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Convalescent Plasma Trial in COVID -19 Patients

NCT04356534 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-10-26

No results posted yet for this study

Summary

Plasma therapy using convalescent plasma has been shown to be effective in severe acute respiratory syndrome, Ebola virus infection and in H1N1 influenza. More recently there has been a report of the use of convalescent plasma in the treatment of 5 ventilated COVID-19 patients with the suggestion of expedited recovery as the patients improved 1 week after the transfusion. However, this was not a clinical trial and the patients were on other antiviral medication.; therefore, there is a need to undertake such a trial to see if deploying plasma with SARS-CoV-2 neutralizing antibody has utility in managing patients infected with COVID-19 in respiratory distress.

The objective of this pilot study is to compare plasma therapy using convalescent plasma with antibody against SARS-CoV-2 to usual supportive therapy in COVID-19 patients with pneumonia and hypoxia, and to determine if the clinical course is improved. The difference between groups will allow an effect size to be determined for a definitive clinical trial.

Conditions

Interventions

OTHER

plasma therapy using convalescent plasma with antibody against SARS-CoV-2

convalescent patient plasma plus routine local standard of care

OTHER

Routine care for COVID-19 patients

local standard of care which include antivirals and supportive care

Sponsors & Collaborators

  • Salmaniya Medical Complex

    collaborator OTHER_GOV

  • Bahrain Defence Force Hospital

    collaborator OTHER

  • Mohammed Bin Khalifa Bin Sulman Al Khalifa Cardiac Centre, Awali

    collaborator UNKNOWN

  • Royal College of Surgeons in Ireland - Medical University of Bahrain

    lead OTHER

Principal Investigators

  • Manaf Al Qahtani, Dr. · Royal College of Surgeons in Ireland - Bahrain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-19
Primary Completion
2020-06-15
Completion
2020-07-09

Countries

  • Bahrain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04356534 on ClinicalTrials.gov