NCT04442958

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 23, 2020

Completed
Last Updated

July 1, 2020

Status Verified

June 1, 2020

Enrollment Period

1 month

First QC Date

June 17, 2020

Last Update Submit

June 30, 2020

Conditions

Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (6)

  • Plasma ferritin level

    Acute phase reactant

    7. day

  • Lymphocyte count

    Infection markers

    7. day

  • D-Dimer level

    Hypercoagulability

    7. day

  • C-Reactive protein level

    Infection markers

    7. day

  • Plasma procalcitonin level

    Infection markers

    7. day

  • Plasma fibrinogen level

    Coagulopathy

    7. day

Secondary Outcomes (3)

  • Fractional Inspired Oxygen Level

    7. day

  • Partial Oxygen Saturation level

    7. day

  • Arterial Oxygen level

    7. day

Study Arms (2)

Convalescent Plasma Therapy Group

EXPERIMENTAL

One dose of 200 mL of convalescent ımmune plasma derived from recently recovered donors with the neutralizing antibody titers above 1:640 was transfused to the patients as an addition to standart critical care treatment.

Other: Convalescent Immune Plasma

Non-Plasma Therapy Group

NO INTERVENTION

Standart critical care treatment group

Interventions

Convalescent Immune PlasmaOTHER

One dose of 200 mL of convalescent ımmune plasma derived from recently recovered donors with the neutralizing antibody titers above 1:640 was transfused to the patients as an addition to standart critical care treatment.

Convalescent Plasma Therapy Group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Bagcılar Training and Research Hospital

Istanbul, 34375, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Salih SS Sevdi, Md

    Istanbul Bagcılar Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2020

First Posted

June 23, 2020

Study Start

May 15, 2020

Primary Completion

June 15, 2020

Study Completion

June 17, 2020

Last Updated

July 1, 2020

Record last verified: 2020-06

Locations

TU(1)