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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04382924




Registration number
NCT04382924
Ethics application status
Date submitted
8/05/2020
Date registered
11/05/2020
Date last updated
10/12/2020

Titles & IDs
Public title
Safety and Efficacy of NP-120 (Ifenprodil) for the Treatment of Hospitalized Patient With Confirmed COVID-19 Disease
Scientific title
A Randomized Open Label Phase 2b/3 Study of the Safety and Efficacy of NP-120 (Ifenprodil) for the Treatment of Hospitalized Patient With Confirmed COVID-19 Disease
Secondary ID [1] 0 0
AGN120-3
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - NP-120 (Ifenprodil)

Experimental: Treatment Arm A - NP-120 (Ifenprodil) 20 mg TID + Standard of Care

No Intervention: Control Arm - Standard of Care only

Experimental: Treatment Arm B - NP-120 (Ifenprodil) 40 mg TID + Standard of Care


Treatment: Drugs: NP-120 (Ifenprodil)
Ifenprodil, 20 mg TID Ifenprodil, 40 mg TID

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Patient clinical status (on the WHO 7-point ordinal scale) at day 15 in IP versus SOC control group patients: - Not hospitalized, no limitations on activities
Not hospitalized, limitation on activities
Hospitalized, not requiring supplemental oxygen
Hospitalized, requiring supplemental oxygen
Hospitalized, on non-invasive ventilation or high flow oxygen devices
Hospitalized, on invasive mechanical ventilation or ECMO
Death
Timepoint [1] 0 0
Day 15
Secondary outcome [1] 0 0
Status on an ordinal scale assessed daily while hospitalized and on days 15 and 28 in IP versus control group patients
Timepoint [1] 0 0
Days 1 through 28
Secondary outcome [2] 0 0
NEWS assessed days 3, 5, 8 ,11 daily while hospitalized and on days 15 and 29 in IP versus control group patients
Timepoint [2] 0 0
Days 3, 5, 8, 11, 25, 29
Secondary outcome [3] 0 0
Rate of mechanical ventilation in IP versus control group patients
Timepoint [3] 0 0
Day 15, 28
Secondary outcome [4] 0 0
Duration of mechanical ventilation (if applicable) in IP versus control group patients
Timepoint [4] 0 0
Day 15, 28
Secondary outcome [5] 0 0
Duration of supplemental oxygen in IP versus control group patients
Timepoint [5] 0 0
Day 15, 28
Secondary outcome [6] 0 0
Time to return to room pressure (SpO2 > 94%) on room air
Timepoint [6] 0 0
Day 15, 28
Secondary outcome [7] 0 0
Duration in ICU (if applicable) in IP versus control group patients
Timepoint [7] 0 0
Day 15, 28
Secondary outcome [8] 0 0
Rate of Mortality in IP versus control group patients
Timepoint [8] 0 0
Day 15, 28
Secondary outcome [9] 0 0
Duration of hospitalization in IP versus control group patients
Timepoint [9] 0 0
Day 15, 28
Secondary outcome [10] 0 0
Time to discharge in IP versus control group patients
Timepoint [10] 0 0
Day 15, 28
Secondary outcome [11] 0 0
Effect on the rate of change of partial pressure of oxygen (PaO2) and PaO2/FiO2 ratio taken at baseline and measured once daily up to 2 weeks of treatment in IP versus control group patients
Timepoint [11] 0 0
Up to day 15, day 28

Eligibility
Key inclusion criteria
1. Male and female subjects aged =18 years of age

2. Confirmed coronavirus infection

1. Positive real-time fluorescence polymerase chain reaction of the patient's
respiratory or blood specimens for COVID-19 nucleic acid

2. Viral gene sequences in respiratory or blood specimens that are highly homologous
to COVID-19

3. Any other diagnostic test accepted by local regulatory authorities

3. Must be hospitalized and requiring supplemental oxygen, or on non-invasive ventilation
or high flow oxygen devices (Score of 4 or 5 on WHO Ordinal Clinical Scale)

4. Female subjects of childbearing potential who are sexually active with a
non-sterilized male partner must use at least 1 highly effective method of
contraception (e.g. oral contraceptives, intrauterine device, diaphragm plus
spermicide) from the time of screening and must agree to continue using such
precautions for 90 days after the final dose of study drug(s)

5. 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)

6. Subjects (or reasonable legal designate) must have the capacity to understand, sign
and date a written, informed consent form and any required authorization prior to
initiation of any study procedures
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with vasodilatory shock, orthostatic hypotension, hypotension, or tachycardia
at screening/baseline

2. Patients experiencing cerebral hemorrhage or cerebral infarction at baseline

3. ALT/AST > 5 times the upper limit of normal; Child-Pugh Score 10 to 15

4. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30)

5. Patients on mechanical ventilation or extracorporeal membrane oxygenation (ECMO)

6. Patients taking droxidopa

7. Pregnant and lactating women and those planning to get pregnant

8. Known or suspected allergy to the trial drug or the relevant drugs given in the trial

9. Presence of other disease that may interfere with testing procedures or in the
judgement of the Investigator may interfere with trial participation or may put the
patient at risk when participating in this trial

10. Know inability of patient to comply with the protocol for the duration of the study

11. Involvement in a clinical research study within 4 weeks prior to screening and/or
prior enrollment in the study or plan to participate in another interventional
clinical trial during the study period. Participation in observational registry
studies is permitted.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Missouri
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
Philippines
State/province [5] 0 0
Manila
Country [6] 0 0
Philippines
State/province [6] 0 0
Quezon City
Country [7] 0 0
Romania
State/province [7] 0 0
Bucharest

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Algernon Pharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Novotech (Australia)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this adaptive trial is to determine the clinical efficacy of Ifenprodil in the
treatment of patients infected with COVID-19. This Protocol is largely based on the
recommendations of the WHO R&D Blueprint Clinical Trials Expert Group COVID-19 Therapeutic
Trial Synopsis, and associated Master Protocol.

The choice of the primary outcome measure will be determined by a pilot study of the first
150 subjects. Subject clinical status (on a 7-point ordinal scale) at day 15 in treatment
versus the control group is the default primary endpoint.
Trial website
https://clinicaltrials.gov/show/NCT04382924
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications