Trial Outcomes & Findings for CPI-006 Plus Standard of Care Versus Placebo Plus Standard of Care in Mild to Moderately Symptomatic Hospitalized Covid-19 Patients (NCT NCT04734873)

Last Updated: 2022-09-21

Results Overview

Proportion of participants who are alive and free from respiratory deterioration in each active arm compared to placebo arm as measured by the modified World Health Organization (WHO) 8-point Ordinal Scale for Clinical Improvement in which: 1=Not hospitalized, no limitations on activities; 2=Not hospitalized, limitation on activities and/or requiring home oxygen; 3=Hospitalized, not requiring supplemental oxygen - no longer requiring ongoing medical care; 4=Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (Covid-19 related or otherwise); 5=Hospitalized, requiring supplemental oxygen; 6=Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7=Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation; 8=Death.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

46 participants

Primary outcome timeframe

During the 28 days after dosing

Results posted on

2022-09-21

Participant Flow

46 participants were screened and 42 were randomized. Of the 42 participants randomized, only 40 received the treatment assigned at randomization (2 were randomized but withdrew consent prior to receiving study treatment).

Participant milestones

Participant milestones
Measure	Treatment A: CPI-006 2 mg/kg + SOC IV CPI-006 2 mg/kg up to a maximum dose of 200 mg on Day 1 plus standard of care	Treatment B: CPI-006 1 mg/kg + SOC IV CPI-006 1 mg/kg up to a maximum dose of 100 mg on Day 1 plus standard of care	Treatment C: Placebo + SOC IV placebo on Day 1 plus standard of care
Overall Study STARTED	16	14	12
Overall Study COMPLETED	14	11	9
Overall Study NOT COMPLETED	2	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment A: CPI-006 2 mg/kg + SOC IV CPI-006 2 mg/kg up to a maximum dose of 200 mg on Day 1 plus standard of care	Treatment B: CPI-006 1 mg/kg + SOC IV CPI-006 1 mg/kg up to a maximum dose of 100 mg on Day 1 plus standard of care	Treatment C: Placebo + SOC IV placebo on Day 1 plus standard of care
Overall Study Lost to Follow-up	1	3	2
Overall Study Randomized but not dosed	1	0	1

Baseline Characteristics

CPI-006 Plus Standard of Care Versus Placebo Plus Standard of Care in Mild to Moderately Symptomatic Hospitalized Covid-19 Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment A: CPI-006 2 mg/kg + SOC n=16 Participants IV CPI-006 2 mg/kg up to a maximum dose of 200 mg on Day 1 plus standard of care	Treatment B: CPI-006 1 mg/kg + SOC n=14 Participants IV CPI-006 1 mg/kg up to a maximum dose of 100 mg on Day 1 plus standard of care	Treatment C: Placebo + SOC n=12 Participants IV placebo on Day 1 plus standard of care	Total n=42 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=93 Participants	13 Participants n=4 Participants	12 Participants n=27 Participants	38 Participants n=483 Participants
Age, Categorical >=65 years	3 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	4 Participants n=483 Participants
Age, Continuous	56.5 years n=93 Participants	53.0 years n=4 Participants	55.0 years n=27 Participants	56.0 years n=483 Participants
Sex: Female, Male Female	6 Participants n=93 Participants	3 Participants n=4 Participants	9 Participants n=27 Participants	18 Participants n=483 Participants
Sex: Female, Male Male	10 Participants n=93 Participants	11 Participants n=4 Participants	3 Participants n=27 Participants	24 Participants n=483 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=93 Participants	3 Participants n=4 Participants	3 Participants n=27 Participants	12 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=93 Participants	11 Participants n=4 Participants	8 Participants n=27 Participants	27 Participants n=483 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	3 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants	6 Participants n=483 Participants
Race (NIH/OMB) White	13 Participants n=93 Participants	11 Participants n=4 Participants	9 Participants n=27 Participants	33 Participants n=483 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Region of Enrollment United States	16 Participants n=93 Participants	13 Participants n=4 Participants	12 Participants n=27 Participants	41 Participants n=483 Participants
Region of Enrollment Spain	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
8-point Ordinal Scale Assessment 4	0 Participants n=93 Participants	3 Participants n=4 Participants	2 Participants n=27 Participants	5 Participants n=483 Participants
8-point Ordinal Scale Assessment 5	7 Participants n=93 Participants	10 Participants n=4 Participants	7 Participants n=27 Participants	24 Participants n=483 Participants
8-point Ordinal Scale Assessment 6	9 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants	13 Participants n=483 Participants

PRIMARY outcome

Timeframe: During the 28 days after dosing

Population: All participants who received any amount of study drug (CPI-006 or placebo) and have post-baseline efficacy assessment based on the 8-point ordinal scale.

