Trial Outcomes & Findings for COVID-19 and Anti-CD14 Treatment Trial (NCT NCT04391309)

Last Updated: 2023-06-26

Results Overview

The Primary Endpoint is time to clinical recovery, defined as the time from baseline to the first day that a subject is in categories 1, 2, or 3 on the Eight-Point Ordinal Scale through Day 28 (range 1 \[best\] to 8 \[worst\]). The Eight-Point Ordinal Scale is an assessment of the clinical status on each study day. The Scale is defined as follows: 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 requires 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 (ECMO) 8. Death

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

49 participants

Primary outcome timeframe

Within the 28 day period following baseline

Results posted on

2023-06-26

Participant Flow

49 participants were enrolled across 5 US sites from April 2021 to January 2022. Of these enrolled, 41 participants were randomized and 40 initiated study treatment. 8 enrolled participants were not randomized because they did not meet eligibility criteria, and one randomized participant did not initiate study treatment because they withdrew their consent.

8 enrolled participants were not randomized because they did not meet eligibility criteria.

Participant milestones

Participant milestones
Measure	IC14 Subjects received IC14 4 mg/kg intravenously on Day 1, followed by IC14 2 mg/kg/day intravenously on Days 2-4 (totaling 4 consecutive days). Subjects also received remdesivir 200 mg intravenously on Day 1, followed by 100 mg intravenously daily on Days 2-5 (totaling 5 consecutive days).	Placebo Subjects received 0.9% w/v Sodium Chloride in a matching bag and volume administered intravenously daily on Days 1-4 (totaling 4 consecutive days). Subjects also received remdesivir 200 mg intravenously on Day 1, followed by 100 mg intravenously daily on Days 2-5 (totaling 5 consecutive days).
Overall Study STARTED	21	20
Overall Study Included in the Modified Intent to Treat Population (miTT)	20	20
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	6	5

Reasons for withdrawal

Reasons for withdrawal
Measure	IC14 Subjects received IC14 4 mg/kg intravenously on Day 1, followed by IC14 2 mg/kg/day intravenously on Days 2-4 (totaling 4 consecutive days). Subjects also received remdesivir 200 mg intravenously on Day 1, followed by 100 mg intravenously daily on Days 2-5 (totaling 5 consecutive days).	Placebo Subjects received 0.9% w/v Sodium Chloride in a matching bag and volume administered intravenously daily on Days 1-4 (totaling 4 consecutive days). Subjects also received remdesivir 200 mg intravenously on Day 1, followed by 100 mg intravenously daily on Days 2-5 (totaling 5 consecutive days).
Overall Study Death	1	1
Overall Study Lost to Follow-up	3	2
Overall Study Withdrawal by Subject	2	2

Baseline Characteristics

COVID-19 and Anti-CD14 Treatment Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IC14 n=20 Participants Subjects received IC14 4 mg/kg intravenously on Day 1, followed by IC14 2 mg/kg/day intravenously on Days 2-4 (totaling 4 consecutive days). Subjects also received remdesivir 200 mg intravenously on Day 1, followed by 100 mg intravenously daily on Days 2-5 (totaling 5 consecutive days).	Placebo n=20 Participants Subjects received 0.9% w/v Sodium Chloride in a matching bag and volume administered intravenously daily on Days 1-4 (totaling 4 consecutive days). Subjects also received remdesivir 200 mg intravenously on Day 1, followed by 100 mg intravenously daily on Days 2-5 (totaling 5 consecutive days).	Total n=40 Participants Total of all reporting groups
Age, Continuous	54.5 years STANDARD_DEVIATION 14.7 • n=5 Participants	47.1 years STANDARD_DEVIATION 13.6 • n=7 Participants	50.85 years STANDARD_DEVIATION 14.46 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants
Assessment of Clinical Status According to Eight-Point Ordinal Scale 1	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Assessment of Clinical Status According to Eight-Point Ordinal Scale 2	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Assessment of Clinical Status According to Eight-Point Ordinal Scale 3	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Assessment of Clinical Status According to Eight-Point Ordinal Scale 4	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Assessment of Clinical Status According to Eight-Point Ordinal Scale 5	18 Participants n=5 Participants	14 Participants n=7 Participants	32 Participants n=5 Participants
Assessment of Clinical Status According to Eight-Point Ordinal Scale 6	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Assessment of Clinical Status According to Eight-Point Ordinal Scale 7	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Assessment of Clinical Status According to Eight-Point Ordinal Scale 8	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within the 28 day period following baseline

Population: Modified Intent to Treat population (mITT), that included all participants who were randomized and treated with at least one dose of investigational product.

Outcome measures

Outcome measures
Measure	IC14 n=20 Participants Subjects received IC14 4 mg/kg intravenously on Day 1, followed by IC14 2 mg/kg/day intravenously on Days 2-4 (totaling 4 consecutive days). Subjects also received remdesivir 200 mg intravenously on Day 1, followed by 100 mg intravenously daily on Days 2-5 (totaling 5 consecutive days).	Placebo n=20 Participants Subjects received 0.9% w/v Sodium Chloride in a matching bag and volume administered intravenously daily on Days 1-4 (totaling 4 consecutive days). Subjects also received remdesivir 200 mg intravenously on Day 1, followed by 100 mg intravenously daily on Days 2-5 (totaling 5 consecutive days).
The Time to Clinical Recovery, Defined as the Time From Baseline to the First Day That Subject is in Categories 1, 2, or 3 on the Eight-Point Ordinal Scale Through Day 28.	6 days Interval 5.0 to 11.0	5 days Interval 4.0 to 10.0

SECONDARY outcome

Timeframe: Within the 28 day period following baseline.

Population: Modified Intent to Treat population (mITT), that included all participants who were randomized and treated with at least one dose of investigational product.

Episodes of acute respiratory failure are defined as by need for the following oxygen delivery resources: 1. High-flow nasal cannula (flow rates ≥30L/min with FiO2 ≥0.4) 2. Noninvasive positive-pressure ventilation through nasal or face mask, or nasal plugs 3. Endotracheal intubation and mechanical 4. Extracorporeal membrane oxygenation

Outcome measures

Outcome measures
Measure	IC14 n=20 Participants Subjects received IC14 4 mg/kg intravenously on Day 1, followed by IC14 2 mg/kg/day intravenously on Days 2-4 (totaling 4 consecutive days). Subjects also received remdesivir 200 mg intravenously on Day 1, followed by 100 mg intravenously daily on Days 2-5 (totaling 5 consecutive days).	Placebo n=20 Participants Subjects received 0.9% w/v Sodium Chloride in a matching bag and volume administered intravenously daily on Days 1-4 (totaling 4 consecutive days). Subjects also received remdesivir 200 mg intravenously on Day 1, followed by 100 mg intravenously daily on Days 2-5 (totaling 5 consecutive days).
Days Alive and Free of Any Episodes of Acute Respiratory Failure Through Day 28 0 days	1 Participants	1 Participants
Days Alive and Free of Any Episodes of Acute Respiratory Failure Through Day 28 24 days	1 Participants	0 Participants
Days Alive and Free of Any Episodes of Acute Respiratory Failure Through Day 28 27 days	0 Participants	1 Participants
Days Alive and Free of Any Episodes of Acute Respiratory Failure Through Day 28 28 days	18 Participants	18 Participants

SECONDARY outcome

Timeframe: Within the 14 day period following baseline.

Population: Modified Intent to Treat population (mITT), that included all participants who were randomized and treated with at least one dose of investigational product, who additionally had data collected on Day 14.

A larger negative change indicates a greater improvement in clinical status from baseline. The Eight-Point Ordinal Scale is an assessment of the clinical status on each study day (1 is best, 8 is worst). The Scale is defined as follows: 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 requires 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 (ECMO). 8. Death.

Outcome measures

Outcome measures
Measure	IC14 n=17 Participants Subjects received IC14 4 mg/kg intravenously on Day 1, followed by IC14 2 mg/kg/day intravenously on Days 2-4 (totaling 4 consecutive days). Subjects also received remdesivir 200 mg intravenously on Day 1, followed by 100 mg intravenously daily on Days 2-5 (totaling 5 consecutive days).	Placebo n=18 Participants Subjects received 0.9% w/v Sodium Chloride in a matching bag and volume administered intravenously daily on Days 1-4 (totaling 4 consecutive days). Subjects also received remdesivir 200 mg intravenously on Day 1, followed by 100 mg intravenously daily on Days 2-5 (totaling 5 consecutive days).
Change in the Ordinal Scale From Baseline to Day 14	-3.1 units on a scale Standard Deviation 1.6	-2.8 units on a scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: Within the 28 day period following baseline.

Outcome measures

Outcome measures
Measure	IC14 n=15 Participants Subjects received IC14 4 mg/kg intravenously on Day 1, followed by IC14 2 mg/kg/day intravenously on Days 2-4 (totaling 4 consecutive days). Subjects also received remdesivir 200 mg intravenously on Day 1, followed by 100 mg intravenously daily on Days 2-5 (totaling 5 consecutive days).	Placebo n=16 Participants Subjects received 0.9% w/v Sodium Chloride in a matching bag and volume administered intravenously daily on Days 1-4 (totaling 4 consecutive days). Subjects also received remdesivir 200 mg intravenously on Day 1, followed by 100 mg intravenously daily on Days 2-5 (totaling 5 consecutive days).
Change in Ordinal Scale From Baseline to Day 28.	-3.7 units on a scale Standard Deviation 0.6	-3.3 units on a scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: Day 14 following baseline.

The Eight-Point Ordinal Scale is an assessment of the clinical status on each study day (1 is best, 8 is worst). The Scale is defined as follows: 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 requires 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 (ECMO). 8. Death.

Outcome measures

Outcome measures
Measure	IC14 n=17 Participants Subjects received IC14 4 mg/kg intravenously on Day 1, followed by IC14 2 mg/kg/day intravenously on Days 2-4 (totaling 4 consecutive days). Subjects also received remdesivir 200 mg intravenously on Day 1, followed by 100 mg intravenously daily on Days 2-5 (totaling 5 consecutive days).	Placebo n=18 Participants Subjects received 0.9% w/v Sodium Chloride in a matching bag and volume administered intravenously daily on Days 1-4 (totaling 4 consecutive days). Subjects also received remdesivir 200 mg intravenously on Day 1, followed by 100 mg intravenously daily on Days 2-5 (totaling 5 consecutive days).
Ordinal Scale Value on Day 14.	1.9 units on a scale Standard Deviation 1.6	2.0 units on a scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: Within the 28 day period following baseline.

Population: Modified Intent to Treat population (mITT), that included all participants who were randomized and treated with at least one dose of investigational product.

Mortality due to all causes during the observation period.

Outcome measures

Outcome measures
Measure	IC14 n=20 Participants Subjects received IC14 4 mg/kg intravenously on Day 1, followed by IC14 2 mg/kg/day intravenously on Days 2-4 (totaling 4 consecutive days). Subjects also received remdesivir 200 mg intravenously on Day 1, followed by 100 mg intravenously daily on Days 2-5 (totaling 5 consecutive days).	Placebo n=20 Participants Subjects received 0.9% w/v Sodium Chloride in a matching bag and volume administered intravenously daily on Days 1-4 (totaling 4 consecutive days). Subjects also received remdesivir 200 mg intravenously on Day 1, followed by 100 mg intravenously daily on Days 2-5 (totaling 5 consecutive days).
All-Cause Mortality Through Day 28. Alive	19 Participants	20 Participants
All-Cause Mortality Through Day 28. Died	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Within the 60 day period following baseline.

Population: Modified Intent to Treat population (mITT), that included all participants who were randomized and treated with at least one dose of investigational product.

Mortality due to all causes during the observation period.

Outcome measures

Outcome measures
Measure	IC14 n=20 Participants Subjects received IC14 4 mg/kg intravenously on Day 1, followed by IC14 2 mg/kg/day intravenously on Days 2-4 (totaling 4 consecutive days). Subjects also received remdesivir 200 mg intravenously on Day 1, followed by 100 mg intravenously daily on Days 2-5 (totaling 5 consecutive days).	Placebo n=20 Participants Subjects received 0.9% w/v Sodium Chloride in a matching bag and volume administered intravenously daily on Days 1-4 (totaling 4 consecutive days). Subjects also received remdesivir 200 mg intravenously on Day 1, followed by 100 mg intravenously daily on Days 2-5 (totaling 5 consecutive days).
All-Cause Mortality Through Day 60. Alive	19 Participants	19 Participants
All-Cause Mortality Through Day 60. Died	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Within the 28 day period following baseline.

Population: Modified Intent to Treat population (mITT), that included all participants who were randomized and treated with at least one dose of investigational product.

Outcome measures

Outcome measures
Measure	IC14 n=20 Participants Subjects received IC14 4 mg/kg intravenously on Day 1, followed by IC14 2 mg/kg/day intravenously on Days 2-4 (totaling 4 consecutive days). Subjects also received remdesivir 200 mg intravenously on Day 1, followed by 100 mg intravenously daily on Days 2-5 (totaling 5 consecutive days).	Placebo n=20 Participants Subjects received 0.9% w/v Sodium Chloride in a matching bag and volume administered intravenously daily on Days 1-4 (totaling 4 consecutive days). Subjects also received remdesivir 200 mg intravenously on Day 1, followed by 100 mg intravenously daily on Days 2-5 (totaling 5 consecutive days).
Percentage of Participants Alive and Free of Any Episode of Acute Respiratory Failure Through Day 28 No	2 Participants	2 Participants
Percentage of Participants Alive and Free of Any Episode of Acute Respiratory Failure Through Day 28 Yes	18 Participants	18 Participants

SECONDARY outcome

Timeframe: Within the 28 day period following baseline.

Population: Modified Intent to Treat population (mITT), that included all participants who were randomized and treated with at least one dose of investigational product.

Endotracheal intubation and mechanical ventilation.

Outcome measures

Outcome measures
Measure	IC14 n=20 Participants Subjects received IC14 4 mg/kg intravenously on Day 1, followed by IC14 2 mg/kg/day intravenously on Days 2-4 (totaling 4 consecutive days). Subjects also received remdesivir 200 mg intravenously on Day 1, followed by 100 mg intravenously daily on Days 2-5 (totaling 5 consecutive days).	Placebo n=20 Participants Subjects received 0.9% w/v Sodium Chloride in a matching bag and volume administered intravenously daily on Days 1-4 (totaling 4 consecutive days). Subjects also received remdesivir 200 mg intravenously on Day 1, followed by 100 mg intravenously daily on Days 2-5 (totaling 5 consecutive days).
Days Alive and Free of Invasive Mechanical Ventilation Through Day 28 0 days	1 Participants	1 Participants
Days Alive and Free of Invasive Mechanical Ventilation Through Day 28 28 days	19 Participants	19 Participants

SECONDARY outcome

Timeframe: Within the 28 day period following baseline.

Population: Modified Intent to Treat population (mITT), that included all participants who were randomized and treated with at least one dose of investigational product.

Endotracheal intubation and mechanical ventilation.

Outcome measures

Outcome measures
Measure	IC14 n=20 Participants Subjects received IC14 4 mg/kg intravenously on Day 1, followed by IC14 2 mg/kg/day intravenously on Days 2-4 (totaling 4 consecutive days). Subjects also received remdesivir 200 mg intravenously on Day 1, followed by 100 mg intravenously daily on Days 2-5 (totaling 5 consecutive days).	Placebo n=20 Participants Subjects received 0.9% w/v Sodium Chloride in a matching bag and volume administered intravenously daily on Days 1-4 (totaling 4 consecutive days). Subjects also received remdesivir 200 mg intravenously on Day 1, followed by 100 mg intravenously daily on Days 2-5 (totaling 5 consecutive days).
Percentage of Participants Alive and Free of Invasive Mechanical Ventilation Through Day 28 Yes	19 Participants	19 Participants
Percentage of Participants Alive and Free of Invasive Mechanical Ventilation Through Day 28 No	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Within the 28 day period following baseline.

Population: Modified Intent to Treat population (mITT), that included all participants who were randomized and treated with at least one dose of investigational product.

Participants must be alive and discharged from hospital.

Outcome measures

Outcome measures
Measure	IC14 n=20 Participants Subjects received IC14 4 mg/kg intravenously on Day 1, followed by IC14 2 mg/kg/day intravenously on Days 2-4 (totaling 4 consecutive days). Subjects also received remdesivir 200 mg intravenously on Day 1, followed by 100 mg intravenously daily on Days 2-5 (totaling 5 consecutive days).	Placebo n=20 Participants Subjects received 0.9% w/v Sodium Chloride in a matching bag and volume administered intravenously daily on Days 1-4 (totaling 4 consecutive days). Subjects also received remdesivir 200 mg intravenously on Day 1, followed by 100 mg intravenously daily on Days 2-5 (totaling 5 consecutive days).
Percentage of Participants Alive and Discharged From the Hospital Through Day 28 Yes	19 Participants	19 Participants
Percentage of Participants Alive and Discharged From the Hospital Through Day 28 No	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Within the 28 day period following baseline.

Population: Modified Intent to Treat population (mITT), that included all participants who were randomized and treated with at least one dose of investigational product.

Initiation of corticosteroid therapy.

