drugset / Trial / NCT04355897

CoVID-19 Plasma in Treatment of COVID-19 Patients

NCT04355897

Phase 0 Completed 22 enrolled The Christ Hospital
NaSingle-groupOpen-labelTreatment

Summary

The investigatores propose to evaluate intravenous administration of convalescent plasma (CP) obtained from COVID19 survivors in patients requiring hospitalization for symptomatic "high risk" COVID19 disease as reflected by the presence of elevated hsTPN. Supportive data exist for use of convalescent plasma in the treatment of COVID19 and other overwhelming viral illness. Investigators hypothesize that treatment with COVID19 CP will demonstrate salutary effects on COVID19 disease severity/duration, with the primary objective to reduce mortality and a key secondary objective to reduce the requirement for and/or duration of mechanical ventilation. Finally, as the hospital mortality for patients requiring mechanical ventilation is very high (50 to 80%), these patients will be eligible for COVID19 CP treatment as well, even in the absence of elevated hsTPN. Although considerable overlap of these populations has been observed (elevated hsTPN and requirement for mechanical ventilation) there is not 100% redundancy and it is hopeful that COVID19 CP may provide benefit to these critically ill patients.

Timeline

Start
2020-04-28
Primary completion
2020-07-06
Completion
2020-08-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Convalescent Plasma Protein / enzyme biologic 500 ml Intravenous

Indications