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

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ClinicalTrials.gov Identifier: NCT04358081
Recruitment Status : Completed
First Posted : April 22, 2020
Results First Posted : March 17, 2021
Last Update Posted : April 2, 2021
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 pronounced 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 was 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
Covid-19 Drug: HCQ Drug: HCQ+AZT Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 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
Actual Primary Completion Date : July 27, 2020
Actual Study Completion Date : July 27, 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 was initiated within 8-12 hours of the loading dose (not to exceed 12 hours) Azithromycin (AZT) 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. was 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. Number of Participants Who Achieved Clinical Response by Day 15 [ Time Frame: 15 days ]
    Clinical response was defined as a) discharged alive; or b) No need for mechanical ventilation in any participants and no need for supplemental oxygen requirement (SpO2) in participants without pre-morbid O2 requirement.


Secondary Outcome Measures :
  1. Number of Participants Who Achieved Viral Clearance [ Time Frame: 6 days and 10 Days ]
    Number and percentage of participants with negative or below LLOQ SARS-COV-2 based on polymerase chain reaction (PCR) test

  2. Number of Participants Discharged or Ready for Discharge [ Time Frame: 15 days ]
    Number of participants who received hydrochloroquine plus azithromycin relative to placebo who were discharged from hospital

  3. Time to Return to Pre-morbid Supplemental Oxygen Requirement in Participants Receiving Hydrochloroquine or Hydrochloroquine Plus Azithromycin Relative to Placebo [ Time Frame: 15 days ]
    Number of participants requiring supplemental oxygen at the time of randomization who returned to pre-morbid supplemental oxygen



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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


Locations
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United States, California
Novartis Investigative Site
Fullerton, California, United States, 92835
Novartis Investigative Site
Los Angeles, California, United States, 90095-1793
United States, Illinois
Novartis Investigative Site
Chicago, Illinois, United States, 60612
United States, Louisiana
Novartis Investigative Site
Baton Rouge, Louisiana, United States, 70809
United States, Maryland
Novartis Investigative Site
Baltimore, Maryland, United States, 21287
United States, North Carolina
Novartis Investigative Site
Chapel Hill, North Carolina, United States, 27599
United States, Washington
Novartis Investigative Site
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Study Protocol  [PDF] April 8, 2020
Statistical Analysis Plan  [PDF] August 13, 2020

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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
Results First Posted: March 17, 2021
Last Update Posted: April 2, 2021
Last Verified: March 2021
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
covid 19
covid-19
coronavirus
SARS-CoV
SARS-CoV-2
novel coronavirus
adult
JWT629
acute respiratory syndrome coronavirus