BromhexIne And Spironolactone For CoronаVirUs Infection Requiring HospiTalization

Phase 3

• Conditions: COVID 19
• Interventions: Drug: Bromhexine and Spironolactone; Drug: Base therapy

• Registration Number: NCT04424134
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-16
• Study First Submitted: 2020-05-27
• Status Verified: 2020-06
• Study First Submitted QC: 2020-06-07
• Last Update Submitted: 2020-06-07
• Study First Posted: 2020-06-09
• Last Update Posted: 2020-06-09
• Primary Completion: 2020-07-18
• Study Completion: 2020-08-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bromhexine And Spironolactone	Bromhexine and Spironolactone	-
Base therapy	Base therapy	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in clinical assessment score COVID 19 (CAS COVID 19)	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

Name	Time	Method
- Combine endpoint -	12 days, 45 days	time to death or mechanical ventilation
Hospital length of stay	up to 45 days	Time from admission to the hospital to discharge form the hospital
C-reactive protein	12 days, 45 days	- Change from baseline in C-reactive protein
EuroQol Group. EQ-5D™	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.
HADS	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
EuroQol Group. EQ VAS	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.
D-dimer	12 days, 45 days	- Change from baseline in D-dimer

Trial Locations

Locations (1)

Lomonosov Moscow State University Medical Research and Educational Center; 🇷🇺 Moscow, Moscow Region, Russian Federation