Roflumilast as add-on Therapy in Early Cases of ARDS

NCT04744090 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2022-04-04

No results posted yet for this study

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.

Conditions

Respiratory Distress Syndrome, Adult

Interventions

DRUG

Roflumilast

1. Roflumilast 500 mcg daily for up to 28 days 2. Total follow up time will be 28 days. 3. Proinflammatory parameters will be assessed at baseline, day 7, day 14, and at the end of treatment. 4. Roflumilast will be combined with standard of care for ARDS. 5. During hospitalization, clinical and laboratory data will be recorded daily in the medical history of the patient and in data collection table of the study. 6. During hospitalization, adverse drug reaction will be monitored clinically and by laboratory tests. 7. In case of an adverse effect or a need to discontinue the treatment, roflumilast should be suspended.

DRUG

Placebo

Placebo (identical to roflumilast dosage form) will be used for placebo-comparator group.

Sponsors & Collaborators

Cairo University
lead OTHER

Principal Investigators

Eman A Abdel Rasheed, Professor · Cairo University

Study Design

Allocation: RANDOMIZED
Purpose: TREATMENT
Masking: SINGLE
Model: PARALLEL

Eligibility

Min Age: 18 Years
Max Age: 65 Years
Sex: ALL
Healthy Volunteers: No

Timeline & Regulatory

Start: 2021-03-21
Primary Completion: 2021-12-30
Completion: 2022-01-01

Countries

Egypt

Study Locations

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Entities

Drugs