Hydroxychloroquine Monotherapy and in Combination With Azithromycin in Patients With Moderate and Severe COVID-19 Disease
Condition: Covid-19
MeSH terms: COVID-19
Intervention: HCQ; HCQ+AZT; Placebo
Intervention description: Hydroxychloroquine Monotherapy; Hydroxychloroquine with azithromycin; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: covid19; covid 19; covid-19; coronavirus; SARS-CoV; SARS-CoV-2; novel coronavirus; adult; JWT629; acute respiratory syndrome coronavirus

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.
    

Eligibility 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.