Trial Outcomes & Findings for A Trial to Investigate Recovery From COVID-19 With C21 in Adult Subjects (NCT NCT04880642)

NCT ID: NCT04880642

Last Updated: 2023-12-14

Results Overview

Proportion of subjects in the mITT (all randomised, including 5 subjects not treated) with death up to Day 60 follow-up

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 272 participants
• Primary outcome timeframe: Day 1 to Day 60
• Results posted on: 2023-12-14

Participant Flow

316 subjects were screened. Of those, 44 subjects were screening failures, 39 for failure to meet eligibility criteria, 3 due to withdrawal by the subject, and 2 for other reasons. The remaining 272 subjects were randomized. 5 of the randomized subjects did not receive treatment. The screening period was from signing of ICF until randomization.

Participant milestones

Measure	C21 Treatment Oral C21 treatment 100 mg twice daily for 14 days.	Placebo Treatment Oral placebo treatment twice daily for 14 days.
Randomization STARTED	136	136
Randomization COMPLETED	134	133
Randomization NOT COMPLETED	2	3
Treatment Period STARTED	134	133
Treatment Period COMPLETED	122	121
Treatment Period NOT COMPLETED	12	12
Follow-up STARTED	122	121
Follow-up COMPLETED	117	118
Follow-up NOT COMPLETED	5	3

Reasons for withdrawal

Measure	C21 Treatment Oral C21 treatment 100 mg twice daily for 14 days.	Placebo Treatment Oral placebo treatment twice daily for 14 days.
Randomization Withdrawal by Subject	2	3
Treatment Period Adverse Event	0	1
Treatment Period Death	6	6
Treatment Period Lost to Follow-up	1	0
Treatment Period Protocol Violation	0	1
Treatment Period Withdrawal by Subject	5	3
Treatment Period Discontinuation criteria of eGFR	0	1
Follow-up Death	4	3
Follow-up Withdrawal by Subject	1	0

Baseline Characteristics

A Trial to Investigate Recovery From COVID-19 With C21 in Adult Subjects

Baseline characteristics by cohort

Measure	C21 Treatment n=136 Participants Oral C21 treatment 100 mg twice daily for 14 days	Placebo Treatment n=136 Participants Oral placebo treatment twice daily for 14 days	Total n=272 Participants Total of all reporting groups
Age, Continuous	53.5 years n=5 Participants	56.5 years n=7 Participants	55.0 years n=5 Participants
Sex: Female, Male Female	57 Participants n=5 Participants	63 Participants n=7 Participants	120 Participants n=5 Participants
Sex: Female, Male Male	79 Participants n=5 Participants	73 Participants n=7 Participants	152 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	127 Participants n=5 Participants	127 Participants n=7 Participants	254 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	3 Participants n=7 Participants	6 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	43 Participants n=5 Participants	45 Participants n=7 Participants	88 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	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	90 Participants n=5 Participants	87 Participants n=7 Participants	177 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment Colombia	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants
Region of Enrollment Czechia	20 participants n=5 Participants	19 participants n=7 Participants	39 participants n=5 Participants
Region of Enrollment Philippines	3 participants n=5 Participants	5 participants n=7 Participants	8 participants n=5 Participants
Region of Enrollment Ukraine	54 participants n=5 Participants	55 participants n=7 Participants	109 participants n=5 Participants
Region of Enrollment Brazil	4 participants n=5 Participants	5 participants n=7 Participants	9 participants n=5 Participants
Region of Enrollment South Africa	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment India	38 participants n=5 Participants	38 participants n=7 Participants	76 participants n=5 Participants
Region of Enrollment Russia	9 participants n=5 Participants	7 participants n=7 Participants	16 participants n=5 Participants
Height	168.8 Cm n=5 Participants	167.6 Cm n=7 Participants	168.2 Cm n=5 Participants
Weight	81.89 Kg n=5 Participants	79.26 Kg n=7 Participants	80.58 Kg n=5 Participants
Body mass index	28.71 Kg/m^2 n=5 Participants	28.14 Kg/m^2 n=7 Participants	28.42 Kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 60

Proportion of subjects in the mITT (all randomised, including 5 subjects not treated) with death up to Day 60 follow-up

Outcome measures

Measure	Placebo Treatment n=136 Participants Oral placebo treatment twice daily for 14 days	C21 Treatment n=136 Participants Oral C21 treatment 100 mg twice daily for 14 days
All-cause Mortality up to Day 60 Death	10 Participants	10 Participants
All-cause Mortality up to Day 60 Censored	126 Participants	126 Participants

SECONDARY outcome

Timeframe: Day 1 to Day 60

Population: ITT

Time to sustained hospital discharge from Day 1 to Day 60: Time to sustained hospital discharge was defined as the time to the date of discharge from the initial hospitalization or re-hospitalization due to COVID-19 after which the subject was not re-hospitalized for COVID-19 related reasons.

Outcome measures

Measure	Placebo Treatment n=136 Participants Oral placebo treatment twice daily for 14 days	C21 Treatment n=136 Participants Oral C21 treatment 100 mg twice daily for 14 days
Time to Sustained Hospital Discharge up to Day 60	9.0 Days Interval 8.0 to 11.0	9.0 Days Interval 7.0 to 11.0

SECONDARY outcome

Timeframe: Day 1 to Day 29, maximum 28 Days

Population: ITT

Supplemental oxygen-free days from Day 1 up to Day 29, observed range 0 to 28 days. Subjects with deaths imputed as -1 day according to SAP and FDA guidance. Outcome was identical in both groups for both median and range

Outcome measures

Measure	Placebo Treatment n=136 Participants Oral placebo treatment twice daily for 14 days	C21 Treatment n=136 Participants Oral C21 treatment 100 mg twice daily for 14 days
Supplemental Oxygen-free Days up to Day 29	23.0 Days Interval -1.0 to 28.0	23.0 Days Interval -1.0 to 28.0

SECONDARY outcome

Timeframe: Day 15

Population: ITT

Proportion of subjects free of respiratory failure, defined as an 8-point ordinal scale score ≤5, at Day 15. Missing data imputed by MI, proportion given are average over the imputations.

Outcome measures

Measure	Placebo Treatment n=136 Participants Oral placebo treatment twice daily for 14 days	C21 Treatment n=136 Participants Oral C21 treatment 100 mg twice daily for 14 days
Proportion of Subjects Free of Respiratory Failure, Defined as an 8-point Ordinal Scale Score ≤5, at Day 15	0.901 proportion of responders	0.884 proportion of responders

SECONDARY outcome

Timeframe: Day 15

Population: ITT

Proportion of subjects discharged from hospital and free of supplemental oxygen at Day 15. Missing data imputed by MI, proportion given are average over the imputations.

Outcome measures

Measure	Placebo Treatment n=136 Participants Oral placebo treatment twice daily for 14 days	C21 Treatment n=136 Participants Oral C21 treatment 100 mg twice daily for 14 days
Proportion of Subjects Discharged From Hospital and Free of Supplemental Oxygen at Day 15	0.679 proportion of responders	0.676 proportion of responders

Adverse Events

C21 Treatment

Serious events: 15 serious events

Other events: 22 other events

Deaths: 10 deaths

Placebo Treatment

Serious events: 13 serious events

Other events: 24 other events

Deaths: 10 deaths

Serious adverse events

Measure	C21 Treatment n=134 participants at risk Oral C21 treatment 100 mg twice daily for 14 days	Placebo Treatment n=133 participants at risk Oral placebo treatment twice daily for 14 days
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	1.5% 2/134 • Number of events 2 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.	0.75% 1/133 • Number of events 1 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.5% 2/134 • Number of events 2 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.	0.75% 1/133 • Number of events 1 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.5% 2/134 • Number of events 2 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.	0.00% 0/133 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.5% 2/134 • Number of events 2 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.	0.00% 0/133 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/134 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.	0.75% 1/133 • Number of events 1 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.75% 1/134 • Number of events 1 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.	0.00% 0/133 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.75% 1/134 • Number of events 1 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.	0.00% 0/133 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.
Cardiac disorders Cardiac failure acute	1.5% 2/134 • Number of events 2 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.	2.3% 3/133 • Number of events 3 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/134 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.	0.75% 1/133 • Number of events 1 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.
Cardiac disorders Cor pulmonale	0.75% 1/134 • Number of events 1 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.	0.00% 0/133 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.
Cardiac disorders Frederick's syndrome	0.00% 0/134 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.	0.75% 1/133 • Number of events 1 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.
Cardiac disorders Atrial fibrillation	0.75% 1/134 • Number of events 1 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.	0.00% 0/133 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.
Infections and infestations COVID-19	1.5% 2/134 • Number of events 2 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.	1.5% 2/133 • Number of events 2 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.
Infections and infestations Pneumonia	0.75% 1/134 • Number of events 1 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.	0.75% 1/133 • Number of events 1 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.
Infections and infestations COVID-19 pneumonia	0.00% 0/134 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.	0.75% 1/133 • Number of events 1 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.
Infections and infestations Septic shock	0.00% 0/134 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.	0.75% 1/133 • Number of events 1 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.
Gastrointestinal disorders Intestinal obstruction	0.75% 1/134 • Number of events 1 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.	0.00% 0/133 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/134 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.	0.75% 1/133 • Number of events 1 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/134 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.	0.75% 1/133 • Number of events 1 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute lymphocytic leukaemia	0.75% 1/134 • Number of events 1 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.	0.00% 0/133 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.
Renal and urinary disorders Acute kidney injury	0.75% 1/134 • Number of events 1 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.	0.00% 0/133 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.
Vascular disorders Hypotension	0.75% 1/134 • Number of events 1 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.	0.00% 0/133 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.
Vascular disorders Accelerated hypertension	0.75% 1/134 • Number of events 1 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.	0.00% 0/133 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.
General disorders Death	0.00% 0/134 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.	0.75% 1/133 • Number of events 1 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.
Metabolism and nutrition disorders Hyperkalaemia	0.75% 1/134 • Number of events 1 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.	0.00% 0/133 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.

Other adverse events

Measure	C21 Treatment n=134 participants at risk Oral C21 treatment 100 mg twice daily for 14 days	Placebo Treatment n=133 participants at risk Oral placebo treatment twice daily for 14 days
Investigations Alanine aminotransferase increased	5.2% 7/134 • Number of events 9 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.	4.5% 6/133 • Number of events 6 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.
Gastrointestinal disorders Nausea	5.2% 7/134 • Number of events 7 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.	3.0% 4/133 • Number of events 7 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.
General disorders Pyrexia	3.0% 4/134 • Number of events 4 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.	4.5% 6/133 • Number of events 6 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.
Nervous system disorders Headache	3.0% 4/134 • Number of events 4 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.	3.8% 5/133 • Number of events 6 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.
General disorders Asthenia	3.0% 4/134 • Number of events 4 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.	3.0% 4/133 • Number of events 4 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.
Blood and lymphatic system disorders Lymphopenia	0.75% 1/134 • Number of events 1 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.	3.0% 4/133 • Number of events 4 • Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis. All-Cause Mortality was monitored in all randomized subjects (n=272) whereas Serious and Other Adverse Events were assessed in the safety population including treated subjects only (n=267). 5 randomized subjects, but not treated, were not included in the evaluation of adverse events. None of these 5 subjects had any reported adverse events and thereby no deaths.

Additional Information

CEO Carl-Johan Dalsgaard

Vicore Pharma

Phone: +46 (0) 317880560

Email: info@vicorepharma.com

Results disclosure agreements

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