Covid-19 PneumoniaPhase 3CORTIVIDNCT04438980
Glucocorticoids in COVID-19 (CORTIVID)
A Phase 3 study testing Methylprednisolone in people with Covid-19 Pneumonia, run by Fundacion Miguel Servet at 2 sites in Spain.
Trial summary
Around 30% of admitted patients with COVID-19 pneumonia develop a hyper-inflammatory state whose progression to an acute respiratory distress syndrome (ARSD) could be prevented by the early initiation of immune-modulatory agents. The role of glucocorticoids (GC) in this setting remains controversial. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Covid-19 Pneumonia
- What is being tested?
- Methylprednisolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 2 sitesSpain
- Study dates
- 15 May 2020to 9 Apr 2021
- Phase
- Phase 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old.
- Diagnosis of SARS-CoV-2 pneumonia confirmed by reverse transcriptase polymerase chain reaction (RT-PCR) on nasopharyngeal swab or sputum according to the recommendations of the Spanish Ministry of Health.
- Length of symptoms consistent with COVID-19 ≥7 days.
- Hospital admission.
- At least one of the following: CRP >60 mg/L, IL-6 >40 pg/mL, ferritin >1000 μg/L.
- Acceptation of informed consent
Who cannot join
- Allergy or contraindication to any of the drugs under study.
- SpO2 <90% (in air ambient) or PaO2 <60 mmHg (in ambient air) or PaO2/FiO2 <300 mmHg.
- Ongoing treatment with glucocorticoids, immunosuppressive, or biologic drugs with another indication.
- Decompensated diabetes mellitus.
- Uncontrolled hypertension.
- Psychotic or manic disorder.
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- Active cancer.
- Pregnancy or lactation.
- Clinical or biochemical suspicion (procalcitonin >0.5 ng/mL) of active infection other than SARS-CoV-2.
- Out-of-hospital management patient.
- Conservative or palliative management patient.
- Participation in another clinical trial.
- Any important and uncontrolled medical, psychological, psychiatric, geographic or social problem that contraindicates the patient's participation in the trial or that does not allow adequate follow-up and adherence to the protocol and evaluation of the study results.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Complejo Hospitalario de Navarra
Pamplona, Navarre, 31008
Hospital Sant Joan Despí Moisès Broggi
Sant Joan Despí, Barcelona
About this study
Official title: Treatment of COVID-19 Pneumonia With Glucocorticoids. A Randomized Controlled Trial
Around 30% of admitted patients with COVID-19 pneumonia develop a hyper-inflammatory state whose progression to an acute respiratory distress syndrome (ARSD) could be prevented by the early initiation of immune-modulatory agents. The role of glucocorticoids (GC) in this setting remains controversial. This study aims to assess the safety and effectiveness of GC pulses to improve the clinical outcomes of patients with COVID-19 pneumonia with risen inflammatory biomarkers.
- Conditions
- Covid-19 Pneumonia
- Being tested
- Methylprednisolone, Placebo
- Keywords
- Covid-19, pneumonia, Inflammatory phase, Glucocorticoids
- Medical subject headings
- COVID-19, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
-A dose of 120 mg/day of methylprednisolone for 3 days, administered by intravenous infusión
PlaceboOther
-An infusion bag of 100 mL of 0.9% saline
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone Arm | Experimental | Standard of care plus Methylprednisolone Receives: Drug: Methylprednisolone |
| Placebo Arm | Placebo comparator | Standard of care plus placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients developing treatment failure
- Death
Measured: At 14 days after randomization
Proportion of patients developing treatment failure
- Need for admission in an intensive care unit (ICU)
Measured: At 14 days after randomization
Proportion of patients developing treatment failure
- Need for mechanical ventilation
Measured: At 14 days after randomization
Proportion of patients developing treatment failure
- Decrease in SpO2 <90% (in ambient air) or PaO2 <60 mmHg (in ambient air) or PaO2FiO2 <300 mmHg, associated with radiological impairment
Measured: At 14 days after randomization
Secondary outcomes (12)
Mortality at day 28
Measured: At 28 days after randomization
Proportion of patients requiring ICU admission
Measured: At 28 days after randomization
Proportion of patients requiring rescue-therapy with tocilizumab
Measured: At 14 days after randomization
Length of hospital stay
Time in days from randomization until the date of hospital discharge.
Measured: At 28 days after randomization
Proportion of severe adverse events
Any undesirable experience related to the use of the studied drugs, which causes patient's death, life-threatening risk, hospitalization or extension of a previous hospitalization, disability or permanent damage, requires intervention to prevent permanent impairment or damage, or is considered medically relevant
Measured: At 28 days after randomization
Proportion of bacterial, fungal or opportunistic infections
Measured: At 28 days after randomization
Evolution of inflammatory biomarkers related to COVID-19
Change in plasma levels of C-reactive protein (CRP)
Measured: At 14 days after randomization
Evolution of inflammatory biomarkers related to COVID-19
Change in plasma levels of ferritin
Measured: At 14 days after randomization
Evolution of inflammatory biomarkers related to COVID-19
Change in plasma levels of interleukin-6 (IL-6)
Measured: At 14 days after randomization
Evolution of inflammatory biomarkers related to COVID-19
Change in plasma levels of lactate dehydrogenase (LDH)
Measured: At 14 days after randomization
Evolution of inflammatory biomarkers related to COVID-19
Change in plasma levels of D-dimer (DD)
Measured: At 14 days after randomization
Proportion of SARS-CoV-2 clearance.
Negativization of RT-PCR for SARS-CoV-2 on nasopharyngeal swab or sputum
Measured: At 7 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start15 May 2020
- Primary completion12 Mar 2021
- Study completion9 Apr 2021
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-19 PneumoniaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Miguel Servet
- Sponsor type
- University, hospital or other
- Collaborators
- Complejo Hospitalario de Navarra, Hospital de Sant Joan Despí Moisès Broggi
- Responsible party
- Sponsor
- Investigators
- Iñigo Les Bujanda, PhD, Principal investigator, Complejo Hospitalario de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04438980
- Sponsor's protocol ID
- CORTIVID
- Acronym
- CORTIVID
- Status last verified
- May 2021
- First submitted
- 18 Jun 2020
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD will be available for exploitation in future research projects. This statement also includes the availability of the study protocol, the statistical analysis plan, the informed consent form, the clinical study report and the analytic code.
Publications
Les Bujanda I, Loureiro-Amigo J, Bastons FC, Guerra IE, Sanchez JA, Murgadella-Sancho A, Rey RG, Lopez JL, Alvarez JS. Treatment of COVID-19 pneumonia with glucocorticoids (CORTIVID): a structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Jan 11;22(1):43. doi: 10.1186/s13063-020-04999-4.
PubMed 33430891
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of COVID-19 Pneumonia With Glucocorticoids. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04438980
- Acronym / sponsor ID
- CORTIVID / CORTIVID
- Conditions
- Covid-19 Pneumonia
- Keywords
- Covid-19, pneumonia, Inflammatory phase, Glucocorticoids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Fundacion Miguel ServetUniversity, hospital or other
- Collaborators
- Complejo Hospitalario de Navarra, Hospital de Sant Joan Despí Moisès Broggi
- Study start
- 15 May 2020 (actual)
- Primary completion
- 12 Mar 2021 (actual)
- Study completion
- 9 Apr 2021 (actual)
- First posted
- 19 Jun 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.
Around 30% of admitted patients with COVID-19 pneumonia develop a hyper-inflammatory state whose progression to an acute respiratory distress syndrome (ARSD) could be prevented by the early initiation of immune-modulatory agents. The role of glucocorticoids (GC) in this setting remains controversial. This study aims to assess the safety and effectiveness of GC pulses to improve the clinical outcomes of patients with COVID-19 pneumonia with risen inflammatory biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone Arm | Experimental | Drug: MethylprednisoloneStandard of care plus Methylprednisolone |
| Placebo Arm | Placebo comparator | Other: PlaceboStandard of care plus placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years old.
- Diagnosis of SARS-CoV-2 pneumonia confirmed by reverse transcriptase polymerase chain reaction (RT-PCR) on nasopharyngeal swab or sputum according to the recommendations of the Spanish Ministry of Health.
- Length of symptoms consistent with COVID-19 ≥7 days.
- Hospital admission.
- At least one of the following: CRP >60 mg/L, IL-6 >40 pg/mL, ferritin >1000 μg/L.
Key exclusion criteria (13 listed)
- Allergy or contraindication to any of the drugs under study.
- SpO2 <90% (in air ambient) or PaO2 <60 mmHg (in ambient air) or PaO2/FiO2 <300 mmHg.
- Ongoing treatment with glucocorticoids, immunosuppressive, or biologic drugs with another indication.
- Decompensated diabetes mellitus.
- Uncontrolled hypertension.
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 |
|---|---|---|
| Methylprednisolone-A dose of 120 mg/day of methylprednisolone for 3 days, administered by intravenous infusión | Drug | Methylprednisolone Arm |
| Placebo-An infusion bag of 100 mL of 0.9% saline | Other | Placebo Arm |
Primary outcome
Proportion of patients developing treatment failure
Time frame: At 14 days after randomization
• Death
Proportion of patients developing treatment failure
Time frame: At 14 days after randomization
• Need for admission in an intensive care unit (ICU)
Proportion of patients developing treatment failure
Time frame: At 14 days after randomization
• Need for mechanical ventilation
Proportion of patients developing treatment failure
Time frame: At 14 days after randomization
• Decrease in SpO2 <90% (in ambient air) or PaO2 <60 mmHg (in ambient air) or PaO2FiO2 <300 mmHg, associated with radiological impairment
12 secondary outcomes
Mortality at day 28
Time frame: At 28 days after randomization
Proportion of patients requiring ICU admission
Time frame: At 28 days after randomization
Proportion of patients requiring rescue-therapy with tocilizumab
Time frame: At 14 days after randomization
Length of hospital stay
Time frame: At 28 days after randomization
Proportion of severe adverse events
Time frame: At 28 days after randomization
Proportion of bacterial, fungal or opportunistic infections
Time frame: At 28 days after randomization
Evolution of inflammatory biomarkers related to COVID-19
Time frame: At 14 days after randomization
Evolution of inflammatory biomarkers related to COVID-19
Time frame: At 14 days after randomization
Evolution of inflammatory biomarkers related to COVID-19
Time frame: At 14 days after randomization
Evolution of inflammatory biomarkers related to COVID-19
Time frame: At 14 days after randomization
Evolution of inflammatory biomarkers related to COVID-19
Time frame: At 14 days after randomization
Proportion of SARS-CoV-2 clearance.
Time frame: At 7 days after randomization
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 17 May 2021.
- Derived from this study: PubMed 33430891Les Bujanda I, Loureiro-Amigo J, Bastons FC, Guerra IE, Sanchez JA, Murgadella-Sancho A, Rey RG, Lopez JL, Alvarez JS. Treatment of COVID-19 pneumonia with glucocorticoids (CORTIVID): a structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Jan 11;22(1):43. doi: 10.1186/s13063-020-04999-4.
- Individual participant dataSharing planned: Yes. All collected IPD will be available for exploitation in future research projects. This statement also includes the availability of the study protocol, the statistical analysis plan, the informed consent form, the clinical study report and the analytic code.
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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.
Iñigo Les Bujanda, PhD principal investigator
Complejo Hospitalario de Navarra
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methylprednisolone in people with Covid-19 Pneumonia, run by Fundacion Miguel Servet at 2 sites in Spain.
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 13 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 17 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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 phase mean?
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?
Proportion of patients developing treatment failure (time frame: At 14 days after randomization). The study lists 4 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 NCT04438980, 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 17 May 2021.