Phase 4
Completed N=50
Prevention of Infection and Incidence of COVID-19 in Medical Personnel Assisting Patients With New Coronavirus Disease
Increased Risk of SARS-CoV-2 Infection
Source: ClinicalTrials.gov NCT04405999 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcomePrimary: Negative Polymerase Chain Reaction (PCR) — 2; 7 Participants
◆ Published Evidence
Established
22citations · ~6 / year
Bromhexine Hydrochloride Prophylaxis of COVID-19 for Medical Personnel: A Randomized Open-Label Study.
Summary
This is a randomized controlled trial of the efficacy and safety evaluation of oral administration of Bromhexine hydrochloride for the prevention of SARS-CoV-2 infection and COVID-19 disease in medical personnel assisting patients with a new coronavirus disease
Linked Publications
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Bromhexine Hydrochloride Prophylaxis of COVID-19 for Medical Personnel: A Randomized Open-Label Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Negative Polymerase Chain Reaction (PCR) |
2; 7 | — |
| SECONDARY Number of Participants With Asymptomatic SARS-CoV-2 Infection |
2; 2 | — |
| SECONDARY Number of Participants With Mild, Moderate and Severe COVID-19 Disease |
0; 5 | — |
| SECONDARY Number of Participants With Adverse Events |
2; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Age of 18 years or more;
- Negative test (PCR) for SARS-CoV-2 infection;
- The absence of clinical manifestations of a respiratory infection;
- Contact with patients with laboratory and / or clinically confirmed SARS-CoV-2 infection;
- Signed informed consent to participate in the study.
Exclusion Criteria
- Intolerance to Bromhexine hydrochloride;
- Work out of contact with SARS-CoV-2 infection;
- Non-compliance with the rules for the use of personal protective equipment when working with SARS-CoV-2 infection (the rules for the use of personal protective equipment in accordance with the recommendations of the Ministry of Health of Russia and the internal orders of the Director General of Almazov NMRC, relevant to the dates of research);
- Pregnancy and the period of breastfeeding;
- Other circumstances that the researcher considers inappropriate to participate in this study
Data sourced from ClinicalTrials.gov (NCT04405999) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.