Trial · NCT02622724

Efficacy and Safety of FP-1201-lyo (Interferon Beta-1a) in Patients Having Acute Respiratory Distress Syndrome (ARDS)

NCT02622724, Phase 3, Terminated, Faron Pharmaceuticals Ltd; results first posted 2020-03-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of FP-1201-lyo (Interferon Beta-1a) in Patients Having Acute Respiratory Distress Syndrome (ARDS). Trials, record NCT02622724. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02622724

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety of FP-1201-lyo (Interferon Beta-1a) in Patients Having Acute Respiratory Distress Syndrome (ARDS)
NCT number: NCT02622724
Status: Terminated
Phases: Phase 3
Enrollment: 301 participants, actual
Lead sponsor: Faron Pharmaceuticals Ltd
Conditions: Respiratory Distress Syndrome, Adult
Interventions: Interferon beta-1a, Placebo
First posted: 2015-12-04
Last updated: 2020-03-30
Other registries' IDs: eudract:2014-005260-15
Results first posted: 2020-03-30
Limitations and caveats: As the study was terminated early, only a limited amount of data was available at Day 180 and Day 360.

Source ClinicalTrials.gov

Registered outcomes35

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Composite Endpoint (VFDsurv; All-cause Mortality and Number of Days Free of Mechanical Ventilation) at Day 28	Day 28	VFDsurv is a composite measure of all-cause mortality and the number of days free of mechanical ventilation (VFDsurv) within 28 days among survivors. Ventilator-free days (VFDs) correspond to those days when unassisted breathing (UAB) was possible for a complete calendar day. UAB was defined as: spontaneously breathing with face mask, nasal prong oxygen or room air, T-piece breathing, tracheostomy mask breathing, CPAP less than or equal to 5 cmH2O without pressure support or intermittent mandatory ventilation assistance, use of CPAP or BIPAP solely for sleep apnoea management. A patient was reported as ventilator-free after 2 consecutive calendar days of unassisted breathing (a VFD value of 0 is assigned to patients who die without initiating UAB or who require more than 28 days of mechanical ventilation. All patients who die before Day28 are assigned a VFDsurv value of -1).
Secondary	Efficacy Endpoint: All-cause Mortality	At Day 28	Fatalities, mortality all-causes from randomisation up to Day 28
Secondary	Efficacy Endpoint: Mortality in ICU	Up to Day 28	All-cause mortality for subjects who died in Intensive Care Units up to Day 28.
Secondary	Efficacy Endpoint: Mortality in Hospital	Up to Day 28	This is the number of subjects who died in hospital (i.e. outside of Intensive Care Units) up to Day 28.
Secondary	Other Secondary Efficacy Endpoints: Days Free of Organ Failure	Day 28 or last day in intensive care unit [ICU] if patient has left the ICU earlier than Day 28	The total number of days free of organ failure by Sequential Organ Failure Assessment (SOFA) methodology. Overall, the median number of days free of organ failure was 0 days in both the treatment groups.
Secondary	Other Secondary Efficacy Endpoints: Days Free of Renal Support	Day 28	Days without renal support (any renal support was documented). Overall, the median number of days free of renal support was 28 days in the active group and 27 days in the placebo group.
Secondary	Other Secondary Efficacy Endpoints: Days Free of Vasoactive Support	Day 28	Days without vasoactive support. The vasoactive support included catecholamine and non-catecholamine vasopressors, inotropes and vasodilating agents. Overall, the median number of days free of vasoactive support was 20 days in the active group and 21 days in the placebo group.
Secondary	Other Secondary Efficacy Endpoint: Days Free of Mechanical Ventilation	Day 28	The total number of days free of mechanical ventilation has been derived from the Patient Status report recorded on each day during the 28-day period. Patients who died during this period have been assigned a value of zero. This variable differs from the calculated "Ventilation Free Days (VFD) endpoint, which contribute to the VDFsurv primary efficacy endpoint as it require additional conditions of unassisted breathing (UAB) to be met.
Secondary	Other Secondary Efficacy Endpoints: Number of ICU-free Days	Day 28	Number of Intensive Care Unit free days up to Day 28, i.e. the patient is no longer receiving care in ICU. Patients who die during this period have been assigned a value of zero for the number of ICU care free days.
Secondary	Other Secondary Efficacy Endpoints: Number of Days in Hospital	Day 28	Hospitalisation days (including the stay at Intensive Care Units). Patients who died during this period have been assigned a value of 28 for the number of days in ICU or in hospital.

