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NCT04345614 · ClinicalTrials.gov registry record · Phase 2

A Study of Auxora in Patients With Severe COVID-19 Pneumonia

A Phase 2 study of Pneumonia, sponsored by CalciMedica.

Completed
Registry status
Phase 2
Development phase
314
Enrollment target
17
Study locations

NCT04345614 is a Phase 2 study of Pneumonia that has completed, run by CalciMedica. The registered enrollment target is 314 participants, below the 4,513-participant average among 47 other Pneumonia trials with a reported enrollment target (93% lower). The trial reports 17 study locations across 11 states.

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The verdict

NCT04345614, a Phase 2 study of Pneumonia, has completed, sponsored by CalciMedica.

COMPLETED
Registry status
Phase 2
Development phase
314 participants
Enrollment target
17
Study locations

Study Summary

Part 1 of this trial enrolled 30 patients to receive Auxora (formerly CM4620) in a 2:1 randomized, open label trial of patients with severe and critical COVID-19 pneumonia. Part 2 of this study randomized 284 patients and was a randomized, double blind, placebo-controlled (RCT) study that evaluated the efficacy, safety, and the pharmacokinetic profile of Auxora in patients with severe COVID-19 pneumonia. The number of patients with an imputed PaO2/FiO2 \>200 randomized into the study was capped at 26. Another 258 patients with a PaO2/FiO2 ≤200 were enrolled. Patients with an estimated PaO2/FiO2 of 75-200 were stratified to ensure balanced randomization between the Auxora and placebo arms. Subgroup analyses were performed to explore how time to recovery is influenced by baseline variables and to evaluate the treatment effect at different levels of each of these variables. The dose of Auxora was 2.0 mg/kg (1.25 mL/kg) administered at 0 hour, and then 1.6 mg/kg (1 mL/kg) at 24 hours and 1.6 mg/kg (1 mL/kg) at 48 hours from the SFISD. The dose of placebo was 1.25 mL/kg administered at 0 hour and then 1 mL/kg at 24 hours and 1 mL/kg at 48 hours from the SFISD. Remdesivir, corticosteroids and convalescent plasma were allowed. The infusion of Auxora / Placebo started within 12 hours from the time the patient or LAR provided informed consent. Efficacy analyses will be presented by treatment group (Auxora vs Placebo) based on the Efficacy Analysis Set of the imputed PaO2/FiO2 ≤200 subgroup, except where it is specified otherwise. The statistical analysis approach was designed to assess the significance of the primary and first secondary endpoint using the Benjamini and Hochberg method to control the overall trial level alpha level.

Conditions Studied

Pneumonia

Interventions

  • DRUG Auxora (Part 1)
  • DRUG Standard of Care (Part 1)
  • DRUG Auxora (Part 2)
  • DRUG Placebo (Part 2)

Study Locations (17)

California

  • Long Beach Memorial - Long Beach
  • University of Southern California / LA County - Los Angeles
  • Sharp Memorial San Diego - San Diego

Texas

  • Texas Tech University Medical Center - El Paso
  • John Peter Smith Hospital - Fort Worth
  • Houston Methodist Hospital - Houston

Michigan

  • Henry Ford Hospital - Detroit
  • Sinai Grace - Detroit

Minnesota

  • Methodist Hospital - Saint Louis Park
  • Regions Hospital - Saint Paul

Colorado

  • National Jewish Health / St. Joseph's Hospital - Denver

Illinois

  • Northwestern University - Chicago

Louisiana

  • Baton Rouge General - Baton Rouge

Maine

  • Maine Medical Center - Portland

Trial Details

FieldValue
Enrollment Target 314 participants
Start Date 2020-04-08
Est. Completion 2021-07-30
Phase Phase 2

Sponsor

CalciMedica

6 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04345614

The ClinicalTrials.gov registry entry for NCT04345614 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 314 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,513-participant average among 47 other Pneumonia trials with a reported enrollment target (93% lower). The listed sponsor is CalciMedica, which has 6 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Pneumonia appearing as the primary indexed condition, and to 4 interventions - of which Auxora (Part 1) is the first listed.

NCT04345614 reports 17 study locations spanning 11 distinct geographic areas - top geographies include California, Texas, Michigan.

Frequently Asked Questions

What is clinical trial NCT04345614 about?

NCT04345614 is a clinical study titled "A Study of Auxora in Patients With Severe COVID-19 Pneumonia". Part 1 of this trial enrolled 30 patients to receive Auxora (formerly CM4620) in a 2:1 randomized, open label trial of patients with severe and critical COVID-19 pneumonia. Part 2 of this study randomized 284 patients and was a randomized, double blind, placebo-controlled (RCT) study that evaluated ...

What is the current status of trial NCT04345614?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 314 participants. The study started on 2020-04-08. Estimated completion is 2021-07-30.

What conditions does trial NCT04345614 study?

This clinical trial studies the following conditions: Pneumonia.

What interventions are being tested in trial NCT04345614?

The interventions under investigation include: Auxora (Part 1) (DRUG), Standard of Care (Part 1) (DRUG), Auxora (Part 2) (DRUG), Placebo (Part 2) (DRUG).

Who is sponsoring clinical trial NCT04345614?

This trial is sponsored by CalciMedica, which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04345614 being conducted?

This trial has 17 study locations across California, Colorado, Illinois, Louisiana, Maine. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.