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

• Sponsor: Algernon Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04382924
• Collaborator: Novotech (Australia) (Other)
• Enrollment: 168
• Locations: 10
• Arms: 3
• Actual Duration (Months): 5.7
• Patients Per Site: 16.8
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID	Drug: NP-120 (Ifenprodil)	Phase 2/Phase 3

Detailed Description

NP-120 (Ifenprodil) is an N-methyl-D-Aspartate (NDMA) inhibitor that is specific for the NR2B subunit of the NMDA Receptor. The NMDA receptor, and specifically the NR2B subunit, is involved in glutamate signaling, and is expressed on both neutrophils and T cells. In the case of neutrophils, activation of the NMDA receptor can (1) result in expression of CD11b which targets neutrophils via ICAM-1 to areas of inflammation, and (2) trigger the autocrine release of glutamate. In the case of T-cells, activation of T cells via glutamate can cause (1) T cell proliferation and, (2) the release of cytokines. The activation of T cells and cytokine release can be blocked in vitro by the addition of Ifenprodil. As such it could be a potent anti-inflammatory agent.

Ifenprodil was discovered by a genome wide RNAi assay to uncover gene targets associated with cytoprotective activity against highly pathogenic H5N1 influenza, specifically by preserving cell viability in vitro. When tested in a murine model of H5N1, the drug at clinically relevant doses: (1) improved survivability from 0% at day 6 to 40% day 14 post-infection, (2) the drug significantly reduced edema and lung injury score and (3) reduced infiltrating T cells, neutrophils and NK cells and attenuated the 'cytokine storm'. The mortality rate of H5N1 in humans is >50%, whereas the mortality rate of COVID-19 infected patients is < 5%, and both viruses cause acute lung injury and share similar pulmonary pathologies. NP-120 has also been shown to mediate anti-inflammatory responses and reduce pulmonary fibrosis in a murine model of idiopathic pulmonary fibrosis, a complication which can occur after a respiratory virus infection.

Based on the fact that H5N1 has a significantly higher mortality rate than COVID-19 but still shares similar lung pathologies, Algernon Pharmaceuticals believes Ifenprodil could reduce lung injury associated with COVID-19 infection, thereby improving lung function and accelerating patient recovery.

The purpose of this Phase 2b/3 trial is to determine the safety and efficacy of NP-120 in the treatment of COVID-19 infection.

Study Design

• Study Type: Interventional
• Actual Enrollment: 168 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official 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
• Actual Study Start Date: Aug 5, 2020
• Actual Primary Completion Date: Dec 24, 2020
• Actual Study Completion Date: Jan 26, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Arm A NP-120 (Ifenprodil) 20 mg TID + Standard of Care	Drug: NP-120 (Ifenprodil); Ifenprodil, 20 mg TID Ifenprodil, 40 mg TID
No Intervention: Control Arm Standard of Care only
Experimental: Treatment Arm B NP-120 (Ifenprodil) 40 mg TID + Standard of Care	Drug: NP-120 (Ifenprodil); Ifenprodil, 20 mg TID Ifenprodil, 40 mg TID

Outcome Measures

Primary Outcome Measures

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

   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

Secondary Outcome Measures

1. 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]

   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

2. 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]

   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.

3. Rate of Mechanical Ventilation in IP Versus Control Group Patients [Up to Day 28]

   Rate of mechanical ventilation in 20 and 40 mg TID NP-120 versus control group

4. Duration of Mechanical Ventilation (if Applicable) in IP Versus Control Group Patients [Up to day 28]

   Duration of mechanical ventilation in 20 and 40 mg TID subjects versus control who experience mechanical ventilation

5. Duration of Supplemental Oxygen in IP Versus Control Group Patients [Up to Day 29]

   Duration in patients only receiving supplemental oxygen in IP versus control group up to Day 29

6. Time to Return to Room Pressure (SpO2 > 94%) on Room Air [Up to Day 29]

   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%).

