Effect of Dalcetrapib in Patients With Confirmed Mild to Moderate COVID-19
Effect of Dalcetrapib in Patients With Confirmed Mild to Moderate COVID-19
This study is a placebo-controlled, Phase 2a proof-of-concept clinical study which will
 evaluate efficacy and safety of dalcetrapib in outpatients patients with mild to moderate,
 symptomatic, confirmed COVID 19.
Inclusion Criteria:

 -  Patients must satisfy all of the following criteria unless otherwise stated:

 1. Willing and able to provide informed consent

 2. Male or female patients > 18 years of age on the day of informed consent

 3. Have received a confirmed diagnosis of COVID-19 (positive for SARS CoV 2), as
 assessed by PCR or point-of-care within 72 hours of first dose on Day 1

 4. Have mild to moderate signs or symptoms of COVID-19 with onset within 5 days of
 first dose on Day 1, at least two of the following symptoms:

 -  stuffy or runny nose

 -  sore throat

 -  shortness of breath

 -  cough

 -  fatigue

 -  myalgia

 -  headache

 -  chills or shivering

 -  feeling hot or feverish

 -  nausea

 -  vomiting

 -  diarrhea

 -  anosmia

 -  ageusia

 5. Outpatient with COVID-19 disease (not requiring oxygen therapy [WHO COVID-19
 Clinical Improvement Ordinal Scale, score of 3])

 6. Patient is aware of the investigational nature of this study and willing to
 comply with protocol treatments, blood tests, and other evaluations listed in the
 informed consent form (ICF).

 Exclusion Criteria:

 -  Patients will be excluded from the study if they satisfy any of the following criteria
 unless otherwise stated:

 1. Females who are pregnant (negative pregnancy test required for all women of child
 bearing potential at Screening) or breast-feeding

 2. Male patients and women of childbearing potential (women who are not surgically
 sterile or postmenopausal defined as amenorrhea for >12 months) who are not using
 at least one protocol specified method of contraception

 3. Severe COVID-19 disease as defined by the WHO COVID-19 Clinical Improvement
 Ordinal Scale, scores of 5 (non invasive ventilation or high-flow oxygen), 6
 (intubation and mechanical ventilation), or 7 (ventilation + additional organ
 support pressors, renal replacement therapy [RRT], extracorporeal membrane
 oxygenation [ECMO])

 4. Expected survival less than 72 hours

 5. Peripheral capillary oxygen saturation (SpO2) <90% while breathing room air

 6. Treatment with other drugs thought to possibly have activity against SARS CoV 2
 infection like remdesivir, favipiravir, within 7 days prior to enrollment or
 concurrently

 7. History of abuse of drugs or alcohol that could interfere with adherence to study
 requirements as judged by the Investigator

 8. Use of any other concurrent investigational drugs while participating in the
 present study

 9. Patient requires frequent or prolonged use of systemic corticosteroids (≥20 mg of
 prednisone/day or equivalent for >4 weeks) or other immunosuppressive drugs
 (e.g., for organ transplantation or autoimmune conditions)

 10. Known renal disease with an estimated glomerular filtration rate (eGFR) <50
 mL/min based on local laboratory results

 11. Patients with clinically apparent liver disease, e.g., jaundice, cholestasis,
 hepatic synthetic impairment, or active hepatitis

 12. Alanine transaminase (ALT) or aspartate transaminase (AST) >3 × upper limit of
 normal (ULN) or alkaline phosphatase or bilirubin levels > 2 × ULN based on local
 laboratory results

 13. Co administration of clinical doses of orlistat with dalcetrapib

 14. Inability to swallow oral medications or a gastrointestinal disorder with
 diarrhea (e.g., Crohn's disease) or malabsorption at Screening

 15. Any other clinically significant medical condition or laboratory abnormality
 that, in the opinion of the Investigator, would jeopardize the safety of the
 patient or potentially impact patient compliance or the safety/efficacy
 observations in the study

 16. History of an allergic reaction or hypersensitivity to the study drug or any
 component of the study drug formulation.