Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Hospitalized Patients With Moderate to Severe COVID-19
Study Details
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 D5) and azithromycin (500 mg/ 5 days) to treat moderate to severe COVID-19 pneumonia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
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 treat moderate to severe COVID-19 pneumonia.
We aim to demonstrate decrease in hospital related complications among patients who are hospitalized with moderate or severe COVID-19 by treating them with HCQ and AZT on top of standard care compared to patients who receive standard care only.
Patients hospitalized 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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: HCQ + AZT All patients included in the study will receive HCQ (400 mg BID on D1 and 400 mg/day on D2 to D5) and AZT (500 mg/ 5 days) on top of standard care. |
Drug: Hydroxychloroquine Sulfate
All patients included in the study will receive HCQ (400 mg BID on D1 and 400 mg/day on D2 to D5) for 5 days.
Other Names:
Drug: Azithromycin Tablets
All patients included in the study will receive AZT 500 mg per day for 5 days.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Evolution of acute respiratory syndrome, oxygen saturation hemodynamic stability [28 days]
Evaluation of change from baseline. Kaplan-meier method will be used.
Secondary Outcome Measures
- Viral load [Day 6]
Evaluation of change in viral load
- Change in Clinical Condition [28 days]
Time for normalization of body temperature, respiratory rate and cough relief
- Evolution of Acute Respiratory Syndrome [28 days]
Time to wean off oxygen supplementation and / or invasive / non-invasive ventilatory support;
- Hospital discharge [28 days]
Time to be discharged from hospital
- Rate of mortality within 28-days [28 days]
Evaluation of change in acute respiratory syndrome
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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 Criteria:
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Participating in another RCT in the past 12 months;
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Known allergy to HCQ or chloroquine
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Any contraindication to HTC or AZT, including retinopathy and prolonged QT,
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Severely reduced LV function
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Severely reduced renal function;
-
Pregnancy or breast feeding
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Prevent Senior Private Operadora de Saúde LTDA. | São Paulo | Brazil |
Sponsors and Collaborators
- Azidus Brasil
Investigators
- Study Director: Luciana Ferrara, Azidus Brasil
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HIAPRE0320OR