Trial Outcomes & Findings for LSALT Peptide vs. Placebo to Prevent ARDS and Acute Kidney Injury in Patients Infected With SARS-CoV-2 (COVID-19) (NCT NCT04402957)

NCT ID: NCT04402957

Last Updated: 2025-07-09

Results Overview

Respiratory failure is defined as the need for non-invasive or invasive mechanical ventilation, high flow oxygen \[≥ 6 L/minute\], or ECMO. The need for continued RRT at Day 28 will be defined as either dialysis in the past 3 days (Day 26, 27, or 28) or an eGFR on Day 28 \<10 mL/min/1.73 m2.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 61 participants
• Primary outcome timeframe: 28 days
• Results posted on: 2025-07-09

Participant Flow

Participant milestones

Measure	Placebo 100 mL drug-free IV saline infusion over 2 hours daily Placebo: 0.9% saline solution	LSALT 100 mL of 5 mg IV LSALT peptide infusion over 2 hours daily LSALT peptide: LSALT, a peptide drug with the sequence NH3-LSALTPSPSWLKYKAL-COOH, binds to dipeptidase-1 (DPEP-1) but does not inhibit its biologic enzymatic activity. LSALT peptide inhibits leukocyte recruitment in multiple experimental disease models through the direct inhibition of leukocyte adhesion to DPEP-1 present in lungs, kidney, and liver.
Overall Study STARTED	31	30
Overall Study COMPLETED	29	29
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

LSALT Peptide vs. Placebo to Prevent ARDS and Acute Kidney Injury in Patients Infected With SARS-CoV-2 (COVID-19)

Baseline characteristics by cohort

Measure	Placebo n=31 Participants 100 mL drug-free IV saline infusion over 2 hours daily Placebo: 0.9% saline solution	LSALT n=30 Participants 100 mL of 5 mg IV LSALT peptide infusion over 2 hours daily LSALT peptide: LSALT, a peptide drug with the sequence NH3-LSALTPSPSWLKYKAL-COOH, binds to dipeptidase-1 (DPEP-1) but does not inhibit its biologic enzymatic activity. LSALT peptide inhibits leukocyte recruitment in multiple experimental disease models through the direct inhibition of leukocyte adhesion to DPEP-1 present in lungs, kidney, and liver.	Total n=61 Participants Total of all reporting groups
Age, Continuous	57.3 years STANDARD_DEVIATION 10.24 • n=5 Participants	62.3 years STANDARD_DEVIATION 8.71 • n=7 Participants	59.8 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	21 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants	22 Participants n=7 Participants	48 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
BMI	32.29 kg/m2 STANDARD_DEVIATION 10.064 • n=5 Participants	31.72 kg/m2 STANDARD_DEVIATION 5.571 • n=7 Participants	32.04 kg/m2 STANDARD_DEVIATION 8.366 • n=5 Participants
Chronic Lung Disease	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Chronic Renal Disease	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Cardiovascular Disease	15 Participants n=5 Participants	18 Participants n=7 Participants	33 Participants n=5 Participants
Diabetes	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
PaO2/FiO2 Ratio	247.956 mmHg STANDARD_DEVIATION 93.762 • n=5 Participants	247.097 mmHg STANDARD_DEVIATION 111.3844 • n=7 Participants	247.527 mmHg STANDARD_DEVIATION 106.728 • n=5 Participants

PRIMARY outcome

Timeframe: 28 days

Population: The primary efficacy endpoint was the proportion of patients alive and free of respiratory failure (need for non-invasive or invasive mechanical ventilation, high flow oxygen, or ECMO) and free of the need for continued RRT on Day 28.

Respiratory failure is defined as the need for non-invasive or invasive mechanical ventilation, high flow oxygen [≥ 6 L/minute], or ECMO. The need for continued RRT at Day 28 will be defined as either dialysis in the past 3 days (Day 26, 27, or 28) or an eGFR on Day 28 <10 mL/min/1.73 m2.