1 to 10 of 35Source ClinicalTrials.gov

See all 35 registered outcomes

Outcomes36

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Composite Endpoint (VFDsurv; All-cause Mortality and Number of Days Free of Mechanical Ventilation) at Day 28	Day 28	Full Analysis Set (FAS), 296 subjects.	Days	MEDIAN
SECONDARY	Efficacy Endpoint: All-cause Mortality	At Day 28	Full Analysis Set (FAS) defined as all randomised subjects that received atleast one dose of study drug.	percentage of subjects	NUMBER
SECONDARY	Efficacy Endpoint: Mortality in ICU	Up to Day 28	Full Analysis Set	percentage of subjects	NUMBER
SECONDARY	Efficacy Endpoint: Mortality in Hospital	Up to Day 28	Full Analysis Set	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Other Secondary Efficacy Endpoints: Days Free of Organ Failure	Day 28 or last day in intensive care unit [ICU] if patient has left the ICU earlier than Day 28	Full Analysis Set	Days	MEDIAN
SECONDARY	Other Secondary Efficacy Endpoints: Days Free of Renal Support	Day 28	Full Analysis Set	Days	MEDIAN
SECONDARY	Other Secondary Efficacy Endpoints: Days Free of Vasoactive Support	Day 28	Full Analysis Set	Days	MEDIAN
SECONDARY	Other Secondary Efficacy Endpoint: Days Free of Mechanical Ventilation	Day 28	Full Analysis Set	Days	MEDIAN
SECONDARY	Other Secondary Efficacy Endpoints: Number of ICU-free Days	Day 28	Full Analysis Set	Days	MEDIAN
SECONDARY	Other Secondary Efficacy Endpoints: Number of Days in Hospital	Day 28	Full Analysis Set	Days	MEDIAN

1 to 10 of 36Source ClinicalTrials.gov

See all 36 outcomes

Results by group490

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Composite Endpoint (VFDsurv; All-cause Mortality and Number of Days Free of Mechanical Ventilation) at Day 28	FP-1201-lyo 10 μg	10	Full Range -1 to 26	Days
Composite Endpoint (VFDsurv; All-cause Mortality and Number of Days Free of Mechanical Ventilation) at Day 28	Placebo	8.5	Full Range -1 to 26	Days
Efficacy Endpoint: All-cause Mortality	FP-1201-lyo 10 μg	26.4	95% Confidence Interval 19 to 34	percentage of subjects
Efficacy Endpoint: All-cause Mortality	Placebo	23	95% Confidence Interval 17 to 31	percentage of subjects
Efficacy Endpoint: Mortality in ICU	FP-1201-lyo 10 μg	25.7	95% Confidence Interval 19 to 34	percentage of subjects
Efficacy Endpoint: Mortality in ICU	Placebo	23.0	95% Confidence Interval 17 to 31	percentage of subjects
Efficacy Endpoint: Mortality in Hospital	FP-1201-lyo 10 μg	1		Participants
Efficacy Endpoint: Mortality in Hospital	Placebo	0		Participants
Other Secondary Efficacy Endpoints: Days Free of Organ Failure	FP-1201-lyo 10 μg	0	Full Range 0 to 28	Days
Other Secondary Efficacy Endpoints: Days Free of Organ Failure	Placebo	0	Full Range 0 to 28	Days

1 to 10 of 490Source ClinicalTrials.gov

See all 490 results by group

Participant flow14

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	FP-1201-lyo 10 μg	144
Overall Study	STARTED	Placebo	152
Overall Study	Subjects Randomised	FP-1201-lyo 10 μg	146
Overall Study	Subjects Randomised	Placebo	155
Overall Study	Short-Term Follow-Up (Day 28)	FP-1201-lyo 10 μg	105
Overall Study	Short-Term Follow-Up (Day 28)	Placebo	115
Overall Study	Long-Term Follow-Up (Day 90)	FP-1201-lyo 10 μg	96
Overall Study	Long-Term Follow-Up (Day 90)	Placebo	101
Overall Study	Long-Term Follow-Up (Day 180)	FP-1201-lyo 10 μg	73
Overall Study	Long-Term Follow-Up (Day 180)	Placebo	74

1 to 10 of 14Source ClinicalTrials.gov

See all 14 participant flow

Adverse events916

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	PNEUMONIA	Infections and infestations	FP-1201-lyo 10 μg	8	144	8
other	PNEUMONIA	Infections and infestations	Placebo	4	152	4
other	SEPTIC SHOCK	Infections and infestations	FP-1201-lyo 10 μg	1	144	2
other	SEPTIC SHOCK	Infections and infestations	Placebo	3	152	4
other	SEPSIS	Infections and infestations	FP-1201-lyo 10 μg	8	144	8
other	SEPSIS	Infections and infestations	Placebo	3	152	3
other	BACTERAEMIA	Infections and infestations	FP-1201-lyo 10 μg	3	144	3
other	BACTERAEMIA	Infections and infestations	Placebo	5	152	5
other	DEVICE RELATED SEPSIS	Infections and infestations	FP-1201-lyo 10 μg	3	144	3
other	DEVICE RELATED SEPSIS	Infections and infestations	Placebo	1	152	1

1 to 10 of 916Source ClinicalTrials.gov

See all 916 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	FP-1201-lyo 10 μg	51	144
Total, all-cause mortality	Placebo	53	152
Total, other adverse events	FP-1201-lyo 10 μg	109	144
Total, other adverse events	Placebo	110	152
Total, serious adverse events	FP-1201-lyo 10 μg	77	144
Total, serious adverse events	Placebo	77	152

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
32065831	DERIVED	PubMed
36927455	DERIVED	PubMed

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 comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
FP-1201-lyo 10 μg vs Placebo: Exploratory, Extended Long-term Follow-up: Overall Mortality at Day 360	Trial comparisons
FP-1201-lyo 10 μg vs Placebo: Efficacy Endpoint: Mortality in Hospital	Trial comparisons
FP-1201-lyo 10 μg vs Placebo: deaths from any cause	Trial comparisons
FP-1201-lyo 10 μg vs Placebo: serious adverse events	Trial comparisons

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02622724

GET https://conductscience.org/api/trials/v1/NCT02622724/registered?page=2

API reference For AI assistants