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Spironolactone and Dexamethasone in Patients Hospitalized With COVID-19

NCT04826822 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2021-04-01

No results posted yet for this study

Summary

The Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) is a rapidly spreading infection of the respiratory tract. Most infected patients have either asymptomatic disease or mild symptoms. However, a proportion of patients, especially elderly men or patients with comorbidities, are at risk of developing acute respiratory distress syndrome (ARDS). ARDS, alongside clotting abnormalities, is known to be a major contributor to SARS-CoV-2-related mortality and admission to intensive care units, with evidenced effective preventative treatment options lacking. In this study, the investigators test a novel hypothesis that the use of a combination of spironolactone and dexamethasone at low doses will improve the clinical progression of the infection evaluated by the 6-point ordinal scale in patients with moderate and severe disease by blocking exocytosis of the Weibel-Palade bodies from endothelial cells.

Conditions

  • Coronavirus Infection
  • Pneumonia, Viral

Interventions

DRUG

Spironolactone + Dexamethasone

Low doses of orally administered spironolactone and dexamethasone

DRUG

Standard-of-care SARS-CoV-2 treatment

Standard-of-care SARS-CoV-2 treatment administered according to the local guidelines

Sponsors & Collaborators

  • Chita State Regional Clinical Hospital Number 1

    lead OTHER_GOV

Principal Investigators

  • Sergey Lukyanov, MD · Chita State Regional Clinical Hospital Number 1

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-24
Primary Completion
2021-07-08
Completion
2021-09-02

Countries

  • Russia

Study Locations

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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 NCT04826822 on ClinicalTrials.gov