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criskorea@korea.kr
  • Status : Approved
    • First Submitted Date : 2020/06/30
    • Registered Date : 2020/08/11
    • Last Updated Date : 2020/08/04
Background Information
1.Background  
CRIS Registration Number KCT0005307 
Unique Protocol ID AGN120-2 
Public/Brief Title AN OPEN LABEL PHYSICIAN INITIATED 28 DAY PHASE 2A STUDY OF IFENPRODIL ON LUNG FUNCTION IN CONFIRMED COVID-19 INFECTED PATIENTS WITH SEVERE PNEUMONIA 
Scientific Title AN OPEN LABEL PHYSICIAN INITIATED 28 DAY PHASE 2A STUDY OF IFENPRODIL ON LUNG FUNCTION IN CONFIRMED COVID-19 INFECTED PATIENTS WITH SEVERE PNEUMONIA  
Acronym  
MFDS Regulated Study Yes
IND/IDE Protocol Yes
Registered at Other Registry No
Healthcare Benefit
Approval Status
Not applicable
Institutional Review Board Information
2. Institutional Review Board/Ethics Committee  
Board Approval Status Submitted approval 
Board Approval Number DAUHIRB-20-073 
Approval Date 2020-04-23 
Institutional Review Board  
- Name Institutional Review Board of Dong-A University Hospital  
- Address 26, Daesingongwon-ro, Seo-gu, Busan 
- Telephone 051-240-2577 
Data Monitoring Committee No  
Contact Details
3.Contact Details  
Contact Person for Principal Investigator / Scientific Queries
- Name Dong Sik Jung 
- Title Professor 
- Telephone +82-51-240-2622 
- Affiliation Dong-A University Hospital 
- Address 26 Daesingongwon-ro, Dongdaesindong 3(sam)-ga, Seo-gu, Busan 
Contact Person for Public Queries
- Name Dong Sik Jung 
- Title Professor 
- Telephone +82-51-240-2622 
- Affiliation Dong-A University Hospital 
- Address 26 Daesingongwon-ro, Dongdaesindong 3(sam)-ga, Seo-gu, Busan 
Contact Person for Updating Information
- Name Joohyun Cho 
- Title Regulatory Associate 
- Telephone +82-2-2143-6000 
- Affiliation Novotech Asia Korea 
- Address #405, 4F, City Airport, 22 Teheran-ro 87gil, Gangnam-gu, Seoul, 
Status
4. Status Status  
Study Site Multi-center (Number of center : 3)
Overall Recruitment Status Recruiting  
Date of First Enrollment 2020-09-30 , Anticipated
Target Number of Participant 40
Primary Completion Date 2021-11-30 , Anticipated
Study Completion Date 2021-11-30 , Anticipated
Recruitment Status by Participating Study Site 1 
- Name of Study Site Yonsei University, Wonju Severance Christian Hospital 
- Recruitment Status Recruiting  
- Date of First Enrollment 2020-09-30 , Anticipated
Recruitment Status by Participating Study Site 2 
- Name of Study Site Dong-A University Hospital 
- Recruitment Status Recruiting  
- Date of First Enrollment 2020-09-30 , Anticipated
Recruitment Status by Participating Study Site 3 
- Name of Study Site Chung-Ang Univerisity Hospital 
- Recruitment Status Recruiting  
- Date of First Enrollment 2020-09-30 , Anticipated
Source of Monetary / Material Support 정보
5. Source of Monetary/Material Support  
Source of Monetary/Material Support1 
- Organization Name Dong-A University Hospital 
- Organization Type Medical Institute  
- Project ID AGN120-2 
Sponsor Organization
6. Sponsor Organization  
Sponsor Organization 1 
- Organization Name Dong-A University Hospital 
- Organization Type Medical Institute  
Sponsor Organization 2 
- Organization Name Novotech Asia Korea 
- Organization Type Others  
Study Summary
7. Study Summary  
Lay Summary PRIMARY OBJECTIVE:
 To investigate the ability of Ifenprodil (20 mg TID) to improve lung function in patients infected with COVID-19
SECONDARY OBJECTIVES:
 To investigate the effects of Ifenprodil (20 mg TID) on symptoms and biomarkers associated with infection with COVID-19
 To investigate the effects of Ifenprodil (20 mg TID) on lung function and health status in patients infected with COVID-19

SAFETY OBJECTIVES:
 To study the safety of Ifenprodil (20 mg TID) in patients infected with COVID-19


Ifenprodil was discovered by a genome wide RNAi assay to uncover gene targets associated with cytoprotective activity against highly pathogenic H5N1 influenza, specifically by preserving cell viability in vitro. When tested in a murine model of H5N1, the drug at clinically relevant doses: (1) improved survivability from 0% at day 6 to 40% at day 14 post-infection, (2) the drug significantly reduced edemaand lung injury score and (3) reduced infiltrating T cells and NK cells and attenuated the ‘cytokine storm’. The mortality rate of H5N1 in humans is >50%, whereas the mortality rate of COVID-19 infectedpatients is < 5%, and both viruses cause acute lung injury and share similar pulmonary pathologies.
Ifenprodil has also been shown to mediate anti-inflammatory responses and reduce pulmonary fibrosisin a murine model of idiopathic pulmonary fibrosis, a complication which can occur after a respiratory virus infection.
Since H5N1 has a significantly higher mortality rate than COVID-19 but these share similar lung pathologies, Algernon Pharmaceuticals believes Ifenprodil could reduce lung injury associated with COVID-19 infection, thereby improving lung function and accelerating patient recovery.
The purpose of this proof-of-concept trial is to determine the efficacy of Ifenprodil in improving lung function in patients with COVID-19 infection with severe pneumonia.  
Study Design 정보
8. Study Design  
Study Type Interventional Study 
Study Purpose Treatment
Phase Phase2 
Intervention Model Parallel  
Blinding/Masking Open 
Allocation RCT 
Intervention Type Drug  
Intervention Description Treatment Group:
IP (Ifenprodil) plus Standard of Care (SOC) (N=20)
Control Group:
Standard of Care (SOC) (N=20)

TREATMENT:
Test Product: Ifenprodil, 20 mg TID for up to 4 weeks, in conjunction with SOC
Duration of patient participation: Up to 5 weeks

The chemical name of Ifenprodil is (1RS,2SR)-4-[2-(4-Benzylpiperidin-1-yl)-1-hydroxypropyl] phenol hemi-(2R,3R)-tartrate. The drug is more commonly referred to as ifenprodil. Ifenprodil will be provided as white, round, biconvex, film-coated tablets containing 20 mg of the active ingredient.

