Camostat and Artemisia Annua vs Placebo in COVID-19 Outpatients

NCT04530617 | Terminated Phase 2 DMC

• 1 other identifier: 3421
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Covid19; Diabetes; Hypertension; Obesity

Keywords

Covid19; Outpatients; High-risk

Outcome Measures

Primary Outcomes (1)

• Rate of hospitalizations and oxygen use

  Decrease in a composite outcome of hospitalization and supplemental oxygen use at day 14 between treatment pairs.

  14 days

Study Arms (4)

Camostat mesilate

ACTIVE COMPARATOR

100 mg tablet, 600 mg/day. Oral, 2 tablets three times a day, after a meal (600 mg total daily dose) Days 1-14.

Drug: Camostat Mesilate

Camostat Placebo

PLACEBO COMPARATOR

Matched placebo

Drug: Camostat Mesilate

Artemisia annua

ACTIVE COMPARATOR

Tea 225mg per bag,1350 mg/day. Oral, one 8 oz brewed tea (two bags) three times a day, Days 1-14.

Drug: Artemisia Annua Leaf

Artemisia annua Placebo

PLACEBO COMPARATOR

Matched placebo

Drug: Artemisia Annua Leaf

Interventions

Camostat Mesilate DRUG

Tablets

Also known as: Camostat

Camostat Placebo; Camostat mesilate

Artemisia Annua Leaf DRUG

Tea bags

Also known as: Artemisia annua, Artemisia

Artemisia annua; Artemisia annua Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, None - Non-US/Canada, 14020, Mexico

Location

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Related Links

• ohns Hopkins University of Medicine Coronavirus Resource Center Map
• WHO supports scientifically-proven traditional medicine.

MeSH Terms

Conditions

COVID-19; Diabetes Mellitus; Hypertension; Obesity

Interventions

camostat

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jose G Gotes Palazuelos, MD

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The masking of the protocol will be maintained throughout the duration of the study. This will be done with the use of a matched placebo and a non-continuous coding (tablets in the case of camostat and tea bags/coffer for Artemisia) that has the same description and dose as the interventions so that both, the investigators and the patient does not know the treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized, placebo-controlled, parallel, multicenter, multi-arm, phase II trial of novel agents for treatment of high-risk COVID-19 positive outpatients. Subjects who meet the inclusion/exclusion criteria and have properly signed the informed consent will be randomized to the test group or placebo group in the ratio of 1:1:1:1.

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: August 28, 2020
• Study Start: October 5, 2020
• Primary Completion: June 10, 2021
• Study Completion: June 10, 2021
• Last Updated: June 21, 2021

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)