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

NCT04402957 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: AB002
• Study Type: interventional
• Target: 61
• Locations: 3 countries
• Sites: 7

Brief Summary

To evaluate the proportion of subjects alive and free of respiratory failure (e.g. need for non-invasive or invasive mechanical ventilation, high flow oxygen, or ECMO) and free of the need for continued renal replacement therapy (RRT) on Day 28. 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.

Conditions

COVID; Severe Acute Respiratory Syndrome; Sars-CoV2; Acute Kidney Injury; Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• 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)

  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.

  28 days

Secondary Outcomes (24)

• All-cause Mortality

  28 days

• The Presence of and Severity of ARDS as an Ordinal Outcome of the Proportion of Patients Who Have None, Mild, Moderate, or Severe ARDS

  28 days

• Time to Each of Mild, Moderate, or Severe ARDS

  28 days

• The Number of Ventilation-free Days

  28 days

• Time on Nasal Cannula or Oxygen Mask

  28 days

Other Outcomes (3)

• Health Outcomes Endpoint: Total Healthcare Costs From Admission to Discharge Between Treatment Groups

  28 days

• 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

  28 days

• Exploratory Endpoint: Change in Baseline Antiviral Immunoglobulins (IgG, IgM, IgA) at EOS

  28 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

100 mL drug-free IV saline infusion over 2 hours daily

Drug: Placebo

LSALT

EXPERIMENTAL

100 mL of 5 mg IV LSALT peptide infusion over 2 hours daily

Drug: LSALT peptide

Interventions

LSALT peptide DRUG

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.

Also known as: Metablok

LSALT

Placebo DRUG

0.9% saline solution

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female hospitalized patients between 18 and 80 years of age at time of consent.
• Clinical and laboratory diagnosis of COVID-19 infection. Patients must be positive for the SARS-CoV-2 by Real-Time Reverse Transcriptase (RT)-PCR
• Diagnostic Panel or have an existing complication secondary to SARS-CoV-2 infection which was positive within 2 weeks of entry into the study. Further, patients must have at least two of the following three symptoms:
• Fever (oral temperature ≥ 100.4 °F \[\> 38 °C\]) with or without chills
• Dyspnea or difficulty breathing (≤ 2 on mMRC dyspnea scale)
• Nonproductive cough

You may not qualify if:

• Patients must present with moderate to severe illness as defined below:
• Moderate illness: Patients who have evidence of lower respiratory disease by clinical assessment or imaging and an oxygen saturation (SpO2) \> 93% on room air at sea level
• Severe illness: Patients who have a respiratory frequency \> 30 breaths per minute (bpm), SpO2 ≤ 93% on room air at sea level, ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) \< 300, or lung infiltrates \> 50%.
• APACHE II score \< 20 or establishment of survivability of the patient beyond 48 hours following randomization
• Therapies which have been shown to be beneficial and are included in standard COVID-19 treatment guidelines (e.g. those of WHO or NIH, or institutional guidelines) are permitted
• Sexually active women of child-bearing potential (WCBP) must be using a medically acceptable method of birth control throughout the study and for at least 1 day following the end of study, and have a negative urine pregnancy test at the Screening visit. A WCBP is defined as a female who is biologically capable of becoming pregnant. A medically acceptable method of birth control includes intrauterine devices in place for at least 3 months, surgical sterilization, or the implant. In patients who are not sexually active, abstinence is an acceptable form of birth control and urine will be tested per protocol. Women who are of nonchild-bearing potential, i.e., post-menopause, must have this condition captured in their medical history. Pregnant women and nursing mothers are excluded from this study.
• Patient or LAR is available and willing to give written informed consent, after being properly informed of the nature and risks of the study and prior to engaging in any study-related procedures.
• Known sensitivity, allergy, or previous exposure to LSALT peptide.
• Exposure to any investigational drug or device \<90 days prior to entry into study.
• Treatment with immunomodulators or immunosuppressant drugs, including but not limited to IL-6 inhibitors, TNF inhibitors, anti-IL-1 immunomodulators, and JAK inhibitors within five half-lives or 30 days (whichever is longer) prior to randomization and throughout the study period. However, should any of these treatments become standard-of-care and incorporated into clinical treatment guidelines (e.g. those of WHO or NIH), the treatment is permitted. Further, low-dose oral prednisone (\<20 mg/day) and inhaled steroids (e.g. treatment of asthma) are allowed in the study.
• Anticipated transfer to another hospital or medical center within 72 hours, which is not a study site.
• Uncontrolled of poorly treated active hepatitis B (HBV), hepatitis C (HepC), or HIV infection. Those subjects who are positive for HBV, HepC, or HIV but are well-controlled with low viral loads are allowed to participate in this study:
• HBV low viral load defined as \<20,000 IU/mL
• HepC low viral load defined as \<800,000 IU/mL
• HIV low viral load defined as \<5000 copies/mL

Sponsors & Collaborators

• Arch Biopartners Inc.: lead

Study Sites (7)

VA San Diego Healthcare System

San Diego, California, 92161, United States

Location

Broward Health Medical Center

Fort Lauderdale, Florida, 33316, United States

Location

LSU Health Shreveport

Shreveport, Louisiana, 71103, United States

Location

University of Calgary - Foothills Medical Centre

Calgary, Alberta, Canada

Location

University of Calgary - Peter Lougheed Centre

Calgary, Alberta, Canada

Location

Ankara City Hospital

Ankara, Turkey (Türkiye)

Location

Istanbul University Cerrahpasa

Istanbul, 34098, Turkey (Türkiye)

Location

Related Publications (1)

• Somayaji R, Luke DR, Lau A, Guner R, Tabak OF, Hepokoski M, Gardetto N, Conrad SA, Kumar SD, Ghosh K, Robbins SM, Senger DL, Sun D, Lim RKS, Liu J, Eser F, Karaali R, Tremblay A, Muruve D. Multicentre, randomised, double-blind, placebo-controlled, proof of concept study of LSALT peptide as prevention of acute respiratory distress syndrome and acute kidney injury in patients infected with SARS-CoV-2 (COVID-19). BMJ Open. 2024 Mar 15;14(3):e076142. doi: 10.1136/bmjopen-2023-076142.

  PMID: 38490660 DERIVED

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; Acute Kidney Injury; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lung Diseases; Respiration Disorders

Results Point of Contact

• Title: Richard Muruve
• Organization: Arch Biopartners Inc.

rm@archbiopartners.com

647-428-7031

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 27, 2020
• Study Start: October 14, 2020
• Primary Completion: May 27, 2021
• Study Completion: June 2, 2022
• Last Updated: July 9, 2025
• Results First Posted: July 9, 2025

Record last verified: 2025-07

Locations

US (3); CA (2); TU (2)