Combining standard care with glucocorticoids for elderly patients 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

This study is testing if adding low-dose glucocorticoids to standard care can help older adults with mild or moderate COVID-19 avoid getting sicker.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 5815 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Huashan Hospital (Academic / other)
• Locations: 15 sites (Fuzhou, Fujian and 14 other locations)
• Trial ID: NCT05855395 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness and safety of a treatment strategy that combines standard care with low-dose glucocorticoids for elderly patients aged 65 and older who have mild or moderate COVID-19. It is a multicenter, randomized, controlled trial aimed at preventing the progression of the disease to severe stages. Participants must have tested positive for COVID-19 within 7 days of symptom onset and will be monitored for outcomes related to disease progression and mortality. The goal is to identify the best approach to manage COVID-19 in this vulnerable population.

Who should consider this trial

Good fit: Ideal candidates are elderly individuals aged 65 and older with mild to moderate COVID-19 symptoms who have tested positive for the virus.

Not a fit: Patients with serious and uncontrolled comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of severe COVID-19 and improve survival rates among elderly patients.

How similar studies have performed: Other studies have shown promise in using glucocorticoids for COVID-19 treatment, suggesting potential for success in this approach.

Eligibility criteria

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.

Where this trial is running

Fuzhou, Fujian and 14 other locations

• The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (Not_yet_recruiting)
• Quanzhou First Hospital — Quanzhou, Fujian, China (Not_yet_recruiting)
• The Fifth Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
• Attached Hospital of Zunyi Medical College — Zunyi, Guizhou, China (Not_yet_recruiting)
• Huaihua First People's Hospital — Huaihua, Hunan, China (Recruiting)
• Nanjing Hospital of Traditional Chinese Medicine — Nanjing, Jiangsu, China (Recruiting)
• Affiliated Drum Tower Hospital, Medical School of Nanjing University — Nanjing, Jiangsu, China (Not_yet_recruiting)
• Wuxi Fifth People's Hospital — Wuxi, Jiangsu, China (Recruiting)
• The People's Hospital Of Xingguo County — Ganzhou, Jiangxi, China (Not_yet_recruiting)
• The First Hospital of Shanxi Medical University — Taiyuan, Shanxi, China (Recruiting)
• Affiliated Hospital of Southwest Medical University — Luzhou, Sichuan, China (Not_yet_recruiting)
• The First People's Hospital Of YunNan — Kunming, Yunnan, China (Recruiting)
• People's Hospital of Qiubei County, Yunnan Province — Wenshan, Yunnan, China (Recruiting)
• Hangzhou Linping District First People's Hospital — Hanzhou, Zhejiang, China (Not_yet_recruiting)
• Wenzhou Central Hospital — Wenzhou, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Principal investigator: WenHong Zhang, M.D. — Huashan Hospital
• Study coordinator: QiaoLing Ruan, M.D.

Conditions COVID-19; Glucocorticoids; Standard of care; Mild and moderate COVID-19