Outcome measures

Outcome measures
Measure	Treatment A: CPI-006 2 mg/kg + SOC n=15 Participants IV CPI-006 2 mg/kg up to a maximum dose of 200 mg on Day 1 plus standard of care	Treatment B: CPI-006 1 mg/kg + SOC n=14 Participants IV CPI-006 1 mg/kg up to a maximum dose of 100 mg on Day 1 plus standard of care	Treatment C: Placebo + SOC n=11 Participants IV placebo on Day 1 plus standard of care
Proportion of Participants Alive and Respiratory Failure Free of CPI-006 Plus SOC Versus Placebo Plus SOC	14 Participants	12 Participants	9 Participants

SECONDARY outcome

Timeframe: During the 28 days after dosing

Population: All participants who received any amount of study drug (CPI-006 or placebo) and recovered during the 28 days after dosing.

Time to recovery after dosing in each active arm compared to placebo arm as measured by the modified WHO 8-point Ordinal Scale for Clinical Improvement in which: 1=Not hospitalized, no limitations on activities; 2=Not hospitalized, limitation on activities and/or requiring home oxygen; 3=Hospitalized, not requiring supplemental oxygen - no longer requiring ongoing medical care; 4=Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (Covid-19 related or otherwise); 5=Hospitalized, requiring supplemental oxygen; 6=Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7=Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation; 8=Death.

Outcome measures

Outcome measures
Measure	Treatment A: CPI-006 2 mg/kg + SOC n=14 Participants IV CPI-006 2 mg/kg up to a maximum dose of 200 mg on Day 1 plus standard of care	Treatment B: CPI-006 1 mg/kg + SOC n=14 Participants IV CPI-006 1 mg/kg up to a maximum dose of 100 mg on Day 1 plus standard of care	Treatment C: Placebo + SOC n=10 Participants IV placebo on Day 1 plus standard of care
Time to Recovery of CPI-006 Plus SOC Versus Placebo Plus SOC	6.0 days Interval 4.0 to 9.0	4.5 days Interval 3.0 to 8.0	7.0 days Interval 2.0 to 12.0

SECONDARY outcome

Timeframe: During the 28 days after dosing

Population: All participants who received any amount of study drug (CPI-006 or placebo) and achieved clinical improvement during the 28 days after dosing.

Time to clinical improvement in each active arm compared to placebo arm as measured by the modified WHO 8-point Ordinal Scale for Clinical Improvement in which: 1=Not hospitalized, no limitations on activities; 2=Not hospitalized, limitation on activities and/or requiring home oxygen; 3=Hospitalized, not requiring supplemental oxygen - no longer requiring ongoing medical care; 4=Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (Covid-19 related or otherwise); 5=Hospitalized, requiring supplemental oxygen; 6=Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7=Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation; 8=Death. Clinical improvement is defined as ≥ 2 points improvement in the 8-point ordinal scale.

Outcome measures

Outcome measures
Measure	Treatment A: CPI-006 2 mg/kg + SOC n=14 Participants IV CPI-006 2 mg/kg up to a maximum dose of 200 mg on Day 1 plus standard of care	Treatment B: CPI-006 1 mg/kg + SOC n=14 Participants IV CPI-006 1 mg/kg up to a maximum dose of 100 mg on Day 1 plus standard of care	Treatment C: Placebo + SOC n=11 Participants IV placebo on Day 1 plus standard of care
Time to Clinical Improvement of CPI-006 Plus SOC Versus Placebo Plus SOC	6.0 days Interval 4.0 to 9.0	4.5 days Interval 3.0 to 8.0	7.0 days Interval 2.0 to 12.0

SECONDARY outcome

Timeframe: During the 28 days after dosing

Population: All participants who received any amount of study drug (CPI-006 or placebo).

Proportion of participants who died in each active arm compared to placebo arm

Outcome measures

Outcome measures
Measure	Treatment A: CPI-006 2 mg/kg + SOC n=15 Participants IV CPI-006 2 mg/kg up to a maximum dose of 200 mg on Day 1 plus standard of care	Treatment B: CPI-006 1 mg/kg + SOC n=14 Participants IV CPI-006 1 mg/kg up to a maximum dose of 100 mg on Day 1 plus standard of care	Treatment C: Placebo + SOC n=11 Participants IV placebo on Day 1 plus standard of care
Mortality Rate Due to Any Cause of CPI-006 Plus SOC Versus Placebo Plus SOC	0 Participants	0 Participants	0 Participants

Adverse Events

Treatment A: CPI-006 2 mg/kg + SOC

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Treatment B: CPI-006 1 mg/kg + SOC

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Treatment C: Placebo + SOC

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment A: CPI-006 2 mg/kg + SOC n=15 participants at risk IV CPI-006 2 mg/kg up to a maximum dose of 200 mg on Day 1 plus standard of care	Treatment B: CPI-006 1 mg/kg + SOC n=14 participants at risk IV CPI-006 1 mg/kg up to a maximum dose of 100 mg on Day 1 plus standard of care	Treatment C: Placebo + SOC n=11 participants at risk IV placebo on Day 1 plus standard of care
Psychiatric disorders Substance-induced psychotic disorder	0.00% 0/15 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	0.00% 0/14 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	9.1% 1/11 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/15 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	0.00% 0/14 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	9.1% 1/11 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).

