Trial · NCT04732949

Study to Assess Efficacy and Safety of Inhaled Interferon-β Therapy for COVID-19

NCT04732949, Phase 3, Completed, Synairgen Research Ltd.; results first posted 2023-03-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study to Assess Efficacy and Safety of Inhaled Interferon-β Therapy for COVID-19. Trials, record NCT04732949. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04732949

On this page

Trial

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

Title: Study to Assess Efficacy and Safety of Inhaled Interferon-β Therapy for COVID-19
NCT number: NCT04732949
Status: Completed
Phases: Phase 3
Enrollment: 623 participants, actual
Lead sponsor: Synairgen Research Ltd.
Conditions: Severe Acute Respiratory Syndrome Coronavirus 2, COVID-19
Interventions: SNG001, Placebo
First posted: 2021-02-01
Last updated: 2023-03-27
Other registries' IDs: eudract:2020-004743-83
Results first posted: 2023-03-27

Source ClinicalTrials.gov

Registered outcomes18

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

List	Outcome	Time frame	Description
Primary	Time to Hospital Discharge	Day 28	The time to hospital discharge in patients with moderate COVID-19 after administration of SNG001 compared to placebo was evaluated.
Primary	Time to Recovery	Day 28	Recovery in patients with moderate COVID-19 after administration of SNG001 compared to placebo by time to recovery was evaluated.
Secondary	Number of Patients Who Progressed to Severe Disease or Death	Until Day 35	The efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by assessing progression to severe disease or death was evaluated. Severe disease was defined by the Ordinal Scale for Clinical Improvement (OSCI) as a score between 5 and 7. Death was defined by an OSCI score of 8.
Secondary	Number of Patients Who Were Intubated or Who Died	Until Day 35	The efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by assessing progression to intubation or death was evaluated. Intubation was defined by the OSCI as a score between 6 and 7. Death was defined by an OSCI score of 8.
Secondary	Number of Patients Who Died Within 35 Days of First Dose	Until Day 35 of first dose	Patients who died within 35 days of first dose of study intervention were calculated.
Secondary	Cumulative Number of Patients Who Were Discharged From Hospital	Days 7, 14, 21 and 28	The efficacy of SNG001 compared to placebo in patients with moderate COVID-19 was assessed by hospital discharge on given days.
Secondary	Cumulative Number of Patients With Recovery	Days 7, 14, 21 and 28	The efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by assessing recovery was evaluated. Recovery is defined as no limitation of activities according to the Ordinal Scale of Clinical Improvement (OSCI), with no rebound at subsequent assessments.
Secondary	Improvement Based on Entire WHO OSCI Score	Until Day 35	The efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by assessing improvement across the entire WHO OSCI were evaluated. Improvement in clinical status is based on the 9-point OSCI score. The score ranges from 0 to 8, where lower score of 0 represents no clinical or virological evidence of infection and higher score of 8 represents death.Higher scores indicated worse outcome.
Secondary	Change From Baseline in Total Score According to the Breathlessness, Cough and Sputum Scale (BCSS)	Baseline to Day 15	The efficacy of SNG001 compared with placebo in patients with moderate COVID-19 by assessing changes in daily breathlessness, cough and sputum scores on a scale of 0 (no symptoms) up to 4 (severe symptoms) was evaluated. Breathlessness, Cough and Sputum is graded on a score from 0 to 4, where a higher score indicates worse symptoms. The total score is calculated by summing the individual scores and is therefore graded on a scale from 0 to 12. Change in value of BCSS total scale, with negative value indicates an improvement in symptoms.
Secondary	Change From Baseline in National Early Warning Score (NEWS2) During the Hospitalisation Period	Day 1 until Day 28	The efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by assessing changes in NEWS2 during hospitalisation period was evaluated. It is the sum of scores calculated for Respiratory rate, Oxygen Saturation, Systolic BP, Pulse and Temperature when graded on a scale from 0 to 3 where 0 means a normal assessment and a higher score indicates a greater deviation from normal . 2 more points are added if the patient is receiving oxygen and 3 further points are added if the patient has new-onset confusion, disorientation and/or agitation, where previously their mental state was normal. This gives a score between 0 and 20. Higher scores indicates high clinical risk. Change from baseline in NEWS-2 score, in negative values favors improvement.