Outcome measures

Outcome measures
Measure	IC14 n=20 Participants Subjects received IC14 4 mg/kg intravenously on Day 1, followed by IC14 2 mg/kg/day intravenously on Days 2-4 (totaling 4 consecutive days). Subjects also received remdesivir 200 mg intravenously on Day 1, followed by 100 mg intravenously daily on Days 2-5 (totaling 5 consecutive days).	Placebo n=20 Participants Subjects received 0.9% w/v Sodium Chloride in a matching bag and volume administered intravenously daily on Days 1-4 (totaling 4 consecutive days). Subjects also received remdesivir 200 mg intravenously on Day 1, followed by 100 mg intravenously daily on Days 2-5 (totaling 5 consecutive days).
Percent of Participants Who Begin Corticosteroid Therapy for Worsening COVID-19 Illness After Randomization Yes	1 Participants	1 Participants
Percent of Participants Who Begin Corticosteroid Therapy for Worsening COVID-19 Illness After Randomization No	19 Participants	19 Participants

SECONDARY outcome

Timeframe: Within the 28 day period following baseline.

Population: All participants who initiated study treatment.

Number of serious adverse events

Outcome measures

Outcome measures
Measure	IC14 n=20 Participants Subjects received IC14 4 mg/kg intravenously on Day 1, followed by IC14 2 mg/kg/day intravenously on Days 2-4 (totaling 4 consecutive days). Subjects also received remdesivir 200 mg intravenously on Day 1, followed by 100 mg intravenously daily on Days 2-5 (totaling 5 consecutive days).	Placebo n=20 Participants Subjects received 0.9% w/v Sodium Chloride in a matching bag and volume administered intravenously daily on Days 1-4 (totaling 4 consecutive days). Subjects also received remdesivir 200 mg intravenously on Day 1, followed by 100 mg intravenously daily on Days 2-5 (totaling 5 consecutive days).
Serious Adverse Events (SAEs)	6 Serious Adverse Events	4 Serious Adverse Events

SECONDARY outcome

Timeframe: Within the 28 day period following baseline.

Population: All participants who initiated study treatment.

Number of Grade 3 and 4 clinical and/or laboratory adverse events

Outcome measures

Outcome measures
Measure	IC14 n=20 Participants Subjects received IC14 4 mg/kg intravenously on Day 1, followed by IC14 2 mg/kg/day intravenously on Days 2-4 (totaling 4 consecutive days). Subjects also received remdesivir 200 mg intravenously on Day 1, followed by 100 mg intravenously daily on Days 2-5 (totaling 5 consecutive days).	Placebo n=20 Participants Subjects received 0.9% w/v Sodium Chloride in a matching bag and volume administered intravenously daily on Days 1-4 (totaling 4 consecutive days). Subjects also received remdesivir 200 mg intravenously on Day 1, followed by 100 mg intravenously daily on Days 2-5 (totaling 5 consecutive days).
Adverse Events (AEs) Severe (Grade 3)	12 Adverse Events	10 Adverse Events
Adverse Events (AEs) Life Threatening (Grade 4)	1 Adverse Events	1 Adverse Events

Adverse Events

IC14

Serious events: 4 serious events

Other events: 16 other events

Deaths: 1 deaths

Placebo

Serious events: 1 serious events

Other events: 13 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	IC14 n=20 participants at risk Subjects received IC14 4 mg/kg intravenously on Day 1, followed by IC14 2 mg/kg/day intravenously on Days 2-4 (totaling 4 consecutive days). Subjects also received remdesivir 200 mg intravenously on Day 1, followed by 100 mg intravenously daily on Days 2-5 (totaling 5 consecutive days).	Placebo n=20 participants at risk Subjects received 0.9% w/v Sodium Chloride in a matching bag and volume administered intravenously daily on Days 1-4 (totaling 4 consecutive days). Subjects also received remdesivir 200 mg intravenously on Day 1, followed by 100 mg intravenously daily on Days 2-5 (totaling 5 consecutive days).
Blood and lymphatic system disorders Anemia	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60
Cardiac disorders Atrial fibrillation	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60
Gastrointestinal disorders Acute pancreatitis	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60
Gastrointestinal disorders Gastric ulcer	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60
Infections and infestations Lung infection	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60
Renal and urinary disorders Acute renal failure	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60
Respiratory, thoracic and mediastinal disorders Hypoxemia	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60
Renal and urinary disorders Respiratory failure	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60
Vascular disorders Thromboembolic event	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60

Other adverse events

Additional Information

Director, Clinical Research Operations Program

DAIT/NIAID

Phone: 301-594-7669

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	IC14 n=20 participants at risk Subjects received IC14 4 mg/kg intravenously on Day 1, followed by IC14 2 mg/kg/day intravenously on Days 2-4 (totaling 4 consecutive days). Subjects also received remdesivir 200 mg intravenously on Day 1, followed by 100 mg intravenously daily on Days 2-5 (totaling 5 consecutive days).	Placebo n=20 participants at risk Subjects received 0.9% w/v Sodium Chloride in a matching bag and volume administered intravenously daily on Days 1-4 (totaling 4 consecutive days). Subjects also received remdesivir 200 mg intravenously on Day 1, followed by 100 mg intravenously daily on Days 2-5 (totaling 5 consecutive days).
Blood and lymphatic system disorders Leukocytosis	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60	10.0% 2/20 • Number of events 2 • Day 0 - Day 60 Adverse Events were collected through Day 60
Cardiac disorders Myocardial infarction	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60
Cardiac disorders Tachycardia	10.0% 2/20 • Number of events 2 • Day 0 - Day 60 Adverse Events were collected through Day 60	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60
Cardiac disorders Ventricular tachycardia	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60
Eye disorders Blurred vision	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60
Eye disorders Detachment of retinal pigment epithelium	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60
Eye disorders Dry eye syndrome	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60
Eye disorders Dry eyes	10.0% 2/20 • Number of events 2 • Day 0 - Day 60 Adverse Events were collected through Day 60	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60
Eye disorders Dry macular degeneration	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60
Eye disorders Eye pain	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60
Eye disorders Glaucoma	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60	10.0% 2/20 • Number of events 2 • Day 0 - Day 60 Adverse Events were collected through Day 60
Eye disorders Incipient senile cataract	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60
Eye disorders Lattice degeneration of retina	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60
Eye disorders Meibomian gland dysfunction	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60
Eye disorders Neovascular age-related macular degeneration	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60
Eye disorders Retinal hemorrhage	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60
Eye disorders Retinal macroaneurysm	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60
Eye disorders Retinal tear	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60
Eye disorders Senile nuclear sclerosis	25.0% 5/20 • Number of events 6 • Day 0 - Day 60 Adverse Events were collected through Day 60	25.0% 5/20 • Number of events 5 • Day 0 - Day 60 Adverse Events were collected through Day 60
Gastrointestinal disorders Abdominal pain	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60
Infections and infestations Epstein-Barr virus infection	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60
Gastrointestinal disorders Perianal abscess	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60
Gastrointestinal disorders Thrush	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60	5.0% 1/20 • Number of events 2 • Day 0 - Day 60 Adverse Events were collected through Day 60
Injury, poisoning and procedural complications Conjunctival abrasion	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60
Investigations Alanine aminotransferase increased	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60
Investigations Aspartate aminotransferase increased	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60
Investigations Cardiac troponin increased	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60
Investigations Creatinine increased	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60
Investigations GGT increased	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60
Investigations Sputum abnormal	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60
Metabolism and nutrition disorders Hyperglycemia	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60	10.0% 2/20 • Number of events 2 • Day 0 - Day 60 Adverse Events were collected through Day 60
Metabolism and nutrition disorders Hyperkalemia	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60
Metabolism and nutrition disorders Hypokalemia	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60
Metabolism and nutrition disorders Hyponatremia	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60
Musculoskeletal and connective tissue disorders Leg pain	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60
Musculoskeletal and connective tissue disorders Pain in thigh	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Choroidal nevus	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60
Nervous system disorders Headache tension	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60
Nervous system disorders Paresthesia	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60
Psychiatric disorders Acute psychosis	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60
Psychiatric disorders Anxiety	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60
Renal and urinary disorders Renal stone	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60
Respiratory, thoracic and mediastinal disorders Calcified lung nodule	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60
Respiratory, thoracic and mediastinal disorders Hemoptysis	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60	5.0% 1/20 • Number of events 1 • Day 0 - Day 60 Adverse Events were collected through Day 60
Skin and subcutaneous tissue disorders Localized maculopapular rash	0.00% 0/20 • Day 0 - Day 60 Adverse Events were collected through Day 60	5.0% 1/20 • Number of events 2 • Day 0 - Day 60 Adverse Events were collected through Day 60