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An Adaptive Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study Assessing Efficacy and Safety of Sarilumab for Hospitalized Patients With COVID-19

Trial Profile

An Adaptive Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study Assessing Efficacy and Safety of Sarilumab for Hospitalized Patients With COVID-19

Status: Discontinued
Phase of Trial: Phase II/III

Latest Information Update: 22 Jul 2020

At a glance

  • Drugs Sarilumab (Primary)
  • Indications COVID 2019 infections; Hypoxaemia; Pneumonia; Respiratory insufficiency
  • Focus Pharmacodynamics; Therapeutic Use
  • Sponsors Regeneron Pharmaceuticals
  • Most Recent Events

    • 16 Jul 2020 Planned End Date changed from 20 Jul 2021 to 31 Aug 2020.
    • 16 Jul 2020 Planned primary completion date changed from 20 May 2021 to 24 Jul 2020.
    • 02 Jul 2020 Results (n=194) presented in a Sanofi Media Release.

Trial Overview

Outcome

Primary endpoint not met - negative

Purpose

This phase 2/3 study is investigating addition of Kevzara (sailumab) to usual supportive care, compared to supportive care plus placebo in patients with severe COVID-19 infection across approximately 16 U.S. sites.
This adaptive design study has two parts: first part will evaluate the impact of Kevzara on fever and patients' need for supplemental oxygen. The second, larger part of the trial will evaluate the improvement in longer-term outcomes including preventing death and reducing the need for mechanical ventilation, supplemental oxygen and/or hospitalization.

Comments

According to a Regeneron Pharmaceuticals Media Release, based on the latest results ( 400mg cohort), the trial did not meet its primary and key secondary endpoints. So, the company has been stopped this study.

Primary Endpoints

Not met, 02 Jul 2020

Proportion of patients with at least 1-point improvement in clinical status using the 7-point ordinal scale in patients with critical COVID-19 receiving mechanical ventilation at baseline

description: Phase 3 Cohort 1

7-point Ordinal Scale

Death;

Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO);

Hospitalized, requiring non-invasive ventilation or high flow oxygen devices;

Hospitalized, requiring supplemental oxygen;

Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise)

Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care

Not hospitalized

time_frame: Up to day 22 [1]

Percent change in C-reactive protein (CRP) levels

description: Phase 2 Only
time_frame: Day 4

Time to improvement (2 points) in clinical status assessment using the 7-point ordinal scale in patients with serum IL-6 levels greater than the upper limit of normal

description: Phase 3 Only
7-point Ordinal Scale:
Death;
Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO);
Hospitalized, requiring non-invasive ventilation or high flow oxygen devices;
Hospitalized, requiring supplemental oxygen;
Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise)
Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care
Not hospitalized
time_frame: Up to day 29

Proportion of patients with at least 1-point improvement in clinical status using the 7-point ordinal scale in patients with COVID-19 receiving mechanical ventilation at baseline

description: Phase 3 Cohort 2

time_frame: Up to day 22

Proportion of patients with at least 1-point improvement in clinical status using the 7-point ordinal scale in patients with COVID-19 not on mechanical ventilation but on high-intensity oxygen therapy* at baseline

description: Phase 3 Cohort 3

*High intensity oxygen therapy is defined as the use of non-rebreather mask with an oxygen flow rate of at least 10 L/min; use of a high flow device with at least 50% FiO2, or use of non-invasive ventilation (eg, BiPAP™) or CPAP to treat hypoxemia

time_frame: Up to day 22

Percent change in C-reactive protein (CRP) levels in patients with serum IL-6 level greater than the upper limit of normal

description: Phase 2

time_frame: Day 4

Other Endpoints

Time to improvement (2 points) in clinical status assessment on the 7-point ordinal scale in severe or critical patients with serum IL-6 levels greater than the upper limit of normal

description: Phase 2
time_frame: Up to day 29

Time to improvement (2 points) in clinical status assessment on the 7-point ordinal scale reporting in severe or critical patients with all IL-6 levels

description: Phase 2
time_frame: Up to day 29

Time to resolution of fever for at least 48 hours without antipyretics in patients with documented fever

description: Phase 2
Resolution of fever defined as postbaseline body temperature <37.2°C (oral), or <37.6°C (rectal or tympanic) or <36.8°C (temporal or axillary)
Documented fever defined as ≥38°C (oral), ≥38.4°C (rectal or tympanic), or ≥37.6°C (temporal or axillary)
time_frame: Up to day 29

Time to resolution of fever for at least 48 hours without antipyretics by clinical severity

description: Phase 2
Defined as postbaseline body temperature <37.2°C (oral), or <37.6°C (rectal or tympanic) or <36.8°C (temporal or axillary)
time_frame: Up to day 29

Time to resolution of fever for at least 48 hours without antipyretics by baseline IL-6 levels

description: Phase 2
Defined as postbaseline body temperature <37.2°C (oral), or <37.6°C (rectal or tympanic) or <36.8°C (temporal or axillary)
time_frame: Up to day 29

Time to improvement in oxygenation for at least 48 hours

description: Phase 2
Improvement in oxygenation defined as increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2
time_frame: Up to day 29

Time to improvement in oxygenation for at least 48 hours by clinical severity

description: Phase 2
Defined as increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2
time_frame: Up to day 29

Time to improvement in oxygenation for at least 48 hours by baseline IL-6 levels

description: Phase 2
Defined as increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2
time_frame: Up to day 29

Time to resolution of fever and improvement in oxygenation for at least 48 hours

description: Phase 2
Resolution of fever defined as postbaseline body temperature <37.2°C (oral), or <37.6°C (rectal or tympanic) or <36.8°C (temporal or axillary)
Improvement in oxygenation defined as increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2
time_frame: Up to day 29

Mean change in the 7-point ordinal scale

description: Phase 2
time_frame: Up to day 29

Percentage of patients in each clinical status category using the 7-point ordinal scale

description: Phase 2
time_frame: Up to day 29

Time to discharge or to a National Early Warning Score 2 (NEWS2) of ≤2 and maintained for 24 hours

description: Phase 2
NEWS2 consists of: Physiological Parameters: Respiration rate (per minute), SpO2 Scale 1 (%), SpO2 Scale 2 (%), Use of Air or oxygen, Systolic blood pressure (mmHg), Pulse (per minute), Consciousness, Temperature (°C)
time_frame: Up to day 29

Change from baseline in NEWS2 scoring system

description: Phase 2
time_frame: Up to day 29

Number of days with fever

description: Phase 2
Defined as ≥38°C (oral), ≥38.4°C (rectal or tympanic) or ≥37.6°C (temporal or axillary)
time_frame: Up to day 29

Proportion of patients alive, off oxygen

description: Phase 2
time_frame: At day 29

Number of days of resting respiratory rate >24 breaths/min

description: Phase 2
time_frame: Up to day 29

Number of days with hypoxemia

description: Phase 2
time_frame: Up to day 29

Number of days of supplemental oxygen use

description: Phase 2
time_frame: Up to day 29

Time to saturation ≥94% on room air

description: Phase 2
time_frame: Up to day 29

Number of ventilator free days in the first 28 days

description: Phase 2
time_frame: Baseline to day 29

Number of patients requiring initiation of mechanical ventilation

description: Phase 2
time_frame: Up to day 29

Number of patients requiring non-invasive ventilation

description: Phase 2
time_frame: Up to day 29

Number of patients requiring the use of high flow nasal cannula

description: Phase 2
time_frame: Up to day 29

Number of patients admitted into an intensive care unit (ICU)

description: Phase 2
time_frame: Up to day 29

Number of days of hospitalization among survivors

description: Phase 2
time_frame: Up to day 29

Number of deaths due to any cause

description: Phase 2
time_frame: Up to day 60

Proportion of patients with at least 1-point improvement in clinical status using the 7-point ordinal scale

description: Phase 3
time_frame: Up to day 22

Proportion of patients who recover

description: Phase 3
Defined as discharged, or alive without supplemental oxygen use or at pre-COVID oxygen use
time_frame: Up to day 22

Proportion of deaths

description: Phase 3
time_frame: Through day 29
time_frame: Through day 60

Proportion of patients alive not receiving mechanical ventilation

description: Phase 3
time_frame: At day 22

Proportion of patients alive not requiring extracorporeal membrane oxygenation (ECMO)

description: Phase 3
time_frame: At day 22

Proportion of patients with a 2-point improvement in clinical status on the 7-point ordinal scale

description: Phase 3
time_frame: Up to day 22

Time to at least 1-point improvement in clinical status assessment on the 7-point ordinal scale

description: Phase 3
time_frame: Up to day 29

Time to at least 2-point improvement in clinical status assessment on the 7-point ordinal scale

description: Phase 3
time_frame: Up to day 29

Proportion of patients receiving mechanical ventilation

description: Phase 3
time_frame: Up to day 22

Proportion of patients receiving ECMO

description: Phase 3
time_frame: Up to day 22

Proportion of patients discharged and alive

description: Phase 3
time_frame: At day 22

Time to recovery

description: Phase 3
Defined as discharged or alive without supplemental oxygen use or at pre-COVID oxygen use
time_frame: Up to day 29

Time to death due to any cause

description: Phase 3
time_frame: Through day 60

Number of ventilator free days

description: Phase 3
time_frame: Up to day 29

Number of days of hospitalization among survivors

description: Phase 3
time_frame: Up to day 29

Proportion of patients with serious adverse events

description: Phase 2 and Phase 3
time_frame: Up to Day 29

Proportion of patients with Grade 4 neutropenia (ANC <500/mm3)

description: Phase 2 and Phase 3
time_frame: Up to day 29

Proportion of patients with severe or life-threatening bacterial, invasive fungal, or opportunistic infection

description: Phase 2 and Phase 3
time_frame: Up to day 29

Proportion of patients with severe or life-threatening bacterial, invasive fungal, or opportunistic infection in patients with Grade 4 neutropenia (ANC <500/mm3)

description: Phase 2 and Phase 3
time_frame: Up to day 29

Proportion of patients with hypersensitivity reactions

description: Phase 2 and Phase 3
time_frame: Up to day 29

Proportion of patients with infusion reactions

description: Phase 2 and Phase 3
time_frame: Up to day 29

Proportion of patients with gastrointestinal perforation

description: Phase 2 and Phase 3
time_frame: Up to day 29

White blood cell count

description: Phase 2 and Phase 3
time_frame: Up to day 29 if still hospitalized

Hemoglobin levels

description: Phase 2 and Phase 3
time_frame: Up to day 29 if still hospitalized

Platelet count

description: Phase 2 and Phase 3
time_frame: Up to day 29 if still hospitalized

Creatinine levels

description: Phase 2 and Phase 3
time_frame: Up to day 29 if still hospitalized

Total bilirubin level

description: Phase 2 and Phase 3
time_frame: Up to day 29 if still hospitalized

Alanine aminotransferase (ALT) level

description: Phase 2 and Phase 3
time_frame: Up to day 29 if still hospitalized

Aspartate aminotransferase (AST) level

description: Phase 2 and Phase 3
time_frame: Up to day 29 if still hospitalized [2]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -
Hypoxaemia treatment -
Pneumonia treatment -
Respiratory insufficiency treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 2500

    Actual: 1912

  • Sex male & female
  • Age Group ≥ 18 years

Patient Inclusion Criteria

Key - Laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR), result from any specimen (or other commercial or public health assay) within 2 weeks prior to randomization and no alternative explanation for current clinical condition - Hospitalized with illness of any duration with evidence of pneumonia, requires supplemental oxygen and/or assisted ventilation and meets one of the following: - Phase 2 and Phase 3 Cohort 1: Meets 1 of the following criteria at baseline: - Severe disease or - Critical disease or - Multi-system organ dysfunction or - Immunocompromised - Phase 3 Cohort 2: Patients must be receiving mechanical ventilation to treat respiratory failure due to COVID-19 - Ability to provide informed consent signed by study patient or legally acceptable representative - Willingness and ability to comply with study-related procedures/assessments Key

Patient Exclusion Criteria

- In the opinion of the investigator, not expected to survive for more than 48 hours from screening - Presence of any of the following abnormal laboratory values at screening: absolute neutrophil count (ANC) less than 2000 mm3, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 x upper limit of normal (ULN), platelets <50,000 per mm3 - Treatment with anti-IL 6, anti-IL-6R antagonists, or with Janus kinase inhibitors (JAKi) in the past 30 days or plans to receive during the study period - Current treatment with the simultaneous combination of leflunomide and methotrexate - Known active tuberculosis (TB), history of incompletely treated TB, suspected or known extrapulmonary TB, suspected or known systemic bacterial or fungal infections - Participation in a double-blind clinical research study evaluating an investigational product (IP) or therapy within 3 months and less than 5 half-lives of IP prior to the screening visit (The use of remdesivir, hydroxychloroquine, or other treatments being used for COVID-19 treatments in the context of an open-label study, Emergency Use Authorization (EUA), compassionate use protocol or open-label use is permitted) - Any physical examination findings, and/or history of any illness, concomitant medications or recent live vaccines that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study - Known systemic hypersensitivity to sarilumab or the excipients of the drug product - Phase 3 Cohort 2 only: - Known or suspected history of immunosuppression or immunodeficiency disorder - Patients who require renal replacement therapy for acute kidney injury at randomization or who required renal replacement therapy within 72 hours prior to randomization - Patients who have circulatory shock requiring vasopressors at randomization or within 24 hours prior to randomization - Use of extracorporeal life support (eg, ECMO) or, in the opinion of the investigator, there is a high likelihood that extracorporeal life support will be initiated within 48 hours after randomization NOTE: Other protocol defined inclusion / exclusion criteria may apply

Trial Details

Identifiers

Identifier Owner
NCT04315298 ClinicalTrials.gov: US National Institutes of Health
6R88COV2040 -

Organisations

  • Sponsors Regeneron Pharmaceuticals
  • Affiliations Regeneron Pharmaceuticals; Sanofi

Trial Dates

  • Initiation Dates

    Actual : 18 Mar 2020

  • Primary Completion Dates

    Planned : 24 Jul 2020

  • End Dates

    Planned : 31 Aug 2020

Other Details

  • Design double-blind; multicentre; parallel; prospective; randomised
  • Phase of Trial Phase II/III
  • Location USA
  • Focus Pharmacodynamics; Therapeutic Use

Interventions

Drugs Route Formulation
SarilumabPrimary Drug Intravenous Injection

Sarilumab high dose (P3:C2)

Phase 3: Cohort 2 Drug: Sarilumab (Single or multiple intravenous (IV) doses of sarilumab. Additional doses may be administered if the patient meets protocol defined criteria.) Other Name: Kevzara®, REGN88, SAR153191 Drug: Placebo (Single or multiple intravenous (IV) doses of placebo to match sarilumab administration)

Sarilumab low dose (P2)

Phase 2 Drug: Sarilumab (Single or multiple intravenous (IV) doses of sarilumab. Additional doses may be administered if the patient meets protocol defined criteria.) Other Name: Kevzara®, REGN88, SAR153191 Drug: Placebo (Single or multiple intravenous (IV) doses of placebo to match sarilumab administration)

Sarilumab low dose (P3:C1)

Phase 3: Cohort 1 Drug: Sarilumab (Single or multiple intravenous (IV) doses of sarilumab. Additional doses may be administered if the patient meets protocol defined criteria.) Other Name: Kevzara®, REGN88, SAR153191 Drug: Placebo (Single or multiple intravenous (IV) doses of placebo to match sarilumab administration)

Sarilumab mid dose (P2)

Phase 2 Drug: Sarilumab (Single or multiple intravenous (IV) doses of sarilumab. Additional doses may be administered if the patient meets protocol defined criteria.) Other Name: Kevzara®, REGN88, SAR153191 Drug: Placebo (Single or multiple intravenous (IV) doses of placebo to match sarilumab administration)

Sarilumab mid dose (P3:C1)

Phase 3: Cohort 1 Drug: Sarilumab (Single or multiple intravenous (IV) doses of sarilumab. Additional doses may be administered if the patient meets protocol defined criteria.) Other Name: Kevzara®, REGN88, SAR153191 Drug: Placebo (Single or multiple intravenous (IV) doses of placebo to match sarilumab administration)

Results

Therapeutic efficacy

Updates results from the phase III portion of the trial showed that following treatment with sarilumab, minor positive trends were observed in the primary pre-specified analysis group (n = 194) (critical patients on sarilumab 400 mg who were mechanically ventilated at baseline) however statistical significance was not achieved. These were countered by negative trends in a subgroup of critical patients who were not mechanically ventilated at baseline including the proportion of patients with a 1-point improvement on day 22 (primary endpoint for mechanical ventilation group); the proportion of patients who died by day 29; and the proportion of patients who recovered by day 22. Preliminary results from the phase II portion of the phase II/III trial showed that primary end point of the trial was met as indicated by rapidly lowered C-reactive protein in sarilumab treated patients. Baseline levels of IL-6 were elevated across all treatment arms, with higher levels observed in "critical" patients compared to "severe" patients. Explorarory analysis results showed that no notable benefit on clinical outcomes when combining the "severe" and "critical" groups, versus placebo was observed in sarilumab treated patients. However, negative trends for most outcomes in the "severe" group, while positive trends for all outcomes in the "critical" group were observed. Review of the discontinued "severe" group data revealed that the negative trends in the phase II trial (n=126) were not reproduced in phase III trial (n=276), and that clinical outcomes were balanced across the sarilumab and placebo treatment arms. Outcomes for the "severe" group were better than expected based on prior reports, regardless of treatment assignment as evident from example that in the phase II portion, approximately 80% were discharged, 10% of patients died and 10% remain hospitalized in the severe group [1] [3] .
2020-07-06 14:23:00.990

Adverse events

COVID-2019 Infections: Updated resultd from the phase III portion of the trial showed that in the primary analysis group (n = 194) adverse events were experienced by 80% of sarilumab patients and 77% of placebo patients. Multi-organ dysfunction syndrome (6% sarilumab, 5% placebo) and hypotension (4% sarilumab, 3% placebo) were the serious adverse events reported in at least 3% of patients and more frequently among sarilumab patients [1] [3] .

Publications

  1. Regeneron Pharmaceuticals. Regeneron and Sanofi Provide Update on Kevzara(RM) (sarilumab) Phase 3 U.S. Trial in COVID-19 Patients. Media-Rel 2020;.

    Media Release
  2. Regeneron Pharmaceuticals, Sanofi. Regeneron and Sanofi Provide Update on U.S. Phase 2/3 Adaptive-Designed Trial of Kevzara(Rm) (sarilumab) in Hospitalized COVID-19 Patients. Media-Rel 2020;.

    Media Release
  3. Sanofi. Sanofi and Regeneron provide update on U.S. Phase 2/3 adaptive-designed trial in hospitalized COVID-19 patients. Media-Rel 2020;.

    Media Release
  4. Sanofi. Sanofi and Regeneron provide update on Kevzara(Rm) (sarilumab) Phase 3 U.S. trial in COVID-19 patients. Media-Rel 2020;.

    Media Release

Authors

Author Total Publications First Author Last Author
Regeneron Pharmaceuticals 2 2 1
Sanofi 3 2 3

Trial Centres

Centres

Centre Name Location Trial Centre Country
Regeneron Pharmaceuticals
Clinical Trials Administrator
844-734-6643
clinicaltrials@regeneron.com
show details
-
-
Regeneron Study Site Ann Arbor, Michigan USA
Regeneron Study Site Atlanta, Georgia USA
Regeneron Study Site Aurora, Colorado USA
Regeneron Study Site Baltimore, Maryland USA
Regeneron Study Site Boston, Massachusetts USA
Regeneron Study Site Bronx, New York USA
Regeneron Study Site Brooklyn, New York USA
Regeneron Study Site Buffalo, New York USA
Regeneron Study Site Chicago, Illinois USA
Regeneron Study Site Coral Gables, Florida USA
Regeneron Study Site Dallas, Texas USA
Regeneron Study Site Danville, Pennsylvania USA
Regeneron Study Site Decatur, Georgia USA
Regeneron Study Site Denver, Colorado USA
Regeneron Study Site Edison, New Jersey USA
Regeneron Study Site Elmhurst, New York USA
Regeneron Study Site Everett, Washington USA
Regeneron Study Site Falls Church, Virginia USA
Regeneron Study Site Gainesville, Florida USA
Regeneron Study Site Hackensack, New Jersey USA
Regeneron Study Site Livingston, New Jersey USA
Regeneron Study Site Los Angeles, California USA
Regeneron Study Site Marietta, Georgia USA
Regeneron Study Site Morristown, New Jersey USA
Regeneron Study Site Murray, Utah USA
Regeneron Study Site Neptune, New Jersey USA
Regeneron Study Site New Haven, Connecticut USA
Regeneron Study Site New Orleans, Louisiana USA
Regeneron Study Site New York, New York USA
Regeneron Study Site Newark, New Jersey USA
Regeneron Study Site Orlando, Florida USA
Regeneron Study Site Philadelphia, Pennsylvania USA
Regeneron Study Site Portland, Oregon USA
Regeneron Study Site Renton, Washington USA
Regeneron Study Site Richmond, Virginia USA
Regeneron Study Site Rochester, Minnesota USA
Regeneron Study Site Sacramento, California USA
Regeneron Study Site Santa Monica, California USA
Regeneron Study Site Scranton, Pennsylvania USA
Regeneron Study Site Stony Brook, New York USA
Regeneron Study Site Tampa, Florida USA
Regeneron Study Site Teaneck, New Jersey USA
Regeneron Study Site Tulsa, Oklahoma USA
Regeneron Study Site Valhalla, New York USA
Regeneron Study Site Washington, District of Columbia USA
Regeneron Study Site Wilkes-Barre, Pennsylvania USA
Regeneron Study Site 1 Bronx, New York USA
Regeneron Study Site 1 Manhasset, New York USA
Regeneron Study Site 1 New York, New York USA
Regeneron Study Site 2 Bronx, New York USA
Regeneron Study Site 2 Manhasset, New York USA
Regeneron Study Site 2 New York, New York USA
Sanofi
-
-

Trial History

Event Date Event Type Comment
22 Jul 2020 Other trial event Last checked against Clinicaltrials.gov record. Updated 22 Jul 2020
16 Jul 2020 Completion date Planned End Date changed from 20 Jul 2021 to 31 Aug 2020. Updated 22 Jul 2020
16 Jul 2020 Other trial event Planned primary completion date changed from 20 May 2021 to 24 Jul 2020. Updated 22 Jul 2020
02 Jul 2020 Results Results (n=194) presented in a Sanofi Media Release. Updated 09 Jul 2020
02 Jul 2020 Endpoint not met Primary endpoint did not met (Proportion of patients with at least 1-point improvement in clinical status using the 7-point ordinal scale in patients with critical COVID-19 receiving mechanical ventilation at baseline), according to a Regeneron Pharmaceuticals media release. Updated 07 Jul 2020
02 Jul 2020 Other trial event According to a Regeneron Pharmaceuticals Media Release, 21 patients are enrolled in the second cohort (800 mg). However, the company now has stopped the study. Updated 07 Jul 2020
02 Jul 2020 Other trial event According to a Regeneron Pharmaceuticals Media Release, data from this study will be submitted to a peer-reviewed publication later this year. Updated 07 Jul 2020
02 Jul 2020 Other trial event According to a Regeneron Pharmaceuticals Media Release, based on the latest results ( 400mg cohort), the trial did not meet its primary and key secondary endpoints. So, the company has been stopped this study. Updated 07 Jul 2020
02 Jul 2020 Status change - discontinued Status changed from recruiting to discontinued, according to a Regeneron Pharmaceuticals Media Release. Updated 07 Jul 2020
02 Jul 2020 Results Results (n=194) presented in a Regeneron Pharmaceuticals media release. Updated 07 Jul 2020
04 Jun 2020 Other trial event Planned number of patients changed from 400 to 2500. Updated 10 Jun 2020
04 Jun 2020 Completion date Planned End Date changed from 1 Apr 2021 to 20 Jul 2021. Updated 10 Jun 2020
04 Jun 2020 Other trial event Planned primary completion date changed from 9 Mar 2021 to 20 May 2021. Updated 10 Jun 2020
27 Apr 2020 Results Results presented in a Sanofi Media Release. Updated 30 Apr 2020
27 Apr 2020 Other trial event According to a Regeneron Pharmaceuticals Media Release, this trial has been funded in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; and BARDA, under OT number: HHSO100201700020C. Updated 29 Apr 2020
27 Apr 2020 Other trial event According to a Regeneron Pharmaceuticals Media Release, enrollment in the phase 3 portion is ongoing currently includes more than 600 patients in the "critical" group. Regeneron and Sanofi remain blinded to the ongoing portion of the Phase 3 trial and expect to report results by June. Updated 29 Apr 2020
27 Apr 2020 Protocol amendment According to a Regeneron Pharmaceuticals Media Release, Independent Data Monitoring Committee recommended continuing ongoing Phase 3 trial only in the more advanced "critical" group with Kevzara higher-dose (400mg) versus placebo and to discontinue lower-dose Kevzara (200 mg). Updated 29 Apr 2020
27 Apr 2020 Results Results presented in the Regeneron Pharmaceuticals Media Release. Updated 29 Apr 2020
02 Apr 2020 Completion date Planned End Date changed from 16 Mar 2021 to 1 Apr 2021. Updated 07 Apr 2020
02 Apr 2020 Other trial event Planned primary completion date changed from 16 Mar 2021 to 9 Mar 2021. Updated 07 Apr 2020
21 Mar 2020 Other trial event According to a US Department of Health and Human Services media release, the company will receive funds from the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response (ASPR) for this trial. Updated 26 Mar 2020
20 Mar 2020 Other trial event According to the Feinstein Institute for Medical Research media release, the lead investigator on this study is Negin Hajizadeh, MD, assistant professor in the Institute of Health Innovations & Outcomes Research at Feinstein, and a pulmonary and critical care physician. Updated 23 Mar 2020
20 Mar 2020 Other trial event New source identified and integrated (ClinicalTrials.gov: NCT04315298). Updated 20 Mar 2020
18 Mar 2020 New trial record New trial record Updated 18 Mar 2020
16 Mar 2020 Other trial event According to a Regeneron Pharmaceuticals media release, Regeneron Pharmaceuticals and Sanofi have started a clinical program evaluating Kevzara (sarilumab) in patients hospitalized with severe COVID-19 infection.Regeneron is leading this U.S. trial, Sanofi will lead upcoming ex-U.S. trials. Updated 20 Mar 2020
16 Mar 2020 Other trial event According to a Regeneron Pharmaceuticals media release, if the trial continues with all three treatment arms to the end, it is expected to enroll approximately 400 patients, depending on the status of the COVID-19 outbreak and the proportion of patients with severe COVID-19 and high levels of IL-6. Updated 20 Mar 2020
16 Mar 2020 Other trial event According to a Regeneron Pharmaceuticals media release, Regeneron and Sanofi have worked closely with the U.S. Food and Drug Administration and the Biomedical Advanced Research and Development Authority, to initiate this trial quickly, so that the results may inform evidence-based treatment of this ongoing pandemic of COVID-19.Regeneron is leading U.S. trials, Sanofi will lead upcoming ex-U.S. trials. Updated 20 Mar 2020
16 Mar 2020 Other trial event According to a Regeneron Pharmaceuticals media release, the Phase 2 findings will be utilized in an adaptive manner to determine transition into Phase 3, helping to determine the endpoints, patient numbers and doses.The second, larger part of the trial will evaluate the improvement in longer-term outcomes including preventing death and reducing the need for mechanical ventilation, supplemental oxygen and/or hospitalization. Updated 20 Mar 2020
16 Mar 2020 Other trial event According to a Sanofi media release, this trial will begin at medical centers in New York, one of the epicenters of the U.S. COVID-19 outbreak. Updated 18 Mar 2020

References

  1. Regeneron Pharmaceuticals. Regeneron and Sanofi Provide Update on Kevzara(RM) (sarilumab) Phase 3 U.S. Trial in COVID-19 Patients. Media-Rel 2020;.

    Media Release
  2. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  3. Regeneron Pharmaceuticals, Sanofi. Regeneron and Sanofi Provide Update on U.S. Phase 2/3 Adaptive-Designed Trial of Kevzara(Rm) (sarilumab) in Hospitalized COVID-19 Patients. Media-Rel 2020;.

    Media Release
  4. US Department of Health and Human Services. HHS Funds Phase 2/3 Clinical Trial for Potential Treatment for COVID-19. Media-Rel 2020;.

    Media Release
  5. Sanofi. Sanofi and Regeneron begin global Kevzara(Rm) (sarilumab) clinical trial program in patients with severe COVID-19. Media-Rel 2020;.

    Media Release
  6. The Feinstein Institute for Medical Research. Feinstein Institutes begins enrolling patients in multiple COVID-19 clinical trials. Media-Rel 2020;.

    Media Release
  7. Sanofi. Sanofi and Regeneron provide update on U.S. Phase 2/3 adaptive-designed trial in hospitalized COVID-19 patients. Media-Rel 2020;.

    Media Release
  8. Regeneron Pharmaceuticals, Sanofi. Regeneron and Sanofi Begin Global Kevzara(R) (sarilumab) Clinical Trial Program in Patients with Severe COVID-19. Media-Rel 2020;.

    Media Release
  9. Sanofi. Sanofi and Regeneron provide update on Kevzara(Rm) (sarilumab) Phase 3 U.S. trial in COVID-19 patients. Media-Rel 2020;.

    Media Release
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