BromhexIne And Spironolactone For CoronаVirUs Infection Requiring HospiTalization

COVID 19 Clinical Trial

— BISCUIT  

Official title:

Open Label Randomized Clinical Trial BromhexIne And Spironolactone For CoronаVirUs Infection Requiring HospiTalization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04424134
• Other study ID #: MSU160520
• Status: Recruiting
• Phase: Phase 3
• Start date: May 16, 2020
• Est. completion date: August 23, 2020

Study information

• Verified date: June 2020
• Source: Lomonosov Moscow State University Medical Research and Educational Center
• Contact: Julia Begrambekova
• Phone: +79854679273
• Email: julia.begrambekova[@]ossn.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 23, 2020
• Est. primary completion date: July 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infections
• COVID 19
• Severe Acute Respiratory Syndrome

Intervention

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

Locations

Country	Name	City	State
Russian Federation	Lomonosov Moscow State University Medical Research and Educational Center	Moscow	Moscow Region

Sponsors (1)

Lead Sponsor	Collaborator
Lomonosov Moscow State University Medical Research and Educational Center

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline, day 12
Secondary	- Combine endpoint -	time to death or mechanical ventilation	12 days, 45 days
Secondary	C-reactive protein	- Change from baseline in C-reactive protein	12 days, 45 days
Secondary	D-dimer	- Change from baseline in D-dimer	12 days, 45 days
Secondary	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.	12 days, 45 days
Secondary	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.	12 days, 45 days
Secondary	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	14 days, 45 days
Secondary	Hospital length of stay	Time from admission to the hospital to discharge form the hospital	up to 45 days