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Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Ambulatory Patients With Mild COVID-19

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: NCT04348474
Recruitment Status : Suspended (Azidus, the CRO hired for this study by Prevent Senior has lost the interest to conduct this study.)
First Posted : April 16, 2020
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Azidus Brasil

Tracking Information
First Submitted Date  ICMJE April 13, 2020
First Posted Date  ICMJE April 16, 2020
Last Update Posted Date April 22, 2020
Estimated Study Start Date  ICMJE April 20, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2020)
Change in Clinical Condition [ Time Frame: 28 days ]
Ordinal scale (7 points ordinal scale that measures illness severity over time)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2020)
  • Hospitalization [ Time Frame: 28 days ]
    Number of patients that needed to be hospitalized
  • Change in Clinical Condition [ Time Frame: 28 days ]
    Time for normalization of body temperature
  • Change in Clinical Condition [ Time Frame: 28 days ]
    Time for normalization of of respiratory rate
  • Change in Clinical Condition [ Time Frame: 28 days ]
    Time for cough relief
  • Rate of mortality within 28-days [ Time Frame: 28 days ]
    Evaluation of change in acute respiratory syndrome
  • Change in Clinical Condition related to comorbidity [ Time Frame: 28 days ]
    Subgroup analysis by comorbidities
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Ambulatory Patients With Mild COVID-19
Official Title  ICMJE Open Label, Multicentric, Non Randomized, Exploratory Clinical Trial to Assess the Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Mild Acute Respiratory Syndrome (COVID-19) Caused by SARS-CoV-2 Virus
Brief Summary This is an exploratory study to evaluate the efficacy of hydroxychloroquine (400 mg BID on D1 and 400 mg/day on D2 to D7) and azithromycin (500 mg/ 5 days) to treat mild ambulatory COVID-19 patients.
Detailed Description

This is an exploratory study to evaluate the efficacy of hydroxychloroquine (400 mg BID on D1 and 400 mg/day on D2 to D7) and azithromycin (500 mg/ 5 days) to treat mild ambulatory COVID-19 patients.

We aim to demonstrate decrease in hospital related complications among ambulatory patients with mild COVID-19 by treating them with HCQ and AZT on top of standard care compared to patients who receive standard care only.

Ambulatory patients on day 3 of symptoms and with confirmed diagnosis of COVID-19 will receive the treatment.

Patients that do not fulfill the inclusion/exclusion criteria or that is not willing to participate in the study will be invited to consent the use of their data as part of a "control" group.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Covid-19
Intervention  ICMJE
  • Drug: Hydroxychloroquine Sulfate
    All patients included in the study will receive HCQ (400 mg BID on D1 and 400 mg/day on D2 to D7) for 7 days.
    Other Name: Reuquinol
  • Drug: Azithromycin Tablets
    All patients included in the study will receive AZT 500 mg per day for 5 days.
    Other Name: Azithromycin
Study Arms  ICMJE Experimental: HCQ + AZT
All patients included in the study will receive hydroxychloroquine (HCQ) 400 mg (00 mg BID on D1 and 400 mg/day on D2 to D7) and azithromycin (AZT) (500 mg/ 5 days) on top of standard care.
Interventions:
  • Drug: Hydroxychloroquine Sulfate
  • Drug: Azithromycin Tablets
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: April 13, 2020)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Informed consent from patient or legal representative.
  2. Male or female, and:

    1. aged ≥ 70 years; or
    2. aged < 70 with associated risk factors (chronic obstructive pulmonary disease; heart failure, immunosuppressed, obesity (BMI ≥ 35) uncontrolled diabetes and uncontrolled systemic arterial hypertension)
  3. One or more mild symptoms characteristic of COVID-19 for 3 days, such as fever, cough and signs of respiratory distress, which do not require hospitalization.

Exclusion Criteria:

  1. Participating in another RCT in the past 12 months;
  2. Known allergy to HCQ or chloroquine
  3. Any contraindication to HTC or AZT, including retinopathy and prolonged QT,
  4. Severely reduced LV function
  5. Severely reduced renal function;
  6. Pregnancy or breast feeding
  7. Any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of the investigational products
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04348474
Other Study ID Numbers  ICMJE HIAPRE0420OR
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data of the study will become public.
Responsible Party Azidus Brasil
Study Sponsor  ICMJE Azidus Brasil
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Azidus Brasil
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP