Roflumilast as add-on Therapy in Early Cases of ARDS

PHASE2CompletedINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

March 21, 2021

Primary Completion Date

December 30, 2021

Study Completion Date

January 1, 2022

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.

Trial Locations (2)

Unknown

Misr International Hospital, Giza

Cairo University Hospitals, Cairo

All Listed Sponsors
lead

Cairo University

OTHER

NCT04744090 - Roflumilast as add-on Therapy in Early Cases of ARDS | Biotech Hunter | Biotech Hunter