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

Prospective Randomized Open-label Comparative Study of the Use of Intranasal Form of Interferon Gamma Human Recombinant in Patients for the Prevention of Acute Respiratory Viral Infections, Including COVID-19

It is known that the pretreatment with exogenous interferon blocks SARS-CoV-2 infection, but intervention is much more effective if administered prior to infection. In this study the primary aim is to investigate 28-day regime of nasal interferon gama use in healthy participants for COVID-19 and other respiratory infections prevention.

Study Overview

• Status: Completed
• Conditions: COVID-19 Respiratory Infection; Acute Respiratory Disease
• Intervention / Treatment: Drug: Interferon gamma human recombinant (IFN-G)

Detailed Description

The tissues of the upper respiratory tract: the mucous membrane of the oropharynx, nose, - as well as the lung parenchyma are identified as the main targets of SARS-CoV-2. Previously published data from studies describe that in vitro and in vivo observations SARS-CoV-2 replicates exponentially during the first few days after infection to the peak of the host's antiviral response. It is assumed that it is the violation of the antiviral immunity of the nasal epithelium that may underlie the development of a severe form of the disease. The significance of interferon protection proven in early studies supposes that it can reduce peak viral load and viral reproduction index.

To confirm the efficacy and safety of nasal interferon gama use in healthy participants for COVID-19 and other respiratory infections prevention there is a need of interventional study. Interferon gamma has many years of clinical experience in the prevention and treatment of various viral infections, including coronavirus nature, flu and pneumonia.

After participant enrollment, comprehensive baseline documentation of anamnestic, clinical and allergy data is collected on the same day if possible. For participants who develops acute respiratory symptoms or recieve positive PCR test for SARS-CoV-2, all parameters are collected that may be necessary to assess the type and severity of acute respiratory disease. Furthermore, data is collected that may be suitable for an assessment of the safety profile. In particular, questions are asked about known infection risks, lifestyle, alternative prevention methods, immune competence, rate of acute respiratory infections, the history of symptoms and tests relating to COVID-19, preexisting medication, as well as ethnicity.

On the day of inclusion (day -3-1) routine clinical values, safety-relevant data, WHO scale score, concomitant medication and anamnesis, as well as study criteria analysis are documented.

On the day 0 (randomization visit) and at termination visit (up to 90 days) repeated routine clinical values, safety-relevant data, WHO scale score, and concomitant medication are collected. If the patient falls ill, the necessary disease information is documented. If the patient dies, the date and cause of death are documented.

On days 24-30 after randomization, a follow-up call takes place with particular attention to the health-related events such as respiratory diseases or other changes in health and vital status and drug compliance. If the participant cannot be reached for the follow-up call, the including study center will attempt to reach the participant, otherwise exclude the participant.

A nasopharynx swab is obtained on days 0 to exclude asymptomatic patients before the randomisation. If possible, sputum is obtained for termination visit and during the acute respiratory symproms manifestation to confirm COVID-19.

• Study Type: Interventional
• Enrollment (Actual): 630
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 121374
    • City Clinical Hospital named after M.E. Zhadkevich Moscow City Health Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Volunteers of both sexes over 18 years of age.
• Obtaining written informed consent.
• Ability and consent to participate in this research.
• Absence of symptoms of respiratory infection.
• A negative result of a PCR study for the presence of RNA SARS-CoV-2 according to biomaterial obtained by nasopharyngeal smear.

Exclusion Criteria:

• Any other concomitant diseases or conditions, which, in the opinion of the research doctor, may distort research results, restrict the rights of a volunteer or put him/her at greater risk.
• Contraindications to the use of the investigated medicinal product.
• Individual intolerance to the ingredients included in the composition of the investigational medicinal product.
• Pregnancy or breastfeeding.
• Doubtful result of a PCR test for the presence of RNA SARS-CoV-2 in the biomaterial obtained by nasopharyngeal smear.
• Participation in a clinical trial using study therapy within 30 days prior to enrollment in this study.
• Disagreement to follow in the research reliable contraceptive measures (abstinence; or a combination of 2 different methods: for example, barrier and spermicides, or barrier and intrauterine device, or barrier and hormonal, etc.) - for participants with saved reproductive potential.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug: Interferon Gamma; IFN-G administered for 2 10-day courses with a 1-week pause between the courses.	Drug: Interferon gamma human recombinant (IFN-G); nasal form; Other Names: Ingaron
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Proportion of Patients With Acute Respiratory Viral Infections, Including COVID-19, at the End of the Prophylactic 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)	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Proportion of Patients With Confirmed COVID-19 at the End of the Prophylactic 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)	28 days
The Proportion of Patients With Acute Respiratory Viral Infections, Including COVID-19, at the End of the Follow-up Period	The proportion of patients with acute respiratory viral infections, including COVID-19, assessed at visit 3 (at the end of the study)	2 months
Proportion of Patients With Confirmed COVID-19 at the End of the Follow-up Period	The proportion of patients with COVID-19, assessed at visit 3 (at the end of the study)	2 months
Number of Participants With a Complicated Course of Infection	The rate of complicated courses of infection among cases	2 months
The Proportion of Participants With Each Score of the WHO Clinical Improvement Scale	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	28 days
The Proportion of Participants With Each Score of the WHO Clinical Improvement Scale	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	2 months
The Duration of Symptoms in Participants With Acute Respiratory Viral Infections, Including COVID-19	The duration of symptoms in participants with acute respiratory viral infections, including COVID-19, assessed at the end of the study	2 months
The Duration of Symptoms in Participants With Acute Respiratory Viral Infections, Including COVID-19	The duration of symptoms in participants with acute respiratory viral infections, including COVID-19, assessed at the end of prevention course	28 days

Collaborators and Investigators

• Sponsor: SPP Pharmaclon Ltd.
• Investigators: Study Director: Anatoly I Saulin, Master, SPP Pharmaclon Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2020
• Primary Completion (Actual): May 25, 2021
• Study Completion (Actual): September 2, 2021

Study Registration Dates

• First Submitted: September 21, 2021
• First Submitted That Met QC Criteria: September 21, 2021
• First Posted (Actual): September 23, 2021

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19 prevention, interferon gamma, nasal drops
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Infections; Communicable Diseases; Virus Diseases; Respiratory Tract Infections; Respiration Disorders; Respiratory Tract Diseases; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Interferons; Interferon-gamma
• Other Study ID Numbers: RAIN-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No