NCT04424134

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2020

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 16, 2020

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2020

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

2 months

First QC Date

May 27, 2020

Last Update Submit

June 7, 2020

Conditions

COVID 19

Keywords

COVID 19bromhexinespironolactone

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • - Combine endpoint -

    12 days, 45 days

  • C-reactive protein

    12 days, 45 days

  • D-dimer

    12 days, 45 days

  • EuroQol Group. EQ-5D™

    12 days, 45 days

  • EuroQol Group. EQ VAS

    12 days, 45 days

  • +2 more secondary outcomes

Study Arms (2)

Bromhexine And Spironolactone

EXPERIMENTAL
Drug: Bromhexine and Spironolactone

Base therapy

ACTIVE COMPARATOR
Drug: Base therapy

Interventions

Bromhexine and SpironolactoneDRUG

Bromhexine 8 mg x 4 times a day x 10 days Spironolactone 50 mg x once a day x 10 days

Bromhexine And Spironolactone
Base therapyDRUG

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

Base therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lomonosov Moscow State University Medical Research and Educational Center

Moscow, Moscow Oblast, 119620, Russia

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

BromhexineSpironolactone

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Aniline CompoundsAminesOrganic ChemicalsCyclohexylaminesLactonesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Central Study Contacts

Julia Begrambekova

CONTACT

+79854679273julia.begrambekova@ossn.ru

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2020

First Posted

June 9, 2020

Study Start

May 16, 2020

Primary Completion

July 18, 2020

Study Completion

August 23, 2020

Last Updated

June 9, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF, 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

Locations

RU(1)