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

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04438694

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
COVID19	Biological: Convalescent Plasma Drug: Standard of Care	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

67 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Intervention 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+CPThis 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)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2020

Anticipated Primary Completion Date :

May 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: STANDARD OF COARE Receiving SOC	Drug: Standard of Care Standard of Care drugs administered as per Cairo University ICU protocol
Experimental: STANDARD CP DOSE Adm (Two infusions) Two infusions 48 hours apart	Biological: Convalescent Plasma Convalescent Plasma Drug: Standard of Care Standard of Care drugs administered as per Cairo University ICU protocol

Arm

Intervention/Treatment

Active Comparator: STANDARD OF COARE

Receiving SOC

Drug: Standard of Care

Standard of Care drugs administered as per Cairo University ICU protocol

Experimental: STANDARD CP DOSE Adm (Two infusions)

Two infusions 48 hours apart

Biological: Convalescent Plasma

Convalescent Plasma

Drug: Standard of Care

Standard of Care drugs administered as per Cairo University ICU protocol

Outcome Measures

Primary Outcome Measures

Duration of hospitalization/Recovery status [2-3 weeks]
Decrease of hospital days of safety until discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo University Hospital	Cairo		Egypt

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nermeen El Desouky, PROFESSOR OF CLINICAL PATHOLOGY, Cairo University

ClinicalTrials.gov Identifier:

NCT04438694

Other Study ID Numbers:

N39-2020

First Posted:

Jun 19, 2020

Last Update Posted:

Sep 29, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nermeen El Desouky, PROFESSOR OF CLINICAL PATHOLOGY, Cairo University

DONOR

RECIPIENT

CONVALESCENT PLASMA

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Sep 29, 2020