COVID-19 (SARS-CoV-2 infection) Infections and Infestations COVID-19 (SARS-CoV-2 infection), coronavirus Infection, coronavirus
Conditions
Interventions
Among the full staff of HCWs at a designated COVID-19 hospital, 100 HCWs will be randomly invited to participate in the study by members of a study team in accordance with the protocol. The data from
four inhalation sessions per day with 4 h in between sessions.
Data on treatment adherence and adverse events are collected on day 7 and day 14, with additional follow-up information
Sponsors
North-Western State Medical University named after I.I. Mechnikov
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Willing and able to provide informed consent 2. Aged 18-80 years 3. Healthy volunteer 4. Healthcare workers (HCWs) exposed to routine COVID-19 positive contacts 5. Agrees to cooperate adequately to all aspects of the study, can understand the information provided about the study, and is willing to comply with the requirements of the study protocol
Exclusion criteria
Exclusion criteria: 1. Detection of SARS-CoV-2 virus RNA by polymerase chain reaction (PCR) in biomaterial samples and/or positive enzyme-linked immunosorbent assay ELISA IgM and ELISA IgG to the virus 2. Hypersensitivity or individual intolerance to the components of the combination therapy according to medical history 4. Criteria related to the concomitant pathology 5. Obviously or likely unable to understand and evaluate the information regarding this study within the process of signing the informed consent form, in particular regarding the expected risks and possible discomfort 6. The inability or unwillingness to follow the rules for carrying out the study and participating in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. New cases of SARS-CoV 2 infection in the treated group and untreated equal population of HCWs measured by study visits, weekly questionnaires, routine genetic tests and IgM/IgG seroconversion at 7,14, and 28 days. Statistical analyses include the assumption that up 11% of HCWs at risk will become infected if no prophylactic treatment is provided. Therefore it is expected that the investigated pre-exposure prophylaxis eliminates SARS-CoV-2 positive cases detected by genetic or immunological tests to 3% or less within 28 days study period; with alpha error rate of 0.05, beta error 0.85, and a sample size of ~100 participants in the study group. 2. Occurrence of adverse events collected at 7 and 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Rate of SARS-CoV 2 infections in the treated group and untreated equal population as determined by study visits, weekly questionnaires, routine genetic tests and IgM/IgG seroconversion at 7,14, and 28 days 2. Rate of SARS-CoV 2 infections in study participants receiving ACM as measured by IgM/IgG seroconversion at 7,14, and 28 days | — |
Countries
Russian Federation
Contacts
Public ContactNataliya;Veronika Shvetc;Gomonova
;
Outcome results
None listed