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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04575558
Recruitment Status : Withdrawn (Withdrawn due to lack of study centers interested in participating.)
First Posted : October 5, 2020
Last Update Posted : October 5, 2020
Sponsor:
Collaborator:
Oncoclínicas
Information provided by (Responsible Party):
Latin American Cooperative Oncology Group

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

Condition or disease Intervention/treatment Phase
Sars-CoV2 Drug: Hydroxychloroquine and Azithromycin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Multi-institutional, Phase 2 Study of Hydroxichloroquine Plus Azithromycin for High Risk SARS-CoV-2 Positive Patients (COVID-19)
Estimated Study Start Date : June 30, 2020
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : October 30, 2020


Arm Intervention/treatment
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 Name: 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 Name: Reuquinol + Zitromax




Primary Outcome Measures :
  1. Clinical deterioration rate [ Time Frame: 37 days ]
    Clinical deterioration throughout treatment


Secondary Outcome Measures :
  1. 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

  2. Incidence and type of Adverse Events (EAs) [ Time Frame: 37 days ]
  3. Incidence and type of Serious Adverse Events (SAE) [ Time Frame: 37 days ]
  4. Discontinuation rate or temporary suspension of treatment [ Time Frame: 37 days ]
  5. Descriptive radiologic changes on chest CT scans [ Time Frame: 37 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04575558


Locations
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Brazil
Núcleo de Oncologia da Bahia - NOB
Salvador, BA, Brazil
Oncoclínicas BH
Belo Horizonte, MG, Brazil
Centro Oncológico do Triângulo - COT
Uberlândia, MG, Brazil
Multihemo
Recife, PE, Brazil
Oncoclinicas RJ
Rio De Janeiro, RJ, Brazil
Centro de Pesquisa em Oncologia PUCRS
Porto Alegre, RS, Brazil
Centro Paulista de Oncologia
São Paulo, SP, Brazil
Sponsors and Collaborators
Latin American Cooperative Oncology Group
Oncoclínicas
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Responsible Party: Latin American Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT04575558    
Other Study ID Numbers: LACOG 0220
First Posted: October 5, 2020    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Azithromycin
Hydroxychloroquine
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents