Therapeutic effects of plasma of recovered people from COVID-19 on hospitalized patients with this disease

Phase 3

Recruiting

• Conditions: COVID-19.; U07.1; COVID-19, virus identified

• Registration Number: IRCT20151228025732N53
• Lead Sponsor: Semnan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 18 May 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

(As a plasma donor): Complete resolution of COVID-19 disease symptoms at least 14 days prior to donation.
(As a plasma donor): Donors do not have a history of blood or blood product transfusion
(As a plasma donor): COVID-19 neutralizing antibody titers be greater than 1:320 (If possibly checked)
(As a plasma donor): The donor's age be between 25 and 55 years old
(As a plasma donor): Negative results for COVID-19 by PCR
(As a plasma donor): Be in suitable general health condition for plasmapheresis
(As a plasma recipient): Patients admitted to the ICU who is receipt of mechanical invasive or non-invasive ventilation, partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300mmHg (93%). Current receipt of intravenous vasoactive medications to maintain mean arterial pressure >65 mmHg
(As a plasma recipient): Respiratory frequency = 30/min
(As a plasma recipient): Laboratory-confirmed COVID-19 infection (by real time PCR).

Exclusion Criteria

(As a plasma recipient): Negative real-time PCR from respiratory secretions or blood within 48 h prior to CP transfusion
(As a plasma recipient): History of allergic reaction to blood or plasma products
(As a plasma recipient): Known IgA deficiency

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Checking the amount of ventilation. Timepoint: Before intervention, 30 minutes after each step of intervention and daily. Method of measurement: Artificial respirator or ventilator.;White blood cell count, CRP in patients with COVID-19. Timepoint: Every 24 hours (Before and after intervention). Method of measurement: Cell counter.;Percentage of T CD8 in peripheral blood. Timepoint: Before and after the intervention. Method of measurement: Evaluation of T CD8 percentage by Flow cytometry.;Percentage of T CD4 in peripheral blood. Timepoint: Before and after the intervention. Method of measurement: Evaluation of T CD4 percentage by Flow cytometry.;C-Reactive Protein (CRP) in patients with COVID-19. Timepoint: Every 24 hours (Before and after intervention). Method of measurement: Rapid test.