COVIDPhase 2NCT04402957
LSALT Peptide vs. Placebo to Prevent ARDS and Acute Kidney Injury in Patients Infected With SARS-CoV-2 (COVID-19)
A Phase 2 study testing LSALT peptide in people with COVID and Severe Acute Respiratory Syndrome, run by Arch Biopartners Inc. at 7 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID, Severe Acute Respiratory Syndrome, Sars-CoV2
- What is being tested?
- LSALT peptide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 14 Oct 2020to 2 Jun 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Or other signs and symptoms of established complications to SARS-CoV-2 infection (e.g. coagulopathy, cardiomyopathy, acute kidney injury, and/or acute liver injury) within the limits of Exclusion Criteria 8
- 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.
Who cannot join
- 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
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- HepC low viral load defined as <800,000 IU/mL
- HIV low viral load defined as <5000 copies/mL
- Participation in another drug or device study at any time during this study, for example:
- Ulinastatin 200,000 IU or greater
- High dose intravenous Vitamin C
- Budesonide and formoterol
- Bevacizumab to prevent ARDS
- Dornase alfa to reduce hypoxemia in ventilated trauma patients.
- As indicated in the inclusion criteria, pregnant female patients are excluded from study. Further, female patients who are nursing are excluded from study.
- Has any medical condition considered to be clinically significant and could potentially affect patient safety or study outcome, including but not limited to:
- Acute or chronic kidney disease (stage-4 or -5 renal impairment; eGFR<30 mL/min/1.73 m2 or hemodialysis)
- End-stage malignancy undergoing treatment
- Immunocompromised patients or those with medical/surgical conditions (e.g., solid organ transplantation) which require chronic immunosuppression
- Chronic hematologic disease which, in the opinion of the PI, prohibits the patient from entering into study
- Acute liver injury with AST and/or ALT levels greater than 3x ULN unless recent injury (within 2 weeks) likely due to COVID-19 infection
- History of coagulopathy within the last year as defined by abnormal ACT, aPTT, and/or PT/INR values at least 2-fold outside normal limits, and currently present at screening, and/or
- End-stage lung disease, acute lung injury, severe chronic obstructive pulmonary disease (COPD) as assessed by the GOLD criteria (GOLD Stage IV), or mechanical ventilation.
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
United States3 sites
Broward Health Medical Center
Fort Lauderdale, Florida, 33316
VA San Diego Healthcare System
San Diego, California, 92161
LSU Health Shreveport
Shreveport, Louisiana, 71103
Canada2 sites
University of Calgary - Foothills Medical Centre
Calgary, Alberta
University of Calgary - Peter Lougheed Centre
Calgary, Alberta
Turkey (Türkiye)2 sites
Ankara City Hospital
Ankara
Istanbul University Cerrahpasa
Istanbul, 34098
About this study
Official title: Multicenter, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study of LSALT Peptide as Prevention of Acute Respiratory Distress Syndrome (ARDS) and Acute Kidney Injury in Patients Infected With SARS-CoV-2 (COVID-19)
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.
Read the detailed description
This study is a parallel group, randomized, third-party blinded, multicenter study to assess safety and efficacy of LSALT peptide versus placebo in hospitalized patients with confirmed infection or recent confirmed infection with complications associated with COVID-19. Following screening and after establishing baseline parameters such as lung and renal function, clinical chemistries, coagulation, hematology, and urinalysis, and satisfying all inclusion and exclusion criteria, patients will be randomized to one of two blinded treatment regimens:
- 100 mL of 5 mg IV LSALT peptide infusion over 2 hours daily
- 100 mL drug-free IV saline infusion over 2 hours daily.
Thirty (30) patients will be randomized to active drug (LSALT peptide) and 30 patients will be randomized to matching placebo. This study will be third-party blind with only the Pharmacist at the site unblinded for the purpose of preparing drug/placebo for injection.
