing of viral load of SARS-CoV2Day 1,3, 7, 12Copies of COVID-19 per ml

Secondary

MeasureTime frameDescription
Changes at the cytokine pattern12 days
Intensive Care Unit AdmissionDay 7,12,28Proportion of patients with Intensive Care Unit Admission requirement
Length of hospital stayDay 7, 12, 28Days of Hospitalization
Changes in immunglobulin G COVID-19 antibody titer12 daysImmunoglobulin G COVID-19 antibodies Immunglobulin G antibody titer
Clinical StatusDay 7, 12, 28Clinical status assessed according to the World Health Organization guideline
MortalityDay 7, 12, 28Proportion of death patients at days
Duration of mechanical ventilationDay 7, 12, 28Days with mechanical ventilation

Countries

Hungary

Contacts

Primary ContactEszter Fodor, medical doctor
eszter.fodor@orthosera.com+36306640494
Backup ContactZsombor Lacza, MD, PhD
zsombor.lacza@orthosera.com+36305249554

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026