COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04530617

Jose G Gotes Palazuelos, MD

jose.gotesp@incmnsz.mx

2020-08-28

Terminated

RCT

Randomized

Parallel

Blind label

single-center

Treatment

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

- 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.

3

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

18

100

Mexico

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

246

Rate of hospitalizations and oxygen use

None

Phase 2

[{"arm_notes": "high-risk COVID-19 positive outpatients", "treatment_id": 118, "treatment_name": "Artemisia annua", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "high-risk COVID-19 positive outpatients", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "high-risk COVID-19 positive outpatients", "treatment_id": 245, "treatment_name": "Camostat mesilate", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}]