BromhexIne And Spironolactone For CoronаVirUs Infection Requiring HospiTalization

NCT ID: NCT04424134

Last Updated: 2020-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-16

Study Completion Date

2020-08-23

Brief Summary

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Patients with mild and severe COVID 19 will be randomized 1:1 into two groups: experimental, which will get bromhexine and spironolactone, and control. Patients will get investigated therapy for ten days. Change in clinical assessment score COVID 19 (CAS COVID 19) between baseline and 12th day will be evaluated as a primary endpoint. Forty-five-day risk of death or mechanical ventilation will also be assessed.

Detailed Description

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Conditions

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COVID 19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Bromhexine And Spironolactone

Group Type EXPERIMENTAL

Bromhexine and Spironolactone

Intervention Type DRUG

Bromhexine 8 mg x 4 times a day x 10 days Spironolactone 50 mg x once a day x 10 days

Base therapy

Group Type ACTIVE_COMPARATOR

Base therapy

Intervention Type DRUG

Therapy currently recommended by Ministry of Health of Russian Federation for COVID 19 treatment

Interventions

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Bromhexine and Spironolactone

Bromhexine 8 mg x 4 times a day x 10 days Spironolactone 50 mg x once a day x 10 days

Intervention Type DRUG

Base therapy

Therapy currently recommended by Ministry of Health of Russian Federation for COVID 19 treatment

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

signed inform consent COVID 19 with the mild and severe course. The diagnosis could be made with positive polymerase chain reaction (PCR) (International Statistical Classification (ICD-10) code - U07.1) and/or virus pneumonia in computer tomography (ICD 10 code - U07.2) 5. Lung exposure on CT more than 25% 6. Sp02 without supportive oxygen ≤ 93% 7. C-reactive protein \> 60 mg/l or elevation of C reactive protein 3 times in 8-14 days after first symptoms

Exclusion Criteria

* pregnancy and breastfeeding
* hypersensitivity to Spironolactone
* hypersensitivity to Bromhexine
* Known liver failure
* Glomerular filtration rate \<20 ml/ min
* physician judgment that the patient will need mechanical ventilation in 24 hours
* other indications for Spironolactone
* Active cancer
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lomonosov Moscow State University Medical Research and Educational Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Lomonosov Moscow State University Medical Research and Educational Center

Moscow, Moscow Oblast, Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Julia Begrambekova

Role: CONTACT

+79854679273

Facility Contacts

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Julia Begrambekova, Phd

Role: primary

+79854679273

Yana Orlova, Professor

Role: backup

+791651663002

Other Identifiers

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MSU160520

Identifier Type: -

Identifier Source: org_study_id

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