Covid-19 (Coronavirus Disease 2019) – acute infectious disease of the respiratory system caused by SARS-CoV-2 infection
Conditions
Interventions
Trade Name: OSOCZE OZDROWIENCÓW COVID-19
Pharmaceutical Form: Infusion
Sponsors
Wroclaw Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: FOR CLINICAL TRIAL PARTICIPANTS – THE DONORS: Plasma donors will be recruited from two populations of COVID-19 recoveries: hospitalized and quarantined: 1. Age: from 18 to 65 (inclusive) 2. Body weight = 50 kg 3. Body temperature: Normal body temperature 4. Heart rate: 50 to 100 beats per minute 5. Arterial pressure: blood pressure values =180 mmHg for systolic pressure; =100 mmHg for diastolic pressure 6. Positive assessment of health condition based on a medical examination 7. Laboratory tests (obligatory for blood donors, before the procedure of collecting blood or its components): hemoglobin concentration or morphology, including the number of platelets, the number of white blood cells should remain within the laboratory norms according to the RCKiK SOP procedures 8. Plasma donors will be recruited after meeting the mandatory criteria - according to the RCKiK procedure described in Appendix no. 13 to the protocol FOR CLINICAL TRIAL PARTICIPANTS – THE RECIPIENTS: Patients hospitalized with a diagnosis of severe COVID-19 who meet the following criteria will be eligible for plasma transfusion: 1. Patients =18 years of age, 2. Patients hospitalized with a diagnosis of severe COVID-19, 3. Patients with SARS-CoV-2 infection confirmed by RT-PCR, 4. Patients who meet at least one of the criteria: a. symptoms of respiratory failure with tachypnoea > 30 breaths / minute, b. blood O2 saturation =65 years) yes F.1.3.1 Number of subjects for this age range 500
Exclusion criteria
Exclusion criteria: FOR CLINICAL TRIAL PARTICIPANTS – THE DONORS: Volunteers with absolute contraindications or with temporary inability to donate blood will not be included in the clinical trial. FOR CLINICAL TRIAL PARTICIPANTS – THE RECIPIENTS 1. Patients with a history of hypersensitivity to plasma, including anaphylactic shock in previous transfusions, allergic reactions to citrate, primary IgA deficiency, 2. Patients with symptoms of severe multi-organ failure, 3. Patients with known allergic reactions to chemical compounds used or generated in the procedure of pathogens inactivation, 4. Patients with active thrombosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the efficacy of convalescent plasma (CP) in COVID-19 therapy in the Polish population. Assessment of the difference in serological response in convalescents who have been infected with SARS-CoV-2 asymptomatically and convalescents with clinical symptoms of COVID-19.;Secondary Objective: • Assessment of the impact of anti-SARS-CoV-2 antibodies (IgM, IgG, IgA) in convalescents on the effectiveness of CP therapy in COVID-19. • Assessment of CP safety in COVID-19 therapy in the Polish population; Exploratory objective: To determine new metabolomic markers in the blood of clinical trial participants - donors and recipients influencing and / or determining the clinical response to CP. ;Primary end point(s): 1. Death, for any reason (within 28 days). 2. The need for further hospitalization of the patient, assessed 28 days after administration of the investigational product - plasma. 3. For subjects with respiratory assistance: a. time to take one's own breath (extubation), measured over a period of 28 days b. time of stay in the intensive care unit (ICU), measured over a period of 28 days c. time of disconnection from CPAP / High Flow ventilation, measured over a period of 28 days d. time to elimination of SARS-CoV-2 (RT-PCR), measured over a period of 28 days e. time to serological response (SARS-CoV-2 antibodies) measured in 1, 3, 7 and 28 days. ;Timepoint(s) of evaluation of this end point: Day 1, Day 3, Day 7 and Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Major secondary endpoints: 1. number of patients with hypersensitivity reactions after CP therapy 2. number of patients with renal failure requiring renal replacement therapy 3. number of patients with heart failure. Other secondary and exploratory endpoints: 1. Changes in evaluation criteria in the following scales: a. SIRS, b. ECOG, c. MEWS d. Apache II assessed on the day of transfusion (day 0) and then on days 1, 3, 7 and 28 after plasma transfusion. 2. Changes in laboratory parameters made during the qualification visit and on days 1, 3, 7 and 28 after plasma transfusion: a. Blood count with smear b. Inflammation parameters: CRP, procalcitonin, ferritin, D-Dimer, LDH c. Capillary gasometry 3. Changes in the level of SARS-CoV-2 antibodies (IgM, IgG, IgA) determined during the qualification visit and after 3, 7 and 28 days after plasma transfusion. 4. The number of new metabolomic markers in the blood of clinical trial participants - donors and recipients during the qualifying visit. ;Timepoint(s) of evaluation of this end point: Day 1, Day 3, Day 7 and Day 28 | — |
Countries
Poland
Contacts
Public ContactClinical Trial Coordinator
Department and Clinic of Internal and Occupational Diseases, Hypertension and Clinical Oncology Medical University
Outcome results
None listed