N/A
N=630
Study of the Use of Nasal IFN-γ in Patients for the Prevention of Acute Respiratory Viral Infections, Icluding COVID-19
COVID-19 Respiratory Infection · Acute Respiratory Disease
Bottom Line
View on ClinicalTrials.gov: NCT05054114 ↗Enrolled (actual)
630
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: The Proportion of Patients With Acute Respiratory Viral Infections, Including COVID-19, at the End of the Prophylactic Period — 3; 13 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Interferon gamma human recombinant (IFN-G) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- SPP Pharmaclon Ltd.
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Proportion of Patients With Acute Respiratory Viral Infections, Including COVID-19, at the End of the Prophylactic Period |
3; 13 | — |
| SECONDARY The Proportion of Patients With Confirmed COVID-19 at the End of the Prophylactic Period |
0; 0 | — |
| SECONDARY The Proportion of Patients With Acute Respiratory Viral Infections, Including COVID-19, at the End of the Follow-up Period |
6; 25 | — |
| SECONDARY Proportion of Patients With Confirmed COVID-19 at the End of the Follow-up Period |
0; 2 | — |
| SECONDARY Number of Participants With a Complicated Course of Infection |
0; 0 | — |
| SECONDARY The Proportion of Participants With Each Score of the WHO Clinical Improvement Scale |
0; 0; 6; 25; 0; 1 | — |
| SECONDARY The Proportion of Participants With Each Score of the WHO Clinical Improvement Scale |
0; 0; 6; 25; 0; 1 | — |
| SECONDARY The Duration of Symptoms in Participants With Acute Respiratory Viral Infections, Including COVID-19 |
5.33; 4.15 | — |
| SECONDARY The Duration of Symptoms in Participants With Acute Respiratory Viral Infections, Including COVID-19 |
5.33; 4.15 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05054114). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.