A Phase 2 interventional study of Camostat Mesilate and Artemisia Annua Leaf in Covid19, Diabetes and Hypertension, sponsored by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran. Terminated at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-21.
Sponsored by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · Phase 2, Interventional, and Treatment
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.
Coronavirus Disease 2019 (COVID-19) is a highly contagious disease, caused by a novel enveloped RNA beta-coronavirus, also known as severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). This disease has caused a global health crisis.
While the majority of patients with COVID-19 develop a mild or uncomplicated illness, approximately 20-30% of hospitalized patients have required intensive care support and 5% of those have multi-organ failure or shock. The case fatality rate ranges from 1 to 4% and it is higher among those with pre-existing comorbid conditions (high-risk) such as cardiovascular disease, diabetes mellitus, obesity, chronic respiratory disease, hypertension, and cancer.
To date, treatments for COVID-19 in high-risk individuals remain experimental and therapeutic strategies to deal with the infection are at best supportive, with prevention aimed at reducing transmission in the community as the best weapon. No proven therapies have been demonstrated to prevent progression of COVID-19 to severe illness in confirmed outpatients with COVID-19 and this is a critical unmet need for high-risk individuals and warrants study. Furthermore, there are no effective medications for the use in outpatients with confirmed mild to moderate COVID-19 disease.
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 (serine protease inhibitor) and Artemisia annua (unknown mechanism) immediately after COVID-19 positive testing in mild to moderate disease and high-risk factors such as diabetes, hypertension, and obesity among others. The hypothesis of this study is that the addition of agents that inhibit viral entry or replication of SARS-CoV-2 virus, such as Artemisia annua and camostat, will reduce the rate of a composite outcome of hospitalization due to COVID-19 pneumonia or the use of oxygen therapy; will be devoid of additional moderate to severe toxicities; and will improve viral clearance at Day 14 in high-risk individuals. The main hypothesis is that the clinical outcomes in COVID-19 infected patients at higher risk of poor outcomes following infection will be improved compared to the standard of care when introduced as an early intervention after diagnosis.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 246 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran is the lead sponsor of 141 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects must have at least one of the following high-risk features for clinical deterioration:
Exclusion Criteria:
Severe COVID-19 is defined by one or more of the following:
Life-threatening COVID-19 is defined as one or more of the following:
Specifically:
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
Matched placebo
Drug: Camostat Mesilate
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
Matched placebo
Drug: Artemisia Annua Leaf
Tablets
Also known as: Camostat
Tea bags
Also known as: Artemisia annua, Artemisia
Rate of hospitalizations and oxygen use
Decrease in a composite outcome of hospitalization and supplemental oxygen use at day 14 between treatment pairs.
Time frame: 14 days
Plan to share: No — All IPD results in the publication
This study is terminated, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran