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Clinical Trials/NCT04442958
NCT04442958CompletedNot Applicable

Effectiveness of Convalescent Immune Plasma Therapy in Severe COVID-19 Patients With Acute Respiratory Distress Syndrome

Bagcilar Training and Research Hospital2 sites in 2 countries60 target enrollmentStarted: May 15, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
60
Locations
2
Primary Endpoint
Plasma fibrinogen level

Study Overview

Brief Summary

The aim of the study is to evaluate the safety, improvement of clinical symptoms and laboratory parameters of convalescent immune plasma treatment in severe Covid-19 patients with ARDS.

Detailed Description

The aim of the study is to evaluate the safety, improvement of clinical symptoms with hypoxemia, metabolic and laboratory parameters of patients with convalescent immune plasma treatment in severe Covid-19 patients followed up in critical care unit.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Clinical diagnosis of Covid-19

Exclusion Criteria

  • Age lower than 18 Lower plasma IgA levels PaO2/FiO2 higher than 300 mmHg SpO2 higher than 90

Outcomes

Primary Outcomes

Plasma fibrinogen level

Time Frame: 7. day

Coagulopathy

Plasma procalcitonin level

Time Frame: 7. day

Infection markers

Plasma ferritin level

Time Frame: 7. day

Acute phase reactant

D-Dimer level

Time Frame: 7. day

Hypercoagulability

C-Reactive protein level

Time Frame: 7. day

Infection markers

Lymphocyte count

Time Frame: 7. day

Infection markers

Secondary Outcomes

  • Fractional Inspired Oxygen Level(7. day)
  • Partial Oxygen Saturation level(7. day)
  • Arterial Oxygen level(7. day)

Investigators

Sponsor
Bagcilar Training and Research Hospital
Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (2)

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