Status:
TERMINATED
Novel Agents for Treatment of High-risk COVID-19 Positive Patients
Lead Sponsor:
Susanne Arnold
Conditions:
COVID
Sars-CoV2
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
This is a multi-arm, phase II trial for rapid efficacy and toxicity assessment of multiple therapies immediately after COVID19 positive testing in high-risk individuals. Therapies include stand-alone ...
Detailed Description
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). The fi...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Age ≥18 years
- Laboratory-confirmed SARS-CoV-2 infection within the past 7 days or the presence of symptoms or physical examination signs providing high probability of COVID-19 disease
- Patients must have adequate organ and marrow function measured within the last 6 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, Emphysema, Cystic Fibrosis, or Asthma
- Cancer patients who have received any immunosuppressive drugs within a year from enrollment
- Sickle Cell disease or thalessemia
- Age \> or = 50
- BMI \> or = 30
- 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 COVID-19 Telehealth Treatment Team
- Exclusion Criteria
- Severe or life threating COVID
- Weight less than 45 kg.
- Pregnant or breast-feeding females
- Subjects on dialysis or with creatinine clearance \< 45 ml/min
- Existing DMID Toxicity Scale for Determining Severity of Adverse Events grade 3 or greater hepatic failure
- Previously documented moderate or severe retinopathy or macular degeneration
- Uncontrolled Seizure disorder
- Prolonged QT, defined as QTc ≥470 milliseconds for men and as QTc ≥480 for women using Bazett's formula
- Known allergy to artesunate, artemisia annua, hydroxychloroquine, macrolides, 4-aminoquinolines, camostat mesilate, or other agents to be used in the trial.
- Currently receiving any study medications for other indications
- Concurrent use of medication that would cause drug-drug interactions
- Patients with psychiatric illness/social situations that would limit compliance
Exclusion
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 12 2022
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04374019
Start Date
May 1 2020
End Date
January 12 2022
Last Update
January 20 2022
Active Locations (1)
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1
University of Kentucky Markey Cancer Center
Lexington, Kentucky, United States, 40532