Acute Kidney Injury, Acute Respiratory Distress Syndrome, COVID, Sars-CoV2, Severe Acute Respiratory Syndrome
Conditions
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.
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: 1. 100 mL of 5 mg IV LSALT peptide infusion over 2 hours daily 2. 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.
Interventions
DRUGLSALT 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.
DRUGPlacebo
0.9% saline solution
Sponsors
Arch Biopartners Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
(Amendment 3, 15FEB2021): 1. Male and female hospitalized patients between 18 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 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 * 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 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 or establishment of survivability of the patient beyond 48 hours following randomization 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, or institutional guidelines) 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Daily Sequential Organ Failure Assessment (SOFA) Score From Baseline in Patients With Extrapulmonary Organ Dysfunction | 28 days | Change in SOFA score (0 to 4) with 4 being the most severe outcome |
| Change in Renal Function by Estimated Glomerular Filtration Rate (eGFR) Test | 28 days | eGFR measured in ml/min/1.73m2 |
| Change in Hs-troponin Levels | 28 days | — |
| Change in Antiviral IgG, IgA, and IgM Levels | 28 days | Immunoglobulins measured in mg/dL |
| 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 | — |
| Length of Stay in ICU and Hospital (Admission to Discharge) | 28 days | — |
| Virologic Clearance Rate | 28 days | SARS-CoV2 testing by swab (nasopharyngeal, nasal, throat, sputum, or lower respiratory tract) at baseline (Day 1) and every 3 days thereafter until eradication |
| Worst PaO2/FiO2 Ratio Following Enrollment | 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. |
| Change in PaO2/FiO2 Ratio | 28 days | — |
| Change in Baseline Modified Medical Research Council (mMRC) Score | 28 days | 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. |
| Change in Acute Physiologic Assessment and Chronic Health Evaluation (APACHE) II Score | 28 days | Change in APACHE II score (0 to 71) with 71 being the most severe outcome |
| Change in Liver Function by Alanine Aminotransferase (ALT) Test | 28 days | ALT measured in IU/L |
| Change in Liver Function by Aspartate Transferase (AST) Test | 28 days | AST measured in IU/L |
| Change in Liver Function by Total Bilirubin Test | 28 days | Total bilirubin measured in umol/L |
| Change in Renal Function by Serum Creatinine (SCr) Test | 28 days | SCr measured in umol/L |
| Change in Activated Coagulation Time (ACT) | 28 days | ACT measured in seconds |
| Change in Activated Partial Thromboplastin Time (aPTT) | 28 days | aPTT measured in seconds |
| Change in Prothrombin International Normalized Ratio (INR) | 28 days | — |
| Vasopressor-free Days | 28 days | — |
| Change From Maximal Radiographic Damage to EOT | 28 days | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory Endpoint: Change in Baseline Antiviral Immunoglobulins (IgG, IgM, IgA) at EOS | 28 days | Immunoglobulins measured in mg/dL |
| 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 | Fold change from baseline cytokines measured in ng/mL |
| Health Outcomes Endpoint: Total Healthcare Costs From Admission to Discharge Between Treatment Groups | 28 days | — |
Countries
Canada, Turkey (Türkiye), United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo 100 mL drug-free IV saline infusion over 2 hours daily
Placebo: 0.9% saline solution | 31 |
| 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. | 30 |
| Total | 61 |
Baseline characteristics
| Characteristic | LSALT | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 62.3 years STANDARD_DEVIATION 8.71 | 59.8 years STANDARD_DEVIATION 9.8 | 57.3 years STANDARD_DEVIATION 10.24 |
| BMI | 31.72 kg/m2 STANDARD_DEVIATION 5.571 | 32.04 kg/m2 STANDARD_DEVIATION 8.366 | 32.29 kg/m2 STANDARD_DEVIATION 10.064 |
| Cardiovascular Disease | 18 Participants | 33 Participants | 15 Participants |
| Chronic Lung Disease | 5 Participants | 8 Participants | 3 Participants |
| Chronic Renal Disease | 1 Participants | 2 Participants | 1 Participants |
| Diabetes | 13 Participants | 23 Participants | 10 Participants |
| PaO2/FiO2 Ratio | 247.097 mmHg STANDARD_DEVIATION 111.3844 | 247.527 mmHg STANDARD_DEVIATION 106.728 | 247.956 mmHg STANDARD_DEVIATION 93.762 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 7 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 22 Participants | 48 Participants | 26 Participants |
| Sex: Female, Male Female | 9 Participants | 20 Participants | 11 Participants |
| Sex: Female, Male Male | 21 Participants | 41 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 1 / 30 |
| other Total, other adverse events | 22 / 31 | 14 / 30 |
| serious Total, serious adverse events | 8 / 31 | 10 / 30 |
Outcome results
Primary
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | 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 |
| LSALT | 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 |
Secondary
All-cause Mortality
Time frame: 28 days
Population: The all-cause mortality rate within 28 days from randomization was compared between the treatment groups using a CMH test.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | All-cause Mortality | 0 Participants |
| LSALT | All-cause Mortality | 1 Participants |
Secondary
Change From Maximal Radiographic Damage to EOT
Time frame: 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.
