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

• 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).

Study Overview

• Status: Unknown
• Conditions: COVID19
• Intervention / Treatment: Biological: Convalescent Plasma; Drug: Standard of Care

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 Type: Interventional
• Enrollment (Anticipated): 67
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Nermeen ElDesouky, MD PhD; Phone Number: 01006029006; Email: nermeen.eldesoukey@kasralainy.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Cairo University Hospital
    • Contact: Mostafa ElShazly, MD PhD
    • Sub-Investigator: Omar Fahmy, MD PhD
    • Sub-Investigator: Akram AbdelBarry, MD PhD
    • Sub-Investigator: Yasser Nassar, MD PhD
    • Sub-Investigator: Heba Sharaf, Md PhD
    • Sub-Investigator: Azza AboulEnin, MD PhD
    • Sub-Investigator: Ashraf ElFiky, MD PhD
    • Sub-Investigator: Ahmed Mokhtar, MD PhD
    • Sub-Investigator: Taghreed Gaafar, MD PhD
    • Sub-Investigator: Nevine S El Shakhs, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of hospitalization/Recovery status	Decrease of hospital days of safety until discharge	2-3 weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Anticipated): May 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: June 16, 2020
• First Submitted That Met QC Criteria: June 17, 2020
• First Posted (Actual): June 19, 2020

Study Record Updates

• Last Update Posted (Actual): September 29, 2020
• Last Update Submitted That Met QC Criteria: September 25, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: DONOR; RECIPIENT; CONVALESCENT PLASMA
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: N39-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No