Trial Outcomes & Findings for Study of the Use of Nasal IFN-γ in Patients for the Prevention of Acute Respiratory Viral Infections, Icluding COVID-19 (NCT NCT05054114)

NCT ID: NCT05054114

Last Updated: 2024-08-09

Results Overview

The proportion of patients with acute respiratory viral infections, including COVID-19, assessed at visit 2 (at the end of the prophylaxis course and before the start of the follow-up period)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 630 participants
• Primary outcome timeframe: 28 days
• Results posted on: 2024-08-09

Participant Flow

Participant milestones

Measure	Drug: Interferon Gamma IFN-G administered for 2 10-day courses with a 1-week pause between the courses. Interferon gamma human recombinant (IFN-G): nasal form	Control: No Intervention Any preventive method including a variety of pharmacologic therapies against COVID-19, alongside the use of antiviral and immunomodulating agents, with the exception of drugs prescribed off-label or for research purposes, and IFN-G as well.
Overall Study STARTED	315	315
Overall Study COMPLETED	302	313
Overall Study NOT COMPLETED	13	2

Reasons for withdrawal

Measure	Drug: Interferon Gamma IFN-G administered for 2 10-day courses with a 1-week pause between the courses. Interferon gamma human recombinant (IFN-G): nasal form	Control: No Intervention Any preventive method including a variety of pharmacologic therapies against COVID-19, alongside the use of antiviral and immunomodulating agents, with the exception of drugs prescribed off-label or for research purposes, and IFN-G as well.
Overall Study Protocol Violation	13	1
Overall Study Pregnancy	0	1

Baseline Characteristics

Study of the Use of Nasal IFN-γ in Patients for the Prevention of Acute Respiratory Viral Infections, Icluding COVID-19

Baseline characteristics by cohort

Measure	Drug: Interferon Gamma n=315 Participants IFN-G administered for 2 10-day courses with a 1-week pause between the courses. Interferon gamma human recombinant (IFN-G): nasal form	Control: No Intervention n=315 Participants Any preventive method including a variety of pharmacologic therapies against COVID-19, alongside the use of antiviral and immunomodulating agents, with the exception of drugs prescribed off-label or for research purposes, and IFN-G as well.	Total n=630 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	305 Participants n=93 Participants	299 Participants n=4 Participants	604 Participants n=27 Participants
Age, Categorical >=65 years	10 Participants n=93 Participants	16 Participants n=4 Participants	26 Participants n=27 Participants
Sex: Female, Male Female	115 Participants n=93 Participants	117 Participants n=4 Participants	232 Participants n=27 Participants
Sex: Female, Male Male	200 Participants n=93 Participants	198 Participants n=4 Participants	398 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	56 Participants n=93 Participants	61 Participants n=4 Participants	117 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	259 Participants n=93 Participants	254 Participants n=4 Participants	513 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment Russia	315 participants n=93 Participants	315 participants n=4 Participants	630 participants n=27 Participants
Vaccination against COVID-19	57 Participant n=93 Participants	74 Participant n=4 Participants	131 Participant n=27 Participants

PRIMARY outcome

Timeframe: 28 days

Population: The results of the assessment of the incidence rate at the end of the prophylaxis period

The proportion of patients with acute respiratory viral infections, including COVID-19, assessed at visit 2 (at the end of the prophylaxis course and before the start of the follow-up period)

Outcome measures

Measure	Drug: Interferon Gamma n=315 Participants IFN-G administered for 2 10-day courses with a 1-week pause between the courses. Interferon gamma human recombinant (IFN-G): nasal form	Control: No Intervention n=315 Participants Any preventive method including a variety of pharmacologic therapies against COVID-19, alongside the use of antiviral and immunomodulating agents, with the exception of drugs prescribed off-label or for research purposes, and IFN-G as well.
The Proportion of Patients With Acute Respiratory Viral Infections, Including COVID-19, at the End of the Prophylactic Period	3 participants	13 participants

SECONDARY outcome

Timeframe: 28 days

Population: The results of the assessment of the incidence of COVID-19 at the end of the prevention period

The proportion of patients with COVID-19, assessed at visit 2 (at the end of the prophylaxis course and before the start of the follow-up period)

Outcome measures

Measure	Drug: Interferon Gamma n=315 Participants IFN-G administered for 2 10-day courses with a 1-week pause between the courses. Interferon gamma human recombinant (IFN-G): nasal form	Control: No Intervention n=315 Participants Any preventive method including a variety of pharmacologic therapies against COVID-19, alongside the use of antiviral and immunomodulating agents, with the exception of drugs prescribed off-label or for research purposes, and IFN-G as well.
The Proportion of Patients With Confirmed COVID-19 at the End of the Prophylactic Period	0 participants	0 participants

