NCT04826822

Spironolactone and Dexamethasone in Patients Hospitalized With COVID-19

Spironolactone and Dexamethasone in Patients Hospitalized With Moderate-to-severe COVID-19 (SPIDEX-II): a Randomized Clinical Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 440 (estimated)
• Sponsor: Chita State Regional Clinical Hospital Number 1 · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2021-02-24
• Primary completion: 2021-07-08
• Completion: 2021-09-02
• First posted: 2021-04-01
• Last updated: 2021-04-01

Locations

1 site across 1 country: Russia