BromhexIne And Spironolactone For CoronаVirUs Infection Requiring HospiTalization

NCT04424134 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-06-09

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Lomonosov Moscow State University Medical Research and Educational Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-16
Primary Completion
2020-07-18
Completion
2020-08-23

Countries

  • Russia

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04424134 on ClinicalTrials.gov