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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug: Interferon Gamma | Experimental | IFN-G administered for 2 10-day courses with a 1-week pause between the courses. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon gamma human recombinant (IFN-G) | Drug | nasal form |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anatoly I Saulin, Master | SPP Pharmaclon Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City Clinical Hospital named after M.E. Zhadkevich Moscow City Health Department | Moscow | 121374 | Russia |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Control: No Intervention |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 17, 2021 | Aug 29, 2022 |
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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 |
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.
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Vaccination against COVID-19 | Number | Participant |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | The results of the assessment of the incidence rate at the end of the prophylaxis period | Posted | Number | participants | 28 days |
|
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| Secondary | 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) | The results of the assessment of the incidence of COVID-19 at the end of the prevention period | Posted | Number | participants | 28 days |
|
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| Secondary | 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) | The results of the assessment of the incidence rate at the end of the study | Posted | Number | participants | 2 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | 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) | The results of the assessment of the incidence of COVID-19 at the end of the prevention period | Posted | Number | participants | 2 months |
|
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| Secondary | Number of Participants With a Complicated Course of Infection | The rate of complicated courses of infection among cases | The results of assessing the frequency of complicated course | Posted | Number | participants | 2 months |
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| Secondary | 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 | The results of assessing the frequency of different scores on the WHO scale at the end of the prophylaxis period | Posted | Number | participants | 28 days |
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| Secondary | 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 | The results of assessing the frequency of different scores on the WHO scale at the end of the prophylaxis period | Posted | Number | participants | 2 months |
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| Secondary | 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 | Duration of disease symptoms at the end of the study (2 months) | Posted | Median | Full Range | days | 2 months |
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| Secondary | 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 | Duration of disease symptoms at the end of the prophylaxis period (28 days) | Posted | Median | Inter-Quartile Range | days | 28 days |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 315 | 0 | 315 | 24 | 315 |
| EG001 | 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. | 0 | 315 | 0 | 315 | 21 | 315 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Increase in blood pressure | Vascular disorders | Systematic Assessment |
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| Joint pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Skin hardening | Infections and infestations | Systematic Assessment |
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| Lower abdominal pain | Reproductive system and breast disorders | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | Systematic Assessment |
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| Rashes on the nasal mucosa (herpetic) | Infections and infestations | Systematic Assessment |
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| Frequent urination | Renal and urinary disorders | Systematic Assessment |
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| Increasing PSA levels | Reproductive system and breast disorders | Systematic Assessment |
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| Pain when urinating (exacerbation of chronic prostatitis) | Reproductive system and breast disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julia Isakova | SPP Pharmaclon Ltd. | 81079055353311 | isakova@pharmaclon.ru |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 12, 2021 | Aug 29, 2022 | SAP_001.pdf |
| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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