NCT04424134

BromhexIne And Spironolactone For CoronаVirUs Infection Requiring HospiTalization

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Lomonosov Moscow State University Medical Research and Educational Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID 19

Interventions

Type	Name	Description
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
DRUG	Base therapy	Therapy currently recommended by Ministry of Health of Russian Federation for COVID 19 treatment

Timeline

• Start date: 2020-05-16
• Primary completion: 2020-07-18
• Completion: 2020-08-23
• First posted: 2020-06-09
• Last updated: 2020-06-09

Locations

1 site across 1 country: Russia