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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Glucocorticoid


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>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) | Drug: Glucocorticoid<br>* 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)<br>* Other names: methylprednisolone;|
| No Intervention: Group B<br>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.） | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who progress to severe or critical COVID-19 within 28 days | Definition of severe COVID-19 At rest, oxygen saturation ≤ 93% when inhaling air; Progression due to COVID-19 (defined as >50% of significant progression of lesions within 24 48 hours on lung imaging; or respiratory failure requiring mechanical ventilation; or emergency department visits or hospitalizations with shock) and/or complications (comitant other organ failure requiring intensive care unit monitoring). | In 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of antigen or nucleic acid negative conversion | Duration of antigen or nucleic acid negative conversion | In 28 days | 
| Day 14 antigen or nucleic acid conversion rate | Day 14 antigen or nucleic acid conversion rate | Day 14 | 
| Time for initial symptom relief，Duration of symptom relief | Time for initial all symptoms relief (Date when symptoms were first reported as mild or asymptomatic), Duration of all symptoms relief(The date when all symptoms were first reported as mild or asymptomatic, followed by remaining mild or asymptomatic until the 14th day） | In 14 days | 
| All-cause mortality | Short-term case fatality rate defined in the study, including case fatality on day 28 | In 28 days | 
| Days of respiratory symptoms | Days of respiratory symptoms | In 28 days | 
| Duration of outpatient hospitalization/emergency department visits due to COVID-19 progression(from the date of enrollment) | Duration of outpatient hospitalization/emergency department visits due to COVID-19 progression(from the date of enrollment) | In 28 days | 
| Length of hospital stay for any reason | Length of hospital stay for any reason | In 28 days | 
| Proportion of patients who progress to severe or critical COVID-19 within 28 days | Oxygen saturation ≤ 93% when inhaling air at rest | In 28 days | 
| Proportion of emergency department visits or hospitalizations due to COVID-19 progression | Progression due to COVID-19 (defined as >50% of significant progression of lesions within 24 48 hours on lung imaging; or respiratory failure requiring mechanical ventilation; or emergency department visits or hospitalizations with shock) and/or complications (comitant other organ failure requiring intensive care unit monitoring). | In 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glucocorticoids, Standard of care, Mild and moderate COVID-19