Outcome measures

Measure	Placebo n=31 Participants 100 mL drug-free IV saline infusion over 2 hours daily Placebo: 0.9% saline solution	LSALT n=30 Participants 100 mL of 5 mg IV LSALT peptide infusion over 2 hours daily LSALT peptide: LSALT, a peptide drug with the sequence NH3-LSALTPSPSWLKYKAL-COOH, binds to dipeptidase-1 (DPEP-1) but does not inhibit its biologic enzymatic activity. LSALT peptide inhibits leukocyte recruitment in multiple experimental disease models through the direct inhibition of leukocyte adhesion to DPEP-1 present in lungs, kidney, and liver.
To Evaluate the Proportion of Subjects Alive and Free of Respiratory Failure and Free of the Need for Continued Renal Replacement Therapy (RRT) on Day 28 (as Per Protocol AB002 - Version 1, Dated 09JUNE2020)	28 Participants	28 Participants

SECONDARY outcome

Timeframe: 28 days

Population: The all-cause mortality rate within 28 days from randomization was compared between the treatment groups using a CMH test.

Outcome measures

Measure	Placebo n=31 Participants 100 mL drug-free IV saline infusion over 2 hours daily Placebo: 0.9% saline solution	LSALT n=30 Participants 100 mL of 5 mg IV LSALT peptide infusion over 2 hours daily LSALT peptide: LSALT, a peptide drug with the sequence NH3-LSALTPSPSWLKYKAL-COOH, binds to dipeptidase-1 (DPEP-1) but does not inhibit its biologic enzymatic activity. LSALT peptide inhibits leukocyte recruitment in multiple experimental disease models through the direct inhibition of leukocyte adhesion to DPEP-1 present in lungs, kidney, and liver.
All-cause Mortality	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 28 days

Population: Number of patients with ARDS on Day 28 (EOS).

Outcome measures

Measure	Placebo n=31 Participants 100 mL drug-free IV saline infusion over 2 hours daily Placebo: 0.9% saline solution	LSALT n=30 Participants 100 mL of 5 mg IV LSALT peptide infusion over 2 hours daily LSALT peptide: LSALT, a peptide drug with the sequence NH3-LSALTPSPSWLKYKAL-COOH, binds to dipeptidase-1 (DPEP-1) but does not inhibit its biologic enzymatic activity. LSALT peptide inhibits leukocyte recruitment in multiple experimental disease models through the direct inhibition of leukocyte adhesion to DPEP-1 present in lungs, kidney, and liver.
The Presence of and Severity of ARDS as an Ordinal Outcome of the Proportion of Patients Who Have None, Mild, Moderate, or Severe ARDS Mild ARDS	1 Participants	1 Participants
The Presence of and Severity of ARDS as an Ordinal Outcome of the Proportion of Patients Who Have None, Mild, Moderate, or Severe ARDS Moderate ARDS	0 Participants	0 Participants
The Presence of and Severity of ARDS as an Ordinal Outcome of the Proportion of Patients Who Have None, Mild, Moderate, or Severe ARDS Severe ARDS	1 Participants	1 Participants
The Presence of and Severity of ARDS as an Ordinal Outcome of the Proportion of Patients Who Have None, Mild, Moderate, or Severe ARDS No ARDS	29 Participants	28 Participants

SECONDARY outcome

Timeframe: 28 days

Population: The proportion of patients that will develop ARDS at a given time point in the study.

Outcome measures

Measure	Placebo n=31 Participants 100 mL drug-free IV saline infusion over 2 hours daily Placebo: 0.9% saline solution	LSALT n=30 Participants 100 mL of 5 mg IV LSALT peptide infusion over 2 hours daily LSALT peptide: LSALT, a peptide drug with the sequence NH3-LSALTPSPSWLKYKAL-COOH, binds to dipeptidase-1 (DPEP-1) but does not inhibit its biologic enzymatic activity. LSALT peptide inhibits leukocyte recruitment in multiple experimental disease models through the direct inhibition of leukocyte adhesion to DPEP-1 present in lungs, kidney, and liver.
Time to Each of Mild, Moderate, or Severe ARDS Day 3	0.13 proportion of participants	0.1 proportion of participants
Time to Each of Mild, Moderate, or Severe ARDS Day 14	0.2 proportion of participants	0.13 proportion of participants
Time to Each of Mild, Moderate, or Severe ARDS Day 28	0.2 proportion of participants	0.13 proportion of participants

SECONDARY outcome

Timeframe: 28 days

Population: Comparison of ventilation-free days in placebo and LSALT treated patients.

Outcome measures

Measure	Placebo n=31 Participants 100 mL drug-free IV saline infusion over 2 hours daily Placebo: 0.9% saline solution	LSALT n=30 Participants 100 mL of 5 mg IV LSALT peptide infusion over 2 hours daily LSALT peptide: LSALT, a peptide drug with the sequence NH3-LSALTPSPSWLKYKAL-COOH, binds to dipeptidase-1 (DPEP-1) but does not inhibit its biologic enzymatic activity. LSALT peptide inhibits leukocyte recruitment in multiple experimental disease models through the direct inhibition of leukocyte adhesion to DPEP-1 present in lungs, kidney, and liver.
The Number of Ventilation-free Days	20.9 days Standard Deviation 9.94	22.8 days Standard Deviation 7.34

SECONDARY outcome

Timeframe: 28 days

Population: Only patients that were on nasal cannula or oxygen mask were analysed.

Outcome measures

Measure	Placebo n=20 Participants 100 mL drug-free IV saline infusion over 2 hours daily Placebo: 0.9% saline solution	LSALT n=17 Participants 100 mL of 5 mg IV LSALT peptide infusion over 2 hours daily LSALT peptide: LSALT, a peptide drug with the sequence NH3-LSALTPSPSWLKYKAL-COOH, binds to dipeptidase-1 (DPEP-1) but does not inhibit its biologic enzymatic activity. LSALT peptide inhibits leukocyte recruitment in multiple experimental disease models through the direct inhibition of leukocyte adhesion to DPEP-1 present in lungs, kidney, and liver.
Time on Nasal Cannula or Oxygen Mask	203.6 hours Interval 88.0 to 319.2	192.1 hours Interval 43.3 to 340.9

SECONDARY outcome

Timeframe: 28 days

Outcome measures

Measure	Placebo n=31 Participants 100 mL drug-free IV saline infusion over 2 hours daily Placebo: 0.9% saline solution	LSALT n=30 Participants 100 mL of 5 mg IV LSALT peptide infusion over 2 hours daily LSALT peptide: LSALT, a peptide drug with the sequence NH3-LSALTPSPSWLKYKAL-COOH, binds to dipeptidase-1 (DPEP-1) but does not inhibit its biologic enzymatic activity. LSALT peptide inhibits leukocyte recruitment in multiple experimental disease models through the direct inhibition of leukocyte adhesion to DPEP-1 present in lungs, kidney, and liver.
Length of Stay in ICU and Hospital (Admission to Discharge) Length of stay in hospital	9 days Interval 3.0 to 28.0	9.5 days Interval 4.0 to 28.0
Length of Stay in ICU and Hospital (Admission to Discharge) Length of stay in ICU	0 days Interval 0.0 to 0.0	0 days Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 28 days

Population: The virologic clearance rate (proportion of patients with a negative test result) at day 28 (EOS).

SARS-CoV2 testing by swab (nasopharyngeal, nasal, throat, sputum, or lower respiratory tract) at baseline (Day 1) and every 3 days thereafter until eradication

Outcome measures

Measure	Placebo n=31 Participants 100 mL drug-free IV saline infusion over 2 hours daily Placebo: 0.9% saline solution	LSALT n=30 Participants 100 mL of 5 mg IV LSALT peptide infusion over 2 hours daily LSALT peptide: LSALT, a peptide drug with the sequence NH3-LSALTPSPSWLKYKAL-COOH, binds to dipeptidase-1 (DPEP-1) but does not inhibit its biologic enzymatic activity. LSALT peptide inhibits leukocyte recruitment in multiple experimental disease models through the direct inhibition of leukocyte adhesion to DPEP-1 present in lungs, kidney, and liver.
Virologic Clearance Rate	21 Participants	17 Participants

SECONDARY outcome

Timeframe: 28 days

The worst change in PaO2/FiO2 ratio from baseline (Day 1) over the course of the study was analyzed in patients. A negative value indicates a decrease in PaO2/FiO2 ratio compared to baseline.

Outcome measures

Measure	Placebo n=31 Participants 100 mL drug-free IV saline infusion over 2 hours daily Placebo: 0.9% saline solution	LSALT n=30 Participants 100 mL of 5 mg IV LSALT peptide infusion over 2 hours daily LSALT peptide: LSALT, a peptide drug with the sequence NH3-LSALTPSPSWLKYKAL-COOH, binds to dipeptidase-1 (DPEP-1) but does not inhibit its biologic enzymatic activity. LSALT peptide inhibits leukocyte recruitment in multiple experimental disease models through the direct inhibition of leukocyte adhesion to DPEP-1 present in lungs, kidney, and liver.
Worst PaO2/FiO2 Ratio Following Enrollment	-175.9 mmHg Interval -447.62 to 411.9	-200.89 mmHg Interval -410.71 to 183.18

SECONDARY outcome

Timeframe: 28 days

Population: Change from baseline to day 28 (EOS) in PaO2/FiO2 ratio.

