COVID-19NCT04273321
Efficacy and Safety of Corticosteroids in COVID-19
A study testing Methylprednisolone in people with COVID-19 and Novel Coronavirus Pneumonia, run by Beijing Chao Yang Hospital at 7 sites in China.
Trial summary
There is still controversy about the effective of glucocorticoids for the treatment of novel coronavirus pneumonia. This is a prospective randomized controlled trails. The aim is to explore the effectiveness and safety of glucocorticoids in the treatment of novel coronavirus pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Novel Coronavirus Pneumonia
- What is being tested?
- Methylprednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 7 sitesChina
- Study dates
- 14 Feb 2020to 15 Apr 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age more than 18 years old
- accord with the clinical diagnosis and/ or etiological diagnosis diagnostic criteria of Novel coronavirus pneumonia (COVID-19).
- admitted in the general wards
- be able to sign informed consent
Who cannot join
- severe immunosuppression (HIV infection, long-term use of immunosuppressive agents
- pregnant or lactation period women
- glucocorticoids are needed for other diseases
- unwilling or unable to participate or complete the study
- participate in other study
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Beijing YouAn Hospital
Beijing
Hubei province hospital of integrated Chinese & Western Medicine
Wuhan, Hubei
Renmin Hospital of Wuhan University
Wuhan
Tianyou Hospital Affiliated to Wuhan University of science and technology
Wuhan
Union Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology
Wuhan
the first peopel hospital of Xiangyang
Xiangyang
Yichang first people's Hospital
Yichang, Hubei
About this study
Official title: Efficacy and Safety of Corticosteroids in COVID-19: A Prospective Randomized Controlled Trails
There is still controversy about the effective of glucocorticoids for the treatment of novel coronavirus pneumonia. This is a prospective randomized controlled trails. The aim is to explore the effectiveness and safety of glucocorticoids in the treatment of novel coronavirus pneumonia.
- Conditions
- COVID-19, Novel Coronavirus Pneumonia
- Being tested
- Methylprednisolone
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone 1mg/kg/day ivgtt for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| MP group | Experimental | Not described Receives: Drug: Methylprednisolone |
| Con group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of treatment failure in 14 days
The clinical symptoms and signs continue to deteriorate, or new pulmonary or extrapulmonary lesions appear, or the chest imaging indicates the progress, and the patient is transferred to ICU or intubation and invasive ventilation or died.
Measured: 14 days
Secondary outcomes (4)
clinical cure incidence in 14 days
The clinical symptoms and signs improved or alleviated (the temperature be normal , respiratory symptoms improved significantly, imaging showed obvious absorption) and no additional or alternative treatment was needed.
Measured: 14 days
the duration of virus change to negative
the duration from admission to virus negative
Measured: 30 days
mortality at day 30
the patient die in 30 days
Measured: 30 days
ICU admission rate in 30 days
the patients transform to ICU because of clinical deteriorate in 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start14 Feb 2020
- Primary completion15 Apr 2020
- Study completion15 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Beijing Chao Yang 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
- Single group
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shi Huanzhong, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04273321
- Sponsor's protocol ID
- Methylprednisolone in COVID-19
- Status last verified
- Apr 2020
- First submitted
- 15 Feb 2020
- Last updated
- 11 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Tang X, Feng YM, Ni JX, Zhang JY, Liu LM, Hu K, Wu XZ, Zhang JX, Chen JW, Zhang JC, Su J, Li YL, Zhao Y, Xie J, Ding Z, He XL, Wang W, Jin RH, Shi HZ, Sun B. Early Use of Corticosteroid May Prolong SARS-CoV-2 Shedding in Non-Intensive Care Unit Patients with COVID-19 Pneumonia: A Multicenter, Single-Blind, Randomized Control Trial. Respiration. 2021;100(2):116-126. doi: 10.1159/000512063. Epub 2021 Jan 22.
PubMed 33486496
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Corticosteroids in COVID-19: A Prospective Randomized Controlled Trails
- ClinicalTrials.gov ID
- NCT04273321
- Acronym / sponsor ID
- Methylprednisolone in COVID-19
- Conditions
- COVID-19, Novel Coronavirus Pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 14 Feb 2020 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 18 Feb 2020 (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.
There is still controversy about the effective of glucocorticoids for the treatment of novel coronavirus pneumonia. This is a prospective randomized controlled trails. The aim is to explore the effectiveness and safety of glucocorticoids in the treatment of novel coronavirus pneumonia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MP group | Experimental | Drug: Methylprednisolone |
| Con group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age more than 18 years old
- accord with the clinical diagnosis and/ or etiological diagnosis diagnostic criteria of Novel coronavirus pneumonia (COVID-19).
- admitted in the general wards
- be able to sign informed consent
Key exclusion criteria (5 listed)
- severe immunosuppression (HIV infection, long-term use of immunosuppressive agents
- pregnant or lactation period women
- glucocorticoids are needed for other diseases
- unwilling or unable to participate or complete the study
- participate in other study
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 |
|---|---|---|
| MethylprednisoloneMethylprednisolone 1mg/kg/day ivgtt for 7 days. | Drug | MP group |
Primary outcome
the incidence of treatment failure in 14 days
Time frame: 14 days
The clinical symptoms and signs continue to deteriorate, or new pulmonary or extrapulmonary lesions appear, or the chest imaging indicates the progress, and the patient is transferred to ICU or intubation and invasive ventilation or died.
4 secondary outcomes
clinical cure incidence in 14 days
Time frame: 14 days
the duration of virus change to negative
Time frame: 30 days
mortality at day 30
Time frame: 30 days
ICU admission rate in 30 days
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2020.
- Derived from this study: PubMed 33486496Tang X, Feng YM, Ni JX, Zhang JY, Liu LM, Hu K, Wu XZ, Zhang JX, Chen JW, Zhang JC, Su J, Li YL, Zhao Y, Xie J, Ding Z, He XL, Wang W, Jin RH, Shi HZ, Sun B. Early Use of Corticosteroid May Prolong SARS-CoV-2 Shedding in Non-Intensive Care Unit Patients with COVID-19 Pneumonia: A Multicenter, Single-Blind, Randomized Control Trial. Respiration. 2021;100(2):116-126. doi: 10.1159/000512063. Epub 2021 Jan 22.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methylprednisolone in people with COVID-19 and Novel Coronavirus Pneumonia, run by Beijing Chao Yang Hospital at 7 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 11 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of treatment failure in 14 days (time frame: 14 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 NCT04273321, which also lists 1 linked publication.
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 11 May 2020.