i

A RANDOMIZED OPEN LABEL PHASE 2B/3 STUDY OF THE SAFETY AND EFFICACY OF NP-120 (IFENPRODIL) FOR THE TREATMENT OF HOSPITALIZED PATIENTS WITH CONFIRMED COVID 19 DISEASE

PHRR200812-002818

AGN120-3

2020-CT0544

A RANDOMIZED OPEN LABEL PHASE 2B/3 STUDY OF THE SAFETY AND EFFICACY OF NP-120 (IFENPRODIL) FOR THE TREATMENT OF HOSPITALIZED PATIENTS WITH CONFIRMED COVID 19 DISEASE

This study is an open-label, adaptive, multi-center, randomized, parallel group study. 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. This study will be using NP-120 (Ifenprodil tartrate) as the investigational drug. NP-120 (Ifenprodil) is an N-methyl-D-Aspartate (NDMA) inhibitor that is specific for the NR2B subunit of the NMDA Receptor.

The purpose of this adaptive Phase 2b/3 trial is to determine the safety and efficacy of NP-120 in the treatment of COVID-19 infection and to investigate the clinical efficacy and safety of NP-120 (20 mg TID) compared to standard of care in patients hospitalized with COVID-19.

Regime Classification Priority
2017 - 2022 Global competitiveness and innovation in health Drug discovery and development
Start Date Duration in Months Target Completion Date Actual Completion Date
2020-08-10 12 2021-08-10 0000-00-00

Terminated

Sponsor decided not to proceed with phase 3 of the study.

Institution Classification Region LTO #
Algernon Pharmaceuticals Private Non-profit United Kingdom N/A
Institution Classification Region LTO #
Novotech (Australia) Pty. Ltd. - Philippine Branch Private Business NCR 3000002140826
Institution Region
Algernon Pharmaceuticals United Kingdom
Name E-Mail Institution and Institution Address
Jennifer Arellano jenny.arellano@novotech-cro.com Ortigas City Philippines
Name E-Mail Institution and Institution Address
Mark William Ph.D. nstewart@gvicds.com Chief Scientific Officer, Algernon Pharmaceuticals Suite 915-700 West Pender Street Vancouver, BC, Canada V6C 1G8
Name Expertise Affiliation
Joel M. Santiaguel, MD Pulmonologist University of the Philippines - Philippine General Hospital, Department of Medicine
Lawrence Raymond, MD IM_Pulmonologist Lung Center of the Philippines
Maria Tarcela S. Gler, MD IM Pulmonologist Makati Medical Center
Project Location Institutional Ethics Review Board
University of the Philippines - Philippine General Hospital, Department of Medicine N/A
Lung Center of the Philippines Lung Center of the Philippines Ethics Review Committee
Makati Medical Center Makati Medical Center Institutional Review Board

COVID Study

To investigate the clinical efficacy and safety of NP-120 (20 and 40 mg TID) compared to standard of care in patients hospitalized with COVID-19 disease.

 

- The choice of the primary outcome measure will be determined by a pilot study of the first 150 subjects.

-  Subject clinical status (on the WHO7-point ordinal scale) at day 15 is the default primary endpoint

SECONDARY OBJECTIVES: To investigate the clinical efficacy of NP-120 (20 and 40 mg TID) as compared to the control arm as assessed by:
• Ordinal scale:
o Time to an improvement of one category from baseline on an ordinal scale.
o Subject clinical status on an ordinal scale at days 3, 5, 8, 11, and 29.
o Mean change in the ranking on an ordinal scale from baseline to days 3, 5, 8, 11, 15 and 29 from baseline
• National Early Warning Score (NEWS):
o The time to discharge or to a NEWS of ≤ 2 and maintained for 24 hours, whichever occurs first.
o Change from baseline to days 3, 5, 8, 11, 15, and 29 in NEWS
• Oxygenation:
o Oxygenation free days in the first 28 days (to day 29)
o 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
• Mechanical Ventilation:
o Ventilator free days in the first 28 days (to day 29)
o Incidence and duration of new mechanical ventilation use during the trial

• Hospitalization:
o Duration of hospitalization (days)
o Time to discharge (days)
• Mortality:
o 15-day mortality
o 28-day mortality
EXPLORATORY OBJECTIVES: To investigate the effects of NP-120 (20 and 40 mg TID) on lung function, health status, and SARS-CoV-2 RNA status in hospitalized patients with COVID-19 disease.
SAFETY OBJECTIVES: To study the safety of NP-120 (20 and 40 mg TID) in hospitalized patients with COVID-19 disease.
PATIENT POPULATION: Individuals with COVID-19 disease that are currently hospitalized, and either requiring supplemental oxygen, or non-invasive ventilation or high flow oxygen devices. This corresponds to a score of 4 or 5 (moderate and severe disease) on the WHO proposed ordinal scale for clinical improvement.

Pending

Clinical Trial

AGN120-3

2019-CT0544

2020-07-10

0000-00-00

150

Unspecified

Unspecified

2020-08-10

INCLUSION CRITERIA:

1. Male and female subjects aged ≥18 years of age

2. Confirmed coronavirus infection

a) Positive real-time fluorescence polymerase chain reaction of the patient’s respiratory or blood specimens for SARS-CoV-2 nucleic acid

b) Viral gene sequences in respiratory or blood specimens that are highly homologous to SARS-CoV-2

c) 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 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 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

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.

Interventional

NP-120 (IFENPRODIL

Unspecified

None

Randomized

Open Label

Unspecified

Single

The purpose of this adaptive trial is to determine the clinical efficacy of Ifenprodil in the treatment of patients with COVID-19 disease. 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. 

Phase II

Utilization Utilization Info
Publication
Oral Presentation
Drug Literature
Posters
Others
©2022 HERDIN PLUS. All rights reserved. | Contact Us | Keep up to date