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

NCT04438694 | Unknown Phase 1 DMC

• 1 other identifier: N39-2020
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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).

Conditions

COVID19

Keywords

DONOR; RECIPIENT; CONVALESCENT PLASMA

Outcome Measures

Primary Outcomes (1)

• Duration of hospitalization/Recovery status

  Decrease of hospital days of safety until discharge

  2-3 weeks

Study Arms (2)

STANDARD OF COARE

ACTIVE COMPARATOR

Receiving SOC

Drug: Standard of Care

STANDARD CP DOSE Adm (Two infusions)

EXPERIMENTAL

Two infusions 48 hours apart

Biological: Convalescent Plasma; Drug: Standard of Care

Interventions

Convalescent Plasma BIOLOGICAL

Convalescent Plasma

STANDARD CP DOSE Adm (Two infusions)

Standard of Care DRUG

Standard of Care drugs administered as per Cairo University ICU protocol

STANDARD CP DOSE Adm (Two infusions); STANDARD OF COARE

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University Hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Nermeen ElDesouky, MD PhD

CONTACT

01006029006; nermeen.eldesoukey@kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR OF CLINICAL PATHOLOGY

Model Details: 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

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 19, 2020
• Study Start: June 1, 2020
• Primary Completion: May 31, 2021
• Study Completion: December 31, 2021
• Last Updated: September 29, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)