LSALT Peptide vs. Placebo to Prevent ARDS and Acute Kidney Injury in Patients Infected With SARS-CoV-2 (COVID-19)
Completed · Phase 2 · Has a placebo group
Conditions studied: COVID, Severe Acute Respiratory Syndrome, Sars-CoV2, Acute Kidney Injury, Acute Respiratory Distress Syndrome
In brief
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.
Key facts
- Study ID
- NCT04402957
- Run by
- Arch Biopartners Inc.
- People needed
- 61
- Starts
- 2020-10-14
- Expected to finish
- 2022-06-02
- Last updated by the study team
- 2025-07-09
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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
- 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.
Where it is running
- VA San Diego Healthcare System — San Diego, California, United States
- Broward Health Medical Center — Fort Lauderdale, Florida, United States
- LSU Health Shreveport — Shreveport, Louisiana, United States
- University of Calgary - Foothills Medical Centre — Calgary, Alberta, Canada
- University of Calgary - Peter Lougheed Centre — Calgary, Alberta, Canada
- Ankara City Hospital — Ankara, Turkey (Türkiye)
- Istanbul University Cerrahpasa — Istanbul, Turkey (Türkiye)
Full record on ClinicalTrials.gov
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