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

Completed · Phase 2/Phase 3

Conditions studied: COVID

In brief

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.

Key facts

Study ID

NCT04382924

Run by

Algernon Pharmaceuticals

People needed

168

Starts

2020-08-05

Expected to finish

2021-01-26

Last updated by the study team

2021-12-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Westchester Research Center — Miami, Florida, United States
• Affinity Health - Loretto Hospital — Chicago, Illinois, United States
• Heartland Regional Medical Center — Saint Joseph, Missouri, United States
• Promedica Health: Toledo Hospital and BayPark Hospital — Toledo, Ohio, United States
• Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
• Royal Melbourne Hospital — Parkville, Victoria, Australia
• Makati Medical Center — Manila, Philippines
• Philippine General Hospital — Manila, Philippines
• Lung Center of the Philippines — Quezon City, Philippines
• National Institute of Infectious Diseases — Bucharest, Romania

Full record on ClinicalTrials.gov

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