Safety and Efficacy of NP-120 (Ifenprodil) for the Treatment of Hospitalized Patient With Confirmed COVID-19 Disease

NCT04382924 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: AGN120-3
• Study Type: interventional
• Target: 168
• Locations: 4 countries
• Sites: 10

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 World Health Organization (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.

Conditions

COVID

Outcome Measures

Primary Outcomes (1)

• Patient Clinical Status (on the WHO 7-point Ordinal Scale) at Day 15 in IP Versus SOC Control Group Patients:

  1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or ECMO 7. Death

  Day 15

Secondary Outcomes (11)

• Status on an Ordinal Scale Assessed Daily While Hospitalized and on Days 15 and 28 in IP Versus Control Group Patients

  Days 1 through 28

• NEWS Assessed Days 3, 5, 8 ,11 Daily While Hospitalized and on Days 15 and 29 in IP Versus Control Group Patients

  Days 3, 5, 8, 11, 25, 29

• Rate of Mechanical Ventilation in IP Versus Control Group Patients

  Up to Day 28

• Duration of Mechanical Ventilation (if Applicable) in IP Versus Control Group Patients

  Up to day 28

• Duration of Supplemental Oxygen in IP Versus Control Group Patients

  Up to Day 29

Study Arms (3)

Treatment Arm A

EXPERIMENTAL

NP-120 (Ifenprodil) 20 mg TID + Standard of Care

Drug: NP-120 (Ifenprodil)

Control Arm

NO INTERVENTION

Standard of Care only

Treatment Arm B

EXPERIMENTAL

NP-120 (Ifenprodil) 40 mg TID + Standard of Care

Drug: NP-120 (Ifenprodil)

Interventions

NP-120 (Ifenprodil) DRUG

Ifenprodil, 20 mg TID Ifenprodil, 40 mg TID

Treatment Arm A; Treatment Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects aged ≥18 years of age
• Confirmed coronavirus infection
• Positive real-time fluorescence polymerase chain reaction of the patient's respiratory or blood specimens for COVID-19 nucleic acid
• Viral gene sequences in respiratory or blood specimens that are highly homologous to COVID-19
• Any other diagnostic test accepted by local regulatory authorities
• 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)
• 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)
• 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)
• 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

You may not qualify if:

• Patients with vasodilatory shock, orthostatic hypotension, hypotension, or tachycardia at screening/baseline
• Patients experiencing cerebral hemorrhage or cerebral infarction at baseline
• ALT/AST \> 5 times the upper limit of normal; Child-Pugh Score 10 to 15
• Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR \< 30)
• Patients on mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
• Patients taking droxidopa
• Pregnant and lactating women and those planning to get pregnant
• Known or suspected allergy to the trial drug or the relevant drugs given in the trial
• 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
• Know inability of patient to comply with the protocol for the duration of the study
• 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.

Sponsors & Collaborators

• Algernon Pharmaceuticals: lead
• Novotech (Australia): collaborator

Study Sites (10)

Westchester Research Center

Miami, Florida, 33155, United States

Location

Affinity Health - Loretto Hospital

Chicago, Illinois, 60644, United States

Location

Heartland Regional Medical Center

Saint Joseph, Missouri, 64507, United States

Location

Promedica Health: Toledo Hospital and BayPark Hospital

Toledo, Ohio, 43606, United States

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

Makati Medical Center

Manila, Philippines

Location

Philippine General Hospital

Manila, Philippines

Location

Lung Center of the Philippines

Quezon City, Philippines

Location

National Institute of Infectious Diseases

Bucharest, 021105, Romania

Location

MeSH Terms

Interventions

ifenprodil

Results Point of Contact

• Title: Dr. Christopher Bryan
• Organization: Algernon Pharmaceuticals

cbryan@algernonpharmaceuticals.com

2045572308

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 11, 2020
• Study Start: August 5, 2020
• Primary Completion: December 24, 2020
• Study Completion: January 26, 2021
• Last Updated: December 3, 2021
• Results First Posted: December 3, 2021

Record last verified: 2021-12

Locations

AU (2); US (4); RO (1); PH (3)