Clinical Efficacy of Early Administration of Convalescent Plasma Among COVID-19 Cases in Egypt

Covid19 Clinical Trial

Official title:

Clinical Efficacy of Early Administration of Convalescent Plasma Among COVID-19 Cases in Egypt

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04816942
• Other study ID #: 10-2020/13
• Status: Completed
• Phase: Phase 3
• Start date: April 23, 2020
• Est. completion date: October 12, 2020

Study information

• Verified date: March 2021
• Source: Ministry of Health and Population, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

One investigational treatment being explored for COVID-19 is the use of convalescent plasma collected from individuals who have recovered from COVID-19 (Refs. 1-4). Convalescent plasma that contains antibodies to severe acute respiratory syndrome coronavirus 2 or SARSCoV-2 (the virus that causes COVID-19) is being studied for administration to patients with COVID-19. Use of convalescent plasma has been studied in outbreaks of other respiratory infections, including the 2003 SARS-CoV-1 epidemic, the 2009-2010 H1N1 influenza virus pandemic, and the 2012 MERS-CoV epidemic (Refs. 5-7).

Although promising, convalescent plasma has not yet been shown to be safe and effective as a treatment for COVID-19. Therefore, it is important to study the safety and efficacy of COVID19 convalescent plasma in clinical trials. This guidance provides recommendations to health care providers and investigators on the administration and study of investigational convalescent plasma collected from individuals who have recovered from COVID-19 (COVID-19 convalescent plasma) during the public health emergency. This guidance also provides recommendations to blood establishments on the collection of COVID-19 convalescent plasma..

Description:

laboratory-confirmed patients using qRT-PCR will be enrolled in the study. Eligibility criteria for recipients are ; laboratory-confirmed SARS-CoV-2, Severe or immediately life-threatening. Severe disease defined as one or more of the following; shortness of breath( dyspnoea), respiratory frequency≥ 30/min, blood oxygen saturation ≤93%, a partial pressure of arterial oxygen to fraction of inspired oxygen ratio <300, and lung infiltrates >50% within 24-48 hours. While a life-threatening disease is defined as one or more of the following; respiratory failure, need for mechanical ventilation, septic shock and multiple organ dysfunction or failure.

Intervention: All patients included in the study provided will be administered with two plasma units (each unit is 200cc).

Primary measure is the degree of clinical improvement among the COVID-19 patients who receive CPT within seven days as compared with the patients who receive after seven days. Case Fatality will be assessed among the enrolled cases

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: October 12, 2020
• Est. primary completion date: July 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Laboratory confirmed COVID-19. Severe or immediately life-threatening COVID-19,

Exclusion Criteria Not fitting inclusion criteria

Related Conditions & MeSH terms

• Convalescent Plasma
• Covid19
• Egypt
• Immunoglobulins
• Plasma

Intervention

Biological:
• Convalescent Plasma
Two units of ABO compatible COVID-19 convalescent plasma will be administered.

Locations

Country	Name	City	State
Egypt	Ministry of Health	Cairo	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Health and Population, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COVID-19 Cure rate	Primary measure was the degree of clinical improvement among the COVID-19 patients who received CPT within seven days as compared with the patients who received after seven days	30 days