NCT04575558

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

7 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

June 30, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
Last Updated

October 5, 2020

Status Verified

October 1, 2020

Enrollment Period

2 months

First QC Date

May 18, 2020

Last Update Submit

October 2, 2020

Conditions

Sars-CoV2

Outcome Measures

Primary Outcomes (1)

  • Clinical deterioration rate

    Clinical deterioration throughout treatment

    37 days

Secondary Outcomes (5)

  • Mortality and cause of death

    60 days

  • Incidence and type of Adverse Events (EAs)

    37 days

  • Incidence and type of Serious Adverse Events (SAE)

    37 days

  • Discontinuation rate or temporary suspension of treatment

    37 days

  • Descriptive radiologic changes on chest CT scans

    37 days

Study Arms (2)

Hydroxychloroquine + Azithromycin

EXPERIMENTAL

Hydroxychloroquine 400mg PO BID 2 times a day + Azithromycin 500mg PO QD, both for 7 days

Drug: Hydroxychloroquine and Azithromycin

Hydroxychloroquine + Placebo tablets

PLACEBO COMPARATOR

Hydroxychloroquine 400mg PO BID 2 times a day + Placebo, both for 7 days

Drug: Hydroxychloroquine and Azithromycin

Interventions

Hydroxychloroquine and AzithromycinDRUG

Hydroxychloroquine 400mg PO BID 2 times a day + Azithromycin 500mg PO QD

Also known as: Reuquinol + Zitromax
Hydroxychloroquine + AzithromycinHydroxychloroquine + Placebo tablets

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years and by 1 of the following criteria:
  • 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
  • Antineoplastic treatment with radiotherapy or had received the last fraction within 90 days from randomization, or
  • Undergone surgery for cancer treatment within 90 days from randomization, or
  • 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%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Núcleo de Oncologia da Bahia - NOB

Salvador, Estado de Bahia, Brazil

Location

Oncoclínicas BH

Belo Horizonte, Minas Gerais, Brazil

Location

Centro Oncológico do Triângulo - COT

Uberlândia, Minas Gerais, Brazil

Location

Multihemo

Recife, Pernambuco, Brazil

Location

Oncoclinicas RJ

Rio de Janeiro, Rio de Janeiro, Brazil

Location

Centro de Pesquisa em Oncologia PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Location

Centro Paulista de Oncologia

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Interventions

HydroxychloroquineAzithromycin

Intervention Hierarchy (Ancestors)

ChloroquineAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2020

First Posted

October 5, 2020

Study Start

June 30, 2020

Primary Completion

September 1, 2020

Study Completion

October 30, 2020

Last Updated

October 5, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

BR(7)