7. Duration in ICU (if Applicable) in IP Versus Control Group Patients [Up to Day 29]

   Duration of subject in ICU in 20 and 40 TID mg groups versus control group patients

8. Rate of Mortality in IP Versus Control Group Patients [Up to Day 29]

   Rate of Overall Mortality in 20, 40 mg TID groups versus control group

9. Duration of Hospitalization in IP Versus Control Group Patients [Day 15, 28]

10. Time to Discharge in IP Versus Control Group Patients [Day 15, 28]

11. 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 [Up to day 15, day 28]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

2. Confirmed coronavirus infection

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

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

5. Any other diagnostic test accepted by local regulatory authorities

6. 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)

7. 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)

8. 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)

9. 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

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Westchester Research Center	Miami	Florida	United States	33155
2	Affinity Health - Loretto Hospital	Chicago	Illinois	United States	60644
3	Heartland Regional Medical Center	Saint Joseph	Missouri	United States	64507
4	Promedica Health: Toledo Hospital and BayPark Hospital	Toledo	Ohio	United States	43606
5	Princess Alexandra Hospital	Woolloongabba	Queensland	Australia	4102
6	Royal Melbourne Hospital	Parkville	Victoria	Australia	3050
7	Makati Medical Center	Manila		Philippines
8	Philippine General Hospital	Manila		Philippines
9	Lung Center of the Philippines	Quezon City		Philippines
10	National Institute of Infectious Diseases	Bucharest		Romania	021105

Sponsors and Collaborators

• Algernon Pharmaceuticals
• Novotech (Australia)

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Nov 16, 2020
• Statistical Analysis Plan - Jan 15, 2021

More Information

Publications

None provided.

• Responsible Party: Algernon Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT04382924
• Other Study ID Numbers: AGN120-3
• First Posted: May 11, 2020
• Last Update Posted: Dec 3, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Ifenprodil

Study Results

Participant Flow

Arm/Group Title	Treatment Arm A	Treatment Arm B	Control Arm
Arm/Group Description	NP-120 (Ifenprodil) 20 mg TID + Standard of Care	NP-120 (Ifenprodil) 40 mg TID + Standard of Care	Standard of Care only
Period Title: Overall Study
STARTED	52	56	60
COMPLETED	44	46	48
NOT COMPLETED	8	10	12

Baseline Characteristics

Arm/Group Title	Treatment Arm A	Treatment Arm B	Control Arm	Total
Arm/Group Description	NP-120 (Ifenprodil) 20 mg TID + Standard of Care	NP-120 (Ifenprodil) 40 mg TID + Standard of Care	Standard of Care only	Total of all reporting groups
Overall Participants	52	56	60	168
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	38 73.1%	36 64.3%	36 60%	110 65.5%
>=65 years	14 26.9%	20 35.7%	24 40%	58 34.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.1 (13.1)	58.5 (14.5)	59.7 (12.9)	58.2 (13.5)
Sex: Female, Male (Count of Participants)
Female	20 38.5%	27 48.2%	21 35%	68 40.5%
Male	32 61.5%	29 51.8%	39 65%	100 59.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 3.8%	4 7.1%	7 11.7%	13 7.7%
Not Hispanic or Latino	49 94.2%	52 92.9%	53 88.3%	154 91.7%
Unknown or Not Reported	1 1.9%	0 0%	0 0%	1 0.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	16 30.8%	18 32.1%	18 30%	52 31%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	1 1.9%	1 1.8%	0 0%	2 1.2%
White	35 67.3%	35 62.5%	41 68.3%	111 66.1%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	2 3.6%	1 1.7%	3 1.8%
Region of Enrollment (participants) [Number]
Romania	29 55.8%	29 51.8%	30 50%	88 52.4%
United States	7 13.5%	10 17.9%	12 20%	29 17.3%
Philippines	15 28.8%	17 30.4%	18 30%	50 29.8%
Australia	1 1.9%	0 0%	0 0%	1 0.6%
Patient clinical status on WHO 7 point ordinal scale (scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [scores on a scale]	4.23 (0.425)	4.25 (0.548)	4.25 (0.437)	4.24 (0.471)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Analysis performed on the number of patients with WHO-7 data

