Plasma Rich Antibodies From Recovered Patients From COVID19

NCT04348877 | Unknown DMC

• 1 other identifier: FMASU P15/ 2020
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective interventional study, single arm of purified convalescent plasma transfusion as an add on therapy for the standard of care treatment (national guideline) (Oseltamivir (75mg/12 hours for 5-10 days) and hydroxychroquine (400mg twice in first day, 200 twice for 4-9 days) ± Azithromycin 500mg daily for 5 days

Conditions

Coronavirus Disease (COVID-19)

Keywords

Egypt

Outcome Measures

Primary Outcomes (1)

• viral COVID-19 clearance

  Two successive negative COVID-19 PCR analysis tests 72 hours apart

  14 days

Secondary Outcomes (2)

• Decrease of radiological abnormalities

  14 days

• Clinical improvement

  14 days

Study Arms (1)

Antibody-Rich Plasma

OTHER

400 millimeter of Antibody-Rich Plasma from COVID-19 recovered patients will be transfused to patients with severe or immediately life-threatening COVID-19

Other: Antibody-Rich Plasma from COVID-19 recovered patients

Interventions

Antibody-Rich Plasma from COVID-19 recovered patients OTHER

400 millimeter of Antibody-Rich Plasma from COVID-19 recovered patients will be transfused to patients with severe or immediately life-threatening COVID-19

Antibody-Rich Plasma

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult 18 -80 years old
• Must have laboratory confirmed COVID-19
• 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 Life-threatening disease is defined as: respiratory failure, septic shock, and/or multiple organ dysfunction or failure
• Must provide informed consent by patient or his/her legal guardian or Professional Legal Representative

You may not qualify if:

• Patient with mild or moderate COVID-19
• Participation in any investigational clinical study, other than observational, within the past 30 days; or plans to participate in such a study at any time from the day of enrollment until 30 days post-treatment in the current study.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center

Cairo, Non-US, 11556, Egypt

Location

MeSH Terms

Conditions

COVID-19

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Faculty of Medicine

Model Details: Antibody-Rich Plasma from COVID-19 recovered patients

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: April 16, 2020
• Study Start: April 20, 2020
• Primary Completion: October 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 20, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)