Convalescent Plasma for Treatment of COVID-19: An Exploratory Dose Identifying Study

COVID-19 Clinical Trial

Official title: Convalescent Plasma for Treatment of COVID-19: An Exploratory Dose Identifying Study

Status Completed

Clinical Trial Summary

Convalescent plasma has been shown to be safe and effective for treatment of several diseases. Preliminary data indicates that it is safe and effective for treatment of COVID. However, data is limited to small studies and case series on severely ill patients.

In a preliminary safety study 10 patients with severe COVID-19, defined as requiring supplementary oxygen, having fever and a duration of illness less than 11 days were treated with 200 ml of CP. CP was given as a slow infusion without obvious adverse events. Eight patients had viremia. One patient rapidly cleared the virus and recovered following CP treatment. CP infusion did not appear to clear viremia in 7/8 patients. Five of these were eventually admitted to ICU. Thus CP did not appear to cause acute toxicity but did not seem to be effective at the dose used. Viremia seemed to be a marker of a high risk of disease progression The proposed study thus aims to treat a high risk population identified by having viremia irrespective of but hopefully before they develop pulmonary injury such that they require supplementary oxygen therapy. Moreover the dose of plasma will be increased incrementally with the aim of clearing viremia as our initial study indicates that continued viremia is driving COVID-19.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• COVID-19

• NCT number: NCT04384497
• Study type: Interventional
• Source: Karolinska University Hospital
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 7, 2020
• Completion date: December 1, 2020