Status:
TERMINATED
Hydroxychloroquine,Hydroxychloroquine,Azithromycin in the Treatment of SARS CoV-2 Infection
Lead Sponsor:
Washington University School of Medicine
Conditions:
Coronavirus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This Phase III trial four treatment strategies non-critically ill hospitalized participants (not requiring intensive care unit (ICU) admission and/or mechanical ventilation) with SARS CoV-2 infection,...
Detailed Description
This Phase III trial will utilize four treatment strategies in non-critically ill hospitalized participants (not requiring mechanical ventilation) with SARS CoV-2 infection, Participants will receive ...
Eligibility Criteria
Inclusion
- Hospitalization for management of SARS CoV-2 infection
- Positive SARS CoV-2 test
- Age \>=18 years
- Provision of informed consent
- Electrocardiogram (ECG) ≤48 hours prior to enrollment
- Complete blood count, glucose-6 phosphate-dehydrogenase (G6PD), comprehensive metabolic panel and magnesium ≤48 hours prior to enrollment from standard of care.
- If participating in sexual activity that could lead to pregnancy, individuals of reproductive potential who can become pregnant must agree to use contraception throughout the study. At least one of the following must be used throughout the study:
- Condom (male or female) with or without spermicide
- Diaphragm or cervical cap with spermicide
- Intrauterine device (IUD)
- Hormone-based contraceptive
Exclusion
- Contraindication or allergy to chloroquine, hydroxychloroquine or azithromycin
- Current use hydroxychloroquine, chloroquine or azithromycin
- Concurrent use of another investigational agent
- Invasive mechanical ventilation
- Participants who have any severe and/or uncontrolled medical conditions such as:
- unstable angina pectoris,
- symptomatic congestive heart failure,
- myocardial infarction,
- cardiac arrhythmias or know prolonged QTc \>470 males, \>480 female on ECG
- pulmonary insufficiency,
- epilepsy (interaction with chloroquine),
- Prior retinal eye disease
- Concurrent malignancy requiring chemotherapy
- Known Chronic Kidney disease, eGFR\<10 or dialysis
- G-6-PD deficiency, if unknown requires G6PD testing prior to enrollment
- Known Porphyria
- Known myasthenia gravis
- Currently pregnant or planning on getting pregnant while on study
- Breast feeding
- AST/ALT \>five times the upper limit of normal ULN\*
- Bilirubin \>five times the ULN\*
- Magnesium \<1.4 mEq/L\*
- Calcium \<8.4mg/dL \>10.6mg/dL\*
- Potassium \<3.3 \>5.5 mEg/L\*
Key Trial Info
Start Date :
April 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04341727
Start Date
April 4 2020
End Date
April 1 2021
Last Update
April 25 2024
Active Locations (2)
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1
Washington University School of Medicine Infectious Disease Clinical Research Unit
St Louis, Missouri, United States, 63110
2
Washington University School of Medicine
St Louis, Missouri, United States, 63110