Clinical trial: LSALT Peptide vs. Placebo to Prevent ARDS and Acute Kidney Injury in Patients Infected With SARS-CoV-2 (COVID-19) (NCT04402957)

Eligibility 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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
Subject must be at most 80 Years

Patient description (medical language): The patient is a 38-year-old man with cough and body ache that started 3 days ago.  He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx.

Patient description (patient's own words): I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat.

Does the patient match the trial criteria? Contradiction