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

Early Phase 1

Suspended

• Conditions: Covid-19
• Interventions: Drug: Hydroxychloroquine Sulfate; Drug: Azithromycin Tablets

• Registration Number: NCT04348474
• Lead Sponsor: Azidus Brasil

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 D7) and azithromycin (500 mg/ 5 days) to treat mild ambulatory COVID-19 patients.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-04-13
• Study First Submitted QC: 2020-04-13
• Study First Posted: 2020-04-16
• Study Start: 2020-04-20
• Primary Completion: 2020-06-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-03
• Last Update Posted: 2022-11-04
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HCQ + AZT	Azithromycin Tablets	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.
HCQ + AZT	Hydroxychloroquine Sulfate	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.

Primary Outcome Measures

Name	Time	Method
Change in Clinical Condition	28 days	Ordinal scale (7 points ordinal scale that measures illness severity over time)

Secondary Outcome Measures

Name	Time	Method
Change in Clinical Condition	28 days	Time for cough relief
Rate of mortality within 28-days	28 days	Evaluation of change in acute respiratory syndrome
Change in Clinical Condition related to comorbidity	28 days	Subgroup analysis by comorbidities
Hospitalization	28 days	Number of patients that needed to be hospitalized

Trial Locations

Locations (1)

Prevent Senior Private Operadora de Saúde LTDA.; 🇧🇷 São Paulo, Brazil