CompletedPhase 2

Roflumilast as add-on Therapy in Early Cases of ARDS

Egypt76 participantsStarted 2021-03-21

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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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

What they're measuring

Change in clinical picture (two-point reduction in patient's admission status)

Timeframe: Follow up for up to 28 days.

Trial details

NCT IDNCT04744090

SponsorCairo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-30

View on ClinicalTrials.gov More Respiratory Distress Syndrome, Adult trials