Patients will be followed for safety and efficacy up to Day 28, with Day 1 being the day of randomization to assess safety. After assessing the risk of ARDS and satisfying all inclusion and exclusion criteria, the patient will be randomized to 5 mg LSALT peptide or blinded placebo to be given intravenously once daily for a maximum of 14 days. Physical and respiratory examinations, vital signs, and adverse events will be recorded throughout the study, including Day 28 (EOS). Blood chemistries, hematology, coagulation, urinalysis, ECG, SARS-CoV-2 tests, eGFR, and chest x-ray (CXR) will be assessed at Day 1 (Screening/Baseline) prior to initiation of study drug, and on Day 3, EOT, and at EOS, as well as when clinically indicated. The ECG at EOS will only be obtained if clinically indicated. An additional CXR will be obtained at time of clinical improvement. Cytokines/biomarkers and pharmacokinetics (PK) will be assessed at Day 1 (Screening/Baseline) prior to initiation of study drug, at 1 (mid-dose) and 2 hours (end of infusion) of drug therapy on Days 1, 3, EOT, and a single blood sample at EOS for cytokines/biomarkers only. Where applicable, a urinary pregnancy test will be obtained at Screening in women of childbearing potential. Questionnaires (APACHE II, SOFA) will be obtained at Baseline, Day 3, EOT, and EOS; venous blood gas (VBG) or HCO3 (bicarbonate) levels may be substituted for arterial blood gas (ABG) if it is considered standard-of-care (SOC) or in the patient's best interest, and results in comparable APACHE II and SOFA scores. Other questionnaires (Berlin Definition and modified Medical Research Council Dyspnea Scale) will be assessed at Baseline, Day 3, EOT, and EOS. IgG, IgA, and IgM antiviral antibodies will be collected at Baseline and EOS. Patients will be maintained on the SOC per institutional guidelines, including prophylaxis or treatment of VTE, throughout the study.
A Data and Safety Monitoring Board (DSMB) will evaluate patients on a continuing basis for primarily safety assessments. Per the DSMB Charter, the DSMB will meet at least monthly if not more frequently based upon enrollment throughout the study period.
- Conditions
- COVID, Severe Acute Respiratory Syndrome, Sars-CoV2, Acute Kidney Injury, Acute Respiratory Distress Syndrome
- Being tested
- LSALT peptide, Placebo
- Medical subject headings
- Severe Acute Respiratory Syndrome, Acute Kidney Injury, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LSALT peptideDrug
Also called Metablok
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.
PlaceboDrug
0.9% saline solution
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 100 mL drug-free IV saline infusion over 2 hours daily Receives: Drug: Placebo |
| LSALT | Experimental | 100 mL of 5 mg IV LSALT peptide infusion over 2 hours daily Receives: Drug: LSALT peptide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (24)
All-cause Mortality
Measured: 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
Measured: 28 days
Time to Each of Mild, Moderate, or Severe ARDS
Measured: 28 days
The Number of Ventilation-free Days
Measured: 28 days
Time on Nasal Cannula or Oxygen Mask
Measured: 28 days
Length of Stay in ICU and Hospital (Admission to Discharge)
Measured: 28 days
Virologic Clearance Rate
SARS-CoV2 testing by swab (nasopharyngeal, nasal, throat, sputum, or lower respiratory tract) at baseline (Day 1) and every 3 days thereafter until eradication
Measured: 28 days
Worst PaO2/FiO2 Ratio Following Enrollment
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.
Measured: 28 days
Change in PaO2/FiO2 Ratio
Measured: 28 days
Change in Baseline Modified Medical Research Council (mMRC) 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.
Measured: 28 days
Change in Acute Physiologic Assessment and Chronic Health Evaluation (APACHE) II Score
Change in APACHE II score (0 to 71) with 71 being the most severe outcome
Measured: 28 days
Change in Daily Sequential Organ Failure Assessment (SOFA) Score From Baseline in Patients With Extrapulmonary Organ Dysfunction
Change in SOFA score (0 to 4) with 4 being the most severe outcome
Measured: 28 days
Change in Liver Function by Alanine Aminotransferase (ALT) Test
ALT measured in IU/L
Measured: 28 days
Change in Liver Function by Aspartate Transferase (AST) Test
AST measured in IU/L
Measured: 28 days
Change in Liver Function by Total Bilirubin Test
Total bilirubin measured in umol/L
Measured: 28 days
Change in Renal Function by Serum Creatinine (SCr) Test
SCr measured in umol/L
Measured: 28 days
Change in Activated Coagulation Time (ACT)
ACT measured in seconds
Measured: 28 days
Change in Activated Partial Thromboplastin Time (aPTT)
aPTT measured in seconds
Measured: 28 days
Change in Prothrombin International Normalized Ratio (INR)
Measured: 28 days
Vasopressor-free Days
Measured: 28 days
Change From Maximal Radiographic Damage to EOT
Measured: 28 days
Change in Renal Function by Estimated Glomerular Filtration Rate (eGFR) Test
eGFR measured in ml/min/1.73m2
Measured: 28 days
Change in Hs-troponin Levels
Measured: 28 days
Change in Antiviral IgG, IgA, and IgM Levels
Immunoglobulins measured in mg/dL
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start14 Oct 2020
- Primary completion27 May 2021
- Study completion2 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arch Biopartners Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402957
- Sponsor's protocol ID
- AB002
- Status last verified
- Jul 2025
- First submitted
- 12 May 2020
- Last updated
- 9 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38490660
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study of LSALT Peptide as Prevention of Acute Respiratory Distress Syndrome (ARDS) and Acute Kidney Injury in Patients Infected With SARS-CoV-2 (COVID-19)
- ClinicalTrials.gov ID
- NCT04402957
- Acronym / sponsor ID
- AB002
- Conditions
- COVID, Severe Acute Respiratory Syndrome, Sars-CoV2, Acute Kidney Injury, Acute Respiratory Distress Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Arch Biopartners Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 27 May 2021 (actual)
- Study completion
- 2 Jun 2022 (actual)
- First posted
- 27 May 2020 (actual)
- Results
- Posted 9 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a parallel group, randomized, third-party blinded, multicenter study to assess safety and efficacy of LSALT peptide versus placebo in hospitalized patients with confirmed infection or recent confirmed infection with complications associated with COVID-19. Following screening and after establishing baseline parameters such as lung and renal function, clinical chemistries, coagulation, hematology, and urinalysis, and satisfying all inclusion and exclusion criteria, patients will be randomized to one of two blinded treatment regimens:
- 100 mL of 5 mg IV LSALT peptide infusion over 2 hours daily
- 100 mL drug-free IV saline infusion over 2 hours daily.
Thirty (30) patients will be randomized to active drug (LSALT peptide) and 30 patients will be randomized to matching placebo. This study will be third-party blind with only the Pharmacist at the site unblinded for the purpose of preparing drug/placebo for injection.
