Status:
COMPLETED
Study of the Use of the Ingaron in Volunteers for the Prevention of COVID-19
Lead Sponsor:
SPP Pharmaclon Ltd.
Conditions:
COVID-19 Respiratory Infection
Eligibility:
All Genders
21-62 years
Brief Summary
The main purpose of this study is to evaluate the effectiveness of the prophylactic use of Ingaron (INN: recombinant interferon gamma human, lyophilisate for solution for intranasal administration 100...
Detailed Description
Distribution between groups is made randomly at the request of the participant. According to the methodology approved by the observational program, the participant must use or not use the investigatio...
Eligibility Criteria
Inclusion
- Medical workers and medical personnel working in the "red zone" and in contact with patients infected with COVID-19.
- Men and women over 18 years of age.
- Signing an informed consent form for data processing.
- Ability and agreement to complete the questionnaire (part 1) of the participant.
- No symptoms of a respiratory infection.
- Negative PCR test result for the presence of SARS-CoV-2 RNA according to the biomaterial obtained by nasopharyngeal swab.
Exclusion
- Any clinically confirmed or documented history of diseases that may complicate the interpretation of the data being assessed (HIV, cancer, organ transplantation, etc.).
- Any other comorbidities or conditions that, in the opinion of the investigator, may distort the results of the study, limit the rights of the volunteer, or put him at greater risk.
- Contraindications to the use of the investigational medicinal product.
- Individual intolerance to the ingredients that make up the study drug.
- Pregnancy or breastfeeding.
- The presence of antibodies to SARS-CoV-2 (IgM, IgG).
Key Trial Info
Start Date :
April 23 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 15 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05386446
Start Date
April 23 2020
End Date
June 15 2020
Last Update
May 23 2022
Active Locations (1)
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1
City Clinical Hospital named after M.E. Zhadkevich Moscow City Health Department
Moscow, Russia, 121374