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

Primary Purpose

COVID-19

Status

Suspended

Phase

Early Phase 1

Locations

Brazil

Study Type

Interventional

Intervention

Hydroxychloroquine Sulfate

Azithromycin Tablets

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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).

Exclusion Criteria:

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

Sites / Locations

Prevent Senior Private Operadora de Saúde LTDA.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HCQ + AZT

Arm Description

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.

Outcomes

Primary Outcome Measures

Evolution of acute respiratory syndrome, oxygen saturation hemodynamic stability

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

Secondary Outcome Measures

Viral load

Evaluation of change in viral load

Change in Clinical Condition

Time for normalization of body temperature, respiratory rate and cough relief

Evolution of Acute Respiratory Syndrome

Time to wean off oxygen supplementation and / or invasive / non-invasive ventilatory support;

Hospital discharge

Time to be discharged from hospital

Rate of mortality within 28-days

Evaluation of change in acute respiratory syndrome

Full Information

NCT ID

NCT04329572

First Posted

March 29, 2020

Last Updated

November 3, 2022

Sponsor

Azidus Brasil

1. Study Identification

Unique Protocol Identification Number

NCT04329572

Brief Title

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

Official Title

Open, Multicentric, Non Randomized, Exploratory Clinical Trial to Assess the Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Acute Respiratory Syndrome (COVID-19) Caused by SARS-CoV-2 Virus

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Suspended

Why Stopped

Azidus, the CRO hired for this study by Prevent Senior has lost the interest to conduct this study.

Study Start Date

April 23, 2020 (Actual)

Primary Completion Date

May 31, 2020 (Actual)

Study Completion Date

June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Azidus Brasil

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HCQ + AZT

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Hydroxychloroquine Sulfate

Other Intervention Name(s)

Reuquinol

Intervention Description

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

Intervention Name(s)

Azithromycin Tablets

Other Intervention Name(s)

Azithromycin

Intervention Description

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

Primary Outcome Measure Information:

Title

Evolution of acute respiratory syndrome, oxygen saturation hemodynamic stability

Description

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

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Viral load

Description

Evaluation of change in viral load

Time Frame

Day 6

Title

Change in Clinical Condition

Description

Time for normalization of body temperature, respiratory rate and cough relief

Time Frame

28 days

Title

Evolution of Acute Respiratory Syndrome

Description

Time to wean off oxygen supplementation and / or invasive / non-invasive ventilatory support;

Time Frame

28 days

Title

Hospital discharge

Description

Time to be discharged from hospital

Time Frame

28 days

Title

Rate of mortality within 28-days

Description

Evaluation of change in acute respiratory syndrome

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Luciana Ferrara

Organizational Affiliation

Azidus Brasil

Official's Role

Study Director

Facility Information:

Facility Name

Prevent Senior Private Operadora de Saúde LTDA.

City

São Paulo

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data of the study will become public.

Learn more about this trial

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

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