Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Hospitalized Patients With Moderate to Severe COVID-19
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|ClinicalTrials.gov Identifier: NCT04329572|
Recruitment Status : Suspended (Azidus, the CRO hired for this study by Prevent Senior has lost the interest to conduct this study.)
First Posted : April 1, 2020
Last Update Posted : April 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Hydroxychloroquine Sulfate Drug: Azithromycin Tablets||Early Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All patients included in the study will receive hydroxychloroquine (HCQ) 400 mg (BID/ 7 days) and azithromycin (AZT) (500 mg/ 5 days) on top of standard care. Patients that do not consent to participate or that do not fulfill eligibility criteria will be invited to participate as control group and will receive standard care only.|
|Masking:||None (Open Label)|
|Official Title:||Open, Multicentric, Non Randomized, Exploratory Clinical Trial to Assess the Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Acute Respiratory Syndrome (COVID-19) Caused by SARS-CoV-2 Virus|
|Estimated Study Start Date :||April 23, 2020|
|Estimated Primary Completion Date :||May 31, 2020|
|Estimated Study Completion Date :||June 30, 2020|
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 Name: Reuquinol
Drug: Azithromycin Tablets
All patients included in the study will receive AZT 500 mg per day for 5 days.
Other Name: Azithromycin
- Evolution of acute respiratory syndrome, oxygen saturation hemodynamic stability [ Time Frame: 28 days ]Evaluation of change from baseline. Kaplan-meier method will be used.
- Viral load [ Time Frame: Day 6 ]Evaluation of change in viral load
- Change in Clinical Condition [ Time Frame: 28 days ]Time for normalization of body temperature, respiratory rate and cough relief
- Evolution of Acute Respiratory Syndrome [ Time Frame: 28 days ]Time to wean off oxygen supplementation and / or invasive / non-invasive ventilatory support;
- Hospital discharge [ Time Frame: 28 days ]Time to be discharged from hospital
- Rate of mortality within 28-days [ Time Frame: 28 days ]Evaluation of change in acute respiratory syndrome
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04329572
|Prevent Senior Private Operadora de Saúde LTDA.|
|São Paulo, Brazil|
|Study Director:||Luciana Ferrara||Azidus Brasil|