Trial Outcomes & Findings for Assessing Safety, Hospitalization and Efficacy of rNAPc2 in COVID-19 (NCT NCT04655586)

Last Updated: 2023-02-21

Results Overview

Proportional change is represented as percent change, and is defined as: 100 × (D-Dimer level at Day 8 or early discharge - D-Dimer level at baseline) / D-Dimer level at baseline. Baseline and post-baseline D-Dimer results are tested in the same laboratory, i.e. both from central laboratory, or local laboratory paired samples if the central laboratory values are not available.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

160 participants

Primary outcome timeframe

8 days

Results posted on

2023-02-21

Participant Flow

Eligible participants were men and women (18 to 90 years) with a confirmed COVID-19 diagnosis requiring inpatient medical care and an elevated D-dimer level at screening. Enrollment began DEC2020 with the last assessment in MAR2022. 160 participants were enrolled at 15 clinical sites in Argentina, Brazil, and the United States. Originally designed as a sequential Phase 2B/3, the Ph2B top line results dictated substantial design changes for progression to Ph3 and the study was concluded at Ph2.

All study participants provided informed consent for study participation. Eligible participants were randomized (1:1:2) to receive treatment (i.e., rNAPc2 \[1 of 2 dose regimens\] or heparin). Randomization was centralized and stratified by local laboratory D-dimer level at screening. Study participants and endpoint assessors were blinded to treatment assignment.

Participant milestones

Participant milestones
Measure	rNAPc2 Lower Dose loading dose of 5 ug/kg SC on Day 1 followed by 3 ug/kg SC on Days 3 and 5 rNAPc2: two dose regimens of rNAPc2	rNAPc2 Higher Dose loading dose of 7.5 μg/kg SC on Day 1 followed by 5 μg/kg SC on Days 3 and 5 rNAPc2: two dose regimens of rNAPc2	Heparin heparin at either prophylactic or therapeutic doses per Standard of Care at Institution Heparin: standard of care heparin per institution (therapeutic or prophylactic regimen)
Overall Study STARTED	40	40	80
Overall Study COMPLETED	38	34	75
Overall Study NOT COMPLETED	2	6	5

Reasons for withdrawal

Reasons for withdrawal
Measure	rNAPc2 Lower Dose loading dose of 5 ug/kg SC on Day 1 followed by 3 ug/kg SC on Days 3 and 5 rNAPc2: two dose regimens of rNAPc2	rNAPc2 Higher Dose loading dose of 7.5 μg/kg SC on Day 1 followed by 5 μg/kg SC on Days 3 and 5 rNAPc2: two dose regimens of rNAPc2	Heparin heparin at either prophylactic or therapeutic doses per Standard of Care at Institution Heparin: standard of care heparin per institution (therapeutic or prophylactic regimen)
Overall Study Physician Decision	1	3	4
Overall Study Withdrawal by Subject	1	3	1

