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Hydroxychloroquine Monotherapy and in Combination With Azithromycin in Patients With Moderate and Severe COVID-19 Disease

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04358081
Recruitment Status : Recruiting
First Posted : April 22, 2020
Last Update Posted : May 21, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:

Two recent studies have suggested that in patients with Covid19, treatment with hydroxychloroquine may shorten the duration of symptoms and improve viral clearance, an effect that appears most pronounce when combined with azithromycin. Hydroxychloroquine treatment may inhibit viral nucleic acid-mediated activation of various innate immune pathways, as well as blockade of lysosomal functions in cell types relevant for viral entry and antigen presentation.

The purpose of the study is to determine if oral hydroxychloroquine monotherapy, or in combination with azithromycin results in clinical benefit in patients hospitalized with COVID19 pneumonia.


Condition or disease Intervention/treatment Phase
Pneumonia Drug: HCQ Drug: HCQ+AZT Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 444 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of Hydroxychloroquine Monotherapy and in Combination With Azithromycin in Patients With Moderate and Severe COVID-19 Disease
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : June 25, 2020
Estimated Study Completion Date : July 24, 2020


Arm Intervention/treatment
Experimental: Arm 1: hydroxychloroquine + aithromycin placebo
Hydroxychloroquine 600mg o.d. as loading dose (Day 1) +followed by 200mg t.i.d to be initiated within 8-12 hours of the loading dose (not to exceed 12 hours) Azithromycin (AZI) placebo o.d.
Drug: HCQ
Hydroxychloroquine Monotherapy
Other Name: JWT629

Experimental: Arm 2: hydroxychloroquine + azithromycin
Hydroxychloroquine 600 mg o.d. as a loading dose (Day 1) followed by 200 mg t.i.d. to be initiated within 8-12 hours of the loading dose (not to exceed 12 hours) Azithromycin: 500 mg as a loading dose (Day 1) followed by 250 mg o.d. Day 2 - Day 5
Drug: HCQ+AZT
Hydroxychloroquine with azithromycin
Other Name: JWT629 + AZT

Placebo Comparator: Arm 3; hydroxychloroquine placebo + azithromycin placebo
Hydroxychloroquine placebo o.d. (day 1) followed by hydroxychloroquine placebo t.i.d Azythromycin placebo o.d.
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Percentage of participants who achieve clinical response [ Time Frame: 15 days ]
    To demonstrate in patients receiving standard of care that the percentage who achieve clinical response with hydroxychloroquine or hydroxychloroquine and azithromycin is superior to placebo at Day 15


Secondary Outcome Measures :
  1. Percentage of Participants with Viral Clearance [ Time Frame: 15 Days ]
    To demonstrate in patients receiving standard of care that the percentage with viral clearance at Day 15 with hydroxychloroquine or hydroxychloroquine and azithromycin is superior to placebo

  2. Number of participants receiving hydroxychloroquine or hydroxychloroquine and azithromycin with adverse events of hydroxychloroquin or hydroxychloroquine and azithromycin compared to placebo [ Time Frame: 40 days ]
    To assess in patients receiving standard of care the safety of hydroxychloroquine or hydroxychloroquine and azithromycin compared to placebo



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:

  1. Informed consent must be obtained prior to participation in the study
  2. Adult patient ≥ 18 years old
  3. Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test from respiratory tract specimen (e.g nasopharyngeal swab)
  4. Onset of signs and symptoms of COVID19 illness ≤ 7 days prior to randomization (including but not limited to fever, cough, myalgias, fatigue, abnormal chest imaging)
  5. Currently hospitalized or requiring hospitalization due to COVID-19 disease

Exclusion Criteria:

  1. Use of other investigational drugs or newly approved COVID-19 treatments within 5-half lives or 30 days of enrolment
  2. History of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes
  3. Participation in any other clinical trial of an experimental treatment for COVID-19
  4. Expectation of concurrent treatment with any other agents or potential direct acting antiviral activity against SARS-Co V-2 during study drug dosing
  5. Requires, in the judgement of the investigator, admission to the intensive care unit (ICU) or mechanical ventilatory support (invasive or non-invasive) prior to first dose of study drug (There might be a patient who cannot be admitted to the ICU, even if the patient's condition is severe enough, due to administrative reasons under the current circumstances. This case is also considered under admission to the ICU judged by the investigator)
  6. Evidence of cytokine storm syndrome or multi-organ system failure
  7. Confirmed co-infection with influenza
  8. Creatinine clearance < 45 mL/min or requiring acute renal replacement therapy
  9. History or current diagnosis of ECG abnormalities indicating significant risk of safety for participants participating in the study
  10. Any other condition which in the opinion of the investigator, would put the safety of the participant at risk, impede compliance or hinder completion of the study
  11. Pregnant or nursing (lactating) women
  12. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they agree to use basic methods of contraception during dosing of study treatment.

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): NCT04358081


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Locations
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United States, California
Novartis Investigative Site Recruiting
Los Angeles, California, United States, 90095-1793
Novartis Investigative Site Recruiting
San Francisco, California, United States, 94110
United States, Florida
Novartis Investigative Site Recruiting
Gainesville, Florida, United States, 32608
United States, Illinois
Novartis Investigative Site Recruiting
Chicago, Illinois, United States, 60612
United States, Louisiana
Novartis Investigative Site Recruiting
Baton Rouge, Louisiana, United States, 70809
United States, Maryland
Novartis Investigative Site Recruiting
Baltimore, Maryland, United States, 21201
Novartis Investigative Site Recruiting
Baltimore, Maryland, United States, 21287
United States, Missouri
Novartis Investigative Site Recruiting
Columbia, Missouri, United States, 65212
United States, North Carolina
Novartis Investigative Site Recruiting
Chapel Hill, North Carolina, United States, 27599
United States, Washington
Novartis Investigative Site Recruiting
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04358081    
Other Study ID Numbers: CJWT629A12301
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
covid19
coronavirus
SARS-CoV
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections