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

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

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.

Study Overview

• Status: Suspended
• Conditions: COVID-19
• Intervention / Treatment: Drug: Hydroxychloroquine Sulfate; Drug: Azithromycin Tablets

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.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil
    • Prevent Senior Private Operadora de Saúde LTDA.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.; Other Names: Reuquinol; Drug: Azithromycin Tablets; All patients included in the study will receive AZT 500 mg per day for 5 days.; Other Names: Azithromycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	28 days
Evolution of Acute Respiratory Syndrome	Time to wean off oxygen supplementation and / or invasive / non-invasive ventilatory support;	28 days
Hospital discharge	Time to be discharged from hospital	28 days
Rate of mortality within 28-days	Evaluation of change in acute respiratory syndrome	28 days

Collaborators and Investigators

• Sponsor: Azidus Brasil
• Investigators: Study Director: Luciana Ferrara, Azidus Brasil

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2020
• Primary Completion (Actual): May 31, 2020
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: March 29, 2020
• First Submitted That Met QC Criteria: March 30, 2020
• First Posted (Actual): April 1, 2020

Study Record Updates

• Last Update Posted (Actual): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 3, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Azithromycin; Hydroxychloroquine
• Other Study ID Numbers: HIAPRE0320OR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No