Other adverse events

Additional Information

Study Director

Corvus Pharmaceuticals

Phone: 650-900-4520

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Investigators are free to publish/present study results from their site upon occurrence of one of either: a multi-center publication, no publication is submitted within 18 months after end of study, or sponsor confirms there will be no publication. Investigators must provide the sponsor all draft publications for review at least 30 days prior to submission. Sponsor may request to defer publication and/or delete sponsor's confidential information to allow the sponsor to preserve its IP rights.
Publication restrictions are in place

Restriction type: OTHER

Measure	Treatment A: CPI-006 2 mg/kg + SOC n=15 participants at risk IV CPI-006 2 mg/kg up to a maximum dose of 200 mg on Day 1 plus standard of care	Treatment B: CPI-006 1 mg/kg + SOC n=14 participants at risk IV CPI-006 1 mg/kg up to a maximum dose of 100 mg on Day 1 plus standard of care	Treatment C: Placebo + SOC n=11 participants at risk IV placebo on Day 1 plus standard of care
Eye disorders Myopia	0.00% 0/15 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	7.1% 1/14 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	0.00% 0/11 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).
Eye disorders Visual impairment	0.00% 0/15 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	0.00% 0/14 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	9.1% 1/11 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).
Gastrointestinal disorders Abdominal hernia	6.7% 1/15 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	0.00% 0/14 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	0.00% 0/11 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).
Gastrointestinal disorders Abdominal pain upper	0.00% 0/15 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	0.00% 0/14 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	9.1% 1/11 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).
Gastrointestinal disorders Dry mouth	0.00% 0/15 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	7.1% 1/14 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	0.00% 0/11 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).
Hepatobiliary disorders Hepatomegaly	6.7% 1/15 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	0.00% 0/14 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	0.00% 0/11 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).
Infections and infestations Diverticulitis	6.7% 1/15 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	0.00% 0/14 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	0.00% 0/11 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).
Infections and infestations Pneumonia escherichia	6.7% 1/15 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	0.00% 0/14 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	0.00% 0/11 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).
Infections and infestations Pneumonia klebsiella	6.7% 1/15 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	0.00% 0/14 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	0.00% 0/11 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).
Infections and infestations Skin candida	6.7% 1/15 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	0.00% 0/14 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	0.00% 0/11 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).
Metabolism and nutrition disorders Hypokalaemia	6.7% 1/15 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	0.00% 0/14 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	0.00% 0/11 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/15 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	7.1% 1/14 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	0.00% 0/11 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).
Nervous system disorders Amnesia	6.7% 1/15 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	0.00% 0/14 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	0.00% 0/11 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).
Nervous system disorders Dizziness	6.7% 1/15 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	0.00% 0/14 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	0.00% 0/11 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).
Nervous system disorders Dyskinesia	6.7% 1/15 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	0.00% 0/14 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	0.00% 0/11 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).
Nervous system disorders Headache	0.00% 0/15 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	0.00% 0/14 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	9.1% 1/11 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).
Nervous system disorders Hypoaesthesia	0.00% 0/15 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	7.1% 1/14 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	0.00% 0/11 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).
Nervous system disorders Presyncope	0.00% 0/15 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	7.1% 1/14 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	0.00% 0/11 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).
Nervous system disorders Syncope	0.00% 0/15 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	0.00% 0/14 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	9.1% 1/11 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).
Nervous system disorders Tremor	0.00% 0/15 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	7.1% 1/14 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	0.00% 0/11 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).
Psychiatric disorders Insomnia	0.00% 0/15 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	7.1% 1/14 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	0.00% 0/11 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).
Renal and urinary disorders Pollakiuria	0.00% 0/15 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	7.1% 1/14 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	0.00% 0/11 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/15 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	7.1% 1/14 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	0.00% 0/11 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).
Skin and subcutaneous tissue disorders Rash	0.00% 0/15 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	7.1% 1/14 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).	0.00% 0/11 • From initiation of study treatment through study Day 28 (4 weeks) The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).