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

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..

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Key information

Conditions

Convalescent Plasma COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Egypt Immunoglobulins Infections Lung Diseases Nidovirales Infections Plasma Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ministry of Health

Cairo, Giza Governorate, 00202, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Not fitting inclusion criteria

Treatment and study plan

Convalescent Plasma

Biological

Two units of ABO compatible COVID-19 convalescent plasma will be administered.

Primary outcomes

COVID-19 Cure rate

Time frame: 30 days

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

Sponsors and collaborators

Lead sponsor

Ministry of Health and Population, Egypt

Other Gov

Registry information

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Mar 25, 2021
Registry last updated: Mar 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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