Roflumilast as add-on Therapy in Early Cases of ARDS
Condition: Respiratory Distress Syndrome, Adult
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      • Methodology in details:

        -  Informed consent will be obtained from included participants.

        -  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.

        -  Randomization:

      Randomization will be in 1:1 ratio using permuted blocks of different sizes. Random.org
      website will be used for random selection of a sequence of blocks. The latter will be used to
      generate a randomized list which will be generated and stored by a third party independent of
      the study team. For allocation concealment, the list will be used to make sequentially
      numbered sealed opaque envelopes, each containing the sequential randomization number and
      allocation of subsequent cases. Envelopes will be handed to the study team member responsible
      for medication preparation. Each envelope will be opened only after:

        1. Screening for eligibility

        2. Obtaining consent

        3. Recording baseline characters The treatment allocation dictated in the envelope will be
           documented in the case record form and will be subject to audit to assure correct
           randomization according to the original list.

             -  Intervention:

      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.
    

Intervention name(s): Roflumilast; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Roflumilast 500 mcg daily for up to 28 days
Total follow up time will be 28 days.
Proinflammatory parameters will be assessed at baseline, day 7, day 14, and at the end of treatment.
Roflumilast will be combined with standard of care for ARDS.
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.
During hospitalization, adverse drug reaction will be monitored clinically and by laboratory tests.
In case of an adverse effect or a need to discontinue the treatment, roflumilast should be suspended.; Placebo (identical to roflumilast dosage form) will be used for placebo-comparator group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment