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NCT04315298 · ClinicalTrials.gov registry record · Phase 2

Evaluation of the Efficacy and Safety of Sarilumab in Hospitalized Patients With COVID-19

A Phase 2 study of COVID-19, sponsored by Regeneron Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
1,912
Enrollment target
20
Study locations

NCT04315298 is a Phase 2 study of COVID-19 that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 1,912 participants, below the 55,205-participant average among 203 other COVID-19 trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 10 states.

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The verdict

NCT04315298, a Phase 2 study of COVID-19, has completed, sponsored by Regeneron Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
1,912 participants
Enrollment target
20
Study locations

Study Summary

Phase 2: The primary objective of the study is to evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with COVID-19 regardless of disease severity strata. Phase 3 Cohort 1: The primary objective of the study is to evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with critical COVID-19 receiving mechanical ventilation at baseline. Phase 3 Cohort 2: The primary objective of the study is to evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with COVID-19 receiving mechanical ventilation at baseline.

Conditions Studied

COVID-19

Interventions

  • DRUG Placebo
  • DRUG Sarilumab

Study Locations (20)

California

  • Regeneron Study Site - Los Angeles
  • Regeneron Study Site - Sacramento
  • Regeneron Study Site - Santa Monica

Florida

  • Regeneron Study Site - Gainesville
  • Regeneron Study Site - Orlando
  • Regeneron Study Site - Tampa

Georgia

  • Regeneron Study Site - Atlanta
  • Regeneron Study Site - Decatur
  • Regeneron Study Site - Marietta

Massachusetts

  • Regeneron Study Site - Boston
  • Regeneron Study Site - Boston
  • Regeneron Study Site - Boston

Colorado

  • Regeneron Study Site - Aurora
  • Regeneron Study Site - Denver

Illinois

  • Regeneron Study Site - Chicago
  • Regeneron Study Site - Chicago

Connecticut

  • Regeneron Study Site - New Haven

District of Columbia

  • Regeneron Study Site - Washington D.C.

Trial Details

FieldValue
Enrollment Target 1,912 participants
Start Date 2020-03-18
Est. Completion 2020-09-02
Phase Phase 2

Sponsor

Regeneron Pharmaceuticals

280 total trials

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What the Registry Record Tells You About NCT04315298

The ClinicalTrials.gov registry entry for NCT04315298 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 1,912 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 55,205-participant average among 203 other COVID-19 trials with a reported enrollment target (97% lower). The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with COVID-19 appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04315298 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT04315298 about?

NCT04315298 is a clinical study titled "Evaluation of the Efficacy and Safety of Sarilumab in Hospitalized Patients With COVID-19". Phase 2: The primary objective of the study is to evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with COVID-19 regardless of disease severity strata. Phase 3 Cohort 1: The primary objective of the study is to evaluate the clinical efficacy o...

What is the current status of trial NCT04315298?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,912 participants. The study started on 2020-03-18. Estimated completion is 2020-09-02.

What conditions does trial NCT04315298 study?

This clinical trial studies the following conditions: COVID-19.

What interventions are being tested in trial NCT04315298?

The interventions under investigation include: Placebo (DRUG), Sarilumab (DRUG).

Who is sponsoring clinical trial NCT04315298?

This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04315298 being conducted?

This trial has 20 study locations across California, Colorado, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.