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

NCT ID: NCT04329572

Last Updated: 2022-11-07

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-23
• Study Completion Date: 2023-06-30

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.

Detailed Description

This is an exploratory, open label, multi-center study to evaluate the efficacy of hydroxychloroquine (HCQ) (400 mg BID on D1 and 400 mg/day on D2 to D5) and azithromycin (AZT) (500 mg/ 5 days) to treat moderate to severe COVID-19 pneumonia.

We aim to demonstrate decrease in hospital related complications among patients who are hospitalized with moderate or severe COVID-19 by treating them with HCQ and AZT on top of standard care compared to patients who receive standard care only.

Patients hospitalized 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.

Conditions

COVID-19

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HCQ + AZT

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.

Group Type: EXPERIMENTAL

Hydroxychloroquine Sulfate

Intervention Type: 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.

Azithromycin Tablets

Intervention Type: DRUG

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

Interventions

Hydroxychloroquine Sulfate

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.

Intervention Type: DRUG

Azithromycin Tablets

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

Intervention Type: DRUG

Other Intervention Names

Reuquinol; Azithromycin

Eligibility Criteria

Inclusion Criteria

1. Informed consent from patient or legal representative.

2. Male or female, aged ≥ 18 years;

3. Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source;

4. At least one of the characteristic symptoms of COVID-19

5. Hospitalized for up to 36h with non-invasive ventilation or up to 24h with invasive ventilation.

6. Negative result for pregnancy test (if applicable).

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azidus Brasil

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luciana Ferrara

Role: STUDY_DIRECTOR

Azidus Brasil

Locations

Prevent Senior Private Operadora de Saúde LTDA.

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

HIAPRE0320OR

Identifier Type: -

Identifier Source: org_study_id