sing of convalescent plasma in the treatment of COVID-19 patients

Phase 1

• Conditions: Covid-19 (Coronavirus Disease 2019) – acute infectious disease of the respiratory system caused by SARS-CoV-2 infection; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-005486-14-PL
• Lead Sponsor: Wroclaw Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-04
• Last Update Posted: 21 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 500

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 <94%,
c.O2 partial pressure (PaO2) = 80 mmHg,
d.MEWS severity score = 3 points.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 500

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified