Trial · NCT03202394
Evaluation of Safety & Efficacy of BIO-11006 Inhalation Solution in Patients With ARDS
NCT03202394, Phase 2, Completed, BioMarck Pharmaceuticals, Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of Safety & Efficacy of BIO-11006 Inhalation Solution in Patients With ARDS. Trials, record NCT03202394. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03202394
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Safety & Efficacy of BIO-11006 Inhalation Solution in Patients With ARDS
- NCT number
- NCT03202394
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 38 participants, actual
- Lead sponsor
- BioMarck Pharmaceuticals, Ltd.
- Conditions
- Respiratory Distress Syndrome, Adult
- Interventions
- BIO-11006, Placebo
- First posted
- 2017-06-28
- Last updated
- 2020-06-25
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of treatment-emergent adverse events | 28 days | Assessment of frequency, type, severity, and duration of treatment-emergent Adverse Events (AE) daily during 28 day treatment period, including clinically significant laboratory abnormalities |
| Secondary | Incidence of mortality | End of treatment period (28 days) and end of follow up period (180 days) | Mortality will be assessed daily during treatment for 28 days and at day 180 after enrollment. |
| Secondary | Number of Intensive Care Unit (ICU)-free days | 28 days | Number of days not in the ICU assessed daily during the 28 day treatment period. |
| Secondary | Number of ventilator-free days | 28 days | Number of days off the ventilator assessed daily during 28 day treatment |
| Secondary | Change in oxygen saturation / fraction of inspired oxygen (S/F) ratio | 28 days | Change in theS/F ratio assessed daily during the 28 day treatment period |
| Secondary | Change in pro-inflammatory biomarkers from baseline to end of treatment | pretreatment and end of treatment period (28 days) | ARDS associated biomarkers will be measured in plasma |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03202394
GET https://conductscience.org/api/trials/v1/NCT03202394/registered