Outcome measures

Measure	Placebo n=31 Participants 100 mL drug-free IV saline infusion over 2 hours daily Placebo: 0.9% saline solution	LSALT n=30 Participants 100 mL of 5 mg IV LSALT peptide infusion over 2 hours daily LSALT peptide: LSALT, a peptide drug with the sequence NH3-LSALTPSPSWLKYKAL-COOH, binds to dipeptidase-1 (DPEP-1) but does not inhibit its biologic enzymatic activity. LSALT peptide inhibits leukocyte recruitment in multiple experimental disease models through the direct inhibition of leukocyte adhesion to DPEP-1 present in lungs, kidney, and liver.
Change in PaO2/FiO2 Ratio	-25.708 mmHg Standard Deviation 254.6656	-141.217 mmHg Standard Deviation 169.476

SECONDARY outcome

Timeframe: 28 days

Population: Change from baseline to day 28 (EOS) of modified Medical Research Council score.

Change in modified Medical Research Council score (0 to 4) with 4 being the most severe outcome. This scale is used to assess the degree of baseline functional disability due to dyspnea.

Outcome measures

Measure	Placebo n=28 Participants 100 mL drug-free IV saline infusion over 2 hours daily Placebo: 0.9% saline solution	LSALT n=27 Participants 100 mL of 5 mg IV LSALT peptide infusion over 2 hours daily LSALT peptide: LSALT, a peptide drug with the sequence NH3-LSALTPSPSWLKYKAL-COOH, binds to dipeptidase-1 (DPEP-1) but does not inhibit its biologic enzymatic activity. LSALT peptide inhibits leukocyte recruitment in multiple experimental disease models through the direct inhibition of leukocyte adhesion to DPEP-1 present in lungs, kidney, and liver.
Change in Baseline Modified Medical Research Council (mMRC) Score	-1 score on a scale Standard Deviation 1.12	-1.4 score on a scale Standard Deviation 1.01

SECONDARY outcome

Timeframe: 28 days

Population: Change from baseline to day 28 (EOS) in APACHE II score.

Change in APACHE II score (0 to 71) with 71 being the most severe outcome

Outcome measures

Measure	Placebo n=24 Participants 100 mL drug-free IV saline infusion over 2 hours daily Placebo: 0.9% saline solution	LSALT n=21 Participants 100 mL of 5 mg IV LSALT peptide infusion over 2 hours daily LSALT peptide: LSALT, a peptide drug with the sequence NH3-LSALTPSPSWLKYKAL-COOH, binds to dipeptidase-1 (DPEP-1) but does not inhibit its biologic enzymatic activity. LSALT peptide inhibits leukocyte recruitment in multiple experimental disease models through the direct inhibition of leukocyte adhesion to DPEP-1 present in lungs, kidney, and liver.
Change in Acute Physiologic Assessment and Chronic Health Evaluation (APACHE) II Score	-0.8 score on a scale Standard Deviation 4.39	-1.9 score on a scale Standard Deviation 3.87

SECONDARY outcome

Timeframe: 28 days

Population: A comparison of change from baseline in SOFA score. A negative value indicates a decrease in SOFA score compared to the baseline.

Change in SOFA score (0 to 4) with 4 being the most severe outcome

Outcome measures

Measure	Placebo n=24 Participants 100 mL drug-free IV saline infusion over 2 hours daily Placebo: 0.9% saline solution	LSALT n=21 Participants 100 mL of 5 mg IV LSALT peptide infusion over 2 hours daily LSALT peptide: LSALT, a peptide drug with the sequence NH3-LSALTPSPSWLKYKAL-COOH, binds to dipeptidase-1 (DPEP-1) but does not inhibit its biologic enzymatic activity. LSALT peptide inhibits leukocyte recruitment in multiple experimental disease models through the direct inhibition of leukocyte adhesion to DPEP-1 present in lungs, kidney, and liver.
Change in Daily Sequential Organ Failure Assessment (SOFA) Score From Baseline in Patients With Extrapulmonary Organ Dysfunction	-1.2 score on a scale Interval -4.0 to 3.0	-0.7 score on a scale Interval -4.0 to 3.0

SECONDARY outcome

Timeframe: 28 days

Population: Change from baseline liver function by ALT.

ALT measured in IU/L

Outcome measures

Measure	Placebo n=31 Participants 100 mL drug-free IV saline infusion over 2 hours daily Placebo: 0.9% saline solution	LSALT n=30 Participants 100 mL of 5 mg IV LSALT peptide infusion over 2 hours daily LSALT peptide: LSALT, a peptide drug with the sequence NH3-LSALTPSPSWLKYKAL-COOH, binds to dipeptidase-1 (DPEP-1) but does not inhibit its biologic enzymatic activity. LSALT peptide inhibits leukocyte recruitment in multiple experimental disease models through the direct inhibition of leukocyte adhesion to DPEP-1 present in lungs, kidney, and liver.
Change in Liver Function by Alanine Aminotransferase (ALT) Test	-1.4 IU/L Interval -14.3 to 11.4	-5.9 IU/L Interval -19.0 to 7.2

SECONDARY outcome

Timeframe: 28 days

Population: Change from baseline in liver function by AST.

AST measured in IU/L

Outcome measures

Measure	Placebo n=31 Participants 100 mL drug-free IV saline infusion over 2 hours daily Placebo: 0.9% saline solution	LSALT n=30 Participants 100 mL of 5 mg IV LSALT peptide infusion over 2 hours daily LSALT peptide: LSALT, a peptide drug with the sequence NH3-LSALTPSPSWLKYKAL-COOH, binds to dipeptidase-1 (DPEP-1) but does not inhibit its biologic enzymatic activity. LSALT peptide inhibits leukocyte recruitment in multiple experimental disease models through the direct inhibition of leukocyte adhesion to DPEP-1 present in lungs, kidney, and liver.
Change in Liver Function by Aspartate Transferase (AST) Test	-19.4 IU/L Interval -28.9 to -9.9	-15.4 IU/L Interval -25.3 to -5.5

SECONDARY outcome

Timeframe: 28 days

Population: Change from baseline in liver function by bilirubin.

Total bilirubin measured in umol/L

Outcome measures

Measure	Placebo n=31 Participants 100 mL drug-free IV saline infusion over 2 hours daily Placebo: 0.9% saline solution	LSALT n=30 Participants 100 mL of 5 mg IV LSALT peptide infusion over 2 hours daily LSALT peptide: LSALT, a peptide drug with the sequence NH3-LSALTPSPSWLKYKAL-COOH, binds to dipeptidase-1 (DPEP-1) but does not inhibit its biologic enzymatic activity. LSALT peptide inhibits leukocyte recruitment in multiple experimental disease models through the direct inhibition of leukocyte adhesion to DPEP-1 present in lungs, kidney, and liver.
Change in Liver Function by Total Bilirubin Test	2.8112 umol/L Standard Deviation 5.47094	-1.0602 umol/L Standard Deviation 5.52912

SECONDARY outcome

Timeframe: 28 days

Population: Change in serum creatinine from baseline at day 28 (EOS)

SCr measured in umol/L

Outcome measures

Measure	Placebo n=28 Participants 100 mL drug-free IV saline infusion over 2 hours daily Placebo: 0.9% saline solution	LSALT n=28 Participants 100 mL of 5 mg IV LSALT peptide infusion over 2 hours daily LSALT peptide: LSALT, a peptide drug with the sequence NH3-LSALTPSPSWLKYKAL-COOH, binds to dipeptidase-1 (DPEP-1) but does not inhibit its biologic enzymatic activity. LSALT peptide inhibits leukocyte recruitment in multiple experimental disease models through the direct inhibition of leukocyte adhesion to DPEP-1 present in lungs, kidney, and liver.
Change in Renal Function by Serum Creatinine (SCr) Test	-1.463 umol/L Standard Deviation 16.6250	-1.664 umol/L Standard Deviation 15.4972

SECONDARY outcome

Timeframe: 28 days

Population: Change from baseline to day 28 (EOS) in prothrombin time (PT).

ACT measured in seconds

Outcome measures

Measure	Placebo n=21 Participants 100 mL drug-free IV saline infusion over 2 hours daily Placebo: 0.9% saline solution	LSALT n=16 Participants 100 mL of 5 mg IV LSALT peptide infusion over 2 hours daily LSALT peptide: LSALT, a peptide drug with the sequence NH3-LSALTPSPSWLKYKAL-COOH, binds to dipeptidase-1 (DPEP-1) but does not inhibit its biologic enzymatic activity. LSALT peptide inhibits leukocyte recruitment in multiple experimental disease models through the direct inhibition of leukocyte adhesion to DPEP-1 present in lungs, kidney, and liver.
Change in Activated Coagulation Time (ACT)	0.0991 sec Standard Deviation 2.79345	-0.7688 sec Standard Deviation 0.82439

SECONDARY outcome

Timeframe: 28 days

Population: Change from baseline to day 28 (EOS) in aPTT.

aPTT measured in seconds

Outcome measures

Measure	Placebo n=25 Participants 100 mL drug-free IV saline infusion over 2 hours daily Placebo: 0.9% saline solution	LSALT n=24 Participants 100 mL of 5 mg IV LSALT peptide infusion over 2 hours daily LSALT peptide: LSALT, a peptide drug with the sequence NH3-LSALTPSPSWLKYKAL-COOH, binds to dipeptidase-1 (DPEP-1) but does not inhibit its biologic enzymatic activity. LSALT peptide inhibits leukocyte recruitment in multiple experimental disease models through the direct inhibition of leukocyte adhesion to DPEP-1 present in lungs, kidney, and liver.
Change in Activated Partial Thromboplastin Time (aPTT)	2.232 sec Standard Deviation 9.43189	1.4667 sec Standard Deviation 5.21783

SECONDARY outcome

Timeframe: 28 days

Population: Change from baseline to day 28 (EOS) in prothrombin INR.

Outcome measures

Measure	Placebo n=27 Participants 100 mL drug-free IV saline infusion over 2 hours daily Placebo: 0.9% saline solution	LSALT n=24 Participants 100 mL of 5 mg IV LSALT peptide infusion over 2 hours daily LSALT peptide: LSALT, a peptide drug with the sequence NH3-LSALTPSPSWLKYKAL-COOH, binds to dipeptidase-1 (DPEP-1) but does not inhibit its biologic enzymatic activity. LSALT peptide inhibits leukocyte recruitment in multiple experimental disease models through the direct inhibition of leukocyte adhesion to DPEP-1 present in lungs, kidney, and liver.
Change in Prothrombin International Normalized Ratio (INR)	0.0331 ratio Standard Deviation 0.29399	-0.0658 ratio Standard Deviation 0.08495

SECONDARY outcome

Timeframe: 28 days

Population: The data are not reported because testing for this specific measure was not run as the clinical sites did not have the ability/means to perform the assessment. Additionally, there are no plans to collect or analyze the data in the future.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days

Population: The data are not reported because testing for this specific measure was not run as the clinical sites did not have the ability/means to perform the assessment. Additionally, there are no plans to collect or analyze the data in the future.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days

Population: The data are not reported because testing for this specific measure was not run as the clinical sites did not have the ability/means to perform the assessment. Additionally, there are no plans to collect or analyze the data in the future.

eGFR measured in ml/min/1.73m2

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days

Population: The data are not reported because testing for this specific measure was not run as the clinical sites did not have the ability/means to perform the assessment. Additionally, there are no plans to collect or analyze the data in the future.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days

Population: The data are not reported because testing for this specific measure was not run as the clinical sites did not have the ability/means to perform the assessment. Additionally, there are no plans to collect or analyze the data in the future.

Immunoglobulins measured in mg/dL

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 28 days

Population: Healthcare costs were not analyzed in this study.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 28 days

Population: Fold change in serum cytokine levels from baseline to day 28 (EOT).

