An Early Phase 1 interventional study of Hydroxychloroquine Sulfate and Azithromycin Tablets in COVID-19, sponsored by Azidus Brasil. Suspended at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-07.
Sponsored by Azidus Brasil · Early Phase 1, Interventional, and Treatment
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.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 400 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Azidus Brasil is the lead sponsor of 78 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Drug: Azithromycin Tablets
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.
Also known as: Reuquinol
All patients included in the study will receive AZT 500 mg per day for 5 days.
Also known as: Azithromycin
Evolution of acute respiratory syndrome, oxygen saturation hemodynamic stability
Evaluation of change from baseline. Kaplan-meier method will be used.
Time frame: 28 days
Viral load
Evaluation of change in viral load
Time frame: Day 6
Change in Clinical Condition
Time for normalization of body temperature, respiratory rate and cough relief
Time frame: 28 days
Evolution of Acute Respiratory Syndrome
Time to wean off oxygen supplementation and / or invasive / non-invasive ventilatory support;
Time frame: 28 days
Hospital discharge
Time to be discharged from hospital
Time frame: 28 days
Rate of mortality within 28-days
Evaluation of change in acute respiratory syndrome
Time frame: 28 days
Plan to share: No — 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.
No publications or documents are linked to this record.
This study is suspended, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Azidus Brasil