Camostat and Artemisia Annua vs Placebo in COVID-19 Outpatients

This is an interventional treatment trial for Covid19 focused on measuring Covid19, Outpatients, High-risk Read More

Inclusion Criteria:

• Age ≥18 years
• Laboratory-confirmed SARS-CoV-2 infection within 3 days (of proposed consent) or the presence of symptoms or signs providing a high probability of COVID-19 disease who have symptoms within 7 days prior to diagnosis as determined by Infectious Disease specialist or treating physicians.
• Outpatients. No previous hospitalization within the past 3 months.

• Subjects must have at least one of the following high-risk features for clinical deterioration:

  • Hypertension
  • Diabetes mellitus
  • Moderate to severe Chronic Obstructive Pulmonary Disease or asthma
  • Cancer patients who have received any immunosuppressive drugs within a year from enrollment.
  • Obesity as defined by a body mass index > 30 kg/m2.
  • Living in a nursing home or long-term facility
  • Underlying serious heart condition as determined by the treating physician
  • Immunocompromised subject as defined by the treating physician or by the Infectious Disease specialist
  • Ability to provide informed consent by the patient or healthcare proxy.
  • Ability to return for repeated testing and observation to the hospital.
  • Patients must have adequate organ and marrow function measured within the last 30 days as defined below:
• platelets ≥100,000
• aspartate transaminase or alanine transaminase ≤3 times institutional upper limit of normal
• creatinine ≤ 1.5 times institutional upper limit of normal OR
• glomerular filtration rate ≥45 mL/min/1.73 m2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m2

Exclusion Criteria:

• Severe COVID-19 is defined by one or more of the following:

  • blood oxygen saturation ≤ 90%
  • partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300
  • lung infiltrates ≥ 50% within 24 to 48 hours

• Life-threatening COVID-19 is defined as one or more of the following:

  • respiratory failure
  • septic shock
  • multiple organ dysfunction or failure
• Weight less than 45 kg.
• Pregnant or breast-feeding females
• Subjects on dialysis or with creatinine clearance < 45 ml/min
• Subjects who need antiviral administration due to severe viral diseases other than COVID-19, such as HIV, hepatitis B, and hepatitis C
• Existing Division of Microbiology and Infectious Disease Toxicity Scale for determining the severity of adverse events grade 3 or greater.
• Uncontrolled seizure disorder
• Subjects with reflux esophagitis after chronic pancreatitis and gastrectomy surgery.
• Patients with reflux esophagitis after surgery.
• Known allergy to Artemisia annua or camostat mesilate.
• Currently receiving any study medications for other indications.
• Concurrent use of medication that would cause moderate or severe due to drug-drug interactions with study medication.

Specifically:

• Patients receiving Artemisia annua tea may not be currently taking strong inducers of CYP2A6, including phenobarbital and rifampin.
• Receipt in the 12 hours prior to enrollment, or planned administration during the 14-day study period that treating clinicians feel cannot be substituted for another medication, of any of the following: amiodarone; cimetidine; dofetilide; phenobarbital; phenytoin; or sotalol.
• Cancer patients receiving active immunosuppressive treatment cannot be enrolled unless they are on a treatment holiday with no antineoplastic treatment with 3 weeks of enrollment.
• Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
• Subjects who have a history of drug and/or alcohol abuse within 52 weeks before screening
• Enrollment on other experimental therapies for COVID-19.
• Inability to receive enteral medications
• Patients with psychiatric illness/social situations that would limit compliance with study requirements.
• Subjects who have a history of drug and/or alcohol abuse within 52 weeks before screening
• Any other condition that in the opinion of the treating physician justifies exclusion from the study.