Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Ambulatory Patients With Mild COVID-19
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|ClinicalTrials.gov Identifier: NCT04348474|
Recruitment Status : Suspended (Azidus, the CRO hired for this study by Prevent Senior has lost the interest to conduct this study.)
First Posted : April 16, 2020
Last Update Posted : November 4, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Covid-19||Drug: Hydroxychloroquine Sulfate Drug: Azithromycin Tablets||Early Phase 1|
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.
We aim to demonstrate decrease in hospital related complications among ambulatory patients with mild COVID-19 by treating them with HCQ and AZT on top of standard care compared to patients who receive standard care only.
Ambulatory patients on day 3 of symptoms and 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 :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open Label, Multicentric, Non Randomized, Exploratory Clinical Trial to Assess the Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Mild Acute Respiratory Syndrome (COVID-19) Caused by SARS-CoV-2 Virus|
|Actual Study Start Date :||April 20, 2020|
|Actual Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||July 2023|
Experimental: HCQ + AZT
All patients included in the study will receive hydroxychloroquine (HCQ) 400 mg (00 mg BID on D1 and 400 mg/day on D2 to D7) and azithromycin (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 D7) for 7 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
- Change in Clinical Condition [ Time Frame: 28 days ]Ordinal scale (7 points ordinal scale that measures illness severity over time)
- Hospitalization [ Time Frame: 28 days ]Number of patients that needed to be hospitalized
- Change in Clinical Condition [ Time Frame: 28 days ]Time for normalization of body temperature
- Change in Clinical Condition [ Time Frame: 28 days ]Time for normalization of of respiratory rate
- Change in Clinical Condition [ Time Frame: 28 days ]Time for cough relief
- Rate of mortality within 28-days [ Time Frame: 28 days ]Evaluation of change in acute respiratory syndrome
- Change in Clinical Condition related to comorbidity [ Time Frame: 28 days ]Subgroup analysis by comorbidities
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
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): NCT04348474
|Prevent Senior Private Operadora de Saúde LTDA.|
|São Paulo, Brazil|
|Responsible Party:||Azidus Brasil|
|Other Study ID Numbers:||
|First Posted:||April 16, 2020 Key Record Dates|
|Last Update Posted:||November 4, 2022|
|Last Verified:||November 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Plan Description:||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.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases
Molecular Mechanisms of Pharmacological Action