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

NCT05054114 | Completed Results

• 1 other identifier: RAIN-2020
• Study Type: interventional
• Target: 630
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19 Respiratory Infection; Acute Respiratory Disease

Keywords

COVID-19 prevention, interferon gamma, nasal drops

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• The Proportion of Patients With Confirmed COVID-19 at the End of the Prophylactic Period

  28 days

• The Proportion of Patients With Acute Respiratory Viral Infections, Including COVID-19, at the End of the Follow-up Period

  2 months

• Proportion of Patients With Confirmed COVID-19 at the End of the Follow-up Period

  2 months

• Number of Participants With a Complicated Course of Infection

  2 months

• The Proportion of Participants With Each Score of the WHO Clinical Improvement Scale

  28 days

Study Arms (2)

Drug: Interferon Gamma

EXPERIMENTAL

IFN-G administered for 2 10-day courses with a 1-week pause between the courses.

Drug: Interferon gamma human recombinant (IFN-G)

Control: No intervention

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.

Interventions

Interferon gamma human recombinant (IFN-G) DRUG

nasal form

Also known as: Ingaron

Drug: Interferon Gamma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SPP Pharmaclon Ltd.: lead

Study Sites (1)

City Clinical Hospital named after M.E. Zhadkevich Moscow City Health Department

Moscow, 121374, Russia

Location

Results Point of Contact

• Title: Julia Isakova
• Organization: SPP Pharmaclon Ltd.

isakova@pharmaclon.ru

81079055353311

Study Officials

• Anatoly I Saulin, Master

  SPP Pharmaclon Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: September 23, 2021
• Study Start: December 21, 2020
• Primary Completion: May 25, 2021
• Study Completion: September 2, 2021
• Last Updated: August 9, 2024
• Results First Posted: August 9, 2024

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)