Trial · NCT04682444

Efficacy and Safety of Enisamium Iodide for the Treatment of Acute Respiratory Viral Infections, Including Influenza.

NCT04682444, Phase 2, Phase 3, Completed, Joint Stock Company "Farmak"; results first posted 2026-01-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Enisamium Iodide for the Treatment of Acute Respiratory Viral Infections, Including Influenza. Trials, record NCT04682444. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04682444

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Trial

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

Title: Efficacy and Safety of Enisamium Iodide for the Treatment of Acute Respiratory Viral Infections, Including Influenza.
NCT number: NCT04682444
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 100 participants, actual
Lead sponsor: Joint Stock Company "Farmak"
Conditions: Acute Respiratory Viral Infections, Human Influenza
Interventions: Enisamium Iodide, Placebo
First posted: 2020-12-23
Last updated: 2026-01-08
Results first posted: 2026-01-08

Source ClinicalTrials.gov

Registered outcomes27

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

List	Outcome	Time frame	Description
Primary	Efficacy: Number of Participants -- Absence of Objective Symptoms -- Overall	Day 0 (baseline), 3, 7, 14.	Count of participants WITHOUT objective symptoms -- overall. Objective symptoms of acute respiratory viral infection (ARVI), including influenza, were monitored: fever, pharyngeal hyperemia, rhinitis, arterial blood pressure, enlarged lymph nodes, auscultation findings for lung and heart. Clinical improvement was assessed by the investigator, relating to the severity of clinical symptoms of acute respiratory viral infection (ARVI), including influenza. A score system used to assess participants' health. A higher score implies worse outcome. Objective symptoms scores were: normal or abnormal blood pressure: 0 or 4 score points; lung auscultation: 0 points; vesicular breath sound and wheezing or crepitation 2 or 4 points, respectively; clear and rhythmic heart sounds -- each 0 points; noisy and arrhythmic heart sounds -- each 2 score points.
Primary	Efficacy: Number of Participants -- Days Without Routine Activities -- Summary	Day 0 (baseline), 3, 7, 14.	Count of participants who had days WITHOUT routine activities. Disability to perform routine tasks and activities were reported by the participants to the investigator at each study visit.
Primary	Efficacy: Number of Participants -- Viral Antigens -- Overall	Day 0 (baseline), 3, 7.	Viral antigens that were evaluated: adenovirus, corona virus, influenza A, influenza B, parainfluenza virus, respiratory syncytial virus. Virus antigens were isolated from nasal swabs and detected by using validated immunofluorescence staining methods. Efficacy assessment was based on the determination of viral antigen on treatment days (Day 3 and Day 7) compared with the baseline (Day 0) in the active treatment group and the placebo group. Results represent the count of participants who did NOT have detectable viral antigens.
Secondary	Efficacy: Number of Participants -- Absence of Subjective Symptoms -- Overall	Day 0 (baseline), 3, 7, 14.	Count of participants WITHOUT overall subjective symptoms. Subjective symptoms of acute respiratory viral infection (ARVI) including influenza, that were monitored: elevated body temperature, chills, cough, headache, myalgia, sore throat, weakness. Evaluate the number of participants in the treatment and the placebo groups without the subjective symptoms from Day 3 after therapy start. Clinical improvement was assessed by the investigator, relating to the severity of clinical symptoms of ARVI, including influenza. The subjective symptoms were assessed using a 4-point Likert scale, ranging from score 1 (absent symptoms ) to score 4 (severe symptoms).
Secondary	Efficacy: Subjective Symptom Sum Score (4-point Likert Scale)	Day 0 (baseline), 3, 7, 14.	Subjective symptom sum score. Subjective symptoms of acute respiratory viral infection (ARVI) including influenza, that were monitored: elevated body temperature, chills, cough, headache, myalgia, sore throat, weakness. The subjective symptoms were assessed using a 4-point Likert scale for the individual assessment of the severity of the above 7 symptoms, ranging from absent (0), mild (1), moderate (2), or severe (3). A higher score implies worse outcome.
Secondary	Efficacy: Number of Participants -- Absence of Subjective Symptom -- Chills	Day 0 (baseline), 3, 7, 14.	Chills. Count of participants WITHOUT the subjective symptom: chills. Evaluate the number of participants in the treatment and the placebo groups regarding clinical status from Day 3 after therapy start. Clinical improvement was assessed by the investigator, relating to the severity of clinical symptoms of acute respiratory viral infection (ARVI), including influenza.
Secondary	Efficacy: Number of Participants -- Absence of Subjective Symptom -- Cough	Day 0 (baseline), 3, 7, 14.	Cough. Count of participants WITHOUT the subjective symptom: cough. Evaluate the number of participants in the treatment and the placebo groups regarding clinical status from Day 3 after therapy start. Clinical improvement was assessed by the investigator, relating to the severity of clinical symptoms of acute respiratory viral infection (ARVI), including influenza.
Secondary	Efficacy: Number of Participants -- Absence of Subjective Symptom -- Elevated Body Temperature	Day 0 (baseline), 3, 7, 14.	Count of participants WITHOUT perceived elevated body temperature. Evaluate the number of patients in the treatment and the placebo groups regarding clinical status from Day 3 after therapy start. Clinical improvement was assessed by the investigator, relating to the severity of clinical symptoms of acute respiratory viral infection (ARVI), including influenza.
Secondary	Efficacy: Number of Participants -- Absence of Subjective Symptom -- Sore Throat	Day 0 (baseline), 3, 7, 14.	Subjective symptoms. Count of participants WITHOUT the subjective symptom: sore throat. Evaluate the number of patients in the treatment and the placebo groups regarding clinical status from Day 3 after therapy start. Clinical improvement was assessed by the investigator, relating to the severity of clinical symptoms of acute respiratory viral infection (ARVI), including influenza.
Secondary	Efficacy: Number of Participants -- Absence of Subjective Symptom -- Headache	Day 0 (baseline), 3, 7, 14.	Subjective symptoms. Count of participants WITHOUT the subjective symptom: headache. Evaluate the number of patients in the treatment and the placebo groups regarding clinical status from Day 3 after therapy start. Clinical improvement was assessed by the investigator, relating to the severity of clinical symptoms of acute respiratory viral infection (ARVI), including influenza.

1 to 10 of 27Source ClinicalTrials.gov

See all 27 registered outcomes

Outcomes27

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Efficacy: Number of Participants -- Absence of Objective Symptoms -- Overall	Day 0 (baseline), 3, 7, 14.	Intention-to-treat. All randomized patients who received at least one dose of study medication.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Efficacy: Number of Participants -- Days Without Routine Activities -- Summary	Day 0 (baseline), 3, 7, 14.	Intention-to-treat. All randomized patients who received at least one dose of study medication.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Efficacy: Number of Participants -- Viral Antigens -- Overall	Day 0 (baseline), 3, 7.	Intention-to-treat. All randomized patients who received at least one dose of study medication.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Efficacy: Number of Participants -- Absence of Subjective Symptoms -- Overall	Day 0 (baseline), 3, 7, 14.	Intention to treat	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Efficacy: Subjective Symptom Sum Score (4-point Likert Scale)	Day 0 (baseline), 3, 7, 14.	Intention-to-treat. All randomized patients who received at least one dose of study medication.	score on a 4-point Likert scale	MEAN
SECONDARY	Efficacy: Number of Participants -- Absence of Subjective Symptom -- Chills	Day 0 (baseline), 3, 7, 14.	Intention-to-treat. All randomized patients who received at least one dose of study medication.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Efficacy: Number of Participants -- Absence of Subjective Symptom -- Cough	Day 0 (baseline), 3, 7, 14.	Intention-to-treat. All randomized patients who received at least one dose of study medication.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Efficacy: Number of Participants -- Absence of Subjective Symptom -- Elevated Body Temperature	Day 0 (baseline), 3, 7, 14.	Intention-to-treat. All randomized patients who received at least one dose of study medication.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Efficacy: Number of Participants -- Absence of Subjective Symptom -- Sore Throat	Day 0 (baseline), 3, 7, 14.	Intention-to-treat. All randomized patients who received at least one dose of study medication.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Efficacy: Number of Participants -- Absence of Subjective Symptom -- Headache	Day 0 (baseline), 3, 7, 14.	Intention-to-treat. All randomized patients who received at least one dose of study medication.	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 27Source ClinicalTrials.gov

See all 27 outcomes

Results by group326

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

Outcome	Group	Category	Value	Units
Efficacy: Number of Participants -- Absence of Objective Symptoms -- Overall	Group 1 - Active Treatment - Amizon	Study Day 0:	0	Participants
Efficacy: Number of Participants -- Absence of Objective Symptoms -- Overall	Group 2 - Placebo	Study Day 0:	0	Participants
Efficacy: Number of Participants -- Absence of Objective Symptoms -- Overall	Group 1 - Active Treatment - Amizon	Study Day 3:	0	Participants
Efficacy: Number of Participants -- Absence of Objective Symptoms -- Overall	Group 2 - Placebo	Study Day 3:	0	Participants
Efficacy: Number of Participants -- Absence of Objective Symptoms -- Overall	Group 1 - Active Treatment - Amizon	Study Day 7:	9	Participants
Efficacy: Number of Participants -- Absence of Objective Symptoms -- Overall	Group 2 - Placebo	Study Day 7:	4	Participants
Efficacy: Number of Participants -- Absence of Objective Symptoms -- Overall	Group 1 - Active Treatment - Amizon	Study Day 14:	44	Participants
Efficacy: Number of Participants -- Absence of Objective Symptoms -- Overall	Group 2 - Placebo	Study Day 14:	11	Participants
Efficacy: Number of Participants -- Days Without Routine Activities -- Summary	Group 1 - Active Treatment	0 days disability	26	Participants
Efficacy: Number of Participants -- Days Without Routine Activities -- Summary	Group 2 - Placebo	0 days disability	6	Participants

1 to 10 of 326Source ClinicalTrials.gov

See all 326 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Group 1 - Active Treatment	60
Overall Study	STARTED	Group 2 - Placebo	40
Overall Study	COMPLETED	Group 1 - Active Treatment	60
Overall Study	COMPLETED	Group 2 - Placebo	40
Overall Study	NOT COMPLETED	Group 1 - Active Treatment	0
Overall Study	NOT COMPLETED	Group 2 - Placebo	0

Source ClinicalTrials.gov

Adverse events14

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	Bitter taste in mouth	Gastrointestinal disorders	Group 1 - Active Treatment	2	60	2
other	Bitter taste in mouth	Gastrointestinal disorders	Group 2 - Placebo	1	40	1
other	Heartburn	Gastrointestinal disorders	Group 1 - Active Treatment	1	60	1
other	Heartburn	Gastrointestinal disorders	Group 2 - Placebo	0	40	0
other	Burning sensation	Gastrointestinal disorders	Group 1 - Active Treatment	1	60	1
other	Burning sensation	Gastrointestinal disorders	Group 2 - Placebo	0	40	0
other	Acute respiratory disease	Respiratory, thoracic and mediastinal disorders	Group 1 - Active Treatment	0	60	0
other	Acute respiratory disease	Respiratory, thoracic and mediastinal disorders	Group 2 - Placebo	1	40	1
other	Headache	Nervous system disorders	Group 1 - Active Treatment	0	60	0
other	Headache	Nervous system disorders	Group 2 - Placebo	1	40	1

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Group 1 - Active Treatment	0	60
Total, all-cause mortality	Group 2 - Placebo	0	40
Total, other adverse events	Group 1 - Active Treatment	4	60
Total, other adverse events	Group 2 - Placebo	3	40
Total, serious adverse events	Group 1 - Active Treatment	0	60
Total, serious adverse events	Group 2 - Placebo	0	40

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33558285	DERIVED

Source 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 comparisons2

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

Comparison	Source
Group 1 - Active Treatment vs Group 2 - Placebo: deaths from any cause	Trial comparisons
Group 1 - Active Treatment vs Group 2 - 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/NCT04682444

GET https://conductscience.org/api/trials/v1/NCT04682444/registered?page=2

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