Status:
COMPLETED
Roflumilast as add-on Therapy in Early Cases of ARDS
Lead Sponsor:
Cairo University
Conditions:
Respiratory Distress Syndrome, Adult
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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. * A...
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...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
March 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2022
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT04744090
Start Date
March 21 2021
End Date
January 1 2022
Last Update
April 4 2022
Active Locations (2)
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1
Misr International Hospital
Giza, Doki, Egypt
2
Cairo University Hospitals
Cairo, Egypt