A low-intervention study of pre-exposure prophylaxis (PrEP) in healthy volunteers at high risk of coronavirus (SARS-CoV-2) infection.
- Conditions
- COVID-19 (SARS-CoV-2 infection)Infections and InfestationsCOVID-19 (SARS-CoV-2 infection), coronavirus Infection, coronavirus
- Registration Number
- ISRCTN34160010
- Lead Sponsor
- orth-Western State Medical University named after I.I. Mechnikov
- Brief Summary
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34098889/ (added 09/06/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 99
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method