Trial Outcomes & Findings for Study of F-652 (IL-22:IgG2 Fusion Protein) in Patients With Moderate to Severe COVID-19 (NCT NCT04498377)

NCT ID: NCT04498377

Last Updated: 2023-12-21

Results Overview

The proportion of patients with a greater or equal 2-point change in the National Institute of Allergy and Infectious Diseases (NIAID) 8-point ordinal scale from baseline to Day 29. The NIAID 8-point ordinal scale includes the following grades: 1. Death; 2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation; 3. Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplementation oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized, limitation on activities and/or requiring home oxygen; and 8. Not hospitalized, no limitations on activities.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 1 participants
• Primary outcome timeframe: Study day 1 before dose to day 29
• Results posted on: 2023-12-21

Participant Flow

Participant milestones

Measure	F-652 F-652: IL-22 fusion protein administered intravenously	Placebo Placebo: Placebo administered intravenously
Overall Study STARTED	1	0
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of F-652 (IL-22:IgG2 Fusion Protein) in Patients With Moderate to Severe COVID-19

Baseline characteristics by cohort

Measure	F-652 n=1 Participants F-652: IL-22 fusion protein administered intravenously	Placebo Placebo: Placebo administered intravenously	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	—	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Study day 1 before dose to day 29

Population: Only 1 patient enrolled

The proportion of patients with a greater or equal 2-point change in the National Institute of Allergy and Infectious Diseases (NIAID) 8-point ordinal scale from baseline to Day 29.

The NIAID 8-point ordinal scale includes the following grades:

1. Death;

2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation;

3. Hospitalized, on non-invasive ventilation or high-flow oxygen devices;

4. Hospitalized, requiring supplemental oxygen;

5. Hospitalized, not requiring supplementation oxygen - requiring ongoing medical care (COVID-19 related or otherwise);

6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care;

7. Not hospitalized, limitation on activities and/or requiring home oxygen; and

8. Not hospitalized, no limitations on activities.

Outcome measures

Measure	F-652 n=1 Participants F-652: IL-22 fusion protein administered intravenously	Placebo Placebo: Placebo administered intravenously
NIAID 8-point Ordinal Scale	1 Participants	0 Participants

Adverse Events

F-652

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	F-652 n=1 participants at risk F-652: IL-22 fusion protein administered intravenously	Placebo Placebo: Placebo administered intravenously
General disorders Chills	100.0% 1/1 • Number of events 1 • 60 days There is 1 patient enrolled in F-652 arm, no patient enrolled in placebo arm.	— 0/0 • 60 days There is 1 patient enrolled in F-652 arm, no patient enrolled in placebo arm.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	100.0% 1/1 • Number of events 1 • 60 days There is 1 patient enrolled in F-652 arm, no patient enrolled in placebo arm.	— 0/0 • 60 days There is 1 patient enrolled in F-652 arm, no patient enrolled in placebo arm.
Psychiatric disorders Agitation	100.0% 1/1 • Number of events 1 • 60 days There is 1 patient enrolled in F-652 arm, no patient enrolled in placebo arm.	— 0/0 • 60 days There is 1 patient enrolled in F-652 arm, no patient enrolled in placebo arm.

Additional Information

Jianmin Chen

Evive Biotech

Phone: 6095124566

Email: jianmin.chen@evivebiotech.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place