Roflumilast as add-on Therapy in Early Cases of ARDS

Sponsor
Cairo University
Study ID
NCT04744090
Phase
PHASE2
Status
Completed

Conditions

  • Respiratory Distress Syndrome, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

* 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.

Key Dates

Start date
Mar 21, 2021
Status verified
Mar 2022
Primary completion
Dec 30, 2021
Completion
Jan 1, 2022

Study Design

Enrollment
76 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Roflumilast add-on
    Eligible patients will take 500 Mcg of roflumilast once daily (up to 28 days) plus standard of care.
  • Placebo Comparator: Placebo control
    Eligible patients will take placebo plus standard of care.

Primary Outcome Measure

Change in clinical picture (two-point reduction in patient's admission status) [ Time Frame: Follow up for up to 28 days. ]

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