CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
plasma therapy using convalescent plasma with antibody against SARS-CoV-2 +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04356534
NCT04356534N/ACompleted

Use of Convalescent Plasma Therapy for COVID-19 Patients With Hypoxia: a Prospective Randomized Trial

Royal College of Surgeons in Ireland - Medical University of Bahrain·interventional·Posted Apr 22, 2020·Updated Oct 26, 2021

In Brief

A clinical study evaluating plasma therapy using convalescent plasma with antibody against SARS-CoV-2 and Routine care for COVID-19 patients for SARS-CoV 2 and COVID-19. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSARS-CoV 2, COVID-19
CountriesBahrain

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedApr 22, 2020
Enrollment StartApr 19, 2020
Primary CompletionJun 15, 2020
Study CompletionJul 9, 2020
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 6.2 years ago

Interventions

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

convalescent patient plasma plus routine local standard of care

Routine care for COVID-19 patientsother

local standard of care which include antivirals and supportive care