Baseline Characteristics

Assessing Safety, Hospitalization and Efficacy of rNAPc2 in COVID-19

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	rNAPc2 Lower Dose n=40 Participants loading dose of 5 ug/kg SC on Day 1 followed by 3 ug/kg SC on Days 3 and 5 rNAPc2: two dose regimens of rNAPc2	rNAPc2 Higher Dose n=40 Participants loading dose of 7.5 μg/kg SC on Day 1 followed by 5 μg/kg SC on Days 3 and 5 rNAPc2: two dose regimens of rNAPc2	Heparin n=80 Participants heparin at either prophylactic or therapeutic doses per Standard of Care at Institution Heparin: standard of care heparin per institution (therapeutic or prophylactic regimen)	Total n=160 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=113 Participants	30 Participants n=163 Participants	53 Participants n=160 Participants	113 Participants n=483 Participants
Age, Categorical >=65 years	10 Participants n=113 Participants	10 Participants n=163 Participants	27 Participants n=160 Participants	47 Participants n=483 Participants
Age, Continuous	53.9 years STANDARD_DEVIATION 13.29 • n=113 Participants	52.8 years STANDARD_DEVIATION 12.6 • n=163 Participants	57.6 years STANDARD_DEVIATION 12.8 • n=160 Participants	55.5 years STANDARD_DEVIATION 13 • n=483 Participants
Sex: Female, Male Female	16 Participants n=113 Participants	21 Participants n=163 Participants	32 Participants n=160 Participants	69 Participants n=483 Participants
Sex: Female, Male Male	24 Participants n=113 Participants	19 Participants n=163 Participants	48 Participants n=160 Participants	91 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=113 Participants	0 Participants n=163 Participants	1 Participants n=160 Participants	4 Participants n=483 Participants
Race (NIH/OMB) Asian	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=113 Participants	0 Participants n=163 Participants	1 Participants n=160 Participants	1 Participants n=483 Participants
Race (NIH/OMB) Black or African American	10 Participants n=113 Participants	8 Participants n=163 Participants	16 Participants n=160 Participants	34 Participants n=483 Participants
Race (NIH/OMB) White	27 Participants n=113 Participants	32 Participants n=163 Participants	62 Participants n=160 Participants	121 Participants n=483 Participants
Race (NIH/OMB) More than one race	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants	0 Participants n=483 Participants
Region of Enrollment Argentina	1 participants n=113 Participants	1 participants n=163 Participants	2 participants n=160 Participants	4 participants n=483 Participants
Region of Enrollment United States	38 participants n=113 Participants	38 participants n=163 Participants	74 participants n=160 Participants	150 participants n=483 Participants
Region of Enrollment Brazil	1 participants n=113 Participants	1 participants n=163 Participants	4 participants n=160 Participants	6 participants n=483 Participants
WHO COVID Severity Mild	26 Participants n=113 Participants	22 Participants n=163 Participants	50 Participants n=160 Participants	98 Participants n=483 Participants
WHO COVID Severity Severe	14 Participants n=113 Participants	18 Participants n=163 Participants	30 Participants n=160 Participants	62 Participants n=483 Participants
D-Dimer (ng/mL)	450.8 ng/mL STANDARD_DEVIATION 533.8 • n=113 Participants	517.4 ng/mL STANDARD_DEVIATION 588.3 • n=163 Participants	864.2 ng/mL STANDARD_DEVIATION 1794.8 • n=160 Participants	680.1 ng/mL STANDARD_DEVIATION 1354 • n=483 Participants
D-dimer stratification (%) <= 2x Upper limit of normal	18 Participants n=113 Participants	20 Participants n=163 Participants	35 Participants n=160 Participants	73 Participants n=483 Participants
D-dimer stratification (%) > 2x Upper limit of normal	22 Participants n=113 Participants	20 Participants n=163 Participants	45 Participants n=160 Participants	87 Participants n=483 Participants
ACTT Scale 1	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants	0 Participants n=483 Participants
ACTT Scale 2	0 Participants n=113 Participants	0 Participants n=163 Participants	2 Participants n=160 Participants	2 Participants n=483 Participants
ACTT Scale 3	6 Participants n=113 Participants	5 Participants n=163 Participants	12 Participants n=160 Participants	23 Participants n=483 Participants
ACTT Scale 4	10 Participants n=113 Participants	10 Participants n=163 Participants	13 Participants n=160 Participants	33 Participants n=483 Participants
ACTT Scale 5	1 Participants n=113 Participants	1 Participants n=163 Participants	3 Participants n=160 Participants	5 Participants n=483 Participants
ACTT Scale 6	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants	0 Participants n=483 Participants
ACTT Scale 7	0 Participants n=113 Participants	0 Participants n=163 Participants	1 Participants n=160 Participants	1 Participants n=483 Participants
ACTT Scale 8	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants	0 Participants n=483 Participants
ACTT Scale Missing	23 Participants n=113 Participants	24 Participants n=163 Participants	49 Participants n=160 Participants	96 Participants n=483 Participants

PRIMARY outcome

Timeframe: 8 days

Population: Participants included in analysis for whom paired lab results were available.

Outcome measures

Outcome measures
Measure	rNAPc2 Lower Dose n=33 Participants loading dose of 5 ug/kg SC on Day 1 followed by 3 ug/kg SC on Days 3 and 5 rNAPc2: two dose levels of rNAPc2	rNAPc2 Higher Dose n=32 Participants loading dose of 7.5 μg/kg SC on Day 1 followed by 5 μg/kg SC on Days 3 and 5 rNAPc2: two dose levels of rNAPc2	Heparin n=70 Participants heparin at either prophylactic or therapeutic doses per Standard of Care at Institution Heparin: standard of care heparin per institution (therapeutic or prophylactic regimen)
Proportional Change in D-dimer Level From Baseline to Day 8, or Day of Discharge if Prior to Day 8 (Phase 2b)	137 Percent change Standard Deviation 422.3	41.4 Percent change Standard Deviation 194.6	34.7 Percent change Standard Deviation 133.2

SECONDARY outcome

Timeframe: 2 days and 3 days

Population: Participants included in analysis for whom paired lab results were available.

Proportional change is represented as percent change, and is defined as: 100 × (D-Dimer level at Day 2/3 or early discharge - D-Dimer level at baseline)/D-Dimer level at baseline. Baseline and post-baseline D-Dimer results are tested in the same laboratory.

Outcome measures

Outcome measures
Measure	rNAPc2 Lower Dose n=29 Participants loading dose of 5 ug/kg SC on Day 1 followed by 3 ug/kg SC on Days 3 and 5 rNAPc2: two dose levels of rNAPc2	rNAPc2 Higher Dose n=23 Participants loading dose of 7.5 μg/kg SC on Day 1 followed by 5 μg/kg SC on Days 3 and 5 rNAPc2: two dose levels of rNAPc2	Heparin n=55 Participants heparin at either prophylactic or therapeutic doses per Standard of Care at Institution Heparin: standard of care heparin per institution (therapeutic or prophylactic regimen)
Proportional Change in D-dimer Level From Baseline to 24 Hours Post-dose (Day 2) and Day 3 (Phase 2b) Day 2 (24h post D1 dose)	23.9 percentage change Standard Deviation 213.9	-0.1 percentage change Standard Deviation 40.3	43.5 percentage change Standard Deviation 317.5
Proportional Change in D-dimer Level From Baseline to 24 Hours Post-dose (Day 2) and Day 3 (Phase 2b) Day 3 (48h post D1 dose)	65.8 percentage change Standard Deviation 264.5	-2.3 percentage change Standard Deviation 68.5	21.5 percentage change Standard Deviation 147.3

SECONDARY outcome

Timeframe: 8 days

Population: Safety population includes all participants who were randomized and received at least one dose or part of a dose of study treatment post-randomization. Participants were analyzed according to the treatment actually received.

Clinical events as reported by site. ISTH= International Society on Thrombosis and Haemostasis, TIMI= Thrombolysis in Myocardial Infarction. Heparin Dosing Strategy as indicated by Investigator. Where subjects have more than one bleeding event recorded, only the highest level of severity was summarized.

Outcome measures

Outcome measures
Measure	rNAPc2 Lower Dose n=38 Participants loading dose of 5 ug/kg SC on Day 1 followed by 3 ug/kg SC on Days 3 and 5 rNAPc2: two dose levels of rNAPc2	rNAPc2 Higher Dose n=38 Participants loading dose of 7.5 μg/kg SC on Day 1 followed by 5 μg/kg SC on Days 3 and 5 rNAPc2: two dose levels of rNAPc2	Heparin n=80 Participants heparin at either prophylactic or therapeutic doses per Standard of Care at Institution Heparin: standard of care heparin per institution (therapeutic or prophylactic regimen)
Number of Major or Non-major Clinically Relevant Bleeding Events Within Eight (8) Days of Randomization as Compared to Heparin (Phase 2b) Subjects with any ISTH if Major	1 Participants	0 Participants	1 Participants
Number of Major or Non-major Clinically Relevant Bleeding Events Within Eight (8) Days of Randomization as Compared to Heparin (Phase 2b) TIMI Major	0 Participants	0 Participants	1 Participants
Number of Major or Non-major Clinically Relevant Bleeding Events Within Eight (8) Days of Randomization as Compared to Heparin (Phase 2b) TIMI Minor	0 Participants	0 Participants	0 Participants
Number of Major or Non-major Clinically Relevant Bleeding Events Within Eight (8) Days of Randomization as Compared to Heparin (Phase 2b) TIMI Medical attention	0 Participants	0 Participants	0 Participants
Number of Major or Non-major Clinically Relevant Bleeding Events Within Eight (8) Days of Randomization as Compared to Heparin (Phase 2b) ISTH Major or Non-Major Clinically Relevant	0 Participants	0 Participants	1 Participants
Number of Major or Non-major Clinically Relevant Bleeding Events Within Eight (8) Days of Randomization as Compared to Heparin (Phase 2b) TIMI Minimal	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure	rNAPc2 Lower Dose n=38 Participants loading dose of 5 ug/kg SC on Day 1 followed by 3 ug/kg SC on Days 3 and 5 rNAPc2: two dose levels of rNAPc2	rNAPc2 Higher Dose n=38 Participants loading dose of 7.5 μg/kg SC on Day 1 followed by 5 μg/kg SC on Days 3 and 5 rNAPc2: two dose levels of rNAPc2	Heparin n=80 Participants heparin at either prophylactic or therapeutic doses per Standard of Care at Institution Heparin: standard of care heparin per institution (therapeutic or prophylactic regimen)
Number of Major or Non-major Clinically Relevant Bleeding Events With rNAPc2 vs. Heparin Through Day 30 (Phase 2b) ISTH Major or Non-Major Clinically Relevant	1 Participants	1 Participants	1 Participants
Number of Major or Non-major Clinically Relevant Bleeding Events With rNAPc2 vs. Heparin Through Day 30 (Phase 2b) ISTH Major	0 Participants	1 Participants	1 Participants
Number of Major or Non-major Clinically Relevant Bleeding Events With rNAPc2 vs. Heparin Through Day 30 (Phase 2b) ISTH Non-major Clinically Relevant	1 Participants	0 Participants	0 Participants
Number of Major or Non-major Clinically Relevant Bleeding Events With rNAPc2 vs. Heparin Through Day 30 (Phase 2b) Subjects With Any ISTH if Major	3 Participants	2 Participants	1 Participants
Number of Major or Non-major Clinically Relevant Bleeding Events With rNAPc2 vs. Heparin Through Day 30 (Phase 2b) TIMI Major	0 Participants	0 Participants	1 Participants
Number of Major or Non-major Clinically Relevant Bleeding Events With rNAPc2 vs. Heparin Through Day 30 (Phase 2b) TIMI Minor	0 Participants	1 Participants	0 Participants
Number of Major or Non-major Clinically Relevant Bleeding Events With rNAPc2 vs. Heparin Through Day 30 (Phase 2b) ISTH Not Clinically Relevant	2 Participants	1 Participants	0 Participants
Number of Major or Non-major Clinically Relevant Bleeding Events With rNAPc2 vs. Heparin Through Day 30 (Phase 2b) TIMI medical attention	1 Participants	0 Participants	0 Participants
Number of Major or Non-major Clinically Relevant Bleeding Events With rNAPc2 vs. Heparin Through Day 30 (Phase 2b) TIMI Minimal	2 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 8 days

Population: Results analyzed from participants with available lab results.

Central lab samples collected per protocol. Proportional change is represented as percent change, and is defined as: 100 × (Biomarker level at Day 8 or early discharge - Biomarker level at baseline)/Biomarker level at baseline.

Outcome measures

Outcome measures
Measure	rNAPc2 Lower Dose n=26 Participants loading dose of 5 ug/kg SC on Day 1 followed by 3 ug/kg SC on Days 3 and 5 rNAPc2: two dose levels of rNAPc2	rNAPc2 Higher Dose n=25 Participants loading dose of 7.5 μg/kg SC on Day 1 followed by 5 μg/kg SC on Days 3 and 5 rNAPc2: two dose levels of rNAPc2	Heparin n=50 Participants heparin at either prophylactic or therapeutic doses per Standard of Care at Institution Heparin: standard of care heparin per institution (therapeutic or prophylactic regimen)
Change in High Sensitivity C-reactive Protein Laboratory Values From Baseline Through Day 8 (Phase 2b)	-26.1 percent change Standard Deviation 203.9	270.9 percent change Standard Deviation 1556.8	12.8 percent change Standard Deviation 226.3

SECONDARY outcome

Timeframe: 8 days

Population: Results analyzed from participants with available lab results.

Outcome measures

Outcome measures
Measure	rNAPc2 Lower Dose n=15 Participants loading dose of 5 ug/kg SC on Day 1 followed by 3 ug/kg SC on Days 3 and 5 rNAPc2: two dose levels of rNAPc2	rNAPc2 Higher Dose n=17 Participants loading dose of 7.5 μg/kg SC on Day 1 followed by 5 μg/kg SC on Days 3 and 5 rNAPc2: two dose levels of rNAPc2	Heparin n=32 Participants heparin at either prophylactic or therapeutic doses per Standard of Care at Institution Heparin: standard of care heparin per institution (therapeutic or prophylactic regimen)
Change in Interleukin-6 Laboratory Values From Baseline Through Day 8 (Phase 2b)	317.4 percentage change Standard Deviation 821.7	768.1 percentage change Standard Deviation 1798.3	8.4 percentage change Standard Deviation 113.8

SECONDARY outcome

Timeframe: 8 days

Population: Results analyzed from participants with available lab results.

Outcome measures

Outcome measures
Measure	rNAPc2 Lower Dose n=28 Participants loading dose of 5 ug/kg SC on Day 1 followed by 3 ug/kg SC on Days 3 and 5 rNAPc2: two dose levels of rNAPc2	rNAPc2 Higher Dose n=26 Participants loading dose of 7.5 μg/kg SC on Day 1 followed by 5 μg/kg SC on Days 3 and 5 rNAPc2: two dose levels of rNAPc2	Heparin n=52 Participants heparin at either prophylactic or therapeutic doses per Standard of Care at Institution Heparin: standard of care heparin per institution (therapeutic or prophylactic regimen)
Change in Tissue Factor Laboratory Values From Baseline Through Day 8 (Phase 2b)	-21.2 percentage change Standard Deviation 56.3	-1.8 percentage change Standard Deviation 89.2	23.3 percentage change Standard Deviation 103.6

SECONDARY outcome

Timeframe: 8 days

Population: Results analyzed from participants with available lab results.

Proportional change is represented as percent change, and is defined as: 100 × (Biomarker level at Day 8 or early discharge - Biomarker level at baseline)/Biomarker level at baseline.

Outcome measures

Outcome measures
Measure	rNAPc2 Lower Dose n=22 Participants loading dose of 5 ug/kg SC on Day 1 followed by 3 ug/kg SC on Days 3 and 5 rNAPc2: two dose levels of rNAPc2	rNAPc2 Higher Dose n=17 Participants loading dose of 7.5 μg/kg SC on Day 1 followed by 5 μg/kg SC on Days 3 and 5 rNAPc2: two dose levels of rNAPc2	Heparin n=33 Participants heparin at either prophylactic or therapeutic doses per Standard of Care at Institution Heparin: standard of care heparin per institution (therapeutic or prophylactic regimen)
Change in Antiphospholipid Antibodies Laboratory Values From Baseline Through Day 8 (Anti-Beta 2 Glycoprotein IgG) (Phase 2b)	-24.04 percentage change Standard Deviation 51.84	-274.3 percentage change Standard Deviation 1562.57	62.99 percentage change Standard Deviation 479.75

