Trial Evaluating Efficacy and Safety of Nivolumab (Optivo®) in Patients With COVID-19 Infection, Nested in the Corimmuno-19 Cohort. (CORIMUNO-NIVO)

• ClinicalTrials.gov Identifier: NCT04343144
• Recruitment Status: Not yet recruiting
• First Posted: April 13, 2020
• Last Update Posted: April 14, 2020
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

Tracking Information

• First Submitted Date: April 9, 2020
• First Posted Date: April 13, 2020
• Last Update Posted Date: April 14, 2020
• Estimated Study Start Date: April 15, 2020
• Estimated Primary Completion Date: July 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 9, 2020)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 12, 2020)

• 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 ]
  according to CTC AE-4.03
• World Health Organisation (WHO) progression scale [ Time Frame: day 4, 7 and 14 ]
  range, from 0 (healthy) to 10 (death)

Original Secondary Outcome Measures (submitted: April 9, 2020)

• 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 ]
  according to CTC AE-4.03
• WHO scale [ Time Frame: day 4, 7 and 14 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Trial Evaluating Efficacy and Safety of Nivolumab (Optivo®) in Patients With COVID-19 Infection, Nested in the Corimmuno-19 Cohort.
• Official Title: Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients CORIMUNO-19-Nivolumab Trial

Brief 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.

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

2 parallels arms randomized open-label multi center clinical trial

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: COVID19- Infection With SARS-CoV-2 Virus

Intervention

Drug: Nivolumab Injection

Treatment consists of an infusion of OPDIVO® 3mg/kg on day 1 (D1).

Study Arms

• Experimental: Nivolumab
  Intervention: Drug: Nivolumab Injection
• No Intervention: Standard of Card

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: April 9, 2020): 92
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 30, 2020
• Estimated Primary Completion Date: July 31, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Jacques Cadranel, MD PhD; 1 56 01 66 73 ext +33; jacques.cadranel@aphp.fr

• Listed Location Countries: France

Administrative Information

• NCT Number: NCT04343144
• Other Study ID Numbers: APHP200389-5
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Assistance Publique - Hôpitaux de Paris
• Study Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Assistance Publique - Hôpitaux de Paris
• Verification Date: April 2020