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

• Status: Active, not recruiting
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arch Biopartners Inc.

Criteria

Inclusion Criteria:

1. Male and female hospitalized patients between 45 and 80 years of age at time of consent.

2. 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 as well as 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

3. 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%.

4. APACHE II score < 20

5. Therapies which have been shown to be beneficial and are included in standard COVID-19 treatment guidelines (e.g. those of WHO or NIH) are permitted

6. 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.

7. 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.

Exclusion Criteria:

1. Known sensitivity, allergy, or previous exposure to LSALT peptide.

2. Exposure to any investigational drug or device <90 days prior to entry into study.

3. 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.

4. Anticipated transfer to another hospital or medical center within 72 hours, which is not a study site.

5. 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

6. 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.

7. As indicated in the inclusion criteria, pregnant female patients are excluded from study. Further, female patients who are nursing are excluded from study.

8. 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

• 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/or

• End-stage lung disease, acute lung injury, severe chronic obstructive pulmonary disease (COPD), or mechanical ventilation.