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Efficacy of Nafamostat in Covid-19 Patients (RACONA Study)

NCT04352400 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2023-11-01

No results posted yet for this study

Summary

RACONA is a prospective trial that will test the hypothesis that nafamostat can lower lung function deterioration and need for intensive care admission in COVID-19 patients.

Design: Adult hospitalized COVID-19 patients will be randomized in a prospective double-blind randomized placebo-controlled study to test the clinical efficacy of nafamostat mesylate (administered intravenously) on top of best standard of care.

Primary outcome measures: the time-to-clinical improvement, defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven category ordinal scale or live discharge from the hospital, whichever comes first.

Conditions

  • COVID19

Interventions

DRUG

Nafamostat Mesilate

administered intravenously as a continuous infusion

DRUG

Placebo

administered intravenously as a continuous infusion

Sponsors & Collaborators

  • Yokohama City University

    collaborator OTHER

  • University of Zurich

    collaborator OTHER

  • University Hospital Padova

    lead OTHER

Principal Investigators

  • Gian Paolo Rossi, Prof. · University of Padova, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-04
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

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 NCT04352400 on ClinicalTrials.gov