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COVID-19 InfectionsPhase 2/3NCT04244591

Glucocorticoid Therapy for COVID-19 Critically Ill Patients With Severe Acute Respiratory Failure

A Phase 2/3 study testing methylprednisolone therapy in people with COVID-19 Infections, run by Peking Union Medical College Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this multi-center, randomized, control study, the investigators will evaluate the efficacy and safety of glucocorticoid in combination with standard care for COVID-19 patents with Severe acute respiratory failure. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19 Infections
What is being tested?
methylprednisolone therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteChina
Study dates
26 Jan 2020to 13 Apr 2020
Phase
Phase 2/3
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

  • Adult
  • PCR confirmed COVID-19 infection
  • Symptoms developed more than 7 days
  • PaO2/FiO2 < 200 mmHg
  • Positive pressure ventilation (non-invasive or invasive) or high flow nasal cannula (HFNC) higher than 45 L/min for less than 48 hours
  • Requiring ICU admission

Who cannot join

  • pregnancy;
  • patients currently taking corticosteroids (cumulative 400 mg prednisone or equivalent);
  • Severe underlying disease, i.e. end stage of malignancy disease or end stage of pulmonary disease;
  • Severe adverse events before ICU admission, i.e. cardiac arrest;
  • Underlying disease requiring corticosteroids;
  • Contraindication for corticosteroids;
  • Recruited in other clinical intervention trial

Trial locations and contacts

1 site in 1 country.

China1 site

  • Medical ICU,Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 010

Other trials in China

About this study

Official title: Glucocorticoid Therapy for Critically Ill Patients With Severe Acute Respiratory Infections Caused by COVID-19: a Prospective, Randomized Controlled Trial

In this multi-center, randomized, control study, the investigators will evaluate the efficacy and safety of glucocorticoid in combination with standard care for COVID-19 patents with Severe acute respiratory failure.

Read the detailed description

COVID-19 is a novel coronavirus that was initially outbreak in Wuhan, China. Severe acute respiratory infection with COVID-19 causes severe acute respiratory failure with substantial mortality. Currently, the standard care is supportive care, and no treatment is proven to be effective for this condition.

Glucocorticoid therapy is widely used among critically ill patients with other coronavirus infection such as SARS (severe acute respiratory syndrome) and MERS (Middle East respiratory syndrome). However, whether glucocorticoid improved the outcome of COVID-19 remains unknown. We hypothesized that glucocorticoid would improve the prognosis of patietns with COVID-19.

In this study, critically ill patients with COVID-19 were enrolled and randomized to receive ether standard care or standard care in combination with methylprednisolone therapy. The primary outcome is the difference of Murray lung injury score between two groups.

Being tested
methylprednisolone therapy, Standard care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • methylprednisolone therapyDrug

    Also called Steroids

    Methylprednisolone 40 mg q12h for 5 days

  • Standard careOther

    Standard care

Study groups in NCT04244591
Study groupRoleWhat they receive
standard carePlacebo comparatorstandard care
Receives: Other: Standard care
standard care + methylprednisolone therapyExperimentalMethylprednisolone 40 mg q12h for 5 days
Receives: Drug: methylprednisolone therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lower Murray lung injury score

    Murray lung injury score decreased more than one point means better outcome.The Murray scoring system range from 0 to 4 according to the severity of the condition.

    Measured: 7 days after randomization

  2. Lower Murray lung injury score

    Murray lung injury score decreased more than one point means better outcome.The Murray scoring system range from 0 to 4 according to the severity of the condition.

    Measured: 14 days after randomization

Secondary outcomes (8)

  1. The difference of PaO2/FiO2 between two groups

    PaO2/FiO2 denotes ratio of arterial partial pressure of O2 and the fraction of inspired oxygen, with a higher PaO2/FiO2 means favorable outcome.

    Measured: 7 days after randomization

  2. Lower Sequential Organ Failure Assessment (SOFA) score

    Lower SOFA score means better outcome. The SOFA score system range from 0 to 24 according to the severity of the condition.