1 to 10 of 18Source ClinicalTrials.gov

See all 18 registered outcomes

Outcomes18

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Time to Hospital Discharge	Day 28	The Intent-to-Treat (ITT) analysis population consisted of all randomised patients.	days	MEDIAN
PRIMARY	Time to Recovery	Day 28	The ITT analysis population consisted of all randomised patients.	days	MEDIAN
SECONDARY	Number of Patients Who Progressed to Severe Disease or Death	Until Day 35	The ITT analysis population consisted of all randomised patients. Here, the number of participants analyzed signifies the participants with available data that were analyzed for this outcome measure.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Patients Who Were Intubated or Who Died	Until Day 35	The ITT analysis population consisted of all randomised patients.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Patients Who Died Within 35 Days of First Dose	Until Day 35 of first dose	The ITT analysis population consisted of all randomised patients.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Cumulative Number of Patients Who Were Discharged From Hospital	Days 7, 14, 21 and 28	The ITT analysis population consisted of all randomised patients.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Cumulative Number of Patients With Recovery	Days 7, 14, 21 and 28	The ITT analysis population consisted of all randomised patients.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Improvement Based on Entire WHO OSCI Score	Until Day 35		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline in Total Score According to the Breathlessness, Cough and Sputum Scale (BCSS)	Baseline to Day 15	The ITT analysis population consisted of all randomised patients.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in National Early Warning Score (NEWS2) During the Hospitalisation Period	Day 1 until Day 28	The ITT analysis population consisted of all randomised patients. Here, the number of participants analyzed signifies the participants with available data that were analyzed for this outcome measure.	score on a scale	MEAN

1 to 10 of 18Source ClinicalTrials.gov

See all 18 outcomes

Results by group244

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

Outcome	Group	Value	Spread	Units
Time to Hospital Discharge	SNG001	7.0	95% Confidence Interval 7.0 to 8.0	days
Time to Hospital Discharge	Placebo	8.0	95% Confidence Interval 7.0 to 9.0	days
Time to Recovery	SNG001	25.0	95% Confidence Interval 22.0 to NA	days
Time to Recovery	Placebo	25.0	95% Confidence Interval 22.0 to NA	days
Number of Patients Who Progressed to Severe Disease or Death	SNG001	33		Participants
Number of Patients Who Progressed to Severe Disease or Death	Placebo	45		Participants
Number of Patients Who Were Intubated or Who Died	SNG001	20		Participants
Number of Patients Who Were Intubated or Who Died	Placebo	23		Participants
Number of Patients Who Died Within 35 Days of First Dose	SNG001	14		Participants
Number of Patients Who Died Within 35 Days of First Dose	Placebo	17		Participants

1 to 10 of 244Source ClinicalTrials.gov

See all 244 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	SNG001	309
Overall Study	STARTED	Placebo	314
Overall Study	COMPLETED	SNG001	233
Overall Study	COMPLETED	Placebo	231
Overall Study	NOT COMPLETED	SNG001	76
Overall Study	NOT COMPLETED	Placebo	83

Source ClinicalTrials.gov

Adverse events138

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	Headache	Nervous system disorders	SNG001	71	301	84
other	Headache	Nervous system disorders	Placebo	61	303	76
other	Anosmia	Nervous system disorders	SNG001	18	301	18
other	Anosmia	Nervous system disorders	Placebo	20	303	20
other	Ageusia	Nervous system disorders	SNG001	13	301	13
other	Ageusia	Nervous system disorders	Placebo	18	303	19
other	Ear pain	Ear and labyrinth disorders	SNG001	25	301	26
other	Ear pain	Ear and labyrinth disorders	Placebo	9	303	9
other	Productive cough	Respiratory, thoracic and mediastinal disorders	SNG001	70	301	78
other	Productive cough	Respiratory, thoracic and mediastinal disorders	Placebo	72	303	85

1 to 10 of 138Source ClinicalTrials.gov

See all 138 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	SNG001	16	309
Total, all-cause mortality	Placebo	18	314
Total, other adverse events	SNG001	250	301
Total, other adverse events	Placebo	248	303
Total, serious adverse events	SNG001	38	301
Total, serious adverse events	Placebo	55	303

Source ClinicalTrials.gov

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 comparisons5

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

Comparison	Source
SNG001 vs Placebo: Number of Patients Who Were Intubated or Who Died	Trial comparisons
SNG001 vs Placebo: Number of Patients Who Died Within 35 Days of First Dose	Trial comparisons
SNG001 vs Placebo: Number of Patients Who Progressed to Severe Disease or Death	Trial comparisons
SNG001 vs Placebo: deaths from any cause	Trial comparisons
SNG001 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/NCT04732949

GET https://conductscience.org/api/trials/v1/NCT04732949/results?page=2

API reference For AI assistants