Patients will be followed for safety and efficacy up to Day 28, with Day 1 being the day of randomization to assess safety. After assessing the risk of ARDS and satisfying all inclusion and exclusion criteria, the patient will be randomized to 5 mg LSALT peptide or blinded placebo to be given intravenously once daily for a maximum of 14 days. Physical and respiratory examinations, vital signs, and adverse events will be recorded throughout the study, including Day 28 (EOS). Blood chemistries, hematology, coagulation, urinalysis, ECG, SARS-CoV-2 tests, eGFR, and chest x-ray (CXR) will be assessed at Day 1 (Screening/Baseline) prior to initiation of study drug, and on Day 3, EOT, and at EOS, as well as when clinically indicated. The ECG at EOS will only be obtained if clinically indicated. An additional CXR will be obtained at time of clinical improvement. Cytokines/biomarkers and pharmacokinetics (PK) will be assessed at Day 1 (Screening/Baseline) prior to initiation of study drug, at 1 (mid-dose) and 2 hours (end of infusion) of drug therapy on Days 1, 3, EOT, and a single blood sample at EOS for cytokines/biomarkers only. Where applicable, a urinary pregnancy test will be obtained at Screening in women of childbearing potential. Questionnaires (APACHE II, SOFA) will be obtained at Baseline, Day 3, EOT, and EOS; venous blood gas (VBG) or HCO3 (bicarbonate) levels may be substituted for arterial blood gas (ABG) if it is considered standard-of-care (SOC) or in the patient's best interest, and results in comparable APACHE II and SOFA scores. Other questionnaires (Berlin Definition and modified Medical Research Council Dyspnea Scale) will be assessed at Baseline, Day 3, EOT, and EOS. IgG, IgA, and IgM antiviral antibodies will be collected at Baseline and EOS. Patients will be maintained on the SOC per institutional guidelines, including prophylaxis or treatment of VTE, throughout the study.
A Data and Safety Monitoring Board (DSMB) will evaluate patients on a continuing basis for primarily safety assessments. Per the DSMB Charter, the DSMB will meet at least monthly if not more frequently based upon enrollment throughout the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo100 mL drug-free IV saline infusion over 2 hours daily |
| LSALT | Experimental | Drug: LSALT peptide100 mL of 5 mg IV LSALT peptide infusion over 2 hours daily |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
- Patients must present with moderate to severe illness as defined below:
- APACHE II score < 20 or establishment of survivability of the patient beyond 48 hours following randomization
Key exclusion criteria (23 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LSALT peptideAlso: MetablokLSALT, 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. | Drug | LSALT |
| Placebo0.9% saline solution | Drug | Placebo |
Primary outcome
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)
Time frame: 28 days
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.
24 secondary outcomes
All-cause Mortality
Time frame: 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
Time frame: 28 days
Time to Each of Mild, Moderate, or Severe ARDS
Time frame: 28 days
The Number of Ventilation-free Days
Time frame: 28 days
Time on Nasal Cannula or Oxygen Mask
Time frame: 28 days
Length of Stay in ICU and Hospital (Admission to Discharge)
Time frame: 28 days
Virologic Clearance Rate
Time frame: 28 days
Worst PaO2/FiO2 Ratio Following Enrollment
Time frame: 28 days
Change in PaO2/FiO2 Ratio
Time frame: 28 days
Change in Baseline Modified Medical Research Council (mMRC) Score
Time frame: 28 days
Change in Acute Physiologic Assessment and Chronic Health Evaluation (APACHE) II Score
Time frame: 28 days
Change in Daily Sequential Organ Failure Assessment (SOFA) Score From Baseline in Patients With Extrapulmonary Organ Dysfunction
Time frame: 28 days
Change in Liver Function by Alanine Aminotransferase (ALT) Test
Time frame: 28 days
Change in Liver Function by Aspartate Transferase (AST) Test
Time frame: 28 days
Change in Liver Function by Total Bilirubin Test
Time frame: 28 days
Change in Renal Function by Serum Creatinine (SCr) Test
Time frame: 28 days
Change in Activated Coagulation Time (ACT)
Time frame: 28 days
Change in Activated Partial Thromboplastin Time (aPTT)
Time frame: 28 days
Change in Prothrombin International Normalized Ratio (INR)
Time frame: 28 days
Vasopressor-free Days
Time frame: 28 days
Change From Maximal Radiographic Damage to EOT
Time frame: 28 days
Change in Renal Function by Estimated Glomerular Filtration Rate (eGFR) Test
Time frame: 28 days
Change in Hs-troponin Levels
Time frame: 28 days
Change in Antiviral IgG, IgA, and IgM Levels
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38490660Somayaji 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LSALT peptide in people with COVID and Severe Acute Respiratory Syndrome, run by Arch Biopartners Inc. at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada, Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04402957, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.