NCT05855395

The Standard of Care Combined With Glucocorticoid in Elderly People With Mild or Moderate COVID-19

A Bidimensional Early Intervention Strategy of Standard of Care Combined With Host Immunomodulation in Elderly Patients With Mild or Moderate COVID-19: A Multicentre, Randomized, Controlled, Adaptive Platform Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 5,815 (estimated)
• Sponsor: Huashan Hospital · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

This study is aimed to explore the dual-dimensional early intervention strategy of standard of care combined with host immunomodulation in elderly patients with mild and moderate COVID-19.

Detailed description

In this multicentre, randomized, controlled, and adaptive platform trial exploring the efficacy and safety of short-term and low-dose glucocorticoid combined with standard of care in mild or moderate elderly patients (with or without other high-risk factors) who are over 65 years.We are looking for the best treatment strategy to prevent mild or moderate COVID-19 from developing into severe/critical COVID-19, so as to reduce the risk of disease progression and death in the elderly patients and benefit more patients.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Glucocorticoid	standard of care combined with glucocorticoid(dexamethasone: 3mg qd x 5 days; or prednisone: 20mg qd x 5 days; or methylprednisolone: 16mg qd x 5 days)

Timeline

• Start date: 2023-05-26
• Primary completion: 2024-05-01
• Completion: 2024-12-01
• First posted: 2023-05-11
• Last updated: 2023-07-12

Locations

15 sites across 1 country: China