Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Ambulatory Patients With Mild COVID-19

Covid-19 Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04348474
• Other study ID #: HIAPRE0420OR
• Status: Suspended
• Phase: Early Phase 1
• Start date: April 20, 2020
• Est. completion date: July 2023

Study information

• Verified date: November 2022
• Source: Azidus Brasil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 200
• Est. completion date: July 2023
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Informed consent from patient or legal representative.

2. Male or female, and:

1. aged = 70 years; or

2. aged < 70 with associated risk factors (chronic obstructive pulmonary disease; heart failure, immunosuppressed, obesity (BMI = 35) uncontrolled diabetes and uncontrolled systemic arterial hypertension)

3. 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.

Exclusion Criteria:

1. Participating in another RCT in the past 12 months;

2. Known allergy to HCQ or chloroquine

3. Any contraindication to HTC or AZT, including retinopathy and prolonged QT,

4. Severely reduced LV function

5. Severely reduced renal function;

6. Pregnancy or breast feeding

7. 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

Related Conditions & MeSH terms

• Covid-19

Intervention

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.
• Azithromycin Tablets
All patients included in the study will receive AZT 500 mg per day for 5 days.

Locations

Country	Name	City	State
Brazil	Prevent Senior Private Operadora de Saúde LTDA.	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Azidus Brasil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Clinical Condition	Ordinal scale (7 points ordinal scale that measures illness severity over time)	28 days
Secondary	Hospitalization	Number of patients that needed to be hospitalized	28 days
Secondary	Change in Clinical Condition	Time for normalization of body temperature	28 days
Secondary	Change in Clinical Condition	Time for normalization of of respiratory rate	28 days
Secondary	Change in Clinical Condition	Time for cough relief	28 days
Secondary	Rate of mortality within 28-days	Evaluation of change in acute respiratory syndrome	28 days
Secondary	Change in Clinical Condition related to comorbidity	Subgroup analysis by comorbidities	28 days