Prevention of Infection and Incidence of COVID-19 in Medical Personnel Assisting Patients With New Coronavirus Disease

NCT04405999 | Completed Phase 4 Results DMC

• 1 other identifier: 05-20-02-С
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Increased Risk of SARS-CoV-2 Infection

Outcome Measures

Primary Outcomes (1)

• Negative Polymerase Chain Reaction (PCR)

  Number of Participants with Negative PCR of SARS-CoV-2 and The Absence of Clinical Manifestations of COVID-19 Infection in individuals taking Bromhexine hydrochloride 4 weeks after randomization.

  4 weeks after randomization

Secondary Outcomes (3)

• Number of Participants With Asymptomatic SARS-CoV-2 Infection

  14 days after last contact

• Number of Participants With Mild, Moderate and Severe COVID-19 Disease

  14 days after last contact

• Number of Participants With Adverse Events

  14 days after last contact

Study Arms (2)

Bromhexine hydrochloride Group

EXPERIMENTAL

medical personnel at risk for COVID-19 infection with oral administration of Bromhexine hydrochloride

Drug: Bromhexine Hydrochloride

Control Group

NO INTERVENTION

medical personnel at risk for COVID-19 infection without oral administration of Bromhexine hydrochloride

Interventions

Bromhexine Hydrochloride DRUG

Medical personnel at risk for COVID-19 infection will receive study medication for 14 days

Bromhexine hydrochloride Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health: lead

Study Sites (1)

Almazov National Medical Research Centre

Saint Petersburg, 197341, Russia

Location

Related Publications (1)

• Mikhaylov EN, Lyubimtseva TA, Vakhrushev AD, Stepanov D, Lebedev DS, Vasilieva EY, Konradi AO, Shlyakhto EV. Bromhexine Hydrochloride Prophylaxis of COVID-19 for Medical Personnel: A Randomized Open-Label Study. Interdiscip Perspect Infect Dis. 2022 Jan 29;2022:4693121. doi: 10.1155/2022/4693121. eCollection 2022.

  PMID: 35103059 DERIVED

MeSH Terms

Interventions

Bromhexine

Intervention Hierarchy (Ancestors)

Aniline Compounds; Amines; Organic Chemicals; Cyclohexylamines

Results Point of Contact

• Title: Evgeny Mikhaylov
• Organization: Almazov National Medical Research Centre

e.mikhaylov@almazovcentre.ru

+7(812)7023764

Study Officials

• Evgeny Mikhaylov, MD, PhD

  Almazov National Medical Research Centre

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 28, 2020
• Study Start: May 14, 2020
• Primary Completion: August 9, 2020
• Study Completion: August 31, 2020
• Last Updated: April 13, 2022
• Results First Posted: April 13, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)