Clinical Efficacy of Early Administration of Convalescent Plasma Among COVID-19 Cases in Egypt
1 other identifier
interventional
102
1 country
1
Brief 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..
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2020
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 21, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 12, 2020
CompletedFirst Submitted
Initial submission to the registry
February 12, 2021
CompletedFirst Posted
Study publicly available on registry
March 25, 2021
CompletedMarch 25, 2021
March 1, 2021
3 months
February 12, 2021
March 24, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Convalescent Plasma
EXPERIMENTALPatients receiving Two units of ABO compatible COVID-19 convalescent plasma will be administered.P
Interventions
Two units of ABO compatible COVID-19 convalescent plasma will be administered.
Eligibility Criteria
You may qualify if:
- Laboratory confirmed COVID-19. Severe or immediately life-threatening COVID-19,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ministry of Health
Cairo, Giza Governorate, 00202, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2021
First Posted
March 25, 2021
Study Start
April 23, 2020
Primary Completion
July 21, 2020
Study Completion
October 12, 2020
Last Updated
March 25, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share