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

NCT05855395 | Unknown

• 1 other identifier: BEAT-COV
• Study Type: interventional
• Target: 5,815
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

COVID-19

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who progress to severe or critical COVID-19 within 28 days

  Definition of severe COVID-19 1. At rest, oxygen saturation ≤ 93% when inhaling air; 2. 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 Outcomes (9)

• Duration of antigen or nucleic acid negative conversion

  In 28 days

• Day 14 antigen or nucleic acid conversion rate

  Day 14

• Time for initial symptom relief，Duration of symptom relief

  In 14 days

• All-cause mortality

  In 28 days

• Days of respiratory symptoms

  In 28 days

Other Outcomes (1)

• ADRs and SADRs associated with glucocorticoid therapy and antiviral therapy（One of the standard treatments) were collected

  In 14 days

Study Arms (2)

Group A

EXPERIMENTAL

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

Group B

NO INTERVENTION

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.）

Interventions

Glucocorticoid DRUG

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)

Also known as: dexamethasone, prednisone, methylprednisolone

Group A

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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；

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (15)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350004, China

NOT YET RECRUITING

Quanzhou First Hospital

Quanzhou, Fujian, 362000, China

NOT YET RECRUITING

The Fifth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

Attached Hospital of Zunyi Medical College

Zunyi, Guizhou, 563099, China

NOT YET RECRUITING

Huaihua First People's Hospital

Huaihua, Hunan, 418000, China

RECRUITING

Nanjing Hospital of Traditional Chinese Medicine

Nanjing, Jiangsu, 210006, China

RECRUITING

Affiliated Drum Tower Hospital, Medical School of Nanjing University

Nanjing, Jiangsu, 210008, China

NOT YET RECRUITING

Wuxi Fifth People's Hospital

Wuxi, Jiangsu, 214000, China

RECRUITING

The People's Hospital Of Xingguo County

Ganzhou, Jiangxi, 342400, China

NOT YET RECRUITING

The First Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030000, China

RECRUITING

Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, 646000, China

NOT YET RECRUITING

The First People's Hospital Of YunNan

Kunming, Yunnan, 650100, China

RECRUITING

People's Hospital of Qiubei County, Yunnan Province

Wenshan, Yunnan, 663299, China

RECRUITING

Hangzhou Linping District First People's Hospital

Hanzhou, Zhejiang, 310000, China

NOT YET RECRUITING

Wenzhou Central Hospital

Wenzhou, Zhejiang, 325099, China

NOT YET RECRUITING

Related 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.

  PMID: 35144989 BACKGROUND

• 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.

  PMID: 34441840 BACKGROUND

• Agarwal A, Hunt B, Stegemann M, Rochwerg B, Lamontagne F, Siemieniuk RA, Agoritsas T, Askie L, Lytvyn L, Leo YS, Macdonald H, Zeng L, Alhadyan A, Muna A, 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, Haider M, Gotte M, Harley N, Hashimi M, Hui D, Ismail M, 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, Peter J, Preller J, Pshenichnaya N, Qadir N, Ranganathan SS, Relan P, Rylance J, Sabzwari S, Sarin R, Shankar-Hari M, Sharland M, Shen Y, Souza JP, Swanstrom R, Tshokey T, Ugarte S, Uyeki T, Evangelina VC, 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.

  PMID: 32887691 BACKGROUND

• 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.

  PMID: 33474730 BACKGROUND

Related Links

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

MeSH Terms

Conditions

COVID-19; Lymphoma, Follicular

Interventions

Glucocorticoids; Dexamethasone; Prednisone; Methylprednisolone

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Pregnadienediols; Prednisolone

Study Officials

• WenHong Zhang, M.D.

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

QiaoLing Ruan, M.D.

CONTACT

13661856002; ruan_qiao_ling@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Division of Infectious Diseases Affiliation: Huashan Hospital

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: May 11, 2023
• Study Start: May 26, 2023
• Primary Completion: May 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 12, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within two year
• Access Criteria: Not yet

Locations

CN (15)