COVID-19NCT05855395
The Standard of Care Combined With Glucocorticoid in Elderly People With Mild or Moderate COVID-19
A study testing Glucocorticoid in people with COVID-19, run by Huashan Hospital at 15 sites in China.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Glucocorticoid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,815 participants
- Where
- 15 sitesChina
- Study dates
- 26 May 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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；
Who cannot join
- 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);
Show all 10Show fewer
- 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 locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites, 15 recruiting
- Not yet recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350004
Yuekai Hu, M.D.
- Not yet recruiting
The People's Hospital Of Xingguo County
Ganzhou, Jiangxi, 342400
Fei He, M.D.
- Recruiting
The Fifth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000
Xi Liu, M.D.
- Not yet recruiting
Hangzhou Linping District First People's Hospital
Hanzhou, Zhejiang, 310000
XiaoQiang Zhang, M.D.
- Recruiting
Huaihua First People's Hospital
Huaihua, Hunan, 418000
Hongying Yu, M.D.
- Recruiting
The First People's Hospital Of YunNan
Kunming, Yunnan, 650100
Jiawei Geng, M.D.
- Not yet recruiting
Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646000
Fuli Huang, M.D.
- Recruiting
Nanjing Hospital of Traditional Chinese Medicine
Nanjing, Jiangsu, 210006
Yanliang Zhang, M.D.
- Not yet recruiting
Affiliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, 210008
Chao Wu, M.D.
- Not yet recruiting
Quanzhou First Hospital
Quanzhou, Fujian, 362000
Xueping Yu, M.D.
- Recruiting
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030000
Liaoyun Zhang, M.D.
- Recruiting
People's Hospital of Qiubei County, Yunnan Province
Wenshan, Yunnan, 663299
Lili Zhang, M.D., 13619648406
- Not yet recruiting
Wenzhou Central Hospital
Wenzhou, Zhejiang, 325099
Jichan Shi, M.D.
- Recruiting
Wuxi Fifth People's Hospital
Wuxi, Jiangsu, 214000
Feng Zhu, M.D.
- Not yet recruiting
Attached Hospital of Zunyi Medical College
Zunyi, Guizhou, 563099
Yuanbo Lan, M.D.
About this study
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
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.
Read the detailed 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.
- Conditions
- COVID-19
- Being tested
- Glucocorticoid
- Keywords
- Glucocorticoids, Standard of care, Mild and moderate COVID-19
- Medical subject headings
- COVID-19, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucocorticoidDrug
Also called dexamethasone, prednisone, methylprednisolone
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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.） |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: In 28 days
Secondary outcomes (9)
Duration of antigen or nucleic acid negative conversion
Duration of antigen or nucleic acid negative conversion
Measured: In 28 days
Day 14 antigen or nucleic acid conversion rate
Day 14 antigen or nucleic acid conversion rate
Measured: 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）
Measured: In 14 days
All-cause mortality
Short-term case fatality rate defined in the study, including case fatality on day 28
Measured: In 28 days
Days of respiratory symptoms
Days of respiratory symptoms
Measured: 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)
Measured: In 28 days
Length of hospital stay for any reason
Length of hospital stay for any reason
Measured: 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
Measured: 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).
Measured: In 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start26 May 2023
- Primary completion1 May 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,815 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-hong Zhang, Huashan Hospital
- Investigators
- WenHong Zhang, M.D., Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05855395
- Sponsor's protocol ID
- BEAT-COV
- Status last verified
- Jul 2023
- First submitted
- 27 Feb 2023
- Last updated
- 12 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After thesis defense the study will be published internationally to be available for the public.
Publications
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.
PubMed 35144989Song 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.
PubMed 34441840Agarwal 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.
PubMed 32887691Orchard 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.
PubMed 33474730Ruan Q, Zhang Y, Zhao T, Zhu F, Liu X, Cao R, Li Y, Zhang X, Song W, Geng J, Zou D, Li Y, Zhang L, Wu C, Lan Y, Ding X, Huang F, Wu J, Sun F, Shao L, Zhang W. A bidimensional early intervention strategy of standard of care in combination with corticosteroids in elderly patients with mild to moderate COVID-19 (BEAT-COV study): a multicentre, open-label, randomized controlled trial. BMC Infect Dis. 2026 Mar 6;26(1):758. doi: 10.1186/s12879-026-12637-8.
PubMed 41792630
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05855395
- Acronym / sponsor ID
- BEAT-COV
- Conditions
- COVID-19
- Keywords
- Glucocorticoids, Standard of care, Mild and moderate COVID-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,815 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 26 May 2023 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: GlucocorticoidExperimental 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) |
| 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.） |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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；
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlucocorticoidAlso: dexamethasone, prednisone, methylprednisolonestandard 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 | Group A |
Primary outcome
Proportion of patients who progress to severe or critical COVID-19 within 28 days
Time frame: In 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).
9 secondary outcomes
Duration of antigen or nucleic acid negative conversion
Time frame: In 28 days
Day 14 antigen or nucleic acid conversion rate
Time frame: Day 14
Time for initial symptom relief，Duration of symptom relief
Time frame: In 14 days
All-cause mortality
Time frame: In 28 days
Days of respiratory symptoms
Time frame: In 28 days
Duration of outpatient hospitalization/emergency department visits due to COVID-19 progression(from the date of enrollment)
Time frame: In 28 days
Length of hospital stay for any reason
Time frame: In 28 days
Proportion of patients who progress to severe or critical COVID-19 within 28 days
Time frame: In 28 days
Proportion of emergency department visits or hospitalizations due to COVID-19 progression
Time frame: In 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Background: PubMed 35144989Agusti 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.
- Background: PubMed 34441840Song 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.
- Background: PubMed 32887691Agarwal 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.
- Background: PubMed 33474730Orchard 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.
- Derived from this study: PubMed 41792630Ruan Q, Zhang Y, Zhao T, Zhu F, Liu X, Cao R, Li Y, Zhang X, Song W, Geng J, Zou D, Li Y, Zhang L, Wu C, Lan Y, Ding X, Huang F, Wu J, Sun F, Shao L, Zhang W. A bidimensional early intervention strategy of standard of care in combination with corticosteroids in elderly patients with mild to moderate COVID-19 (BEAT-COV study): a multicentre, open-label, randomized controlled trial. BMC Infect Dis. 2026 Mar 6;26(1):758. doi: 10.1186/s12879-026-12637-8.
- Guide：Diagnosis and Treatment Plan for COVID-19 (Tenth Edition on Trial)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. After thesis defense the study will be published internationally to be available for the public.
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
WenHong Zhang, M.D. principal investigator
Huashan Hospital
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucocorticoid in people with COVID-19, run by Huashan Hospital at 15 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact QiaoLing Ruan, M.D. (13661856002, ruan_qiao_ling@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who progress to severe or critical COVID-19 within 28 days (time frame: In 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05855395, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.