Camostat and Artemisia Annua vs Placebo in COVID-19 Outpatients

• Status: Terminated
• Trial end date: 2021-06-10
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double-blind, placebo-controlled, multi-arm, multicenter, phase II trial design to allow a rapid efficacy and toxicity assessment of potential therapies (camostat mesilate and artemisia annua) immediately after COVID-19 positive testing in mild to moderate disease and high-risk factors such as diabetes, hypertension, and obesity among others.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Collaborators: Hospital General de Mexico; Hospital General Dr. Manuel Gea González; Instituto Nacional de Cardiologia Ignacio Chavez
• Treatments: Camostat

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.