COVID19- Infection With SARS-CoV-2 VirusPhase 2CORIMUNO-NIVONCT04343144
Trial Evaluating Efficacy and Safety of Nivolumab (Optivo®) in Patients With COVID-19 Infection, Nested in the Corimmuno-19 Cohort.
A Phase 2 study testing Nivolumab Injection in people with COVID19- Infection With SARS-CoV-2 Virus, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
It appears interesting to use nivolumab in severe patients infected with SARS-CoV-2 requiring hospitalization in conventional unit or in ICU. This protocol CORIMUNO19-NIVO therefore, will evaluate the efficacy and safety of OPTIVO® (nivolumab) COVID-19 patients hospitalized in conventional unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID19- Infection With SARS-CoV-2 Virus
- What is being tested?
- Nivolumab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteFrance
- Study dates
- 15 Apr 2020to 30 Sep 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
- Adults (men and women) age over 18 years old
- At least one nasal swab positive for COVID-19 detected by PCR, maximum 7 days prior to treatment
- Viral pneumonia confirmed by TDM scan
- Patients meeting all of the following 3 criteria:
- Requiring more than 3L/min of oxygen
- WHO progression scale = 5
- No NIV or High flow
Who cannot join
- Patients with active cancer and immunocopromised patients
- Known hypersensitivity to nivolumab or to any of their excipients.
- Pregnancy
- Patient with an autoimmune or inflammatory disease (including but not limited to: Crohn's Disease, rheumatoid arthritis, scleroderma, systemic lupus erythematosus, Grave's disease). Patients with thyroiditis or vitiligo only could be included.
- Patient with a history of thymoma
- Patient with a history of solid organ transplantation or a bone marrow transplantation
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- Patients treated with immune checkpoint inhibitors 3 months prior to the study
- Patients who had a history of grade 3 or 4 immune-related adverse events with a previous treatment with immune-checkpoint inhibtors
- Patients requiring ICU based on Criteria of severity of COVID pneumopathy
- Respiratory failure requiring mechanical ventilation or extracorporeal membrane oxygenation
Trial locations and contacts
1 site in 1 country.
France1 site
Pneumologie hôpital Tenon
Paris, 75019
Jacques Cadranel, MD PhD, 01 56 01 66 73, jacques.cadranel@aphp.fr
About this study
Official title: Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients CORIMUNO-19-Nivolumab Trial
It appears interesting to use nivolumab in severe patients infected with SARS-CoV-2 requiring hospitalization in conventional unit or in ICU.
This protocol CORIMUNO19-NIVO therefore, will evaluate the efficacy and safety of OPTIVO® (nivolumab) COVID-19 patients hospitalized in conventional unit.
The purpose of this study is to show the efficacy of nivolumab in patients with COVID-19 in combination with standard treatments.
A phase 2 randomized open trial will evaluate the efficacy and safety of optivo® (nivolumab) alone versus standard of care (SoC) in patients hospitalized in conventional units.
Patients will be randomly allocated 1:1 to either nivolumab or SoC.
- Conditions
- COVID19- Infection With SARS-CoV-2 Virus
- Being tested
- Nivolumab Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nivolumab InjectionDrug
Treatment consists of an infusion of OPDIVO® 3mg/kg on day 1 (D1).
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab | Experimental | Not described Receives: Drug: Nivolumab Injection |
| Standard of Card | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to clinical improvement
the time required for clinical improvement, defined as the time elapsed between randomization and a two-point improvement on an ordinal scale with seven categories (WHO scale), or the discharge alive from hospital, whatever occurred first
Measured: day 14
Secondary outcomes (8)
Overall survival
Measured: day 28
Overall survival
Measured: day 90
Cumulative incidence of ICU admission
Measured: day 28
Length of hospital stay
Measured: day 90
Positive nasal PCR
Measured: day 7
Incidence of adverse events
Measured: day 28
Incidence of grade 3-4 adverse events
according to CTC AE-4.03
Measured: day 28
World Health Organisation (WHO) progression scale
range, from 0 (healthy) to 10 (death)
Measured: day 4, 7 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start15 Apr 2020 (estimated)
- Primary completion31 Jul 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID19- Infection With SARS-CoV-2 VirusStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Model description
- 2 parallels arms randomized open-label multi center clinical trial
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04343144
- Sponsor's protocol ID
- APHP200389-5
- Acronym
- CORIMUNO-NIVO
- Status last verified
- Apr 2020
- First submitted
- 9 Apr 2020
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients CORIMUNO-19-Nivolumab Trial
- ClinicalTrials.gov ID
- NCT04343144
- Acronym / sponsor ID
- CORIMUNO-NIVO / APHP200389-5
- Conditions
- COVID19- Infection With SARS-CoV-2 Virus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Apr 2020 (estimated)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 13 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.
It appears interesting to use nivolumab in severe patients infected with SARS-CoV-2 requiring hospitalization in conventional unit or in ICU.
This protocol CORIMUNO19-NIVO therefore, will evaluate the efficacy and safety of OPTIVO® (nivolumab) COVID-19 patients hospitalized in conventional unit.
The purpose of this study is to show the efficacy of nivolumab in patients with COVID-19 in combination with standard treatments.
A phase 2 randomized open trial will evaluate the efficacy and safety of optivo® (nivolumab) alone versus standard of care (SoC) in patients hospitalized in conventional units.
Patients will be randomly allocated 1:1 to either nivolumab or SoC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 parallels arms randomized open-label multi center clinical trial
| Arm | Type | Receives |
|---|---|---|
| Nivolumab | Experimental | Drug: Nivolumab Injection |
| Standard of Card | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults (men and women) age over 18 years old
- At least one nasal swab positive for COVID-19 detected by PCR, maximum 7 days prior to treatment
- Viral pneumonia confirmed by TDM scan
- Patients meeting all of the following 3 criteria:
Key exclusion criteria (10 listed)
- Patients with active cancer and immunocopromised patients
- Known hypersensitivity to nivolumab or to any of their excipients.
- Pregnancy
- Patient with an autoimmune or inflammatory disease (including but not limited to: Crohn's Disease, rheumatoid arthritis, scleroderma, systemic lupus erythematosus, Grave's disease). Patients with thyroiditis or vitiligo only could be included.
- Patient with a history of thymoma
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 |
|---|---|---|
| Nivolumab InjectionTreatment consists of an infusion of OPDIVO® 3mg/kg on day 1 (D1). | Drug | Nivolumab |
Primary outcome
Time to clinical improvement
Time frame: day 14
the time required for clinical improvement, defined as the time elapsed between randomization and a two-point improvement on an ordinal scale with seven categories (WHO scale), or the discharge alive from hospital, whatever occurred first
8 secondary outcomes
Overall survival
Time frame: day 28
Overall survival
Time frame: day 90
Cumulative incidence of ICU admission
Time frame: day 28
Length of hospital stay
Time frame: day 90
Positive nasal PCR
Time frame: day 7
Incidence of adverse events
Time frame: day 28
Incidence of grade 3-4 adverse events
Time frame: day 28
World Health Organisation (WHO) progression scale
Time frame: day 4, 7 and 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab Injection in people with COVID19- Infection With SARS-CoV-2 Virus, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 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 14 Apr 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacques Cadranel, MD PhD (1 56 01 66 73 ext. +33, jacques.cadranel@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to clinical improvement (time frame: day 14). 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 14 Apr 2020.