Arm/Group Title	Treatment Arm A	Treatment Arm B	Control Arm
Arm/Group Description	NP-120 (Ifenprodil) 20 mg TID + Standard of Care	NP-120 (Ifenprodil) 40 mg TID + Standard of Care	Standard of Care only
Measure Participants	46	44	48
1. Not hospitalized no limitations on activities	10 19.2%	9 16.1%	18 30%
2. Not hospitalized but limitations on activities	7 13.5%	9 16.1%	2 3.3%
3. Hospitalized not requiring supplemental O2	13 25%	13 23.2%	16 26.7%
4. Hospitalized and requires supplemental O2	13 25%	8 14.3%	7 11.7%
5. Hospitalized and on non-invasive ventilation or high flow O2	1 1.9%	1 1.8%	1 1.7%
6. Hospitalized and on mechanical ventilation or ECMO	2 3.8%	1 1.8%	2 3.3%
7. Death	0 0%	3 5.4%	2 3.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Treatment Arm A, Treatment Arm B, Control Arm
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.025
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio, log
	Estimated Value	0.0001
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Status on an Ordinal Scale Assessed Daily While Hospitalized and on Days 15 and 28 in IP Versus Control Group Patients
Description	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
Time Frame	Days 1 through 28

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Arm A	Treatment Arm B	Control Arm
Arm/Group Description	NP-120 (Ifenprodil) 20 mg TID + Standard of Care	NP-120 (Ifenprodil) 40 mg TID + Standard of Care	Standard of Care only
Measure Participants	52	56	60
Baseline	4.23 (0.425)	4.25 (0.548)	4.25 (0.427)
Day 3	4.22 (0.503)	4.22 (0.718)	4.29 (0.7063)
Day 5	4.12 (0.627)	4.14 (0.917)	4.18 (0.819)
Day 8	3.89 (0.767)	4.02 (1.012)	4.04 (0.988)
Day 11	3.87 (0.777)	4.09 (1.156)	3.97 (1.098)
Day 15	2.87 (1.343)	2.95 (1.628)	2.96 (1.665)
Day 28	1.59 (1.384)	1.80 (1.608)	1.73 (1.730)

3. Secondary Outcome

Title	NEWS Assessed Days 3, 5, 8 ,11 Daily While Hospitalized and on Days 15 and 29 in IP Versus Control Group Patients
Description	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.
Time Frame	Days 3, 5, 8, 11, 25, 29

Outcome Measure Data

Analysis Population Description

NEWS score collected on patients currently hospitalized, or returning for follow up visits

Arm/Group Title	Treatment Arm A	Treatment Arm B	Control Arm
Arm/Group Description	NP-120 (Ifenprodil) 20 mg TID + Standard of Care	NP-120 (Ifenprodil) 40 mg TID + Standard of Care	Standard of Care only
Measure Participants	52	56	60
Baseline	4.7 (1.83)	4.5 (1.58)	4.5 (1.51)
Day 3	4.2 (1.90)	3.7 (1.60)	4.4 (1.91)
Day 5	3.8 (2.04)	3.3 (1.95)	3.7 (1.99)
Day 8	3.5 (2.33)	3.1 (2.04)	3.0 (2.51)
Day 11	3.0 (2.21)	3.0 (2.60)	3.2 (2.39)
Day 15	2.4 (2.85)	1.8 (2.38)	1.8 (2.37)
Day 29	1.1 (1.97)	1.4 (2.10)	1.3 (2.11)

4. Secondary Outcome

Title	Rate of Mechanical Ventilation in IP Versus Control Group Patients
Description	Rate of mechanical ventilation in 20 and 40 mg TID NP-120 versus control group
Time Frame	Up to Day 28

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Arm A	Treatment Arm B	Control Arm
Arm/Group Description	NP-120 (Ifenprodil) 20 mg TID + Standard of Care	NP-120 (Ifenprodil) 40 mg TID + Standard of Care	Standard of Care only
Measure Participants	52	56	60
Count of Participants [Participants]	5 9.6%	2 3.6%	4 6.7%

5. Secondary Outcome

Title	Duration of Mechanical Ventilation (if Applicable) in IP Versus Control Group Patients
Description	Duration of mechanical ventilation in 20 and 40 mg TID subjects versus control who experience mechanical ventilation
Time Frame	Up to day 28

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Arm A	Treatment Arm B	Control Arm
Arm/Group Description	NP-120 (Ifenprodil) 20 mg TID + Standard of Care	NP-120 (Ifenprodil) 40 mg TID + Standard of Care	Standard of Care only
Measure Participants	5	2	4
< 6 hours	0 0%	1 1.8%	0 0%
>= 12 hours but < 24 hours	0 0%	0 0%	0 0%
>= 24 hours but <72 hours	1 1.9%	0 0%	0 0%
>=72 hours but <120 hours	0 0%	1 1.8%	1 1.7%
>= 120 hours	3 5.8%	0 0%	2 3.3%
Ongoing at time of EOS (>= 24 hours but <72 hours	1 1.9%	0 0%	1 1.7%

6. Secondary Outcome

Title	Duration of Supplemental Oxygen in IP Versus Control Group Patients
Description	Duration in patients only receiving supplemental oxygen in IP versus control group up to Day 29
Time Frame	Up to Day 29

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Arm A	Treatment Arm B	Control Arm
Arm/Group Description	NP-120 (Ifenprodil) 20 mg TID + Standard of Care	NP-120 (Ifenprodil) 40 mg TID + Standard of Care	Standard of Care only
Measure Participants	46	48	52
< 6 hours	0 0%	0 0%	0 0%
>= 12 hours but < 24 hours	0 0%	1 1.8%	0 0%
>= 24 hours but < 72 hours	4 7.7%	4 7.1%	5 8.3%
>= 72 hours but < 120 hours	7 13.5%	5 8.9%	8 13.3%
>= 120 hours	35 67.3%	38 67.9%	39 65%

7. Secondary Outcome

Title	Time to Return to Room Pressure (SpO2 > 94%) on Room Air
Description	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%).
Time Frame	Up to Day 29

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Arm A	Treatment Arm B	Control Arm
Arm/Group Description	NP-120 (Ifenprodil) 20 mg TID + Standard of Care	NP-120 (Ifenprodil) 40 mg TID + Standard of Care	Standard of Care only
Measure Participants	11	11	13
Number [Days]	4	5	9

8. Secondary Outcome

Title	Duration in ICU (if Applicable) in IP Versus Control Group Patients
Description	Duration of subject in ICU in 20 and 40 TID mg groups versus control group patients
Time Frame	Up to Day 29

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Arm A	Treatment Arm B	Control Arm
Arm/Group Description	NP-120 (Ifenprodil) 20 mg TID + Standard of Care	NP-120 (Ifenprodil) 40 mg TID + Standard of Care	Standard of Care only
Measure Participants	8	6	9
>= 1 day but < 3 days	0 0%	0 0%	0 0%
>= 3 days but < 7 days	1 1.9%	0 0%	1 1.7%
>=7 days but < 14 days	3 5.8%	3 5.4%	3 5%
>=14 days but < 21 days	1 1.9%	1 1.8%	2 3.3%
>= 21 days	2 3.8%	2 3.6%	2 3.3%
Ongoing at end of study	1 1.9%	0 0%	1 1.7%

9. Secondary Outcome

Title	Rate of Mortality in IP Versus Control Group Patients
Description	Rate of Overall Mortality in 20, 40 mg TID groups versus control group
Time Frame	Up to Day 29

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Arm A	Treatment Arm B	Control Arm
Arm/Group Description	NP-120 (Ifenprodil) 20 mg TID + Standard of Care	NP-120 (Ifenprodil) 40 mg TID + Standard of Care	Standard of Care only
Measure Participants	52	56	60
Count of Participants [Participants]	2 3.8%	5 8.9%	4 6.7%

10. Secondary Outcome

Title	Duration of Hospitalization in IP Versus Control Group Patients
Time Frame	Day 15, 28

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

11. Secondary Outcome

Title	Time to Discharge in IP Versus Control Group Patients
Time Frame	Day 15, 28

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

12. Secondary Outcome

Title	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
Time Frame	Up to day 15, day 28

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	From Day 1 to Day 60
Arm/Group Title	Treatment Arm A		Treatment Arm B		Control Arm
Arm/Group Description	NP-120 (Ifenprodil) 20 mg TID + Standard of Care		NP-120 (Ifenprodil) 40 mg TID + Standard of Care		Standard of Care only
All Cause Mortality
	Treatment Arm A		Treatment Arm B		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/52 (3.8%)		5/56 (8.9%)		4/60 (6.7%)
Serious Adverse Events
	Treatment Arm A		Treatment Arm B		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/52 (3.8%)		6/56 (10.7%)		5/60 (8.3%)
Cardiac disorders
Cardiac Arrest	2/52 (3.8%)	2	1/56 (1.8%)	1	2/60 (3.3%)	2
Cardiopulmonary Failure	0/52 (0%)	0	0/56 (0%)	0	2/60 (3.3%)	2
Acute myocardial infarction	0/52 (0%)	0	0/56 (0%)	0	1/60 (1.7%)	1
Coronary artery disease	0/52 (0%)	0	1/56 (1.8%)	1	0/60 (0%)	0
Infections and infestations
COVID-19 pneumonia	0/52 (0%)	0	1/56 (1.8%)	1	1/60 (1.7%)	1
Investigations
Coagulation test abnormal	0/52 (0%)	0	1/56 (1.8%)	1	0/60 (0%)	0
Nervous system disorders
Seizure	0/52 (0%)	0	1/56 (1.8%)	1	0/60 (0%)	0
Renal and urinary disorders
Pyelonephritis acute	0/52 (0%)	0	1/56 (1.8%)	1	0/60 (0%)	0
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism	0/52 (0%)	0	1/56 (1.8%)	1	0/60 (0%)	0
Other (Not Including Serious) Adverse Events
	Treatment Arm A		Treatment Arm B		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	36/52 (69.2%)		35/56 (62.5%)		30/60 (50%)
Blood and lymphatic system disorders
Coagulopathy	0/52 (0%)	0	4/56 (7.1%)	4	3/60 (5%)	3
Gastrointestinal disorders
Constipation	2/52 (3.8%)	2	3/56 (5.4%)	3	3/60 (5%)	3
Diarrhoea	3/52 (5.8%)	3	1/56 (1.8%)	1	3/60 (5%)	3
Flatulence	1/52 (1.9%)	1	3/56 (5.4%)	3	1/60 (1.7%)	1
Nausea	3/52 (5.8%)	3	0/56 (0%)	0	0/60 (0%)	0
Hepatobiliary disorders
Hepatocellular injury	4/52 (7.7%)	5	5/56 (8.9%)	5	8/60 (13.3%)	8
Infections and infestations
Oral candidiasis	6/52 (11.5%)	6	3/56 (5.4%)	3	1/60 (1.7%)	1
Urinary tract infection	0/52 (0%)	0	3/56 (5.4%)	3	0/60 (0%)	0
Injury, poisoning and procedural complications
Vessel puncture site bruise	3/52 (5.8%)	4	0/56 (0%)	0	1/60 (1.7%)	1
Metabolism and nutrition disorders
Hyperglycaemia	5/52 (9.6%)	5	3/56 (5.4%)	3	1/60 (1.7%)	1
Hypoalbuminaemia	3/52 (5.8%)	3	2/56 (3.6%)	2	4/60 (6.7%)	4
Psychiatric disorders
Anxiety	1/52 (1.9%)	1	5/56 (8.9%)	5	2/60 (3.3%)	2
Insomnia	2/52 (3.8%)	2	3/56 (5.4%)	3	3/60 (5%)	3
Skin and subcutaneous tissue disorders
Intertrigo	3/52 (5.8%)	3	0/56 (0%)	0	0/60 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.