SECONDARY outcome

Timeframe: 2 months

Population: The results of the assessment of the incidence rate at the end of the study

The proportion of patients with acute respiratory viral infections, including COVID-19, assessed at visit 3 (at the end of the study)

Outcome measures

Measure	Drug: Interferon Gamma n=315 Participants IFN-G administered for 2 10-day courses with a 1-week pause between the courses. Interferon gamma human recombinant (IFN-G): nasal form	Control: No Intervention n=315 Participants Any preventive method including a variety of pharmacologic therapies against COVID-19, alongside the use of antiviral and immunomodulating agents, with the exception of drugs prescribed off-label or for research purposes, and IFN-G as well.
The Proportion of Patients With Acute Respiratory Viral Infections, Including COVID-19, at the End of the Follow-up Period	6 participants	25 participants

SECONDARY outcome

Timeframe: 2 months

Population: The results of the assessment of the incidence of COVID-19 at the end of the prevention period

The proportion of patients with COVID-19, assessed at visit 3 (at the end of the study)

Outcome measures

Measure	Drug: Interferon Gamma n=315 Participants IFN-G administered for 2 10-day courses with a 1-week pause between the courses. Interferon gamma human recombinant (IFN-G): nasal form	Control: No Intervention n=315 Participants Any preventive method including a variety of pharmacologic therapies against COVID-19, alongside the use of antiviral and immunomodulating agents, with the exception of drugs prescribed off-label or for research purposes, and IFN-G as well.
Proportion of Patients With Confirmed COVID-19 at the End of the Follow-up Period	0 participants	2 participants

SECONDARY outcome

Timeframe: 2 months

Population: The results of assessing the frequency of complicated course

The rate of complicated courses of infection among cases

Outcome measures

Measure	Drug: Interferon Gamma n=315 Participants IFN-G administered for 2 10-day courses with a 1-week pause between the courses. Interferon gamma human recombinant (IFN-G): nasal form	Control: No Intervention n=315 Participants Any preventive method including a variety of pharmacologic therapies against COVID-19, alongside the use of antiviral and immunomodulating agents, with the exception of drugs prescribed off-label or for research purposes, and IFN-G as well.
Number of Participants With a Complicated Course of Infection	0 participants	0 participants

SECONDARY outcome

Timeframe: 28 days

Population: The results of assessing the frequency of different scores on the WHO scale at the end of the prophylaxis period

The proportion of participants with each score (0-8) on the WHO Clinical Improvement Scale from 0 points - not infected, no manifestations or virological signs of infection, up to 8 points - died, death

Outcome measures

Measure	Drug: Interferon Gamma n=3 Participants IFN-G administered for 2 10-day courses with a 1-week pause between the courses. Interferon gamma human recombinant (IFN-G): nasal form	Control: No Intervention n=13 Participants Any preventive method including a variety of pharmacologic therapies against COVID-19, alongside the use of antiviral and immunomodulating agents, with the exception of drugs prescribed off-label or for research purposes, and IFN-G as well.
The Proportion of Participants With Each Score of the WHO Clinical Improvement Scale 1 points on the WHO scale	3 participants	13 participants
The Proportion of Participants With Each Score of the WHO Clinical Improvement Scale 2 points on the WHO scale	0 participants	0 participants
The Proportion of Participants With Each Score of the WHO Clinical Improvement Scale 3 points on the WHO scale	0 participants	0 participants
The Proportion of Participants With Each Score of the WHO Clinical Improvement Scale 4 points on the WHO scale	0 participants	0 participants
The Proportion of Participants With Each Score of the WHO Clinical Improvement Scale 5 points on the WHO scale	0 participants	0 participants
The Proportion of Participants With Each Score of the WHO Clinical Improvement Scale 6 points on the WHO scale	0 participants	0 participants
The Proportion of Participants With Each Score of the WHO Clinical Improvement Scale 7 points on the WHO scale	0 participants	0 participants
The Proportion of Participants With Each Score of the WHO Clinical Improvement Scale 8 points on the WHO scale	0 participants	0 participants
The Proportion of Participants With Each Score of the WHO Clinical Improvement Scale 0 points on the WHO scale	0 participants	0 participants

SECONDARY outcome

Timeframe: 2 months

Population: The results of assessing the frequency of different scores on the WHO scale at the end of the prophylaxis period

The proportion of participants with each score (0-8) on the WHO Clinical Improvement Scale from 0 points - not infected, no manifestations or virological signs of infection, up to 8 points - died, death

Outcome measures

Measure	Drug: Interferon Gamma n=6 Participants IFN-G administered for 2 10-day courses with a 1-week pause between the courses. Interferon gamma human recombinant (IFN-G): nasal form	Control: No Intervention n=26 Participants Any preventive method including a variety of pharmacologic therapies against COVID-19, alongside the use of antiviral and immunomodulating agents, with the exception of drugs prescribed off-label or for research purposes, and IFN-G as well.
The Proportion of Participants With Each Score of the WHO Clinical Improvement Scale 3 points on the WHO scale	0 participants	0 participants
The Proportion of Participants With Each Score of the WHO Clinical Improvement Scale 2 points on the WHO scale	0 participants	1 participants
The Proportion of Participants With Each Score of the WHO Clinical Improvement Scale 4 points on the WHO scale	0 participants	0 participants
The Proportion of Participants With Each Score of the WHO Clinical Improvement Scale 5 points on the WHO scale	0 participants	0 participants
The Proportion of Participants With Each Score of the WHO Clinical Improvement Scale 6 points on the WHO scale	0 participants	0 participants
The Proportion of Participants With Each Score of the WHO Clinical Improvement Scale 0 points on the WHO scale	0 participants	0 participants
The Proportion of Participants With Each Score of the WHO Clinical Improvement Scale 1 points on the WHO scale	6 participants	25 participants
The Proportion of Participants With Each Score of the WHO Clinical Improvement Scale 7 points on the WHO scale	0 participants	0 participants
The Proportion of Participants With Each Score of the WHO Clinical Improvement Scale 8 points on the WHO scale	0 participants	0 participants

SECONDARY outcome

Timeframe: 2 months

Population: Duration of disease symptoms at the end of the study (2 months)

The duration of symptoms in participants with acute respiratory viral infections, including COVID-19, assessed at the end of the study

Outcome measures

Measure	Drug: Interferon Gamma n=3 Participants IFN-G administered for 2 10-day courses with a 1-week pause between the courses. Interferon gamma human recombinant (IFN-G): nasal form	Control: No Intervention n=13 Participants Any preventive method including a variety of pharmacologic therapies against COVID-19, alongside the use of antiviral and immunomodulating agents, with the exception of drugs prescribed off-label or for research purposes, and IFN-G as well.
The Duration of Symptoms in Participants With Acute Respiratory Viral Infections, Including COVID-19	4.17 days Interval 2.0 to 8.0	6.76 days Interval 1.0 to 24.0

SECONDARY outcome

Timeframe: 28 days

Population: Duration of disease symptoms at the end of the prophylaxis period (28 days)

The duration of symptoms in participants with acute respiratory viral infections, including COVID-19, assessed at the end of prevention course

Outcome measures

Measure	Drug: Interferon Gamma n=3 Participants IFN-G administered for 2 10-day courses with a 1-week pause between the courses. Interferon gamma human recombinant (IFN-G): nasal form	Control: No Intervention n=13 Participants Any preventive method including a variety of pharmacologic therapies against COVID-19, alongside the use of antiviral and immunomodulating agents, with the exception of drugs prescribed off-label or for research purposes, and IFN-G as well.
The Duration of Symptoms in Participants With Acute Respiratory Viral Infections, Including COVID-19	5.33 days Interval 2.0 to 8.0	4.15 days Interval 1.0 to 8.0

Adverse Events

Drug: Interferon Gamma

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Control: No Intervention

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Drug: Interferon Gamma n=315 participants at risk IFN-G administered for 2 10-day courses with a 1-week pause between the courses. Interferon gamma human recombinant (IFN-G): nasal form	Control: No Intervention n=315 participants at risk Any preventive method including a variety of pharmacologic therapies against COVID-19, alongside the use of antiviral and immunomodulating agents, with the exception of drugs prescribed off-label or for research purposes, and IFN-G as well.
Nervous system disorders Headache	3.5% 11/315 • Number of events 11 • Safety assessment was carried out throughout the observation period, starting from the inclusion of the participant in the study - within 2 months. No serious adverse events or reactions were reported during the study.	2.5% 8/315 • Number of events 8 • Safety assessment was carried out throughout the observation period, starting from the inclusion of the participant in the study - within 2 months. No serious adverse events or reactions were reported during the study.
Nervous system disorders Dizziness	0.32% 1/315 • Number of events 1 • Safety assessment was carried out throughout the observation period, starting from the inclusion of the participant in the study - within 2 months. No serious adverse events or reactions were reported during the study.	0.00% 0/315 • Safety assessment was carried out throughout the observation period, starting from the inclusion of the participant in the study - within 2 months. No serious adverse events or reactions were reported during the study.
Gastrointestinal disorders Abdominal pain	0.95% 3/315 • Number of events 3 • Safety assessment was carried out throughout the observation period, starting from the inclusion of the participant in the study - within 2 months. No serious adverse events or reactions were reported during the study.	0.95% 3/315 • Number of events 3 • Safety assessment was carried out throughout the observation period, starting from the inclusion of the participant in the study - within 2 months. No serious adverse events or reactions were reported during the study.
Gastrointestinal disorders Diarrhea	0.32% 1/315 • Number of events 1 • Safety assessment was carried out throughout the observation period, starting from the inclusion of the participant in the study - within 2 months. No serious adverse events or reactions were reported during the study.	0.32% 1/315 • Number of events 1 • Safety assessment was carried out throughout the observation period, starting from the inclusion of the participant in the study - within 2 months. No serious adverse events or reactions were reported during the study.
Vascular disorders Increase in blood pressure	1.3% 4/315 • Number of events 4 • Safety assessment was carried out throughout the observation period, starting from the inclusion of the participant in the study - within 2 months. No serious adverse events or reactions were reported during the study.	0.95% 3/315 • Number of events 3 • Safety assessment was carried out throughout the observation period, starting from the inclusion of the participant in the study - within 2 months. No serious adverse events or reactions were reported during the study.
Injury, poisoning and procedural complications Joint pain	0.32% 1/315 • Number of events 1 • Safety assessment was carried out throughout the observation period, starting from the inclusion of the participant in the study - within 2 months. No serious adverse events or reactions were reported during the study.	0.00% 0/315 • Safety assessment was carried out throughout the observation period, starting from the inclusion of the participant in the study - within 2 months. No serious adverse events or reactions were reported during the study.
Infections and infestations Skin hardening	0.32% 1/315 • Number of events 1 • Safety assessment was carried out throughout the observation period, starting from the inclusion of the participant in the study - within 2 months. No serious adverse events or reactions were reported during the study.	0.00% 0/315 • Safety assessment was carried out throughout the observation period, starting from the inclusion of the participant in the study - within 2 months. No serious adverse events or reactions were reported during the study.
Reproductive system and breast disorders Lower abdominal pain	0.63% 2/315 • Number of events 2 • Safety assessment was carried out throughout the observation period, starting from the inclusion of the participant in the study - within 2 months. No serious adverse events or reactions were reported during the study.	0.00% 0/315 • Safety assessment was carried out throughout the observation period, starting from the inclusion of the participant in the study - within 2 months. No serious adverse events or reactions were reported during the study.
Gastrointestinal disorders Toothache	0.00% 0/315 • Safety assessment was carried out throughout the observation period, starting from the inclusion of the participant in the study - within 2 months. No serious adverse events or reactions were reported during the study.	0.32% 1/315 • Number of events 1 • Safety assessment was carried out throughout the observation period, starting from the inclusion of the participant in the study - within 2 months. No serious adverse events or reactions were reported during the study.
Infections and infestations Rashes on the nasal mucosa (herpetic)	0.00% 0/315 • Safety assessment was carried out throughout the observation period, starting from the inclusion of the participant in the study - within 2 months. No serious adverse events or reactions were reported during the study.	0.63% 2/315 • Number of events 2 • Safety assessment was carried out throughout the observation period, starting from the inclusion of the participant in the study - within 2 months. No serious adverse events or reactions were reported during the study.
Renal and urinary disorders Frequent urination	0.00% 0/315 • Safety assessment was carried out throughout the observation period, starting from the inclusion of the participant in the study - within 2 months. No serious adverse events or reactions were reported during the study.	0.32% 1/315 • Number of events 1 • Safety assessment was carried out throughout the observation period, starting from the inclusion of the participant in the study - within 2 months. No serious adverse events or reactions were reported during the study.
Reproductive system and breast disorders Increasing PSA levels	0.00% 0/315 • Safety assessment was carried out throughout the observation period, starting from the inclusion of the participant in the study - within 2 months. No serious adverse events or reactions were reported during the study.	0.32% 1/315 • Number of events 1 • Safety assessment was carried out throughout the observation period, starting from the inclusion of the participant in the study - within 2 months. No serious adverse events or reactions were reported during the study.
Reproductive system and breast disorders Pain when urinating (exacerbation of chronic prostatitis)	0.00% 0/315 • Safety assessment was carried out throughout the observation period, starting from the inclusion of the participant in the study - within 2 months. No serious adverse events or reactions were reported during the study.	0.32% 1/315 • Number of events 1 • Safety assessment was carried out throughout the observation period, starting from the inclusion of the participant in the study - within 2 months. No serious adverse events or reactions were reported during the study.

Additional Information

Julia Isakova

SPP Pharmaclon Ltd.

Phone: 81079055353311

Email: isakova@pharmaclon.ru

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place