Roflumilast in ARDS

• Status: Recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

Summary

• Mild cases of ARDS will be included in a two-arm protocol, to receive 500 mcg of roflumilast daily up to 28 days (FDA approved dose for COPD) plus standard of care versus standard of care alone.

• Approximately 76 hospitalized patients with ARDS will be enrolled in this study.

• Eligible patients will be randomized at ratio of (1:1) to receive either roflumilast plus standard of care or standard of care alone.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cairo University

Criteria

Inclusion Criteria:

• Ability to sign informed consent

• Patients >18 years old male or female

• Mild cases of ARDS according to the Berlin criteria (PaO/FiO 200 to 300 mmHg)

Exclusion Criteria:

• Pregnancy and breast feeding

• History of hypersensitivity to roflumilast

• Patients with mechanical respiratory assistance (severe ARDS)

• Patients under treatment with roflumilast for COPD

• Patients with psychiatric diseases

• Hepatic cirrhosis (Child-Pugh score B or C)

• Refused to sign informed consent