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Treatment With Pirfenidone for COVID-19 Related Severe ARDS

NCT04653831 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2023-05-23

No results posted yet for this study

Summary

A randomized, open label, two arm, pilot trial of Pirfenidone 2,403 mg administered per nasogastric tube or orally as 801mg TID for 4 weeks in addition to Standard of Care (SoC), compared to SoC alone, in a population of COVID-19 induced severe ARDS. Patients will be randomized according to 1:1 ratio to one of the trial arms: Pirfenidone (intervention arm) or SoC (control arm).

Conditions

  • Covid19
  • ARDS

Interventions

DRUG

Pirfenidone

Treatment with Pirfenidone as mentioned in the experimental arm description.

OTHER

Standard of care

Treatment with SoC as mentioned in the control arm description.

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Soroka University Medical Center

    lead OTHER

Principal Investigators

  • Ori Galante, MD · ICU physician in SMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-11-08
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Israel

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 NCT04653831 on ClinicalTrials.gov