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

Covid-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04358081
• Other study ID #: CJWT629A12301
• Status: Completed
• Phase: Phase 3
• Start date: May 1, 2020
• Est. completion date: July 27, 2020

Study information

• Verified date: October 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 27, 2020
• Est. primary completion date: July 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid-19

Intervention

Drug:
• HCQ
Hydroxychloroquine Monotherapy
• HCQ+AZT
Hydroxychloroquine with azithromycin
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Novartis Investigative Site	Baltimore	Maryland
United States	Novartis Investigative Site	Baton Rouge	Louisiana
United States	Novartis Investigative Site	Chapel Hill	North Carolina
United States	Novartis Investigative Site	Chicago	Illinois
United States	Novartis Investigative Site	Fullerton	California
United States	Novartis Investigative Site	Los Angeles	California
United States	Novartis Investigative Site	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Achieved Clinical Response by Day 15	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.	15 days
Secondary	Number of Participants Who Achieved Viral Clearance	Number and percentage of participants with negative or below LLOQ SARS-COV-2 based on polymerase chain reaction (PCR) test	6 days and 10 Days
Secondary	Number of Participants Discharged or Ready for Discharge	Number of participants who received hydrochloroquine plus azithromycin relative to placebo who were discharged from hospital	15 days
Secondary	Time to Return to Pre-morbid Supplemental Oxygen Requirement in Participants Receiving Hydrochloroquine or Hydrochloroquine Plus Azithromycin Relative to Placebo	Number of participants requiring supplemental oxygen at the time of randomization who returned to pre-morbid supplemental oxygen	15 days

External Links

•   A Plain Language Trial Summary is available on novartisclinicaltrials.com