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Purpose

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, Participants will receive hydroxychloroquine or chloroquine with or without azithromycin.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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 Criteria

  • 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*

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Hydroxychloroquine alone 		Arm 1: Hydroxychloroquine 400mg orally twice a day for one day, followed by 200mg twice a day for four consecutive days (Five days in total). The drug will be supplied in 200mg tablets.
  • Drug: Hydroxychloroquine Sulfate
    anti-rheumatic drug (DMARD)
    Other names:
    • HYDROXYCHLOROQUINE Plaquenil
Active Comparator
Hydroxychloroquine plus azithromycin 		Arm 2: Hydroxychloroquine 400mg orally twice a day for one day, followed by 200mg twice a day for four consecutive days (Five days in total). The drug will be supplied in 200mg tablets. AND Azithromycin 500mg orally once, followed by 250mg daily for four consecutive days (five days total). The drug will be supplied in 250mg tablets.
  • Drug: Hydroxychloroquine Sulfate
    anti-rheumatic drug (DMARD)
    Other names:
    • HYDROXYCHLOROQUINE Plaquenil
  • Drug: Azithromycin
    Antibiotic
    Other names:
    • COMMON BRAND(S): Zithromax GENERIC NAME(S): Azithromycin
Active Comparator
Chloroquine alone 		Arm 3: Chloroquine phosphate 1000mg orally once, followed in 12 hours by 500mg, then 500mg orally twice daily for 4 days (Five days in total). The drug will be supplied in 500mg tablets.
  • Drug: Chloroquine Sulfate
    Antimalarial
    Other names:
    • Aralen GENERIC NAME(S): Chloroquine Phosphate
Active Comparator
Chloroquine plus azithromycin 		Arm 4: Chloroquine phosphate 1000mg orally once, followed in 12 hours by 500mg, then 500mg orally twice daily for 4 days (Five days in total). The drug will be supplied in 500mg tablets. AND Azithromycin 500mg orally once, followed by 250mg daily for 4 consecutive days (5 days total).The drug will be supplied in 250mg tablets.
  • Drug: Azithromycin
    Antibiotic
    Other names:
    • COMMON BRAND(S): Zithromax GENERIC NAME(S): Azithromycin
  • Drug: Chloroquine Sulfate
    Antimalarial
    Other names:
    • Aralen GENERIC NAME(S): Chloroquine Phosphate

Recruiting Locations

More Details

NCT ID
NCT04341727
Status
Terminated
Sponsor
Washington University School of Medicine

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 hydroxychloroquine or chloroquine with or without azithromycin. Investigators are primarily interested in the time to recovery. In addition to study medications there will be daily symptom surveys for 14 days, then weekly thereafter for 4 weeks resulting in a total duration of follow up of 42 days. During hospitalization, daily symptom surveys will be completed in conjunction with the study coordinators. On discharge participants will have the option to complete electronic symptom surveys or complete symptom surveys via telephone with study coordinator. In the event that the participant opts for electronic symptom surveys on discharge participants will in addition receive a follow up call from a study coordination every 7 days during the initial 14 day period. In addition, failure to submit a symptom survey will prompt a study follow up call. Data from standard of care SOC will be collected from medical records.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.