CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 14 enrolled
Drug / intervention
Anti-SARS-CoV-2 Human Convalescent Plasmabiological
Likely dose
Anti-SARS-CoV-2 Human Convalescent Plasma 2 unitfrom 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/NCT04377672
NCT04377672Phase 1Completed

Safety and Pharmacokinetics of Human Convalescent Plasma in High Risk Children Exposed or Infected With SARS-CoV-2

Johns Hopkins University·interventional·Posted May 6, 2020·Updated Mar 27, 2024

In Brief

A Phase 1 clinical trial evaluating Anti-SARS-CoV-2 Human Convalescent Plasma for SARS-CoV-2 Infection. Completed, enrolled 14 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the safety of administration of plasma containing antibodies to the SARS-CoV-2 virus (i.e., convalescent plasma) and if it is able to prevent disease or lessen the severity of disease in individuals who are at high risk of developing COVID-19 due to a recent exposure. This study will also measure the level of anti-SARS-CoV-2 antibodies in patient's blood after the administration of the convalescent plasma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedMay 6, 2020
Enrollment StartMay 28, 2020
Primary CompletionSep 1, 2021
Study CompletionDec 13, 2021
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 6.2 years ago

Interventions

Anti-SARS-CoV-2 Human Convalescent Plasmabiological

1-2 unit (200-250 mL per unit) of plasma with anti-SARS-CoV-19 titers of ≥1:320. The total volume (mL) infused will be based on weight (5 mL/kg) with a maximum volume of 500 mL.