Back to resultsEfficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Ambulatory Patients With Mild COVID-19
Primary Purpose
Covid-19
Status
Suspended
Phase
Early Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Hydroxychloroquine Sulfate
Azithromycin Tablets
Sponsored by
About this trial
This is an interventional treatment trial for Covid-19
Eligibility Criteria
Inclusion Criteria:
- Informed consent from patient or legal representative.
Male or female, and:
- aged ≥ 70 years; or
- aged < 70 with associated risk factors (chronic obstructive pulmonary disease; heart failure, immunosuppressed, obesity (BMI ≥ 35) uncontrolled diabetes and uncontrolled systemic arterial hypertension)
- 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:
- Participating in another RCT in the past 12 months;
- Known allergy to HCQ or chloroquine
- Any contraindication to HTC or AZT, including retinopathy and prolonged QT,
- Severely reduced LV function
- Severely reduced renal function;
- Pregnancy or breast feeding
- 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
Sites / Locations
- Prevent Senior Private Operadora de Saúde LTDA.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HCQ + AZT
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in Clinical Condition
Ordinal scale (7 points ordinal scale that measures illness severity over time)
Secondary Outcome Measures
Hospitalization
Number of patients that needed to be hospitalized
Change in Clinical Condition
Time for normalization of body temperature
Change in Clinical Condition
Time for normalization of of respiratory rate
Change in Clinical Condition
Time for cough relief
Rate of mortality within 28-days
Evaluation of change in acute respiratory syndrome
Change in Clinical Condition related to comorbidity
Subgroup analysis by comorbidities
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04348474
Brief Title
Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Ambulatory Patients With Mild COVID-19
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Suspended
Why Stopped
Azidus, the CRO hired for this study by Prevent Senior has lost the interest to conduct this study.
Study Start Date
April 20, 2020 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azidus Brasil
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HCQ + AZT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine Sulfate
Other Intervention Name(s)
Reuquinol
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Azithromycin Tablets
Other Intervention Name(s)
Azithromycin
Intervention Description
All patients included in the study will receive AZT 500 mg per day for 5 days.
Primary Outcome Measure Information:
Title
Change in Clinical Condition
Description
Ordinal scale (7 points ordinal scale that measures illness severity over time)
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Hospitalization
Description
Number of patients that needed to be hospitalized
Time Frame
28 days
Title
Change in Clinical Condition
Description
Time for normalization of body temperature
Time Frame
28 days
Title
Change in Clinical Condition
Description
Time for normalization of of respiratory rate
Time Frame
28 days
Title
Change in Clinical Condition
Description
Time for cough relief
Time Frame
28 days
Title
Rate of mortality within 28-days
Description
Evaluation of change in acute respiratory syndrome
Time Frame
28 days
Title
Change in Clinical Condition related to comorbidity
Description
Subgroup analysis by comorbidities
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Informed consent from patient or legal representative.
Male or female, and:
aged ≥ 70 years; or
aged < 70 with associated risk factors (chronic obstructive pulmonary disease; heart failure, immunosuppressed, obesity (BMI ≥ 35) uncontrolled diabetes and uncontrolled systemic arterial hypertension)
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:
Participating in another RCT in the past 12 months;
Known allergy to HCQ or chloroquine
Any contraindication to HTC or AZT, including retinopathy and prolonged QT,
Severely reduced LV function
Severely reduced renal function;
Pregnancy or breast feeding
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
Facility Information:
Facility Name
Prevent Senior Private Operadora de Saúde LTDA.
City
São Paulo
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Learn more about this trial
Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Ambulatory Patients With Mild COVID-19
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