    Measured: 7 days after randomization

  3. Mechanical ventilation support

    Percentage of patients requiring Mechanical ventilation support

    Measured: 7 days after randomization

  4. The difference of PaO2/FiO2 between two groups

    PaO2/FiO2 denotes ratio of arterial partial pressure of O2 and the fraction of inspired oxygen, with a higher PaO2/FiO2 means favorable outcome.

    Measured: 14 days after randomization

  5. Lower Sequential Organ Failure Assessment (SOFA) score

    Lower SOFA score means better outcome. The SOFA score system range from 0 to 24 according to the severity of the condition.

    Measured: 14 days after randomization

  6. Mechanical ventilation support

    Percentage of patients requiring Mechanical ventilation support

    Measured: 14 days after randomization

  7. Clearance of noval coronavirus

    Clearance of noval coronavirus in upper respiratory tract or lower respiratory tract

    Measured: 14 days after randomization

  8. All-cause mortality

    All-cause mortality

    Measured: 30 days after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2020
  2. Study start26 Jan 2020
  3. Primary completion13 Apr 2020
  4. Study completion13 Apr 2020

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04244591
Sponsor's protocol ID
Glucocorticoid COVID-19
Status last verified
Feb 2020
First submitted
23 Jan 2020
Last updated
16 Jun 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Arabi YM, Mandourah Y, Al-Hameed F, Sindi AA, Almekhlafi GA, Hussein MA, Jose J, Pinto R, Al-Omari A, Kharaba A, Almotairi A, Al Khatib K, Alraddadi B, Shalhoub S, Abdulmomen A, Qushmaq I, Mady A, Solaiman O, Al-Aithan AM, Al-Raddadi R, Ragab A, Balkhy HH, Al Harthy A, Deeb AM, Al Mutairi H, Al-Dawood A, Merson L, Hayden FG, Fowler RA; Saudi Critical Care Trial Group. Corticosteroid Therapy for Critically Ill Patients with Middle East Respiratory Syndrome. Am J Respir Crit Care Med. 2018 Mar 15;197(6):757-767. doi: 10.1164/rccm.201706-1172OC.

    PubMed 29161116

  • Auyeung TW, Lee JS, Lai WK, Choi CH, Lee HK, Lee JS, Li PC, Lok KH, Ng YY, Wong WM, Yeung YM. The use of corticosteroid as treatment in SARS was associated with adverse outcomes: a retrospective cohort study. J Infect. 2005 Aug;51(2):98-102. doi: 10.1016/j.jinf.2004.09.008.

    PubMed 16038758

  • Raghavendran K, Napolitano LM. Definition of ALI/ARDS. Crit Care Clin. 2011 Jul;27(3):429-37. doi: 10.1016/j.ccc.2011.05.006.

    PubMed 21742209

  • Vincent JL, de Mendonca A, Cantraine F, Moreno R, Takala J, Suter PM, Sprung CL, Colardyn F, Blecher S. Use of the SOFA score to assess the incidence of organ dysfunction/failure in intensive care units: results of a multicenter, prospective study. Working group on "sepsis-related problems" of the European Society of Intensive Care Medicine. Crit Care Med. 1998 Nov;26(11):1793-800. doi: 10.1097/00003246-199811000-00016.

    PubMed 9824069

  • Sultana J, Crisafulli S, Gabbay F, Lynn E, Shakir S, Trifiro G. Challenges for Drug Repurposing in the COVID-19 Pandemic Era. Front Pharmacol. 2020 Nov 6;11:588654. doi: 10.3389/fphar.2020.588654. eCollection 2020.

    PubMed 33240091

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing methylprednisolone therapy in people with COVID-19 Infections, run by Peking Union Medical College Hospital at 1 site 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 6 inclusion and 7 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 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Lower Murray lung injury score (time frame: 7 days after randomization). The study lists 2 primary outcomes in all. 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 NCT04244591, 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 16 Jun 2020.

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