Camostat and Artemisia Annua vs Placebo in COVID-19 Outpatients
Covid19, Diabetes, Hypertension
About this trial
This is an interventional treatment trial for Covid19 focused on measuring Covid19, Outpatients, High-risk
Eligibility Criteria
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.
Sites / Locations
- Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Placebo Comparator
Active Comparator
Placebo Comparator
Camostat mesilate
Camostat Placebo
Artemisia annua
Artemisia annua Placebo
100 mg tablet, 600 mg/day. Oral, 2 tablets three times a day, after a meal (600 mg total daily dose) Days 1-14.
Matched placebo
Tea 225mg per bag,1350 mg/day. Oral, one 8 oz brewed tea (two bags) three times a day, Days 1-14.
Matched placebo