search
Back to results

BromhexIne And Spironolactone For CoronаVirUs Infection Requiring HospiTalization (BISCUIT)

Primary Purpose

COVID 19

Status
Unknown status
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Bromhexine and Spironolactone
Base therapy
Sponsored by
Lomonosov Moscow State University Medical Research and Educational Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID 19 focused on measuring COVID 19, bromhexine, spironolactone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lomonosov Moscow State University Medical Research and Educational CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bromhexine And Spironolactone

Base therapy

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in clinical assessment score COVID 19 (CAS COVID 19)
change in CAS COVID 19 between baseline and 12th +/- 2 days CAS COVID 19 measures clinical and laboratory parameters in 7 domains: respiratory rate (< 18 - 0 point; 18-22 - 1 point; 23-26 - 2 point; >26 - 3 point) body temperature (35.5 - 37.0 - 0 point; < 35.5 - 1 point; 37.1 - 38.5 - 1 point; > 38.5 - 2 point) Sp02 without support oxygen (> 93% - 0 point; 90-93% - 1 point; < 90% - 2 point) ventilation (not required - 0 point; low-flow ventilation - 1 point; Non-invasive positive pressure ventilation - 2 point; mechanical ventilation - 3 point) C-reactive protein (> 10 - 0 point; 10-59 - 1 point; 60-120 - 2 point; > 120 - 3 point) d - dimer (< 0.51 - 0 point; 0.51 - 2.0 - 1 point; 2.01 - 5.0 - 2, > 5.0 - 3 point) exposure area on lung CT (no pneumonia - 0; 1-24% - 1 point; 25-50% - 2; 51-75% - 3, > 75% - 4). Minimal number of points - 0; max - 20.Lower the score-better health

Secondary Outcome Measures

- Combine endpoint -
time to death or mechanical ventilation
C-reactive protein
- Change from baseline in C-reactive protein
D-dimer
- Change from baseline in D-dimer
EuroQol Group. EQ-5D™
Change from baseline in EQ-5D. The EQ-5D descriptive system comprises the 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box to the most appropriate statement. This decision results into a 1-digit number, . The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
EuroQol Group. EQ VAS
Change from baseline in EQ VAS EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome by patient's own judgement.
HADS
- Change from baseline Hospital Anxiety and Depression Scale/The Hospital Anxiety and Depression Scale (HADS) is a 14-item measure designed to assess anxiety and depression symptoms in medical patients, with emphasis on reducing the impact of physical illness on the total score. Items are rated on a 4-point severity scale. The HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states. Scores of greater than or equal to 11 on either scale indicate a definitive case
Hospital length of stay
Time from admission to the hospital to discharge form the hospital

Full Information

First Posted
May 27, 2020
Last Updated
June 7, 2020
Sponsor
Lomonosov Moscow State University Medical Research and Educational Center
search

1. Study Identification

Unique Protocol Identification Number
NCT04424134
Brief Title
BromhexIne And Spironolactone For CoronаVirUs Infection Requiring HospiTalization
Acronym
BISCUIT
Official Title
Open Label Randomized Clinical Trial BromhexIne And Spironolactone For CoronаVirUs Infection Requiring HospiTalization
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 16, 2020 (Actual)
Primary Completion Date
July 18, 2020 (Anticipated)
Study Completion Date
August 23, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lomonosov Moscow State University Medical Research and Educational Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID 19
Keywords
COVID 19, bromhexine, spironolactone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bromhexine And Spironolactone
Arm Type
Experimental
Arm Title
Base therapy
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Bromhexine and Spironolactone
Intervention Description
Bromhexine 8 mg x 4 times a day x 10 days Spironolactone 50 mg x once a day x 10 days
Intervention Type
Drug
Intervention Name(s)
Base therapy
Intervention Description
Therapy currently recommended by Ministry of Health of Russian Federation for COVID 19 treatment
Primary Outcome Measure Information:
Title
Change from baseline in clinical assessment score COVID 19 (CAS COVID 19)
Description
change in CAS COVID 19 between baseline and 12th +/- 2 days CAS COVID 19 measures clinical and laboratory parameters in 7 domains: respiratory rate (< 18 - 0 point; 18-22 - 1 point; 23-26 - 2 point; >26 - 3 point) body temperature (35.5 - 37.0 - 0 point; < 35.5 - 1 point; 37.1 - 38.5 - 1 point; > 38.5 - 2 point) Sp02 without support oxygen (> 93% - 0 point; 90-93% - 1 point; < 90% - 2 point) ventilation (not required - 0 point; low-flow ventilation - 1 point; Non-invasive positive pressure ventilation - 2 point; mechanical ventilation - 3 point) C-reactive protein (> 10 - 0 point; 10-59 - 1 point; 60-120 - 2 point; > 120 - 3 point) d - dimer (< 0.51 - 0 point; 0.51 - 2.0 - 1 point; 2.01 - 5.0 - 2, > 5.0 - 3 point) exposure area on lung CT (no pneumonia - 0; 1-24% - 1 point; 25-50% - 2; 51-75% - 3, > 75% - 4). Minimal number of points - 0; max - 20.Lower the score-better health
Time Frame
baseline, day 12
Secondary Outcome Measure Information:
Title
- Combine endpoint -
Description
time to death or mechanical ventilation
Time Frame
12 days, 45 days
Title
C-reactive protein
Description
- Change from baseline in C-reactive protein
Time Frame
12 days, 45 days
Title
D-dimer
Description
- Change from baseline in D-dimer
Time Frame
12 days, 45 days
Title
EuroQol Group. EQ-5D™
Description
Change from baseline in EQ-5D. The EQ-5D descriptive system comprises the 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box to the most appropriate statement. This decision results into a 1-digit number, . The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Time Frame
12 days, 45 days
Title
EuroQol Group. EQ VAS
Description
Change from baseline in EQ VAS EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome by patient's own judgement.
Time Frame
12 days, 45 days
Title
HADS
Description
- Change from baseline Hospital Anxiety and Depression Scale/The Hospital Anxiety and Depression Scale (HADS) is a 14-item measure designed to assess anxiety and depression symptoms in medical patients, with emphasis on reducing the impact of physical illness on the total score. Items are rated on a 4-point severity scale. The HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states. Scores of greater than or equal to 11 on either scale indicate a definitive case
Time Frame
14 days, 45 days
Title
Hospital length of stay
Description
Time from admission to the hospital to discharge form the hospital
Time Frame
up to 45 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julia Begrambekova
Phone
+79854679273
Email
julia.begrambekova@ossn.ru
Facility Information:
Facility Name
Lomonosov Moscow State University Medical Research and Educational Center
City
Moscow
State/Province
Moscow Region
ZIP/Postal Code
119620
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia Begrambekova, Phd
Phone
+79854679273
Email
begrambekova@ossn.ru
First Name & Middle Initial & Last Name & Degree
Yana Orlova, Professor
Phone
+791651663002
Email
yaorlova@mc.msu.ru

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
After publishing
IPD Sharing Access Criteria
any application for access the data will be evaluated by ethical commite of LOMONOSOV MOSCOW STATE UNIVERSITY MEDICAL RESEARCH AND EDUCATIONAL CENTER

Learn more about this trial

BromhexIne And Spironolactone For CoronаVirUs Infection Requiring HospiTalization

We'll reach out to this number within 24 hrs