Adverse Events

rNAPc2 Lower Dose

Serious events: 18 serious events

Other events: 18 other events

Deaths: 5 deaths

rNAPc2 Higher Dose

Serious events: 29 serious events

Other events: 18 other events

Deaths: 5 deaths

Heparin

Serious events: 26 serious events

Other events: 36 other events

Deaths: 6 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	rNAPc2 Lower Dose n=38 participants at risk loading dose of 5 ug/kg SC on Day 1 followed by 3 ug/kg SC on Days 3 and 5 rNAPc2: two dose regimens of rNAPc2	rNAPc2 Higher Dose n=38 participants at risk loading dose of 7.5 μg/kg SC on Day 1 followed by 5 μg/kg SC on Days 3 and 5 rNAPc2: two dose regimens of rNAPc2	Heparin n=80 participants at risk heparin at either prophylactic or therapeutic doses per Standard of Care at Institution Heparin: standard of care heparin per institution (therapeutic or prophylactic regimen)
Infections and infestations COVID-19 Pneumonia	13.2% 5/38 • Number of events 5 • All AEs were collected from the time of randomization until the participant completed Day 30 or final contact, whichever was longer. All SAEs were collected from the time of consent until the participant completed Day 30 or final contact, whichever was longer. For most participants the final visit/contact was at Day 30 (up to 40 days after screening) or later if delayed due to challenges reaching the participant or obtaining final follow-up information (up to Day 251). Participant counts were summarized using frequencies and percentages. A participant was counted only once per category of summarization (e.g., the participant was only counted once in the overall 'Any AE' row and was counted once in each row for the specific AE category reported), and reflected the highest level of severity/relatedness reported. Data includes all participants who were randomized and received at least one dose or part of a dose of study treatment post-randomization.	10.5% 4/38 • Number of events 4 • All AEs were collected from the time of randomization until the participant completed Day 30 or final contact, whichever was longer. All SAEs were collected from the time of consent until the participant completed Day 30 or final contact, whichever was longer. For most participants the final visit/contact was at Day 30 (up to 40 days after screening) or later if delayed due to challenges reaching the participant or obtaining final follow-up information (up to Day 251). Participant counts were summarized using frequencies and percentages. A participant was counted only once per category of summarization (e.g., the participant was only counted once in the overall 'Any AE' row and was counted once in each row for the specific AE category reported), and reflected the highest level of severity/relatedness reported. Data includes all participants who were randomized and received at least one dose or part of a dose of study treatment post-randomization.	6.2% 5/80 • Number of events 5 • All AEs were collected from the time of randomization until the participant completed Day 30 or final contact, whichever was longer. All SAEs were collected from the time of consent until the participant completed Day 30 or final contact, whichever was longer. For most participants the final visit/contact was at Day 30 (up to 40 days after screening) or later if delayed due to challenges reaching the participant or obtaining final follow-up information (up to Day 251). Participant counts were summarized using frequencies and percentages. A participant was counted only once per category of summarization (e.g., the participant was only counted once in the overall 'Any AE' row and was counted once in each row for the specific AE category reported), and reflected the highest level of severity/relatedness reported. Data includes all participants who were randomized and received at least one dose or part of a dose of study treatment post-randomization.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.6% 1/38 • Number of events 4 • All AEs were collected from the time of randomization until the participant completed Day 30 or final contact, whichever was longer. All SAEs were collected from the time of consent until the participant completed Day 30 or final contact, whichever was longer. For most participants the final visit/contact was at Day 30 (up to 40 days after screening) or later if delayed due to challenges reaching the participant or obtaining final follow-up information (up to Day 251). Participant counts were summarized using frequencies and percentages. A participant was counted only once per category of summarization (e.g., the participant was only counted once in the overall 'Any AE' row and was counted once in each row for the specific AE category reported), and reflected the highest level of severity/relatedness reported. Data includes all participants who were randomized and received at least one dose or part of a dose of study treatment post-randomization.	13.2% 5/38 • Number of events 5 • All AEs were collected from the time of randomization until the participant completed Day 30 or final contact, whichever was longer. All SAEs were collected from the time of consent until the participant completed Day 30 or final contact, whichever was longer. For most participants the final visit/contact was at Day 30 (up to 40 days after screening) or later if delayed due to challenges reaching the participant or obtaining final follow-up information (up to Day 251). Participant counts were summarized using frequencies and percentages. A participant was counted only once per category of summarization (e.g., the participant was only counted once in the overall 'Any AE' row and was counted once in each row for the specific AE category reported), and reflected the highest level of severity/relatedness reported. Data includes all participants who were randomized and received at least one dose or part of a dose of study treatment post-randomization.	7.5% 6/80 • Number of events 6 • All AEs were collected from the time of randomization until the participant completed Day 30 or final contact, whichever was longer. All SAEs were collected from the time of consent until the participant completed Day 30 or final contact, whichever was longer. For most participants the final visit/contact was at Day 30 (up to 40 days after screening) or later if delayed due to challenges reaching the participant or obtaining final follow-up information (up to Day 251). Participant counts were summarized using frequencies and percentages. A participant was counted only once per category of summarization (e.g., the participant was only counted once in the overall 'Any AE' row and was counted once in each row for the specific AE category reported), and reflected the highest level of severity/relatedness reported. Data includes all participants who were randomized and received at least one dose or part of a dose of study treatment post-randomization.
