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Hydroxychloroquine,Hydroxychloroquine,Azithromycin in the Treatment of SARS CoV-2 Infection (WU352)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04341727
Recruitment Status : Suspended (DSMB recommended study suspension slow accrual)
First Posted : April 10, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Jane O'Halloran, Washington University School of Medicine

Brief Summary:
This Phase III trial four treatment strategies non-critically ill hospitalized participants (not requiring ICU admission and/or mechanical ventilation) with SARS CoV-2 infection, Participants will receive hydroxychloroquine or chloroquine with or without azithromycin.

Condition or disease Intervention/treatment Phase
Coronavirus Infection Drug: Hydroxychloroquine Sulfate Drug: Azithromycin Drug: Chloroquine Sulfate Phase 3

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 withthe 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 SOC will be collected from medical records.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: WU 352: Open-label, Randomized Controlled Trial of Hydroxychloroquine Alone or Hydroxychloroquine Plus Azithromycin or Chloroquine Alone or Chloroquine Plus Azithromycin in the Treatment of SARS CoV-2 Infection
Actual Study Start Date : April 4, 2020
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : August 1, 2021


Arm Intervention/treatment
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 Name: 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 Name: HYDROXYCHLOROQUINE Plaquenil

Drug: Azithromycin
Antibiotic
Other Name: 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 Name: 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 Name: COMMON BRAND(S): Zithromax GENERIC NAME(S): Azithromycin

Drug: Chloroquine Sulfate
Antimalarial
Other Name: Aralen GENERIC NAME(S): Chloroquine Phosphate




Primary Outcome Measures :
  1. Hours to recovery [ Time Frame: 42 days ]
    Time (hours) from randomization to recovery defined as 1) absence of fever, as defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications AND 2) absence of symptoms of greater than mild severity for 24 hours AND 3) not requiring supplemental oxygen beyond pre-COVID baseline AND 4) freedom from mechanical ventilation or death


Secondary Outcome Measures :
  1. Time fever resolution [ Time Frame: 42 days ]
    Time to resolution of fever defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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*

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04341727


Locations
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United States, Missouri
Washington University School of Medicine Infectious Disease Clinical Research Unit
Saint Louis, Missouri, United States, 63110
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Jane O'Halloran, MD PhD Washington University School of Medicine (ID-CRU)
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Responsible Party: Jane O'Halloran, Assistant Professor in Medicine, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04341727    
Other Study ID Numbers: 202003188
First Posted: April 10, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Azithromycin
Hydroxychloroquine
Chloroquine
Chloroquine diphosphate
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents
Amebicides
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents