Respiratory Distress Syndrome, AdultPhase 2NCT04744090
Roflumilast as add-on Therapy in Early Cases of ARDS
A Phase 2 study testing Roflumilast in people with Respiratory Distress Syndrome, Adult, run by Cairo University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Respiratory Distress Syndrome, Adult
- What is being tested?
- Roflumilast
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 2 sitesEgypt
- Study dates
- 21 Mar 2021to 1 Jan 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Cairo University Hospitals
Cairo
Misr International Hospital
Giza, Doki
About this study
Official title: The Potential Anti-inflammatory Effect of Roflumilast as Add-on Therapy in The Management of Hospitalized Patients With Mild Acute Respiratory Distress Syndrome
- 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.
Read the 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:
- Screening for eligibility
- Obtaining consent
- 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
- 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.
- Conditions
- Respiratory Distress Syndrome, Adult
- Being tested
- Roflumilast, Placebo
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RoflumilastDrug
- 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.
PlaceboDrug
Placebo (identical to roflumilast dosage form) will be used for placebo-comparator group.
| Study group | Role | What they receive |
|---|---|---|
| Roflumilast add-on | Experimental | Eligible patients will take 500 Mcg of roflumilast once daily (up to 28 days) plus standard of care. Receives: Drug: Roflumilast |
| Placebo control | Placebo comparator | Eligible patients will take placebo plus standard of care. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Discharge
- Hospital admission, not requiring oxygen supplement
- Hospital admission, requiring oxygen supplement
- Hospital admission for high flow oxygen therapy or non-invasive mechanical ventilation
- Hospital admission for mechanical ventilation or extracorporeal membrane oxygenation
Measured: Follow up for up to 28 days.
Secondary outcomes (4)
Evaluation of change in systemic inflammatory parameters, including ferritin.
Measured: Weekly assessment (baseline, day7, day14, at the end) for up to 28 days.
Evaluation of change in systemic inflammatory parameters, including CRP.
Measured: Weekly assessment (baseline, day7, day14, at the end) for up to 28 days.
Evaluation of change in systemic inflammatory parameters, including LDH.
Measured: Weekly assessment (baseline, day7, day14, at the end) for up to 28 days.
Total hospital stay.
Measured: Follow up for up to 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start21 Mar 2021
- Primary completion30 Dec 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, AdultStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Abdel Moniem Abdel Rasheed, Cairo University
- Investigators
- Eman A Abdel Rasheed, Professor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04744090
- Sponsor's protocol ID
- MS-292-2020
- Status last verified
- Mar 2022
- First submitted
- 16 Jan 2021
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Anti-inflammatory Effect of Roflumilast as Add-on Therapy in The Management of Hospitalized Patients With Mild Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT04744090
- Acronym / sponsor ID
- MS-292-2020
- Conditions
- Respiratory Distress Syndrome, Adult
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 21 Mar 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 8 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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:
- Screening for eligibility
- Obtaining consent
- 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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Roflumilast add-on | Experimental | Drug: RoflumilastEligible patients will take 500 Mcg of roflumilast once daily (up to 28 days) plus standard of care. |
| Placebo control | Placebo comparator | Drug: PlaceboEligible patients will take placebo plus standard of care. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roflumilast1. 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 | Roflumilast add-on |
| PlaceboPlacebo (identical to roflumilast dosage form) will be used for placebo-comparator group. | Drug | Placebo control |
Primary outcome
Change in clinical picture (two-point reduction in patient's admission status)
Time frame: Follow up for up to 28 days.
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
4 secondary outcomes
Evaluation of change in systemic inflammatory parameters, including ferritin.
Time frame: Weekly assessment (baseline, day7, day14, at the end) for up to 28 days.
Evaluation of change in systemic inflammatory parameters, including CRP.
Time frame: Weekly assessment (baseline, day7, day14, at the end) for up to 28 days.
Evaluation of change in systemic inflammatory parameters, including LDH.
Time frame: Weekly assessment (baseline, day7, day14, at the end) for up to 28 days.
Total hospital stay.
Time frame: Follow up for up to 28 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eman A Abdel Rasheed, Professor principal investigator
Cairo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Roflumilast in people with Respiratory Distress Syndrome, Adult, run by Cairo University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in clinical picture (two-point reduction in patient's admission status) (time frame: Follow up for up to 28 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.