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

Fudan University

Status: Enrolling

Conditions: COVID-19

Treatments: Drug: Glucocorticoid

Study type: Interventional

Funder types: Other

Identifiers

NCT05855395

BEAT-COV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,815 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 65;
• Male or female;
• Positive test for coronavirus antigen or nucleic acid；
• Within 7 days of onset (fever and/or cough) ；
• mild and moderate；Mild: respiratory tract infection is the main manifestation, such as dry throat, sore throat, cough, fever；Moderate: continuous high fever>3 days or (and) cough, shortness of breath, etc., but respiratory rate (RR)<30 times/minute, oxygen saturation>93% when breathing air at rest. Imaging findings of characteristic pneumonia caused by COVID-19 infection；
• The patient is willing to participate in the trial treatment and follow-up, and sign the informed consent form (if the patient lacks the ability to give informed consent due to his serious medical condition, such as acute respiratory failure or the need for respiratory support, he can obtain the consent of the patient's legal representative)；
• No systemic glucocorticoids treatment in the past 7 days；

Exclusion criteria

• Serious and uncontrolled comorbidities；
• Expected lifetime is less than 1 month；
• Severe/critical;
• Other situations that are evaluated by researchers as not suitable for participating the study.

Criteria for discontinuation

• The subject could not benefit after treatment (discontinued patients could be analyzed according to the PP analysis set);

Withdrawal criteria (if any of the following items are required)

• The subject asked to withdraw from the study;
• The subject needs to withdraw from the study after clinical observation after discontinuing treatment;
• The subject died or lost to follow-up.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

5,815 participants in 2 patient groups

Group A

Experimental group

Description:

Experimental group with 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)

Treatment:

Drug: Glucocorticoid

Group B

No Intervention group

Description:

Control group with standard of care（The clinical standard of care of COVID-19 includes general treatment, oral antiviral drugs, immunotherapy, oxygen therapy and respiratory support, etc.）