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

At a glance

Drugs Ifenprodil (Primary) ; Anti-inflammatories
Indications COVID 2019 infections; Pneumonia
Focus Adverse reactions; First in man

Most Recent Events

13 Nov 2020 According to an Algernon Pharmaceuticals media release, the company will be providing an update on its Ifenprodil Phase 2 human clinical studies presented by Christopher J. Moreau, CEO and Dr. Mark Williams, CSO and hosted by Dr. KSS MD PhD. The BioPub webcast will be held on November 13, 2020
09 Oct 2020 According to an Algernon Pharmaceuticals media release, due to a lack of sufficiently ill patients, which is a direct result of a highly-successful government initiated pandemic mitigation strategy, the company has decided to close this investigator-led trial. Instead, the company will remain focused on its Phase 2b/3 multinational Ifenprodil COVID study.
09 Oct 2020 Status changed from planning to withdrawn prior to enrolment, according to an Algernon Pharmaceuticals media release.

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.

Comments

According to an Algernon Pharmaceuticals media release, due to a lack of sufficiently ill patients, which is a direct result of a highly-successful government initiated pandemic mitigation strategy, the company has decided to close this investigator-led trial. Instead, the company will remain focused on its Phase 2b/3 multinational Ifenprodil COVID study.

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
COVID 2019 infections	treatment	-
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

Drug Name	Highest Phase	Originator
Ifenprodil - Algernon Pharmaceuticals	Phase II	Algernon Pharmaceuticals

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
13 Nov 2020	Other trial event	According to an Algernon Pharmaceuticals media release, the company will be providing an update on its Ifenprodil Phase 2 human clinical studies presented by Christopher J. Moreau, CEO and Dr. Mark Williams, CSO and hosted by Dr. KSS MD PhD. The BioPub webcast will be held on November 13, 2020 Updated 28 Nov 2020
09 Oct 2020	Other trial event	According to an Algernon Pharmaceuticals media release, due to a lack of sufficiently ill patients, which is a direct result of a highly-successful government initiated pandemic mitigation strategy, the company has decided to close this investigator-led trial. Instead, the company will remain focused on its Phase 2b/3 multinational Ifenprodil COVID study. Updated 13 Oct 2020
09 Oct 2020	Status change - withdrawn prior to enrolment	Status changed from planning to withdrawn prior to enrolment, according to an Algernon Pharmaceuticals media release. Updated 13 Oct 2020
25 Jun 2020	Other trial event	According to an Algernon Pharmaceuticals media release, One research site was initiated at the end of May 2020 and two sites were initiated in early June for the trial. Dr. Dong Sik Jung (PI) has now begun the process of screening patients. Updated 06 Jul 2020
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

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