Fold change from baseline cytokines measured in ng/mL

Outcome measures

Measure	Placebo n=25 Participants 100 mL drug-free IV saline infusion over 2 hours daily Placebo: 0.9% saline solution	LSALT n=25 Participants 100 mL of 5 mg IV LSALT peptide infusion over 2 hours daily LSALT peptide: LSALT, a peptide drug with the sequence NH3-LSALTPSPSWLKYKAL-COOH, binds to dipeptidase-1 (DPEP-1) but does not inhibit its biologic enzymatic activity. LSALT peptide inhibits leukocyte recruitment in multiple experimental disease models through the direct inhibition of leukocyte adhesion to DPEP-1 present in lungs, kidney, and liver.
Exploratory Endpoint: Change in Serum Cytokines Including IL-1a, IL-1b, and Ferritin Levels as Well as Other Exploratory Biomarkers Drawn at the Same Time as LSALT Peptide Concentrations CCL7	0.67 foldchange Interval 0.3 to 1.01	0.62 foldchange Interval 0.25 to 0.97
Exploratory Endpoint: Change in Serum Cytokines Including IL-1a, IL-1b, and Ferritin Levels as Well as Other Exploratory Biomarkers Drawn at the Same Time as LSALT Peptide Concentrations CXCL8	0.96 foldchange Interval 0.55 to 1.06	0.73 foldchange Interval 0.55 to 1.14
Exploratory Endpoint: Change in Serum Cytokines Including IL-1a, IL-1b, and Ferritin Levels as Well as Other Exploratory Biomarkers Drawn at the Same Time as LSALT Peptide Concentrations CXCL10	0.52 foldchange Interval 0.16 to 0.79	0.16 foldchange Interval 0.05 to 0.35
Exploratory Endpoint: Change in Serum Cytokines Including IL-1a, IL-1b, and Ferritin Levels as Well as Other Exploratory Biomarkers Drawn at the Same Time as LSALT Peptide Concentrations Ferritin	0.99 foldchange Interval 0.48 to 1.5	0.64 foldchange Interval 0.39 to 1.24
Exploratory Endpoint: Change in Serum Cytokines Including IL-1a, IL-1b, and Ferritin Levels as Well as Other Exploratory Biomarkers Drawn at the Same Time as LSALT Peptide Concentrations IL-1b	1 foldchange Interval 0.96 to 1.86	1 foldchange Interval 0.65 to 1.56
Exploratory Endpoint: Change in Serum Cytokines Including IL-1a, IL-1b, and Ferritin Levels as Well as Other Exploratory Biomarkers Drawn at the Same Time as LSALT Peptide Concentrations IL-1Ra	1.04 foldchange Interval 0.62 to 1.3	1.07 foldchange Interval 0.59 to 1.51
Exploratory Endpoint: Change in Serum Cytokines Including IL-1a, IL-1b, and Ferritin Levels as Well as Other Exploratory Biomarkers Drawn at the Same Time as LSALT Peptide Concentrations IL-5	1.06 foldchange Interval 0.86 to 1.38	1.09 foldchange Interval 1.0 to 1.76
Exploratory Endpoint: Change in Serum Cytokines Including IL-1a, IL-1b, and Ferritin Levels as Well as Other Exploratory Biomarkers Drawn at the Same Time as LSALT Peptide Concentrations IL-6	0.97 foldchange Interval 0.45 to 1.73	0.65 foldchange Interval 0.19 to 1.31

OTHER_PRE_SPECIFIED outcome

Timeframe: 28 days

Population: Change in baseline antiviral immunoglobulins were not analyzed in this study.

