Effect of Dalcetrapib in Patients With Confirmed Mild to Moderate COVID-19
Condition: Covid19
MeSH terms: COVID-19
Intervention: Dalcetrapib; Placebo
Intervention description: Dalcetrapib 300 mg Film-Coated Tablets; Placebo Tablets
Intervention MeSH terms: Dalcetrapib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomized, double blind, multicenter, Phase 2a proof-of-concept study in outpatients with confirmed, mild to moderate, symptomatic COVID-19.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: This is a double blind study.
Enrollment: 227.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID-19; Coronavirus disease; Dalcetrapib

Summary:

      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.
    

Eligibility criteria:

        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.