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

NCT04348474 | Suspended Early Phase 1 DMC

• 1 other identifier: HIAPRE0420OR
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid-19

Outcome Measures

Primary Outcomes (1)

• Change in Clinical Condition

  Ordinal scale (7 points ordinal scale that measures illness severity over time)

  28 days

Secondary Outcomes (6)

• Hospitalization

  28 days

• Change in Clinical Condition

  28 days

• Change in Clinical Condition

  28 days

• Change in Clinical Condition

  28 days

• Rate of mortality within 28-days

  28 days

Study Arms (1)

HCQ + AZT

EXPERIMENTAL

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; Drug: Azithromycin Tablets

Interventions

Hydroxychloroquine Sulfate DRUG

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.

Also known as: Reuquinol

HCQ + AZT

Azithromycin Tablets DRUG

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

Also known as: Azithromycin

HCQ + AZT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Azidus Brasil: lead

Study Sites (1)

Prevent Senior Private Operadora de Saúde LTDA.

São Paulo, Brazil

Location

MeSH Terms

Conditions

COVID-19

Interventions

Hydroxychloroquine; Azithromycin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: April 16, 2020
• Study Start: April 20, 2020
• Primary Completion: June 30, 2020
• Study Completion: July 1, 2023
• Last Updated: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)