Metabolism and nutrition disorders Metabolism and nutrition disorder	5.3% 2/38 • Number of events 2 • All AEs were collected from the time of randomization until the participant completed Day 30 or final contact, whichever was longer. All SAEs were collected from the time of consent until the participant completed Day 30 or final contact, whichever was longer. For most participants the final visit/contact was at Day 30 (up to 40 days after screening) or later if delayed due to challenges reaching the participant or obtaining final follow-up information (up to Day 251). Participant counts were summarized using frequencies and percentages. A participant was counted only once per category of summarization (e.g., the participant was only counted once in the overall 'Any AE' row and was counted once in each row for the specific AE category reported), and reflected the highest level of severity/relatedness reported. Data includes all participants who were randomized and received at least one dose or part of a dose of study treatment post-randomization.	21.1% 8/38 • Number of events 8 • All AEs were collected from the time of randomization until the participant completed Day 30 or final contact, whichever was longer. All SAEs were collected from the time of consent until the participant completed Day 30 or final contact, whichever was longer. For most participants the final visit/contact was at Day 30 (up to 40 days after screening) or later if delayed due to challenges reaching the participant or obtaining final follow-up information (up to Day 251). Participant counts were summarized using frequencies and percentages. A participant was counted only once per category of summarization (e.g., the participant was only counted once in the overall 'Any AE' row and was counted once in each row for the specific AE category reported), and reflected the highest level of severity/relatedness reported. Data includes all participants who were randomized and received at least one dose or part of a dose of study treatment post-randomization.	12.5% 10/80 • Number of events 10 • All AEs were collected from the time of randomization until the participant completed Day 30 or final contact, whichever was longer. All SAEs were collected from the time of consent until the participant completed Day 30 or final contact, whichever was longer. For most participants the final visit/contact was at Day 30 (up to 40 days after screening) or later if delayed due to challenges reaching the participant or obtaining final follow-up information (up to Day 251). Participant counts were summarized using frequencies and percentages. A participant was counted only once per category of summarization (e.g., the participant was only counted once in the overall 'Any AE' row and was counted once in each row for the specific AE category reported), and reflected the highest level of severity/relatedness reported. Data includes all participants who were randomized and received at least one dose or part of a dose of study treatment post-randomization.
Injury, poisoning and procedural complications Transaminases increase	5.3% 2/38 • Number of events 2 • All AEs were collected from the time of randomization until the participant completed Day 30 or final contact, whichever was longer. All SAEs were collected from the time of consent until the participant completed Day 30 or final contact, whichever was longer. For most participants the final visit/contact was at Day 30 (up to 40 days after screening) or later if delayed due to challenges reaching the participant or obtaining final follow-up information (up to Day 251). Participant counts were summarized using frequencies and percentages. A participant was counted only once per category of summarization (e.g., the participant was only counted once in the overall 'Any AE' row and was counted once in each row for the specific AE category reported), and reflected the highest level of severity/relatedness reported. Data includes all participants who were randomized and received at least one dose or part of a dose of study treatment post-randomization.	0.00% 0/38 • All AEs were collected from the time of randomization until the participant completed Day 30 or final contact, whichever was longer. All SAEs were collected from the time of consent until the participant completed Day 30 or final contact, whichever was longer. For most participants the final visit/contact was at Day 30 (up to 40 days after screening) or later if delayed due to challenges reaching the participant or obtaining final follow-up information (up to Day 251). Participant counts were summarized using frequencies and percentages. A participant was counted only once per category of summarization (e.g., the participant was only counted once in the overall 'Any AE' row and was counted once in each row for the specific AE category reported), and reflected the highest level of severity/relatedness reported. Data includes all participants who were randomized and received at least one dose or part of a dose of study treatment post-randomization.	0.00% 0/80 • All AEs were collected from the time of randomization until the participant completed Day 30 or final contact, whichever was longer. All SAEs were collected from the time of consent until the participant completed Day 30 or final contact, whichever was longer. For most participants the final visit/contact was at Day 30 (up to 40 days after screening) or later if delayed due to challenges reaching the participant or obtaining final follow-up information (up to Day 251). Participant counts were summarized using frequencies and percentages. A participant was counted only once per category of summarization (e.g., the participant was only counted once in the overall 'Any AE' row and was counted once in each row for the specific AE category reported), and reflected the highest level of severity/relatedness reported. Data includes all participants who were randomized and received at least one dose or part of a dose of study treatment post-randomization.
Renal and urinary disorders Acute kidney injry	7.9% 3/38 • Number of events 3 • All AEs were collected from the time of randomization until the participant completed Day 30 or final contact, whichever was longer. All SAEs were collected from the time of consent until the participant completed Day 30 or final contact, whichever was longer. For most participants the final visit/contact was at Day 30 (up to 40 days after screening) or later if delayed due to challenges reaching the participant or obtaining final follow-up information (up to Day 251). Participant counts were summarized using frequencies and percentages. A participant was counted only once per category of summarization (e.g., the participant was only counted once in the overall 'Any AE' row and was counted once in each row for the specific AE category reported), and reflected the highest level of severity/relatedness reported. Data includes all participants who were randomized and received at least one dose or part of a dose of study treatment post-randomization.	13.2% 5/38 • Number of events 5 • All AEs were collected from the time of randomization until the participant completed Day 30 or final contact, whichever was longer. All SAEs were collected from the time of consent until the participant completed Day 30 or final contact, whichever was longer. For most participants the final visit/contact was at Day 30 (up to 40 days after screening) or later if delayed due to challenges reaching the participant or obtaining final follow-up information (up to Day 251). Participant counts were summarized using frequencies and percentages. A participant was counted only once per category of summarization (e.g., the participant was only counted once in the overall 'Any AE' row and was counted once in each row for the specific AE category reported), and reflected the highest level of severity/relatedness reported. Data includes all participants who were randomized and received at least one dose or part of a dose of study treatment post-randomization.	2.5% 2/80 • Number of events 2 • All AEs were collected from the time of randomization until the participant completed Day 30 or final contact, whichever was longer. All SAEs were collected from the time of consent until the participant completed Day 30 or final contact, whichever was longer. For most participants the final visit/contact was at Day 30 (up to 40 days after screening) or later if delayed due to challenges reaching the participant or obtaining final follow-up information (up to Day 251). Participant counts were summarized using frequencies and percentages. A participant was counted only once per category of summarization (e.g., the participant was only counted once in the overall 'Any AE' row and was counted once in each row for the specific AE category reported), and reflected the highest level of severity/relatedness reported. Data includes all participants who were randomized and received at least one dose or part of a dose of study treatment post-randomization.