Treatment Administration and Schedule

Tablets will be taken by mouth TID in the in the morning (AM, upon rising), in the afternoon (PM, 6-10 hours following first dose), and evening (PM, 6-10 hours before the next day’s anticipated first dose).
Best efforts should be made to keep the three doses approximately 8 hours apart. The length of dosing for the study is up to 4 weeks.
The first dose of study medication will be taken on day 1 at the first visit, following randomization.
In cases where the patient is unable to swallow tablets the use of a nasogastric/stomach tube is permitted. Crushing and administration of tablets should follow local practices/SOPs. Study drug administration should continue until the end of week 4, or hospital discharge, whichever comes first.  
Number of Arms
Arm 1 Arm Label IP (Ifenprodil) plus Standard of Care (SOC) (N=20) 
Target Number of Participant 20 
Arm Type Experimental 
Arm Description Test Product: Ifenprodil, 20 mg TID for up to 4 weeks, in conjunction with SOC Duration of patient participation: Up to 5 weeks Tablets will be taken by mouth TID in the in the morning (AM, upon rising), in the afternoon (PM, 6-10 hours following first dose), and evening (PM, 6-10 hours before the next day’s anticipated first dose). Best efforts should be made to keep the three doses approximately 8 hours apart. The length of dosing for the study is up to 4 weeks. The first dose of study medication will be taken on day 1 at the first visit, following randomization. 
Arm 2 Arm Label Control Group: Standard of Care (SOC) 
Target Number of Participant 20 
Arm Type Active comparator 
Arm Description Standard of Care (SOC) : up to 4 weeks of SOC Duration of patient participation: Up to 5 weeks 
Subject Eligibility Information
9. Subject  
Condition(s)/Problem(s) * Diseases of th respiratory system
Hospitalized COVID-19 Infected Patients with severe pneumonia  
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 19 Year ~ 85 Year
Description INCLUSION CRITERIA:
1. Male and female patients aged 19-85 years of age, inclusive, as of baseline/screening visit
2. Confirmed coronavirus infection based on possessing at least one of the following etiological
evidence:
a. Positive real-time fluorescence polymerase chain reaction of the patient’s respiratory or
blood specimens for COVID-19 nucleic acid
b. Viral gene sequences in respiratory or blood specimens that are highly homologous to
COVID-19
c. Any other diagnostic test accepted by local regulatory authorities
3. Presence of severe pneumonia as evidenced by any of the following:
a. Respiratory distress with RR >=30 breaths/minute
b. SpO2 <90% on room air and at rest
c. PaO2/FiO2 =< 250 mmHg (1mmHg = 0.133kPa)
4. Chest imaging (x-ray [XR] or computerized tomography [CT]) confirms severe pneumonia AND
shows evidence of inflammatory exudation or pleural effusion
5. Female patients of childbearing potential who are sexually active with a non-sterilized male
partner must use at least 1 highly effective method of contraception from the time of screening
and must agree to continue using such precautions for 90 days after the final dose of study
drug(s)
6. Non-sterilized males who are sexually active with a female partner of childbearing potential must
use condom plus spermicide from day 1 through 90 days after receipt of the last dose of study
drug(s)
Patients (or their legal designates), must have the capacity to understand, sign and date a voluntary
written, informed consent form and any required authorization prior to initiation of any study
procedure.  
Exclusion Criteria EXCLUSION CRITERIA:
1. Patients with vasodilatory shock, orthostatic hypotension, hypotension, or tachycardia at
screening or baseline
2. Patients experiencing cerebral hemorrhage or cerebral infarction at baseline
3. Patients with galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
4. Patients taking drugs that increase risk of bleeding (e.g. anti-coagulants, anti-platelet)
5. Patients taking droxidopa
6. ALT/AST > 5 times the upper limit of normal at baseline
7. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30) at baseline
8. Presence of other disease that may interfere with testing procedures or which in the judgement
of the Investigator may interfere with trial participation or may put the patient at risk when
participating in this trial
9. Pregnant and lactating women and those planning to get pregnant
10. Known or suspected allergy to the trial drug or the relevant drugs given in the trial
11. Patients who have participated in any other clinical trial/s, including a COVID-19 trial, within the
past 3 months
12. The participant is, in the opinion of the PI, unlikely to comply with the clinical study protocol or
is unsuitable for any other reason  
Healthy Volunteers No
Outcome Measure(s) Information
10. Outcome Measure(s)  
Type of Primary Outcome Efficacy 
Primary Outcome(s) 1 
- Outcome Effect on the rate of change of partial pressure of oxygen (PaO2) and PaO2/FiO2 ratio taken at baseline and measured twice daily up to 4 weeks of treatment in IP versus control group patients 
- Timepoint at baseline and measured twice daily up to 4 weeks 
Secondary Outcome(s) 1 
- Outcome Changes in the extent of dyspnea from baseline, using a Likert scale, at 24 hours, 72 hours, 7 days and 14 days in IP versus control group Likert scale: The patient grades his current breathing compared to when he first started the drug (from -3 to 3). "0" = no change, "1" =minimally better, "2" =moderately better, "3" =markedly better, "-1" =minimally worse, "-2" =moderately worse, "-3" =markedly worse 
- Timepoint using a Likert scale, at 24 hours, 72 hours, 7 days and 14 days in IP versus control group Likert scale 
Secondary Outcome(s) 2 
- Outcome Rate of all-cause mortality in IP group versus control group patients 
- Timepoint from the time the patient signs informed consent until completion of the final Safety Follow-up Visit 
Secondary Outcome(s) 3 
- Outcome Rate of mechanical ventilation in IP group versus control group patients 
- Timepoint Measurements at Baseline till the last day of Visit 
Secondary Outcome(s) 4 
- Outcome Time to hospital discharge for IP group versus control group patients 
- Timepoint Measurements at Baseline till the last day of Visit 
Secondary Outcome(s) 5 
- Outcome Type, frequency, severity, and relationship of AEs to investigational product (IP). 
- Timepoint from the time the patient signs informed consent until completion of the final Safety Follow-up Visit 
Secondary Outcome(s) 6 
- Outcome Number of patients who discontinue IP due to any AE. 
- Timepoint from the time the patient signs informed consent until completion of the final Safety Follow-up Visit 
Secondary Outcome(s) 7 
- Outcome Frequency of clinically significant changes in vital signs and/or laboratory findings. 
- Timepoint from the time the patient signs informed consent until completion of the final Safety Follow-up Visit 
Secondary Outcome(s) 8 
- Outcome Rate of change to patient’s experience of cough (Visual analog scale [VAS]) at 24 hours, 72 hours, 7 days and 14 days in IP versus control group VAS: The patient draws a horizontal line on an axial graph (from 0 to 100) to show the degree of how he/she feels about coughing. The number "100" equals the worst coughing the patient has ever felt and the number "0" equals the best he/she has felt since the day of hospital admission. 
- Timepoint At 24 hours, 72 hours, 7 days and 14 days 
Secondary Outcome(s) 9 
- Outcome The area of lung lesions on Chest XR at 7 days and 14 days in IP group versus control group patients 
- Timepoint At 7 days and 14 days 
Secondary Outcome(s) 10 
- Outcome The degree of lung exudation on Chest XR at 7 days and 14 days in IP group versus control group patients 
- Timepoint At 7 days and 14 days 
Secondary Outcome(s) 11 
- Outcome Effect on CRP, cardiac troponin, IL-6, myoglobin and ferritin at 72 hours, 7 days and 14 days between IP group versus control group patients in IP group versus control group patients 
- Timepoint At 72 hours, 7 days and 14 days 
Secondary Outcome(s) 12 
- Outcome Time on mechanical ventilation in IP group versus control group patients 
- Timepoint Measurements at Baseline till the last day of Visit 
Study Results and Publication Information
11. Study Results and Publication
Result Registerd No
Sharing of Study Data Information
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement No