Efficacy and Safety of Hydroxychloroquine and Azithromyci... | NCT04329572

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

NCT04329572

Sponsor

Azidus Brasil

Status

Suspended

Last Update Posted

Nov 7, 2022Actual

Enrollment

400Estimated

Phase

Early Phase 1

Conditions

COVID-19

Interventions

Hydroxychloroquine Sulfate
Azithromycin Tablets

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

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

Expanded Access Info

Start Date

Apr 23, 2020Actual

Primary Completion Date

May 31, 2020Actual

Completion Date

Jun 30, 2023Estimated

First Submitted Date

Mar 29, 2020

First Submission Date that Met QC Criteria

Mar 30, 2020

First Posted Date

Apr 1, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 3, 2022

Last Update Posted Date

Nov 7, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.	HCQ + AZT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evolution of acute respiratory syndrome, oxygen saturation hemodynamic stability	Evaluation of change from baseline. Kaplan-meier method will be used.	28 days

Secondary Outcomes

Measure	Description	Time Frame
Viral load	Evaluation of change in viral load	Day 6
Change in Clinical Condition	Time for normalization of body temperature, respiratory rate and cough relief

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Luciana Ferrara	Azidus Brasil	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prevent Senior Private Operadora de Saúde LTDA.		São Paulo			Brazil

IPD Sharing Statement Module

Plan to Share IPD

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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006886	Hydroxychloroquine
D017963	Azithromycin

Ancestor Terms

ID	Term
D002738	Chloroquine
D000634	Aminoquinolines
D011804	Quinolines
D006574	Heterocyclic Compounds, 2-Ring

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention 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.