Cardiac disorders Cardiac disorders	2.6% 1/38 • Number of events 1 • All AEs were collected from the time of randomization until the participant completed Day 30 or final contact, whichever was longer. All SAEs were collected from the time of consent until the participant completed Day 30 or final contact, whichever was longer. For most participants the final visit/contact was at Day 30 (up to 40 days after screening) or later if delayed due to challenges reaching the participant or obtaining final follow-up information (up to Day 251). Participant counts were summarized using frequencies and percentages. A participant was counted only once per category of summarization (e.g., the participant was only counted once in the overall 'Any AE' row and was counted once in each row for the specific AE category reported), and reflected the highest level of severity/relatedness reported. Data includes all participants who were randomized and received at least one dose or part of a dose of study treatment post-randomization.	2.6% 1/38 • Number of events 1 • All AEs were collected from the time of randomization until the participant completed Day 30 or final contact, whichever was longer. All SAEs were collected from the time of consent until the participant completed Day 30 or final contact, whichever was longer. For most participants the final visit/contact was at Day 30 (up to 40 days after screening) or later if delayed due to challenges reaching the participant or obtaining final follow-up information (up to Day 251). Participant counts were summarized using frequencies and percentages. A participant was counted only once per category of summarization (e.g., the participant was only counted once in the overall 'Any AE' row and was counted once in each row for the specific AE category reported), and reflected the highest level of severity/relatedness reported. Data includes all participants who were randomized and received at least one dose or part of a dose of study treatment post-randomization.	8.8% 7/80 • Number of events 7 • All AEs were collected from the time of randomization until the participant completed Day 30 or final contact, whichever was longer. All SAEs were collected from the time of consent until the participant completed Day 30 or final contact, whichever was longer. For most participants the final visit/contact was at Day 30 (up to 40 days after screening) or later if delayed due to challenges reaching the participant or obtaining final follow-up information (up to Day 251). Participant counts were summarized using frequencies and percentages. A participant was counted only once per category of summarization (e.g., the participant was only counted once in the overall 'Any AE' row and was counted once in each row for the specific AE category reported), and reflected the highest level of severity/relatedness reported. Data includes all participants who were randomized and received at least one dose or part of a dose of study treatment post-randomization.
Gastrointestinal disorders Gastrointestinal disorders	2.6% 1/38 • Number of events 1 • All AEs were collected from the time of randomization until the participant completed Day 30 or final contact, whichever was longer. All SAEs were collected from the time of consent until the participant completed Day 30 or final contact, whichever was longer. For most participants the final visit/contact was at Day 30 (up to 40 days after screening) or later if delayed due to challenges reaching the participant or obtaining final follow-up information (up to Day 251). Participant counts were summarized using frequencies and percentages. A participant was counted only once per category of summarization (e.g., the participant was only counted once in the overall 'Any AE' row and was counted once in each row for the specific AE category reported), and reflected the highest level of severity/relatedness reported. Data includes all participants who were randomized and received at least one dose or part of a dose of study treatment post-randomization.	7.9% 3/38 • Number of events 3 • All AEs were collected from the time of randomization until the participant completed Day 30 or final contact, whichever was longer. All SAEs were collected from the time of consent until the participant completed Day 30 or final contact, whichever was longer. For most participants the final visit/contact was at Day 30 (up to 40 days after screening) or later if delayed due to challenges reaching the participant or obtaining final follow-up information (up to Day 251). Participant counts were summarized using frequencies and percentages. A participant was counted only once per category of summarization (e.g., the participant was only counted once in the overall 'Any AE' row and was counted once in each row for the specific AE category reported), and reflected the highest level of severity/relatedness reported. Data includes all participants who were randomized and received at least one dose or part of a dose of study treatment post-randomization.	5.0% 4/80 • Number of events 4 • All AEs were collected from the time of randomization until the participant completed Day 30 or final contact, whichever was longer. All SAEs were collected from the time of consent until the participant completed Day 30 or final contact, whichever was longer. For most participants the final visit/contact was at Day 30 (up to 40 days after screening) or later if delayed due to challenges reaching the participant or obtaining final follow-up information (up to Day 251). Participant counts were summarized using frequencies and percentages. A participant was counted only once per category of summarization (e.g., the participant was only counted once in the overall 'Any AE' row and was counted once in each row for the specific AE category reported), and reflected the highest level of severity/relatedness reported. Data includes all participants who were randomized and received at least one dose or part of a dose of study treatment post-randomization.
General disorders General disorders and administrative site conditions	2.6% 1/38 • Number of events 1 • All AEs were collected from the time of randomization until the participant completed Day 30 or final contact, whichever was longer. All SAEs were collected from the time of consent until the participant completed Day 30 or final contact, whichever was longer. For most participants the final visit/contact was at Day 30 (up to 40 days after screening) or later if delayed due to challenges reaching the participant or obtaining final follow-up information (up to Day 251). Participant counts were summarized using frequencies and percentages. A participant was counted only once per category of summarization (e.g., the participant was only counted once in the overall 'Any AE' row and was counted once in each row for the specific AE category reported), and reflected the highest level of severity/relatedness reported. Data includes all participants who were randomized and received at least one dose or part of a dose of study treatment post-randomization.	