Trial Outcomes & Findings for Safety and Efficacy of C21 in Subjects With COVID-19 (NCT NCT04452435)

NCT ID: NCT04452435

Last Updated: 2021-06-23

Results Overview

Change in C-reactive protein (CRP) from baseline to the average of the last two assessments in the treatment period

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

206 participants

Primary outcome timeframe

Treatment period of 7 days (Day 1 to Day 8)

Results posted on

2021-06-23

Participant Flow

96 enrolled subjects were screening failures because inclusion criteria 4 was not met. 2 enrolled subjects decided to withdraw from the trial before randomization. 2 subjects died before randomization (pneumonia). The remaining 106 subjects were randomized to trial treatment.

Participant milestones

Participant milestones
Measure	C21 Treatment Oral C21 treatment 100 mg twice daily for 7 days	Placebo Treatment Oral placebo treatment twice daily for 7 days
Screening STARTED	51	55
Screening COMPLETED	51	55
Screening NOT COMPLETED	0	0
Treatment Period STARTED	51	55
Treatment Period COMPLETED	45	43
Treatment Period NOT COMPLETED	6	12
Follow-up STARTED	45	43
Follow-up COMPLETED	45	42
Follow-up NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of C21 in Subjects With COVID-19

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	C21 Treatment n=51 Participants Oral C21 treatment 100 mg twice daily for 7 days	Placebo Treatment n=55 Participants Oral placebo treatment twice daily for 7 days	Total n=106 Participants Total of all reporting groups
Age, Continuous	54.3 years n=5 Participants	51.1 years n=7 Participants	52.6 years n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	42 Participants n=7 Participants	80 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	51 Participants n=5 Participants	55 Participants n=7 Participants	106 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	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	51 Participants n=5 Participants	55 Participants n=7 Participants	106 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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 India	51 participants n=5 Participants	55 participants n=7 Participants	106 participants n=5 Participants
Height	166.1 cm n=5 Participants	166.0 cm n=7 Participants	166.1 cm n=5 Participants
Weight	70.1 kg n=5 Participants	69.2 kg n=7 Participants	69.6 kg n=5 Participants
Body mass index	25.4 kg/m^2 n=5 Participants	25.1 kg/m^2 n=7 Participants	25.2 kg/m^2 n=5 Participants
Supplemental oxygen use at baseline	29 Participants n=5 Participants	32 Participants n=7 Participants	61 Participants n=5 Participants
CRP value ≤ median	24 Participants n=5 Participants	22 Participants n=7 Participants	46 Participants n=5 Participants
CRP value > median	21 Participants n=5 Participants	25 Participants n=7 Participants	46 Participants n=5 Participants

PRIMARY outcome

Timeframe: Treatment period of 7 days (Day 1 to Day 8)

Population: Full analysis set. A total of 45 subjects in the C21 group and 46 subjects in the placebo group were included in the analysis of the primary endpoint in the FAS. For a number of the excluded subjects, the reason for exclusion from the primary endpoint analysis was that they had no baseline value available.

Change in C-reactive protein (CRP) from baseline to the average of the last two assessments in the treatment period

Outcome measures

Outcome measures
Measure	C21 Treatment n=45 Participants Oral C21 treatment 100 mg twice daily for 7 days	Placebo Treatment n=46 Participants Oral placebo treatment twice daily for 7 days
Change From Baseline in C-reactive Protein (CRP) After Treatment With C21 200 mg Daily Dose (100 mg b.i.d.)	0.19 mg/L Interval 0.14 to 0.25	0.22 mg/L Interval 0.17 to 0.29

SECONDARY outcome

Timeframe: Treatment period of 7 days ((Day 1 to Day 8)

Population: Subjects with measurements were included in the analysis for the full analysis set.

Change in body temperature from baseline to the average of the last two assessments in the treatment period

Outcome measures

Outcome measures
Measure	C21 Treatment n=51 Participants Oral C21 treatment 100 mg twice daily for 7 days	Placebo Treatment n=54 Participants Oral placebo treatment twice daily for 7 days
Change From Baseline in Body Temperature	-0.11 °C Interval -0.25 to 0.02	-0.34 °C Interval -0.47 to -0.21

SECONDARY outcome

Timeframe: Treatment period of 7 days (Day 1 to Day 8)

Population: Subjects with measurements were included in the analysis for the full analysis set.

Change in IL-6 from baseline to the average of the last two assessments during the treatment period

Outcome measures

Outcome measures
Measure	C21 Treatment n=31 Participants Oral C21 treatment 100 mg twice daily for 7 days	Placebo Treatment n=34 Participants Oral placebo treatment twice daily for 7 days
Change From Baseline in IL-6	0.73 pg/mL Interval 0.51 to 1.05	0.73 pg/mL Interval 0.51 to 1.03

SECONDARY outcome

Timeframe: Treatment period of 7 days (Day 1 to Day 8)

Population: Subjects with measurements were included in the analysis for the full analysis set.

Change in IL-10 from baseline to the average of the last two assessments during the treatment period

Outcome measures

Outcome measures
Measure	C21 Treatment n=37 Participants Oral C21 treatment 100 mg twice daily for 7 days	Placebo Treatment n=39 Participants Oral placebo treatment twice daily for 7 days
Change From Baseline in IL-10	0.66 pg/mL Interval 0.54 to 0.8	0.73 pg/mL Interval 0.6 to 0.89

SECONDARY outcome

Timeframe: Treatment period of 7 days (Day 1 to Day 8)

Population: Subjects with measurements were included in the analysis for the full analysis set.

Change in TNF from baseline to the average of the last two assessments during the treatment period.

Outcome measures

Outcome measures
Measure	C21 Treatment n=46 Participants Oral C21 treatment 100 mg twice daily for 7 days	Placebo Treatment n=46 Participants Oral placebo treatment twice daily for 7 days
Change From Baseline in TNF	0.91 pg/mL Interval 0.77 to 1.07	1.01 pg/mL Interval 0.86 to 1.19

SECONDARY outcome

Timeframe: Treatment period of 7 days (Day 1 to Day 8)

Population: Subjects with measurements were included in the analysis for the full analysis set.

Change in CA125 from baseline to the average of the last two assessments in the treatment period

Outcome measures

Outcome measures
Measure	C21 Treatment n=46 Participants Oral C21 treatment 100 mg twice daily for 7 days	Placebo Treatment n=48 Participants Oral placebo treatment twice daily for 7 days
Change From Baseline in CA125	1.16 u/mL Interval 1.04 to 1.31	1.17 u/mL Interval 1.05 to 1.31

SECONDARY outcome

Timeframe: Treatment period of 7 days (Day 1 to Day 8)

Population: Subjects with measurements were included in the analysis for the full analysis set.

Change in Ferritin from baseline to the average of the last two assessments during the treatment period.

Outcome measures

Outcome measures
Measure	C21 Treatment n=46 Participants Oral C21 treatment 100 mg twice daily for 7 days	Placebo Treatment n=47 Participants Oral placebo treatment twice daily for 7 days
Change From Baseline in Ferritin	0.75 ng/mL Interval 0.66 to 0.84	0.74 ng/mL Interval 0.66 to 0.84

SECONDARY outcome

Timeframe: End-of treatment, Day 7 or 8

Population: Full analysis set

Number of subjects not in need of oxygen supply at the end of treatment

Outcome measures

Outcome measures
Measure	C21 Treatment n=51 Participants Oral C21 treatment 100 mg twice daily for 7 days	Placebo Treatment n=55 Participants Oral placebo treatment twice daily for 7 days
Number of Subjects Not in Need of Oxygen Supply	37 Participants	30 Participants

SECONDARY outcome

Timeframe: Treatment period of 7 days (Day 1 to Day 8)

Population: Full analysis set

Number of subjects not in need of mechanical invasive or non-invasive ventilation during the treatment period

Outcome measures

Outcome measures
Measure	C21 Treatment n=51 Participants Oral C21 treatment 100 mg twice daily for 7 days	Placebo Treatment n=55 Participants Oral placebo treatment twice daily for 7 days
Number of Subjects Not in Need of Mechanical Invasive or Non-invasive Ventilation	50 Participants	53 Participants

SECONDARY outcome

Timeframe: Treatment period of 7 days

Population: Subjects with measurements were included in the analysis for the full analysis set.

Time to need of mechanical invasive or non-invasive ventilation during treatment period

Outcome measures

Outcome measures
Measure	C21 Treatment n=1 Participants Oral C21 treatment 100 mg twice daily for 7 days	Placebo Treatment n=2 Participants Oral placebo treatment twice daily for 7 days
Time to Need of Mechanical Invasive or Non-invasive Ventilation	60.0 hours Interval 60.0 to 60.0	77.925 hours Interval 59.98 to 95.87

SECONDARY outcome

Timeframe: Treatment period of 7 days (Day 1 to Day 8)

Population: Full analysis set

Time on oxygen supply during the treatment period (for those not needing mechanical invasive or non-invasive ventilation)

Outcome measures

Outcome measures
Measure	C21 Treatment n=51 Participants Oral C21 treatment 100 mg twice daily for 7 days	Placebo Treatment n=55 Participants Oral placebo treatment twice daily for 7 days
Time on Oxygen Supply (for Those Not Needing Mechanical Invasive or Non-invasive Ventilation)	5.0 days Interval 1.0 to 7.0	5.0 days Interval 1.0 to 7.0

SECONDARY outcome

Timeframe: Day 1 to end-of-trial (Visit 9)

Population: Safety analysis set

Adverse events were reported from signing of informed consent until end-of-trial visit. No AEs were reported from signing of informed consent until randomization, except for 2 fatal SAEs described under Adverse events.

Outcome measures

Outcome measures
Measure	C21 Treatment n=51 Participants Oral C21 treatment 100 mg twice daily for 7 days	Placebo Treatment n=55 Participants Oral placebo treatment twice daily for 7 days
Adverse Events	31 Participants	37 Participants

POST_HOC outcome

Timeframe: Follow-up Day 14 (7 days after end-of-treatment)

Population: Full analysis set

Number of subjects requiring oxygen supplementation at Day 14

Outcome measures

Outcome measures
Measure	C21 Treatment n=51 Participants Oral C21 treatment 100 mg twice daily for 7 days	Placebo Treatment n=55 Participants Oral placebo treatment twice daily for 7 days
Oxygen Supplementation at Day 14	1 Participants	11 Participants

Adverse Events

C21 Treatment

Serious events: 1 serious events

Other events: 30 other events

Deaths: 1 deaths

Placebo Treatment

Serious events: 3 serious events

Other events: 36 other events

Deaths: 3 deaths

No Treatment (Before Randomization)

Serious events: 2 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	C21 Treatment n=51 participants at risk Oral C21 treatment 100 mg twice daily for 7 days	Placebo Treatment n=55 participants at risk Oral placebo treatment twice daily for 7 days	No Treatment (Before Randomization) n=100 participants at risk Subjects that were enrolled in the trial but not randomized
Cardiac disorders Cardio-respiratory arrest	2.0% 1/51 • Number of events 1 • From signing of informed consent until end-of-trial visit, 14-19 days. At each visit, the subject was asked about AEs in an objective manner, e.g., "Have you experienced any problems since the last visit?" No AEs were reported from signing of informed consent until randomization except for 2 fatal SAEs.	1.8% 1/55 • Number of events 1 • From signing of informed consent until end-of-trial visit, 14-19 days. At each visit, the subject was asked about AEs in an objective manner, e.g., "Have you experienced any problems since the last visit?" No AEs were reported from signing of informed consent until randomization except for 2 fatal SAEs.	0.00% 0/100 • From signing of informed consent until end-of-trial visit, 14-19 days. At each visit, the subject was asked about AEs in an objective manner, e.g., "Have you experienced any problems since the last visit?" No AEs were reported from signing of informed consent until randomization except for 2 fatal SAEs.
Infections and infestations COVID-19 pneumonia	0.00% 0/51 • From signing of informed consent until end-of-trial visit, 14-19 days. At each visit, the subject was asked about AEs in an objective manner, e.g., "Have you experienced any problems since the last visit?" No AEs were reported from signing of informed consent until randomization except for 2 fatal SAEs.	3.6% 2/55 • Number of events 2 • From signing of informed consent until end-of-trial visit, 14-19 days. At each visit, the subject was asked about AEs in an objective manner, e.g., "Have you experienced any problems since the last visit?" No AEs were reported from signing of informed consent until randomization except for 2 fatal SAEs.	2.0% 2/100 • Number of events 2 • From signing of informed consent until end-of-trial visit, 14-19 days. At each visit, the subject was asked about AEs in an objective manner, e.g., "Have you experienced any problems since the last visit?" No AEs were reported from signing of informed consent until randomization except for 2 fatal SAEs.

Other adverse events

Additional Information

Carl-Johan Dalsgaard

Vicore Pharma

Phone: +46 70 975 98 63

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place