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BromhexIne And Spironolactone For CoronаVirUs Infection Requiring HospiTalization (BISCUIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04424134
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Lomonosov Moscow State University Medical Research and Educational Center

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.

Condition or disease Intervention/treatment Phase
COVID 19 Drug: Bromhexine and Spironolactone Drug: Base therapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Open Label Randomized Clinical Trial BromhexIne And Spironolactone For CoronаVirUs Infection Requiring HospiTalization
Actual Study Start Date : May 16, 2020
Estimated Primary Completion Date : July 18, 2020
Estimated Study Completion Date : August 23, 2020


Arm Intervention/treatment
Experimental: Bromhexine And Spironolactone Drug: Bromhexine and Spironolactone
Bromhexine 8 mg x 4 times a day x 10 days Spironolactone 50 mg x once a day x 10 days

Active Comparator: Base therapy Drug: Base therapy
Therapy currently recommended by Ministry of Health of Russian Federation for COVID 19 treatment




Primary Outcome Measures :
  1. Change from baseline in clinical assessment score COVID 19 (CAS COVID 19) [ Time Frame: baseline, day 12 ]

    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 :
  1. - Combine endpoint - [ Time Frame: 12 days, 45 days ]
    time to death or mechanical ventilation

  2. C-reactive protein [ Time Frame: 12 days, 45 days ]
    - Change from baseline in C-reactive protein

  3. D-dimer [ Time Frame: 12 days, 45 days ]
    - Change from baseline in D-dimer

  4. EuroQol Group. EQ-5D™ [ Time Frame: 12 days, 45 days ]

    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.


  5. EuroQol Group. EQ VAS [ Time Frame: 12 days, 45 days ]

    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.


  6. HADS [ Time Frame: 14 days, 45 days ]
    - 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

  7. Hospital length of stay [ Time Frame: up to 45 days ]
    Time from admission to the hospital to discharge form the hospital



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04424134


Contacts
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Contact: Julia Begrambekova +79854679273 julia.begrambekova@ossn.ru

Locations
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Russian Federation
Lomonosov Moscow State University Medical Research and Educational Center Recruiting
Moscow, Moscow Region, Russian Federation, 119620
Contact: Julia Begrambekova, Phd    +79854679273    begrambekova@ossn.ru   
Contact: Yana Orlova, Professor    +791651663002    yaorlova@mc.msu.ru   
Sponsors and Collaborators
Lomonosov Moscow State University Medical Research and Educational Center
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Responsible Party: Lomonosov Moscow State University Medical Research and Educational Center
ClinicalTrials.gov Identifier: NCT04424134    
Other Study ID Numbers: MSU160520
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: After publishing
Access Criteria: any application for access the data will be evaluated by ethical commite of LOMONOSOV MOSCOW STATE UNIVERSITY MEDICAL RESEARCH AND EDUCATIONAL CENTER

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lomonosov Moscow State University Medical Research and Educational Center:
COVID 19
bromhexine
spironolactone
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Spironolactone
Bromhexine
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Expectorants
Respiratory System Agents