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Convalescent Plasma Therapy on Critically-ill Novel Coronavirus (COVID-19) Patients

Primary Purpose

IMMUNOTHERAPY

Status
Completed
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Convalescent plasma
Hydroxychloroquin with Azithromycin
Sponsored by
Alkarkh Health Directorate-Baghdad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IMMUNOTHERAPY

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 49 critically-ill COVID-19 patients are included.
  • All of the patients were with pneumonia and residing in RCU
  • Age ≥ 18 y
  • With dyspnea and oxygen saturation less than 90% in resting state.
  • At their first 3 days in RCU either receiving O2 therapy, c-pap, or on ventilators.
  • All of the patients were residing in infectious diseases wards before being transferred to RCU.

Exclusion Criteria:

  • The exclusion criteria of the COVID-19 patients were:

    • Previous allergic history to plasma or its ingredients such as sodium citrate.
    • Cases with serious general conditions, such as severe organ dysfunction, that are not suitable for transfusion.
    • Very late stage of the acute respiratory distress (ARDS) where Convalescent plasma (CP) has proved to be of low therapeutic benefit

Sites / Locations

  • Akarkh Healt hdirectorate

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Convalescent plasma group

Control group

Arm Description

21 critically-ill COVID-19 patients were given convalescent plasma: 400 ml of convalescent plasma from COVID-19 recovered subjects. The plasma infusion lasts for one hour.

This group is 28 critically-ill COVID-19 patients who are at the same disease stage to those of experimental group that were treated with conventional therapy without taking convalescent plasma. The conventional therapy: 400 mg once PO Hydroxychloroquine/day with 250mg once PO Azithromycin.

Outcomes

Primary Outcome Measures

Death versus survival of treated patients
evaluate the role of convalescent plasma in saving life of treated patients by measuring the final outcome whether treated patients survived or died

Secondary Outcome Measures

The length of stay in hospitals
this outcome is about measuring the length of stay (in days) of treated patients with convalescent plasma versus tose who were treated with conventional therapies

Full Information

First Posted
June 12, 2020
Last Updated
June 20, 2020
Sponsor
Alkarkh Health Directorate-Baghdad
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1. Study Identification

Unique Protocol Identification Number
NCT04441424
Brief Title
Convalescent Plasma Therapy on Critically-ill Novel Coronavirus (COVID-19) Patients
Official Title
The Therapeutic Potential of Convalescent Plasma Therapy on Treating Critically-ill COVID-19 Patients Residing in Respiratory Care Units in Hospitals in Baghdad, Iraq
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
April 3, 2020 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alkarkh Health Directorate-Baghdad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Out of 49 early-stage critically-ill COVID-19 patients, 21 patients are the experimental group who take convalescent plasma compared to 28 patients receive only conventional therapy without taking Convalescent plasma. Recovery or death, length of stay in hospital, and improvement in the clinical course of the disease are monitored in relation to monitoring through severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) RNA detection via poly chain reaction (PCR), and SARS-CoV-2 immunoglobulin G (IgG) and immunoglobulin M (IgM) serological monitoring.
Detailed Description
Objectives: The current COVID-19 pandemic needs unconventional therapies to tackle the resulted high morbidity and mortality. Convalescent plasma is one of the therapeutic approaches that might be of benefit. Methods: Forty nine early-stage critically-ill COVID-19 patients residing in respiratory care units (RCU) of three hospitals in Baghdad, Iraq were included, 21 received convalescent plasma while 28 did not receive, namely control group. Recovery or death, length of stay in hospital, and improvement in the clinical course of the disease were monitored clinically along with laboratory monitoring through SARS-CoV-2 RNA detection via PCR, and SARS-CoV-2 IgG and IgM serological monitoring.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IMMUNOTHERAPY

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Convalescent plasma group
Arm Type
Experimental
Arm Description
21 critically-ill COVID-19 patients were given convalescent plasma: 400 ml of convalescent plasma from COVID-19 recovered subjects. The plasma infusion lasts for one hour.
Arm Title
Control group
Arm Type
Other
Arm Description
This group is 28 critically-ill COVID-19 patients who are at the same disease stage to those of experimental group that were treated with conventional therapy without taking convalescent plasma. The conventional therapy: 400 mg once PO Hydroxychloroquine/day with 250mg once PO Azithromycin.
Intervention Type
Biological
Intervention Name(s)
Convalescent plasma
Intervention Description
400 ml of convalescent plasma (plasma taken 2 weeks from the recovered COVID-19 patients) and was transfused over 1-2 hours to the recipients by blood donation set.
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquin with Azithromycin
Intervention Description
The control group of COVID-19 patients were given the conventional therapy approved in Iraq for COVID-19, namely Hydroxychloroquine 400mg PO twice per day for 5 days and Azithromycin once PO 500 mg per day for 5 days.
Primary Outcome Measure Information:
Title
Death versus survival of treated patients
Description
evaluate the role of convalescent plasma in saving life of treated patients by measuring the final outcome whether treated patients survived or died
Time Frame
Up to 8 weeks
Secondary Outcome Measure Information:
Title
The length of stay in hospitals
Description
this outcome is about measuring the length of stay (in days) of treated patients with convalescent plasma versus tose who were treated with conventional therapies
Time Frame
Up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 49 critically-ill COVID-19 patients are included. All of the patients were with pneumonia and residing in RCU Age ≥ 18 y With dyspnea and oxygen saturation less than 90% in resting state. At their first 3 days in RCU either receiving O2 therapy, c-pap, or on ventilators. All of the patients were residing in infectious diseases wards before being transferred to RCU. Exclusion Criteria: The exclusion criteria of the COVID-19 patients were: Previous allergic history to plasma or its ingredients such as sodium citrate. Cases with serious general conditions, such as severe organ dysfunction, that are not suitable for transfusion. Very late stage of the acute respiratory distress (ARDS) where Convalescent plasma (CP) has proved to be of low therapeutic benefit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed S Abdulamir, PhD
Organizational Affiliation
Alkarkh health directorate
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akarkh Healt hdirectorate
City
Baghdad
ZIP/Postal Code
14222
Country
Iraq

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34013969
Citation
Piechotta V, Iannizzi C, Chai KL, Valk SJ, Kimber C, Dorando E, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 20;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub4.
Results Reference
derived
PubMed Identifier
33044747
Citation
Chai KL, Valk SJ, Piechotta V, Kimber C, Monsef I, Doree C, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2020 Oct 12;10:CD013600. doi: 10.1002/14651858.CD013600.pub3.
Results Reference
derived

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Convalescent Plasma Therapy on Critically-ill Novel Coronavirus (COVID-19) Patients

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