Secondary
Change in Activated Coagulation Time (ACT)
ACT measured in seconds
Time frame: 28 days
Population: Change from baseline to day 28 (EOS) in prothrombin time (PT).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Activated Coagulation Time (ACT) | 0.0991 sec | Standard Deviation 2.79345 |
| LSALT | Change in Activated Coagulation Time (ACT) | -0.7688 sec | Standard Deviation 0.82439 |
Secondary
Change in Activated Partial Thromboplastin Time (aPTT)
aPTT measured in seconds
Time frame: 28 days
Population: Change from baseline to day 28 (EOS) in aPTT.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Activated Partial Thromboplastin Time (aPTT) | 2.232 sec | Standard Deviation 9.43189 |
| LSALT | Change in Activated Partial Thromboplastin Time (aPTT) | 1.4667 sec | Standard Deviation 5.21783 |
Secondary
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
Time frame: 28 days
Population: Change from baseline to day 28 (EOS) in APACHE II score.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Acute Physiologic Assessment and Chronic Health Evaluation (APACHE) II Score | -0.8 score on a scale | Standard Deviation 4.39 |
| LSALT | Change in Acute Physiologic Assessment and Chronic Health Evaluation (APACHE) II Score | -1.9 score on a scale | Standard Deviation 3.87 |
Secondary
Change in Antiviral IgG, IgA, and IgM Levels
Immunoglobulins measured in mg/dL
Time frame: 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.
Secondary
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.
Time frame: 28 days
Population: Change from baseline to day 28 (EOS) of modified Medical Research Council score.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Baseline Modified Medical Research Council (mMRC) Score | -1 score on a scale | Standard Deviation 1.12 |
| LSALT | Change in Baseline Modified Medical Research Council (mMRC) Score | -1.4 score on a scale | Standard Deviation 1.01 |
Secondary
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
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo | Change in Daily Sequential Organ Failure Assessment (SOFA) Score From Baseline in Patients With Extrapulmonary Organ Dysfunction | -1.2 score on a scale |
| LSALT | Change in Daily Sequential Organ Failure Assessment (SOFA) Score From Baseline in Patients With Extrapulmonary Organ Dysfunction | -0.7 score on a scale |
Secondary
Change in Hs-troponin Levels
Time frame: 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.
Secondary
Change in Liver Function by Alanine Aminotransferase (ALT) Test
ALT measured in IU/L
Time frame: 28 days
Population: Change from baseline liver function by ALT.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo | Change in Liver Function by Alanine Aminotransferase (ALT) Test | -1.4 IU/L |
| LSALT | Change in Liver Function by Alanine Aminotransferase (ALT) Test | -5.9 IU/L |
Secondary
Change in Liver Function by Aspartate Transferase (AST) Test
AST measured in IU/L
Time frame: 28 days
Population: Change from baseline in liver function by AST.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo | Change in Liver Function by Aspartate Transferase (AST) Test | -19.4 IU/L |
| LSALT | Change in Liver Function by Aspartate Transferase (AST) Test | -15.4 IU/L |
Secondary
Change in Liver Function by Total Bilirubin Test
Total bilirubin measured in umol/L
Time frame: 28 days
Population: Change from baseline in liver function by bilirubin.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Liver Function by Total Bilirubin Test | 2.8112 umol/L | Standard Deviation 5.47094 |
| LSALT | Change in Liver Function by Total Bilirubin Test | -1.0602 umol/L | Standard Deviation 5.52912 |
Secondary
Change in PaO2/FiO2 Ratio
Time frame: 28 days
Population: Change from baseline to day 28 (EOS) in PaO2/FiO2 ratio.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in PaO2/FiO2 Ratio | -25.708 mmHg | Standard Deviation 254.6656 |
| LSALT | Change in PaO2/FiO2 Ratio | -141.217 mmHg | Standard Deviation 169.476 |
Secondary
Change in Prothrombin International Normalized Ratio (INR)
Time frame: 28 days
Population: Change from baseline to day 28 (EOS) in prothrombin INR.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Prothrombin International Normalized Ratio (INR) | 0.0331 ratio | Standard Deviation 0.29399 |
| LSALT | Change in Prothrombin International Normalized Ratio (INR) | -0.0658 ratio | Standard Deviation 0.08495 |
Secondary
Change in Renal Function by Estimated Glomerular Filtration Rate (eGFR) Test
eGFR measured in ml/min/1.73m2
Time frame: 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.
Secondary
Change in Renal Function by Serum Creatinine (SCr) Test
SCr measured in umol/L
Time frame: 28 days
Population: Change in serum creatinine from baseline at day 28 (EOS)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Renal Function by Serum Creatinine (SCr) Test | -1.463 umol/L | Standard Deviation 16.625 |
| LSALT | Change in Renal Function by Serum Creatinine (SCr) Test | -1.664 umol/L | Standard Deviation 15.4972 |
Secondary
Length of Stay in ICU and Hospital (Admission to Discharge)
Time frame: 28 days
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Length of Stay in ICU and Hospital (Admission to Discharge) | Length of stay in hospital | 9 days |
| Placebo | Length of Stay in ICU and Hospital (Admission to Discharge) | Length of stay in ICU | 0 days |
| LSALT | Length of Stay in ICU and Hospital (Admission to Discharge) | Length of stay in hospital | 9.5 days |
| LSALT | Length of Stay in ICU and Hospital (Admission to Discharge) | Length of stay in ICU | 0 days |
Secondary
The Number of Ventilation-free Days
Time frame: 28 days
Population: Comparison of ventilation-free days in placebo and LSALT treated patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | The Number of Ventilation-free Days | 20.9 days | Standard Deviation 9.94 |
| LSALT | The Number of Ventilation-free Days | 22.8 days | Standard Deviation 7.34 |
Secondary
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
Population: Number of patients with ARDS on Day 28 (EOS).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| LSALT | 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 | 28 Participants |
| LSALT | 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 |
| LSALT | 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 |
| LSALT | 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 |
Secondary
Time on Nasal Cannula or Oxygen Mask
Time frame: 28 days
Population: Only patients that were on nasal cannula or oxygen mask were analysed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo | Time on Nasal Cannula or Oxygen Mask | 203.6 hours |
| LSALT | Time on Nasal Cannula or Oxygen Mask | 192.1 hours |
Secondary
Time to Each of Mild, Moderate, or Severe ARDS
Time frame: 28 days
Population: The proportion of patients that will develop ARDS at a given time point in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Time to Each of Mild, Moderate, or Severe ARDS | Day 3 | 0.13 proportion of participants |
| Placebo | Time to Each of Mild, Moderate, or Severe ARDS | Day 14 | 0.2 proportion of participants |
| Placebo | Time to Each of Mild, Moderate, or Severe ARDS | Day 28 | 0.2 proportion of participants |
| LSALT | Time to Each of Mild, Moderate, or Severe ARDS | Day 3 | 0.1 proportion of participants |
| LSALT | Time to Each of Mild, Moderate, or Severe ARDS | Day 14 | 0.13 proportion of participants |
| LSALT | Time to Each of Mild, Moderate, or Severe ARDS | Day 28 | 0.13 proportion of participants |
Secondary
Vasopressor-free Days
Time frame: 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.
Secondary
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
Time frame: 28 days
Population: The virologic clearance rate (proportion of patients with a negative test result) at day 28 (EOS).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Virologic Clearance Rate | 21 Participants |
| LSALT | Virologic Clearance Rate | 17 Participants |
Secondary
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.
Time frame: 28 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo | Worst PaO2/FiO2 Ratio Following Enrollment | -175.9 mmHg |
| LSALT | Worst PaO2/FiO2 Ratio Following Enrollment | -200.89 mmHg |
Other Pre-specified
Exploratory Endpoint: Change in Baseline Antiviral Immunoglobulins (IgG, IgM, IgA) at EOS
Immunoglobulins measured in mg/dL
Time frame: 28 days
Population: Change in baseline antiviral immunoglobulins were not analyzed in this study.
Other Pre-specified
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
Fold change from baseline cytokines measured in ng/mL
Time frame: 28 days
Population: Fold change in serum cytokine levels from baseline to day 28 (EOT).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| LSALT | 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 | 0.65 foldchange |
| LSALT | 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 | 0.62 foldchange |
| LSALT | 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 |
| LSALT | 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 | 0.73 foldchange |
| LSALT | 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 | 1.09 foldchange |
| LSALT | 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 | 0.16 foldchange |
| LSALT | 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 | 1.07 foldchange |
| LSALT | 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 | 0.64 foldchange |
Other Pre-specified
Health Outcomes Endpoint: Total Healthcare Costs From Admission to Discharge Between Treatment Groups
Time frame: 28 days
Population: Healthcare costs were not analyzed in this study.