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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04382924
Registration number
NCT04382924
Ethics application status
Date submitted
8/05/2020
Date registered
11/05/2020
Date last updated
3/12/2021
Titles & IDs
Public title
Safety and Efficacy of NP-120 (Ifenprodil) for the Treatment of Hospitalized Patient With Confirmed COVID-19 Disease
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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
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Secondary ID [1]
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AGN120-3
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
COVID
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Patient Clinical Status (on the WHO 7-point Ordinal Scale) at Day 15 in IP Versus SOC Control Group Patients:
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Assessment method [1]
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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
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Timepoint [1]
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Day 15
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Secondary outcome [1]
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Status on an Ordinal Scale Assessed Daily While Hospitalized and on Days 15 and 28 in IP Versus Control Group Patients
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Assessment method [1]
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WHO status of subjects at timepoints from baseline to day 28
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
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Timepoint [1]
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Days 1 through 28
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Secondary outcome [2]
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NEWS Assessed Days 3, 5, 8 ,11 Daily While Hospitalized and on Days 15 and 29 in IP Versus Control Group Patients
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Assessment method [2]
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National Early Warning Score assessed between baseline and Day 29 on subjects in 20, 40 mg TID NP-120 arms versus control group
The National Early Warning Score (NEWS) scale is a composite of 7 physiological parameters: Respiration Rate (per minute),Oxygen Saturations (%), Any Supplemental Oxygen, Temperature (°C), Systolic BP (mmHg), Heart Rate (per minute), Level of Consciousness. The aggregate results from all 7 physiological parameters are used to obtain the NEW Score., ranging from 0 - 20. Higher values reflect a worse outcome.
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Timepoint [2]
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Days 3, 5, 8, 11, 25, 29
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Secondary outcome [3]
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Rate of Mechanical Ventilation in IP Versus Control Group Patients
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Assessment method [3]
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Rate of mechanical ventilation in 20 and 40 mg TID NP-120 versus control group
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Timepoint [3]
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Up to Day 28
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Secondary outcome [4]
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Duration of Mechanical Ventilation (if Applicable) in IP Versus Control Group Patients
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Assessment method [4]
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Duration of mechanical ventilation in 20 and 40 mg TID subjects versus control who experience mechanical ventilation
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Timepoint [4]
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Up to day 28
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Secondary outcome [5]
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Duration of Supplemental Oxygen in IP Versus Control Group Patients
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Assessment method [5]
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Duration in patients only receiving supplemental oxygen in IP versus control group up to Day 29
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Timepoint [5]
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Up to Day 29
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Secondary outcome [6]
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Time to Return to Room Pressure (SpO2 > 94%) on Room Air
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Assessment method [6]
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Time to return to room pressure (SpO2 > 94%) on room air in patients in 20, 40 mg TID NP-120 groups versus control group with 94% blood oxygen levels at enrolment
Time-to-event endpoints with competing risk were analysed for each dosing group using the Cumulative Incidence Function-CIF (KM) graphical display. Data represents the time (in Days) it took for all participants in the group to return to room pressure air (e.g. the time when the CIF curve hit 100%).
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Timepoint [6]
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Up to Day 29
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Secondary outcome [7]
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Duration in ICU (if Applicable) in IP Versus Control Group Patients
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Assessment method [7]
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Duration of subject in ICU in 20 and 40 TID mg groups versus control group patients
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Timepoint [7]
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Up to Day 29
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Secondary outcome [8]
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Rate of Mortality in IP Versus Control Group Patients
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Assessment method [8]
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Rate of Overall Mortality in 20, 40 mg TID groups versus control group
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Timepoint [8]
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Up to Day 29
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Secondary outcome [9]
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Duration of Hospitalization in IP Versus Control Group Patients
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Assessment method [9]
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Timepoint [9]
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Day 15, 28
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Secondary outcome [10]
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Time to Discharge in IP Versus Control Group Patients
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Assessment method [10]
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Timepoint [10]
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Day 15, 28
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Secondary outcome [11]
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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
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Assessment method [11]
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Timepoint [11]
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Up to day 15, day 28
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2/Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/08/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
26/01/2021
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Sample size
Target
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Accrual to date
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Final
168
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [2]
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Royal Melbourne Hospital - Parkville
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Recruitment postcode(s) [1]
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4102 - Woolloongabba
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Recruitment postcode(s) [2]
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3050 - Parkville
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Florida
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Country [2]
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United States of America
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State/province [2]
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Illinois
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Country [3]
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United States of America
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State/province [3]
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Missouri
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Country [4]
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United States of America
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State/province [4]
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Ohio
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Country [5]
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Philippines
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State/province [5]
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Manila
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Country [6]
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Philippines
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State/province [6]
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Quezon City
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Country [7]
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Romania
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State/province [7]
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Bucharest
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Algernon Pharmaceuticals
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Novotech (Australia)
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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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 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04382924
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04382924
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