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

NCT ID: NCT04438694

Last Updated: 2020-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2021-12-31

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.

Conditions

COVID19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

STANDARD OF COARE

Receiving SOC

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: DRUG

Standard of Care drugs administered as per Cairo University ICU protocol

STANDARD CP DOSE Adm (Two infusions)

Two infusions 48 hours apart

Group Type: EXPERIMENTAL

Convalescent Plasma

Intervention Type: BIOLOGICAL

Convalescent Plasma

Standard of Care

Intervention Type: DRUG

Standard of Care drugs administered as per Cairo University ICU protocol

Interventions

Convalescent Plasma

Convalescent Plasma

Intervention Type: BIOLOGICAL

Standard of Care

Standard of Care drugs administered as per Cairo University ICU protocol

Intervention Type: DRUG

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Nermeen El Desouky

PROFESSOR OF CLINICAL PATHOLOGY

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University Hospital

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Nermeen ElDesouky, MD PhD

Role: CONTACT

nermeen.eldesoukey@kasralainy.edu.eg

01006029006

Facility Contacts

Mostafa ElShazly, MD PhD

Role: primary

Other Identifiers

N39-2020

Identifier Type: -

Identifier Source: org_study_id