Viral Pneumonia Human CoronavirusPhase 2CORTI-CovidNCT04344288
Corticosteroids During Covid-19 Viral Pneumonia Related to SARS-Cov-2 Infection
A Phase 2 study testing Prednisone in people with Viral Pneumonia Human Coronavirus and COVID-19, run by Hospices Civils de Lyon at 12 sites in France.
Trial summary
Infection with the SARS-Cov-2 virus, responsible of severe acute respiratory distress syndrome (SARS), is an emerging infectious disease called Covid-19 and declared as pandemic by the World Health Organization on March 11, 2020. This pandemic is responsible of significant mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Viral Pneumonia Human Coronavirus, COVID-19
- What is being tested?
- Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 12 sitesFrance
- Study dates
- 21 Apr 2020to 18 Aug 2020
- Phase
- Phase 2
- 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 ≥ 18 years old,
- Hospitalization for COVID-19 infection confirmed by RT-PCR or other virological method,
- Peripheral saturation by pulse oximeter SpO2 ≤ 94% in ambient air measured twice at 5-15 min intervals, or PaO2 / FiO2 <300 mmHg,
- Abnormalities on the chest x-ray or CT scan suggestive of viral pneumonia,
- Signed informed consent by the patient.
Who cannot join
- Covid-19 infection with first symptoms lasting for more than 9 days according to the patient's interview; D1 of symptoms is defined by the first day with fever, cough, shortness of breath, and / or chills related to Covid-19 infection;
- Patients with primary or secondary immune deficiency, including: HIV, chronic hematological disease, solid organ transplant, ongoing immunosuppressive therapy,
- Long-term corticosteroid therapy defined by a prescription of more than 10 mg/d (prednisone equivalent),
- Suspected or confirmed infection with bacteria, fungal agents or viruses (in addition to Covid-19),
- Known contraindication to systemic corticosteroids,
- Systolic blood pressure <80 mmHg,
Show all 14Show fewer
- SpO2 <90% under 5 L / min of oxygen using medium concentration mask, or higher oxygen requirements,
- Patient on long-term oxygen therapy,
- Ongoing mechanical ventilation,
- Ongoing septic shock ongoing,
- Ongoing multi-organ failure ongoing,
- Participating in other COVID-19 therapeutic clinical trial
- Pregnant or breast-feeding woman (oral diagnosis),
- No affiliation or beneficiary of health insurance,
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Hôpital Pneumologique et Cardiovasculaire Louis Pradel
Bron
CH Annecy-Genevois
Épagny
Groupement Hospitalier Nord
Lyon
Hôpital Edouard Herriot
Lyon
Hôpital St Joseph Saint Luc
Lyon
Hôpital St Joseph
Marseille
Centre hospitalier Lyon Sud
Pierre-Bénite
CHU St Etienne
Saint-Etienne
Clinique Charcot
Sainte-Foy-lès-Lyon
Clinique des Portes du Sud
Vénissieux
CHG Vienne
Vienne
Médipôle
Villeurbanne
About this study
Infection with the SARS-Cov-2 virus, responsible of severe acute respiratory distress syndrome (SARS), is an emerging infectious disease called Covid-19 and declared as pandemic by the World Health Organization on March 11, 2020. This pandemic is responsible of significant mortality. In France, several thousand patients are hospitalized in intensive care units, and their number continues to increase. Mortality during Covid-19 is mainly linked to acute respiratory distress syndrome, which frequency is estimated in France to occur in 6% of infected patients. Comorbidities such as cardiovascular conditions, obesity and diabetes increase susceptibility to severe forms of Covid-19 and associated mortality. Therapeutic management has three components: symptomatic management, including supplementary oxygen therapy and in case of respiratory distress mechanical ventilation; the antiviral approach; and immunomodulation, aiming at reducing inflammation associated with viral infection, which is considered to take part in severe presentations of the disease.
During Covid-19 viral pneumonia related to SARS-COv-2, there is a significant release of pro-inflammatory cytokines in the acute phase of viral infection, which could participate in viral pneumonia lesions. In children with less mature immune system than adults, SARS-Cov-2 infection is less severe. The current prevailing assumption is that severe forms of Covid-19 may not only be related to high viral replication, but also to an excessive inflammatory response favoring acute lung injury and stimulating infection.
Read more
The investigators hypothesize that early control of the excessive inflammatory response may help reducing the risk of acute respiratory distress syndrome.
The investigators will evaluate the benefit, safety and tolerability of corticosteroid therapy to reduce the rate of subjects hospitalized for Covid-19 viral pneumonia who experience clinical worsening with a need of high-flow supplemental oxygen supplementation or transfer in intensive care units for respiratory support.
- Conditions
- Viral Pneumonia Human Coronavirus, COVID-19
- Being tested
- Prednisone, Control group
- Keywords
- Pneumology, viral pneumology, SARS-Cov-2, COVID 19, Prednisone
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
The experimental group will receive oral prednisone during 10 days (0.75 mg/kg/day during 5 days then 20 mg/day during 5 more days)
Control groupOther
The control group will receive standard of care according to the international recommendations and practices of the investigational site. No corticosteroid therapy can be prescribed in this group.
| Study group | Role | What they receive |
|---|---|---|
| Prednisone group | Experimental | Prednisone during 10 days after randomization Receives: Drug: Prednisone |
| Control group | Other | Not described Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with a theoretical respiratory indication for transfer to intensive care unit evaluated by a SpO2 <90% stabilized at rest and under not more than 5 L / min of supplemental oxygen using medium concentration mask.
SpO2 <90% stabilized at rest and under not more than 5 L / min of supplemental oxygen using medium concentration mask. measured twice at 5-15 min intervalsThe average value of the two measurements will be calculated.
Measured: 7 days
Secondary outcomes (9)
disease severity assessed on a 7-level ordinal scale
level1: not hospitalized no limited activities, level 7: death
Measured: 7 days
number of patients with a supplemental oxygen use
Measured: 7 days
radiological signs on chest imaging
Reduction of radiological signs on chest imaging
Measured: 7 days
number of patients transferred to intensive care unit
Measured: 21 days
number of patients requiring invasive ventilation
Measured: 21 days
Duration of oxygen therapy
duration on days
Measured: 21 days
number of adverse events induced by corticosteroid treatment
Measured: 21 days
number of patients with infections other than SARS-CoV-2
Measured: 21 days
number of deaths
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start21 Apr 2020
- Primary completion18 Aug 2020
- Study completion18 Aug 2020
Why it stopped: Competent Authority's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral Pneumonia Human CoronavirusStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-François MORNEX, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344288
- Sponsor's protocol ID
- 69HCL20_0321
- Other IDs
- 2020-001553-48
- Acronym
- CORTI-Covid
- Status last verified
- Oct 2020
- First submitted
- 10 Apr 2020
- Last updated
- 26 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corticosteroids During Covid-19 Viral Pneumonia Related to SARS-Cov-2 Infection
- ClinicalTrials.gov ID
- NCT04344288
- Acronym / sponsor ID
- CORTI-Covid / 69HCL20_0321
- Conditions
- Viral Pneumonia Human Coronavirus, COVID-19
- Keywords
- Pneumology, viral pneumology, SARS-Cov-2, COVID 19, Prednisone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Competent Authority's decision
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 21 Apr 2020 (actual)
- Primary completion
- 18 Aug 2020 (actual)
- Study completion
- 18 Aug 2020 (actual)
- First posted
- 14 Apr 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.
Infection with the SARS-Cov-2 virus, responsible of severe acute respiratory distress syndrome (SARS), is an emerging infectious disease called Covid-19 and declared as pandemic by the World Health Organization on March 11, 2020. This pandemic is responsible of significant mortality. In France, several thousand patients are hospitalized in intensive care units, and their number continues to increase. Mortality during Covid-19 is mainly linked to acute respiratory distress syndrome, which frequency is estimated in France to occur in 6% of infected patients. Comorbidities such as cardiovascular conditions, obesity and diabetes increase susceptibility to severe forms of Covid-19 and associated mortality. Therapeutic management has three components: symptomatic management, including supplementary oxygen therapy and in case of respiratory distress mechanical ventilation; the antiviral approach; and immunomodulation, aiming at reducing inflammation associated with viral infection, which is considered to take part in severe presentations of the disease.
During Covid-19 viral pneumonia related to SARS-COv-2, there is a significant release of pro-inflammatory cytokines in the acute phase of viral infection, which could participate in viral pneumonia lesions. In children with less mature immune system than adults, SARS-Cov-2 infection is less severe. The current prevailing assumption is that severe forms of Covid-19 may not only be related to high viral replication, but also to an excessive inflammatory response favoring acute lung injury and stimulating infection.
The investigators hypothesize that early control of the excessive inflammatory response may help reducing the risk of acute respiratory distress syndrome.
The investigators will evaluate the benefit, safety and tolerability of corticosteroid therapy to reduce the rate of subjects hospitalized for Covid-19 viral pneumonia who experience clinical worsening with a need of high-flow supplemental oxygen supplementation or transfer in intensive care units for respiratory support.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisone group | Experimental | Drug: PrednisonePrednisone during 10 days after randomization |
| Control group | Other | Other: Control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years old,
- Hospitalization for COVID-19 infection confirmed by RT-PCR or other virological method,
- Peripheral saturation by pulse oximeter SpO2 ≤ 94% in ambient air measured twice at 5-15 min intervals, or PaO2 / FiO2 <300 mmHg,
- Abnormalities on the chest x-ray or CT scan suggestive of viral pneumonia,
- Signed informed consent by the patient.
Key exclusion criteria (14 listed)
- Covid-19 infection with first symptoms lasting for more than 9 days according to the patient's interview; D1 of symptoms is defined by the first day with fever, cough, shortness of breath, and / or chills related to Covid-19 infection;
- Patients with primary or secondary immune deficiency, including: HIV, chronic hematological disease, solid organ transplant, ongoing immunosuppressive therapy,
- Long-term corticosteroid therapy defined by a prescription of more than 10 mg/d (prednisone equivalent),
- Suspected or confirmed infection with bacteria, fungal agents or viruses (in addition to Covid-19),
- Known contraindication to systemic corticosteroids,
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 |
|---|---|---|
| PrednisoneThe experimental group will receive oral prednisone during 10 days (0.75 mg/kg/day during 5 days then 20 mg/day during 5 more days) | Drug | Prednisone group |
| Control groupThe control group will receive standard of care according to the international recommendations and practices of the investigational site. No corticosteroid therapy can be prescribed in this group. | Other | Control group |
Primary outcome
Number of patients with a theoretical respiratory indication for transfer to intensive care unit evaluated by a SpO2 <90% stabilized at rest and under not more than 5 L / min of supplemental oxygen using medium concentration mask.
Time frame: 7 days
SpO2 <90% stabilized at rest and under not more than 5 L / min of supplemental oxygen using medium concentration mask. measured twice at 5-15 min intervalsThe average value of the two measurements will be calculated.
9 secondary outcomes
disease severity assessed on a 7-level ordinal scale
Time frame: 7 days
number of patients with a supplemental oxygen use
Time frame: 7 days
radiological signs on chest imaging
Time frame: 7 days
number of patients transferred to intensive care unit
Time frame: 21 days
number of patients requiring invasive ventilation
Time frame: 21 days
Duration of oxygen therapy
Time frame: 21 days
number of adverse events induced by corticosteroid treatment
Time frame: 21 days
number of patients with infections other than SARS-CoV-2
Time frame: 21 days
number of deaths
Time frame: 21 days
Results and safety
The study was stopped early (reason given: Competent Authority's decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
- Individual participant dataSharing planned: Undecided
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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.
Jean-François MORNEX principal investigator
Hospices Civils de Lyon
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prednisone in people with Viral Pneumonia Human Coronavirus and COVID-19, run by Hospices Civils de Lyon at 12 sites in France.
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 5 inclusion and 14 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: stopped early, as of the sponsor's last update on 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. 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.
What does this 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.
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 was stopped early (reason given: Competent Authority's decision). Results are not available in the source record.
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?
Number of patients with a theoretical respiratory indication for transfer to intensive care unit evaluated by a SpO2 <90% stabilized at rest and under not more than 5 L / min of supplemental oxygen using medium concentration mask. (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2020.