Status:
SUSPENDED
Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Ambulatory Patients With Mild COVID-19
Lead Sponsor:
Azidus Brasil
Conditions:
Covid-19
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04348474
Start Date
April 20 2020
End Date
July 1 2023
Last Update
November 4 2022
Active Locations (1)
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1
Prevent Senior Private Operadora de Saúde LTDA.
São Paulo, Brazil