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An investigator-led clinical study of NP-120 (Ifenprodil) for the treatment of COVID-19 infected patients with severe pneumonia

Trial Profile

An investigator-led clinical study of NP-120 (Ifenprodil) for the treatment of COVID-19 infected patients with severe pneumonia

Status: Planning
Phase of Trial: Phase II

Latest Information Update: 23 Apr 2020

At a glance

  • Drugs Ifenprodil (Primary) ; Anti-inflammatories
  • Indications Pneumonia
  • Focus Adverse reactions; First in man
  • Most Recent Events

    • 23 Apr 2020 According to an Algernon Pharmaceuticals media release, enrolment is expected to begin on May 8, 2020.
    • 23 Apr 2020 According to an Algernon Pharmaceuticals media release, Dr. Dong Sik Jung, Professor, in the Division of Infectious Disease of Dong-A University Hospital, Busan is the lead investigator of this study.
    • 23 Apr 2020 According to an Algernon Pharmaceuticals media release, it has received approval from the Ministry of Food and Drug Safety in South Korea, as well as ethics approval, for this investigator-led study.

Trial Overview

Purpose

This is a clinical study of NP-120 (Ifenprodil) for the treatment of COVID-19 (coronavirus). This is a 4 week trial.

Primary Endpoints

rate at which their lung function improves by measuring oxygen levels in the blood (Pa02/Fi02).

Other Endpoints

mortality, rate of mechanical ventilation, and patient reported effects on cough and breathlessness (dyspnea). [1]

Diseases Treated

Indication Qualifiers Patient Segments
Pneumonia treatment severe

Subjects

  • Subject Type patients
  • Number

    Planned: 40

  • Sex male & female

Patient Inclusion Criteria

The 40-patient trial is designed to test the effect of Ifenprodil in COVID-19 infected patients with severe pneumonia

Trial Details

Organisations

  • Affiliations Algernon Pharmaceuticals

Trial Dates

Other Details

  • Design prospective
  • Phase of Trial Phase II
  • Location South Korea
  • Focus Adverse reactions; First in man

Interventions

Drugs Route Formulation
Anti-inflammatories
-
-
IfenprodilPrimary Drug Oral Controlled-release

NP-120 (Ifenprodil)

Standard of care (SOC)

Trial History

Event Date Event Type Comment
23 Apr 2020 Other trial event According to an Algernon Pharmaceuticals media release, enrolment is expected to begin on May 8, 2020. Updated 24 Apr 2020
23 Apr 2020 Other trial event According to an Algernon Pharmaceuticals media release, Dr. Dong Sik Jung, Professor, in the Division of Infectious Disease of Dong-A University Hospital, Busan is the lead investigator of this study. Updated 24 Apr 2020
23 Apr 2020 Other trial event According to an Algernon Pharmaceuticals media release, it has received approval from the Ministry of Food and Drug Safety in South Korea, as well as ethics approval, for this investigator-led study. Updated 24 Apr 2020
09 Apr 2020 Other trial event According to an Algernon Pharmaceuticals media release, Once the trial has been approved, the Company, along with its lead Asia-Pacific CRO Novotech and the physician-investigators, will work to enrol patients and begin the study as soon as possible. Updated 14 Apr 2020
09 Apr 2020 Other trial event According to an Algernon Pharmaceuticals media release, regulatory submission has been made to the Ministry of Food and Drug Safety in South Korea for an investigator-led Phase 2 COVID-19 study of its re-purposed drug NP-120 (Ifenprodil). Updated 14 Apr 2020
02 Apr 2020 Other trial event According to an Algernon Pharmaceuticals media release, the company announced that the protocol for this study in South Korea has been finalized. The Company also wishes to advise that all ethics submission documents are near completion and submission for study approval is expected to occur shortly. Updated 06 Apr 2020
20 Mar 2020 Other trial event According to an Algernon Pharmaceuticals media release, company has chosen to appoint award winning Novotech as the contract research organization (CRO) for a planned physician initiated study of NP-120 (Ifenprodil) for COVID-19 infected patients in South Korea.Novotech will be working to assist the investigators of the planned study, including supporting all aspects of the clinical trial. After the trial is approved, the Company will provide full details on the study protocol and timelines. Updated 26 Mar 2020

References

  1. Algernon Pharmaceuticals. Algernon Announces Regulatory Submission for Ifenprodil COVID-19 Human Trial in South Korea. Media-Rel 2020;.

    Media Release
  2. Algernon Pharmaceuticals. Algernon Appoints Novotech as CRO For Phase 2 Coronavirus Ifenprodil Trial. Media-Rel 2020;.

    Media Release
  3. Algernon Pharmaceuticals. Algernon Provides Update on Phase 2 Human Testing of Ifenprodil for COVID-19. Media-Rel 2020;.

    Media Release
  4. Algernon Pharmaceuticals. Algernon Receives Regulatory and Ethics Approval for Phase 2 Ifenprodil COVID-19 Human Study in South Korea. Media-Rel 2020;.

    Media Release
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