7.9% 3/38 • Number of events 3 • All AEs were collected from the time of randomization until the participant completed Day 30 or final contact, whichever was longer. All SAEs were collected from the time of consent until the participant completed Day 30 or final contact, whichever was longer. For most participants the final visit/contact was at Day 30 (up to 40 days after screening) or later if delayed due to challenges reaching the participant or obtaining final follow-up information (up to Day 251). Participant counts were summarized using frequencies and percentages. A participant was counted only once per category of summarization (e.g., the participant was only counted once in the overall 'Any AE' row and was counted once in each row for the specific AE category reported), and reflected the highest level of severity/relatedness reported. Data includes all participants who were randomized and received at least one dose or part of a dose of study treatment post-randomization.	3.8% 3/80 • Number of events 3 • All AEs were collected from the time of randomization until the participant completed Day 30 or final contact, whichever was longer. All SAEs were collected from the time of consent until the participant completed Day 30 or final contact, whichever was longer. For most participants the final visit/contact was at Day 30 (up to 40 days after screening) or later if delayed due to challenges reaching the participant or obtaining final follow-up information (up to Day 251). Participant counts were summarized using frequencies and percentages. A participant was counted only once per category of summarization (e.g., the participant was only counted once in the overall 'Any AE' row and was counted once in each row for the specific AE category reported), and reflected the highest level of severity/relatedness reported. Data includes all participants who were randomized and received at least one dose or part of a dose of study treatment post-randomization.
Vascular disorders Vascular disorders	2.6% 1/38 • Number of events 1 • All AEs were collected from the time of randomization until the participant completed Day 30 or final contact, whichever was longer. All SAEs were collected from the time of consent until the participant completed Day 30 or final contact, whichever was longer. For most participants the final visit/contact was at Day 30 (up to 40 days after screening) or later if delayed due to challenges reaching the participant or obtaining final follow-up information (up to Day 251). Participant counts were summarized using frequencies and percentages. A participant was counted only once per category of summarization (e.g., the participant was only counted once in the overall 'Any AE' row and was counted once in each row for the specific AE category reported), and reflected the highest level of severity/relatedness reported. Data includes all participants who were randomized and received at least one dose or part of a dose of study treatment post-randomization.	2.6% 1/38 • Number of events 1 • All AEs were collected from the time of randomization until the participant completed Day 30 or final contact, whichever was longer. All SAEs were collected from the time of consent until the participant completed Day 30 or final contact, whichever was longer. For most participants the final visit/contact was at Day 30 (up to 40 days after screening) or later if delayed due to challenges reaching the participant or obtaining final follow-up information (up to Day 251). Participant counts were summarized using frequencies and percentages. A participant was counted only once per category of summarization (e.g., the participant was only counted once in the overall 'Any AE' row and was counted once in each row for the specific AE category reported), and reflected the highest level of severity/relatedness reported. Data includes all participants who were randomized and received at least one dose or part of a dose of study treatment post-randomization.	6.2% 5/80 • Number of events 5 • All AEs were collected from the time of randomization until the participant completed Day 30 or final contact, whichever was longer. All SAEs were collected from the time of consent until the participant completed Day 30 or final contact, whichever was longer. For most participants the final visit/contact was at Day 30 (up to 40 days after screening) or later if delayed due to challenges reaching the participant or obtaining final follow-up information (up to Day 251). Participant counts were summarized using frequencies and percentages. A participant was counted only once per category of summarization (e.g., the participant was only counted once in the overall 'Any AE' row and was counted once in each row for the specific AE category reported), and reflected the highest level of severity/relatedness reported. Data includes all participants who were randomized and received at least one dose or part of a dose of study treatment post-randomization.
Blood and lymphatic system disorders Blood and lymphatic system disorders	5.3% 2/38 • Number of events 2 • All AEs were collected from the time of randomization until the participant completed Day 30 or final contact, whichever was longer. All SAEs were collected from the time of consent until the participant completed Day 30 or final contact, whichever was longer. For most participants the final visit/contact was at Day 30 (up to 40 days after screening) or later if delayed due to challenges reaching the participant or obtaining final follow-up information (up to Day 251). Participant counts were summarized using frequencies and percentages. A participant was counted only once per category of summarization (e.g., the participant was only counted once in the overall 'Any AE' row and was counted once in each row for the specific AE category reported), and reflected the highest level of severity/relatedness reported. Data includes all participants who were randomized and received at least one dose or part of a dose of study treatment post-randomization.	2.6% 1/38 • Number of events 1 • All AEs were collected from the time of randomization until the participant completed Day 30 or final contact, whichever was longer. All SAEs were collected from the time of consent until the participant completed Day 30 or final contact, whichever was longer. For most participants the final visit/contact was at Day 30 (up to 40 days after screening) or later if delayed due to challenges reaching the participant or obtaining final follow-up information (up to Day 251). Participant counts were summarized using frequencies and percentages. A participant was counted only once per category of summarization (e.g., the participant was only counted once in the overall 'Any AE' row and was counted once in each row for the specific AE category reported), and reflected the highest level of severity/relatedness reported. Data includes all participants who were randomized and received at least one dose or part of a dose of study treatment post-randomization.	3.8% 3/80 • Number of events 3 • All AEs were collected from the time of randomization until the participant completed Day 30 or final contact, whichever was longer. All SAEs were collected from the time of consent until the participant completed Day 30 or final contact, whichever was longer. For most participants the final visit/contact was at Day 30 (up to 40 days after screening) or later if delayed due to challenges reaching the participant or obtaining final follow-up information (up to Day 251). Participant counts were summarized using frequencies and percentages. A participant was counted only once per category of summarization (e.g., the participant was only counted once in the overall 'Any AE' row and was counted once in each row for the specific AE category reported), and reflected the highest level of severity/relatedness reported. Data includes all participants who were randomized and received at least one dose or part of a dose of study treatment post-randomization.

Additional Information

Dr. Michael Bristow

Arca biopharma Inc.

Phone: 720-940-2100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place