Immunoglobulins measured in mg/dL

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 8 serious events

Other events: 22 other events

Deaths: 0 deaths

LSALT

Serious events: 10 serious events

Other events: 14 other events

Deaths: 1 deaths

Serious adverse events

Measure	Placebo n=31 participants at risk 100 mL drug-free IV saline infusion over 2 hours daily Placebo: 0.9% saline solution	LSALT n=30 participants at risk 100 mL of 5 mg IV LSALT peptide infusion over 2 hours daily LSALT peptide: LSALT, a peptide drug with the sequence NH3-LSALTPSPSWLKYKAL-COOH, binds to dipeptidase-1 (DPEP-1) but does not inhibit its biologic enzymatic activity. LSALT peptide inhibits leukocyte recruitment in multiple experimental disease models through the direct inhibition of leukocyte adhesion to DPEP-1 present in lungs, kidney, and liver.
Metabolism and nutrition disorders Hyperglycaemia	3.2% 1/31 • 28 days	3.3% 1/30 • 28 days
Metabolism and nutrition disorders Hypocalcaemia	3.2% 1/31 • 28 days	0.00% 0/30 • 28 days
Metabolism and nutrition disorders Hypoglycaemia	3.2% 1/31 • 28 days	0.00% 0/30 • 28 days
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	3.2% 1/31 • 28 days	6.7% 2/30 • 28 days
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	3.2% 1/31 • 28 days	0.00% 0/30 • 28 days
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.2% 1/31 • 28 days	0.00% 0/30 • 28 days
Respiratory, thoracic and mediastinal disorders Respiratory failure	3.2% 1/31 • 28 days	0.00% 0/30 • 28 days
Cardiac disorders Sinus arrest	3.2% 1/31 • 28 days	0.00% 0/30 • 28 days
Cardiac disorders Sinus bradycardia	3.2% 1/31 • 28 days	0.00% 0/30 • 28 days
Infections and infestations Bacterial sepsis	6.5% 2/31 • 28 days	0.00% 0/30 • 28 days
Vascular disorders Embolism	3.2% 1/31 • 28 days	0.00% 0/30 • 28 days
Vascular disorders Hypotension	3.2% 1/31 • 28 days	3.3% 1/30 • 28 days
Immune system disorders Cytokine release syndrome	3.2% 1/31 • 28 days	0.00% 0/30 • 28 days
Investigations Blood glucose increase	3.2% 1/31 • 28 days	0.00% 0/30 • 28 days
Psychiatric disorders Delirium	3.2% 1/31 • 28 days	0.00% 0/30 • 28 days
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/31 • 28 days	3.3% 1/30 • 28 days
Metabolism and nutrition disorders Alkalosis	0.00% 0/31 • 28 days	0.00% 0/30 • 28 days
Vascular disorders Hypertension	0.00% 0/31 • 28 days	3.3% 1/30 • 28 days
Cardiac disorders Atrial tachycardia	0.00% 0/31 • 28 days	3.3% 1/30 • 28 days
General disorders Multiple organ dysfunction syndrome	0.00% 0/31 • 28 days	3.3% 1/30 • 28 days
Infections and infestations Septic shock	0.00% 0/31 • 28 days	3.3% 1/30 • 28 days
Infections and infestations Superinfection	0.00% 0/31 • 28 days	3.3% 1/30 • 28 days
Investigations Alanine aminotransferase increase	0.00% 0/31 • 28 days	3.3% 1/30 • 28 days
Investigations Aspartate aminotransferase increase	0.00% 0/31 • 28 days	3.3% 1/30 • 28 days
Nervous system disorders Cerebrovascular accident	0.00% 0/31 • 28 days	3.3% 1/30 • 28 days
Renal and urinary disorders Acute kidney injury	0.00% 0/31 • 28 days	3.3% 1/30 • 28 days

Other adverse events

Measure	Placebo n=31 participants at risk 100 mL drug-free IV saline infusion over 2 hours daily Placebo: 0.9% saline solution	LSALT n=30 participants at risk 100 mL of 5 mg IV LSALT peptide infusion over 2 hours daily LSALT peptide: LSALT, a peptide drug with the sequence NH3-LSALTPSPSWLKYKAL-COOH, binds to dipeptidase-1 (DPEP-1) but does not inhibit its biologic enzymatic activity. LSALT peptide inhibits leukocyte recruitment in multiple experimental disease models through the direct inhibition of leukocyte adhesion to DPEP-1 present in lungs, kidney, and liver.
Investigations Alanine aminotransferase increase	29.0% 9/31 • 28 days	16.7% 5/30 • 28 days
Investigations Aspartate aminotransferase increase	9.7% 3/31 • 28 days	6.7% 2/30 • 28 days
Investigations Gamma-glutamyltransferase increase	6.5% 2/31 • 28 days	0.00% 0/30 • 28 days
Gastrointestinal disorders Constipation	9.7% 3/31 • 28 days	6.7% 2/30 • 28 days
Gastrointestinal disorders Toothache	6.5% 2/31 • 28 days	0.00% 0/30 • 28 days
Respiratory, thoracic and mediastinal disorders Tachypnoea	6.5% 2/31 • 28 days	0.00% 0/30 • 28 days
Cardiac disorders Bradycardia	6.5% 2/31 • 28 days	0.00% 0/30 • 28 days
General disorders Pyrexia	6.5% 2/31 • 28 days	0.00% 0/30 • 28 days
Metabolism and nutrition disorders Hyperglycaemia	6.5% 2/31 • 28 days	3.3% 1/30 • 28 days
Psychiatric disorders Anxiety	6.5% 2/31 • 28 days	0.00% 0/30 • 28 days
Psychiatric disorders Confusional state	6.5% 2/31 • 28 days	0.00% 0/30 • 28 days
Vascular disorders Hypertension	9.7% 3/31 • 28 days	0.00% 0/30 • 28 days
Gastrointestinal disorders Dyspepsia	0.00% 0/31 • 28 days	6.7% 2/30 • 28 days
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/31 • 28 days	6.7% 2/30 • 28 days

Additional Information

Richard Muruve

Arch Biopartners Inc.

Phone: 647-428-7031

Email: rm@archbiopartners.com

Results disclosure agreements

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