Status:
SUSPENDED
Efficacy and Safety of Hydroxychloroquine and Azithromycin for Patients With Moderate to Severe 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 D5) and azithromycin (500 mg/ 5 days) to treat moderate to severe COVID-19 pneumon...
Detailed Description
This is an exploratory, open label, multi-center study to evaluate the efficacy of hydroxychloroquine (HCQ) (400 mg BID on D1 and 400 mg/day on D2 to D5) and azithromycin (AZT) (500 mg/ 5 days) to tre...
Eligibility Criteria
Inclusion
- Informed consent from patient or legal representative.
- Male or female, aged ≥ 18 years;
- Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source;
- At least one of the characteristic symptoms of COVID-19
- Hospitalized for up to 36h with non-invasive ventilation or up to 24h with invasive ventilation.
- Negative result for pregnancy test (if applicable).
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 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2023
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04329572
Start Date
April 23 2020
End Date
June 30 2023
Last Update
November 7 2022
Active Locations (1)
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1
Prevent Senior Private Operadora de Saúde LTDA.
São Paulo, Brazil