Efficacy and Safety of Hydroxychloroquine and Azithromycin for Patients With Moderate to Severe COVID-19

NCT04329572 | Suspended Early Phase 1 DMC

• 1 other identifier: HIAPRE0320OR
• Study Type: interventional
• Target: 400
• 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 D5) and azithromycin (500 mg/ 5 days) to treat moderate to severe COVID-19 pneumonia.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Evolution of acute respiratory syndrome, oxygen saturation hemodynamic stability

  Evaluation of change from baseline. Kaplan-meier method will be used.

  28 days

Secondary Outcomes (5)

• Viral load

  Day 6

• Change in Clinical Condition

  28 days

• Evolution of Acute Respiratory Syndrome

  28 days

• Hospital discharge

  28 days

• Rate of mortality within 28-days

  28 days

Study Arms (1)

HCQ + AZT

EXPERIMENTAL

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

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 D5) for 5 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, aged ≥ 18 years;
• Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source;
• At least one of the characteristic symptoms of COVID-19
• Hospitalized for up to 36h with non-invasive ventilation or up to 24h with invasive ventilation.
• Negative result for pregnancy test (if applicable).

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 Officials

• Luciana Ferrara

  Azidus Brasil

  STUDY DIRECTOR

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

Model Details: All patients included in the study will receive hydroxychloroquine (HCQ) 400 mg (BID/ 7 days) and azithromycin (AZT) (500 mg/ 5 days) on top of standard care. Patients that do not consent to participate or that do not fulfill eligibility criteria will be invited to participate as control group and will receive standard care only.

Study Record Dates

• First Submitted: March 29, 2020
• First Posted: April 1, 2020
• Study Start: April 23, 2020
• Primary Completion: May 31, 2020
• Study Completion: June 30, 2023
• Last Updated: November 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)