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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05855395
• Other study ID #: BEAT-COV
• Status: Recruiting
• Phase: N/A
• Start date: May 26, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: July 2023
• Source: Huashan Hospital
• Contact: QiaoLing Ruan, M.D.
• Phone: 13661856002
• Email: ruan_qiao_ling[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5815
• Est. completion date: December 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

Agusti A, De Stefano G, Levi A, Munoz X, Romero-Mesones C, Sibila O, Lopez-Giraldo A, Plaza Moral V, Curto E, Echazarreta AL, Marquez SE, Pascual-Guardia S, Santos S, Marin A, Valdes L, Saldarini F, Salgado C, Casanovas G, Varea S, Rios J, Faner R. Add-on inhaled budesonide in the treatment of hospitalised patients with COVID-19: a randomised clinical trial. Eur Respir J. 2022 Mar 10;59(3):2103036. doi: 10.1183/13993003.03036-2021. Print 2022 Mar. — View Citation

Lamontagne F, Agarwal A, Rochwerg B, Siemieniuk RA, Agoritsas T, Askie L, Lytvyn L, Leo YS, Macdonald H, Zeng L, Amin W, da Silva ARA, Aryal D, Barragan FAJ, Bausch FJ, Burhan E, Calfee CS, Cecconi M, Chacko B, Chanda D, Dat VQ, De Sutter A, Du B, Freedman S, Geduld H, Gee P, Gotte M, Harley N, Hashimi M, Hunt B, Jehan F, Kabra SK, Kanda S, Kim YJ, Kissoon N, Krishna S, Kuppalli K, Kwizera A, Lado Castro-Rial M, Lisboa T, Lodha R, Mahaka I, Manai H, Mendelson M, Migliori GB, Mino G, Nsutebu E, Preller J, Pshenichnaya N, Qadir N, Relan P, Sabzwari S, Sarin R, Shankar-Hari M, Sharland M, Shen Y, Ranganathan SS, Souza JP, Stegemann M, Swanstrom R, Ugarte S, Uyeki T, Venkatapuram S, Vuyiseka D, Wijewickrama A, Tran L, Zeraatkar D, Bartoszko JJ, Ge L, Brignardello-Petersen R, Owen A, Guyatt G, Diaz J, Kawano-Dourado L, Jacobs M, Vandvik PO. A living WHO guideline on drugs for covid-19. BMJ. 2020 Sep 4;370:m3379. doi: 10.1136/bmj.m3379. Erratum In: BMJ. 2022 Apr 25;377:o1045. — View Citation

Orchard K, Dignan FL, Lee J, Pearce R, Desai M, McFarlane E, Parkin A, Shearn P, Snowden JA. The NICE COVID-19 rapid guideline on haematopoietic stem cell transplantation: development, implementation and impact. Br J Haematol. 2021 Feb;192(3):467-473. doi: 10.1111/bjh.17280. Epub 2021 Jan 20. No abstract available. — View Citation

Song JY, Yoon JG, Seo YB, Lee J, Eom JS, Lee JS, Choi WS, Lee EY, Choi YA, Hyun HJ, Seong H, Noh JY, Cheong HJ, Kim WJ. Ciclesonide Inhaler Treatment for Mild-to-Moderate COVID-19: A Randomized, Open-Label, Phase 2 Trial. J Clin Med. 2021 Aug 12;10(16):3545. doi: 10.3390/jcm10163545. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ADRs and SADRs associated with glucocorticoid therapy and antiviral therapy(One of the standard treatments) were collected	ADRs and SADRs associated with glucocorticoid therapy and antiviral therapy(One of the standard treatments) were collected	In 14 days
Primary	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	Duration of antigen or nucleic acid negative conversion	Duration of antigen or nucleic acid negative conversion	In 28 days
Secondary	Day 14 antigen or nucleic acid conversion rate	Day 14 antigen or nucleic acid conversion rate	Day 14
Secondary	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
Secondary	All-cause mortality	Short-term case fatality rate defined in the study, including case fatality on day 28	In 28 days
Secondary	Days of respiratory symptoms	Days of respiratory symptoms	In 28 days
Secondary	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
Secondary	Length of hospital stay for any reason	Length of hospital stay for any reason	In 28 days
Secondary	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
Secondary	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

External Links

•   Guide:Diagnosis and Treatment Plan for COVID-19 (Tenth Edition on Trial)