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Assessment of the Effect of Convalescent Plasma Therapy in Patients With Life-threatening COVID19 Infection (CP IN COVID19)

Primary Purpose

COVID19

Status
Unknown status
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Convalescent Plasma
Standard of Care
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID19 focused on measuring DONOR, RECIPIENT, CONVALESCENT PLASMA

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Must have laboratory confirmed COVID-19 and admitted to Cairo University isolation hospital.
  • Admitted to acute care facility.
  • Must have severe or immediately life-threatening COVID-19:

Severe disease is defined as:

  • dyspnea,
  • respiratory frequency ≥ 30/min,
  • blood oxygen saturation ≤ 93%,
  • partial pressure of arterial oxygen to fraction of inspired oxygen ratio <300, and/or
  • lung infiltrates > 50% within 24 to 48 hours (CT finding)

Life-threatening disease is defined as:

  • respiratory failure,
  • septic shock, and/or
  • multiple organ dysfunction or failure

Exclusion Criteria:

  • Pregnancy
  • Autoimmune disorder
  • Participated in a CP trial in the past 6 months

Sites / Locations

  • Cairo University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

STANDARD OF COARE

STANDARD CP DOSE Adm (Two infusions)

Arm Description

Receiving SOC

Two infusions 48 hours apart

Outcomes

Primary Outcome Measures

Duration of hospitalization/Recovery status
Decrease of hospital days of safety until discharge

Secondary Outcome Measures

Full Information

First Posted
June 16, 2020
Last Updated
September 25, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04438694
Brief Title
Assessment of the Effect of Convalescent Plasma Therapy in Patients With Life-threatening COVID19 Infection
Acronym
CP IN COVID19
Official Title
Assessment of the Effect of Convalescent Plasma Therapy in Patients With Life-threatening COVID19 Infection
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
May 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

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
This clinical trial proposal is based on the FDA protocol for emergency use of convalescent plasma for treatment of COVID-19 cases, and on the WHO guidelines for use of convalescent plasma in other infectious diseases. This Clinical trial is to be applied in Cairo University quarantine hospital. The collection, testing and storage of convalescent plasma will be done inside CUH main blood bank. The concept of this clinical trial is built on the collection of convalescent plasma from individuals who had recovered from documented infection with SARS-CoV-2, to be used for patients with- or at high risk of progression to- severe/life-threatening clinical conditions due to SARS-CoV-2 infection. An informed consent is required to join this clinical trial; patients will be transfused with one or two units of ABO compatible convalescent plasma. Those patients will be followed up and the clinical and laboratory data will be compiled, including adverse events related to the administration of convalescent plasma (CP). Other data to be collected retrospectively will include patient demographics, acute care facility resource utilization (total length of stay, days in ICU, days intubated, and survival till discharge from an acute care facility).
Detailed Description
This study will be done inside Cairo university hospitals, it will involve a number of CP donors who were recovered from COVID-19 infection and were treated at Cairo University isolation hospital. The CP donation process will take place at CUH blood bank ,the number of the donors will be determined at the end of the study as it will vary according to the donation process . The study will also include sixty seven /life threatening COVID-19 patients admitted to Cairo University isolation hospital.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID19
Keywords
DONOR, RECIPIENT, CONVALESCENT PLASMA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
This study is a prospective, single-institution, single-arm, study using a historical control group for comparison. Open label, 2 arms: SOC and SOC+CP
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
STANDARD OF COARE
Arm Type
Active Comparator
Arm Description
Receiving SOC
Arm Title
STANDARD CP DOSE Adm (Two infusions)
Arm Type
Experimental
Arm Description
Two infusions 48 hours apart
Intervention Type
Biological
Intervention Name(s)
Convalescent Plasma
Intervention Description
Convalescent Plasma
Intervention Type
Drug
Intervention Name(s)
Standard of Care
Intervention Description
Standard of Care drugs administered as per Cairo University ICU protocol
Primary Outcome Measure Information:
Title
Duration of hospitalization/Recovery status
Description
Decrease of hospital days of safety until discharge
Time Frame
2-3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Must have laboratory confirmed COVID-19 and admitted to Cairo University isolation hospital. Admitted to acute care facility. Must have severe or immediately life-threatening COVID-19: Severe disease is defined as: dyspnea, respiratory frequency ≥ 30/min, blood oxygen saturation ≤ 93%, partial pressure of arterial oxygen to fraction of inspired oxygen ratio <300, and/or lung infiltrates > 50% within 24 to 48 hours (CT finding) Life-threatening disease is defined as: respiratory failure, septic shock, and/or multiple organ dysfunction or failure Exclusion Criteria: Pregnancy Autoimmune disorder Participated in a CP trial in the past 6 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nermeen ElDesouky, MD PhD
Phone
01006029006
Email
nermeen.eldesoukey@kasralainy.edu.eg
Facility Information:
Facility Name
Cairo University Hospital
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mostafa ElShazly, MD PhD
First Name & Middle Initial & Last Name & Degree
Omar Fahmy, MD PhD
First Name & Middle Initial & Last Name & Degree
Akram AbdelBarry, MD PhD
First Name & Middle Initial & Last Name & Degree
Yasser Nassar, MD PhD
First Name & Middle Initial & Last Name & Degree
Heba Sharaf, Md PhD
First Name & Middle Initial & Last Name & Degree
Azza AboulEnin, MD PhD
First Name & Middle Initial & Last Name & Degree
Ashraf ElFiky, MD PhD
First Name & Middle Initial & Last Name & Degree
Ahmed Mokhtar, MD PhD
First Name & Middle Initial & Last Name & Degree
Taghreed Gaafar, MD PhD
First Name & Middle Initial & Last Name & Degree
Nevine S El Shakhs, MD PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Assessment of the Effect of Convalescent Plasma Therapy in Patients With Life-threatening COVID19 Infection

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