Roflumilast as add-on Therapy in Early Cases of ARDS

NCT04744090 | Completed Phase 2 DMC

• 1 other identifier: MS-292-2020
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

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

  Defined as a two-point reduction in patient's admission status on a five-point ordinal scale, or live discharge from hospital whichever came first. • The five-point ordinal scale is as follow: 1. Discharge 2. Hospital admission, not requiring oxygen supplement 3. Hospital admission, requiring oxygen supplement 4. Hospital admission for high flow oxygen therapy or non-invasive mechanical ventilation 5. Hospital admission for mechanical ventilation or extracorporeal membrane oxygenation

  Follow up for up to 28 days.

Secondary Outcomes (4)

• Evaluation of change in systemic inflammatory parameters, including ferritin.

  Weekly assessment (baseline, day7, day14, at the end) for up to 28 days.

• Evaluation of change in systemic inflammatory parameters, including CRP.

  Weekly assessment (baseline, day7, day14, at the end) for up to 28 days.

• Evaluation of change in systemic inflammatory parameters, including LDH.

  Weekly assessment (baseline, day7, day14, at the end) for up to 28 days.

• Total hospital stay.

  Follow up for up to 28 days.

Study Arms (2)

Roflumilast add-on

EXPERIMENTAL

Eligible patients will take 500 Mcg of roflumilast once daily (up to 28 days) plus standard of care.

Drug: Roflumilast

Placebo control

PLACEBO COMPARATOR

Eligible patients will take placebo plus standard of care.

Drug: Placebo

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.

Roflumilast add-on

Placebo DRUG

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

Placebo control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Misr International Hospital

Giza, Doki, Egypt

Location

Cairo University Hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Roflumilast

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Eman A Abdel Rasheed, Professor

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Emeritus

Study Record Dates

• First Submitted: January 16, 2021
• First Posted: February 8, 2021
• Study Start: March 21, 2021
• Primary Completion: December 30, 2021
• Study Completion: January 1, 2022
• Last Updated: April 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)