HOPE: A Trial of Hydroxichloroquine Plus Azithromycin in High Risk COVID-19 (HOPE_BRAZIL)

October 2, 2020 updated by: Latin American Cooperative Oncology Group

A Randomized, Multi-institutional, Phase 2 Study of Hydroxichloroquine Plus Azithromycin for High Risk SARS-CoV-2 Positive Patients (COVID-19)

Multicenter, double blind, randomized clinical trial for high-risk patients over 18 years of age, symptomatic for COVID-19 infection, without any severity criteria

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

COVID-19 is a respiratory disease caused by a new coronavirus (SARS-CoV2) and with substantial morbidity and mortality. Among different populations at risk, cancer patients stand out. These patients undergo immunosuppressive treatments with chemotherapy and radiotherapy and more often require hospital visit for treatment and monitoring.

Several strategies have been investigated to deal with this situation. Antiretrovirals, anti-inflammatories, antibiotics, anti-IL6, immune response modulating agents, among others, including combinations. Most of these experiences have focused on patients with severe hospitalized conditions

As of March 28, approximately 630,000 confirmed cases have been recorded, including 24,282 serious cases and 28,963 deaths worldwide. In Brazil, after one month since the first case, there are 3417 infected and 92 deaths. All states registered cases of the disease, and nine have deaths: Amazonas, Ceará, Pernambuco, Rio de Janeiro, Goiás, Paraná, Santa Catarina, Rio Gran de do Sul and São Paulo. Cases have progressed and currently there is no specific antiviral therapy for coronavirus infections. A few intervention studies have been conducted as most strains of human coronavirus cause self-limiting diseases and requires only supportive care. After the severe acute respiratory syndrome (SARS), the coronavirus was identified in 2002 and caused a major global outbreak, there was a growing interest in the development of specific therapeutic agents. Therefore, since the SARS outbreak, new therapeutic agents targeting viral entry, proteins, proteases, polymerases and methyltransferases have been tested. Nevertheless, none of them have been shown to be effective in clinical trials. Recent publications have drawn attention to the possible benefit of drugs such as chloroquine, hydroxychloroquine associated or not with azithromycin, which have been used in the treatment of patients infected with SARS- CoV.

Using the combination of hydroxychloroquine and azithromycin, French patients confirmed with Covid-19 were included in a single arm protocol between early March and March 16th, receiving 600mg of hydroxychloroquine daily. Nasal swab viral load was tested daily in a hospital setting. Azithromycin was added to the treatment based on the clinical presentation. Control patients included patients from another center and those who refused the protocol. Day End point was presence or absence of virus on day 6 post-inclusion. There were six asymptomatic patients, twnty two with upper respiratory tract infection and eight had symptoms of lower respiratory tract infection. Twenty cases were treated in this study and showed a significant reduction in viral transport at post-day 6 of inclusion compared to controls, and mean transport duration much shorter than that reported in untreated patients in the literature. Despite the small sample size, research shows that treatment with hydroxychloroquine is associated with a significantly reduction / disappearance of viral load in patients with COVID-19, and its effect seems to be reinforced by azithromycin.

Hydroxychloroquine alone or in combination with azithromycin has been increasingly studied and used in the treatment of respiratory disease induced by COVID-19. In March 2020, the Food and Drug Administration (FDA) interim approved the use of the combination of hydroxychloroquine and azithromycin for clinical use in patients with severe respiratory syndrome associated with coronavirus. There are dozens of studies in progress evaluating this therapeutic alternative in different regions of the world. The World Health Organization (WHO) has just launched a global clinical trial evaluating the four treatments considered promising, including hydroxychloroquine. In Brazil, a consortium of clinical research is underway that is conducting three randomized clinical trials with treatments with hydroxychloroquine, azithromycin and corticosteroids. Considering that these medications have been studied in different institutions and regions and in different contexts, it is important to know the role that these medications can play in the prevention or treatment of COVID-19 in a population of cancer patients undergoing cancer treatments such as chemotherapy and immunotherapy.This clinical trial was designed to evaluate the therapeutic effect of the combination of hydroxychloroquine and azithromycin on non-critical adult patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • BA
      • Salvador, BA, Brazil
        • Nucleo de Oncologia da Bahia - NOB
    • MG
      • Belo Horizonte, MG, Brazil
        • Oncoclínicas BH
      • Uberlândia, MG, Brazil
        • Centro Oncológico do Triângulo - COT
    • PE
      • Recife, PE, Brazil
        • Multihemo
    • RJ
      • Rio De Janeiro, RJ, Brazil
        • Oncoclinicas Rj
    • RS
      • Porto Alegre, RS, Brazil
        • Centro de Pesquisa em Oncologia PUCRS
    • SP
      • São Paulo, SP, Brazil
        • Centro Paulista de Oncologia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 years and by 1 of the following criteria:

    1. Cancer diagnosis and systemic antineoplastic treatment (chemotherapy or hormone therapy or immunotherapy or small molecule therapy), or having received the last dose within 90 days from randomization, or
    2. Antineoplastic treatment with radiotherapy or had received the last fraction within 90 days from randomization, or
    3. Undergone surgery for cancer treatment within 90 days from randomization, or
    4. Need for continuous treatment for chronic disease. asthma, COPD, pulmonary fibrosis, pulmonary hypertension, smoking, systemic arterial hypertension, ischemic heart disease, hypertensive heart disease, symptomatic valve heart disease, cardiac arrhythmia, chronic renal failure, stroke, diabetes, autoimmune or other disease at the discretion of the investigator.
  • Confirmed diagnosis of SARS-CoV-2 infection;
  • Symptoms of SARS-Cov-2 (COVID-19) infection but without showing signs / symptoms of severity;
  • Respiratory rate <24ipm;
  • HR <130 bpm (in the absence of fever);
  • Oxygen saturation > 90%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Hydroxychloroquine + Azithromycin
Hydroxychloroquine 400mg PO BID 2 times a day + Azithromycin 500mg PO QD, both for 7 days
Drug: Hydroxychloroquine and Azithromycin
Hydroxychloroquine 400mg PO BID 2 times a day + Azithromycin 500mg PO QD
Other Names:
  • Reuquinol + Zitromax
Placebo Comparator: Hydroxychloroquine + Placebo tablets
Hydroxychloroquine 400mg PO BID 2 times a day + Placebo, both for 7 days
Drug: Hydroxychloroquine and Azithromycin
Hydroxychloroquine 400mg PO BID 2 times a day + Azithromycin 500mg PO QD
Other Names:
  • Reuquinol + Zitromax

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical deterioration rate
Time Frame: 37 days
Clinical deterioration throughout treatment
37 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mortality and cause of death
Time Frame: 60 days
Evaluate the mortality and cause of death, at the end of treatment, at 28 days and 60 days from the start of treatment
60 days
Incidence and type of Adverse Events (EAs)
Time Frame: 37 days
37 days
Incidence and type of Serious Adverse Events (SAE)
Time Frame: 37 days
37 days
Discontinuation rate or temporary suspension of treatment
Time Frame: 37 days
37 days
Descriptive radiologic changes on chest CT scans
Time Frame: 37 days
37 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Latin American Cooperative Oncology Group

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Oncoclínicas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LACOG 0220

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sars-CoV2

Clinical Trials on Hydroxychloroquine and Azithromycin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings