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Clinical Trials/ISRCTN34160010
ISRCTN34160010
Completed
未知

A low-intervention study to determine whether pre-exposure prophylaxis with low dose aerosol combination medication (ACM) can reduce SARS-CoV-2 incidence in healthcare workers exposed to routing COVID-19 positive contacts (LOWACM)

orth-Western State Medical University named after I.I. Mechnikov0 sites99 target enrollmentSeptember 14, 2020
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Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
orth-Western State Medical University named after I.I. Mechnikov
Enrollment
99
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34098889/ (added 09/06/2021)

Registry
who.int
Start Date
September 14, 2020
End Date
September 2, 2020
Last Updated
3 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
orth-Western State Medical University named after I.I. Mechnikov

Eligibility 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

  • •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

Outcomes

Primary Outcomes

Not specified

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