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

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: NCT04329572
Recruitment Status : Suspended (Azidus, the CRO hired for this study by Prevent Senior has lost the interest to conduct this study.)
First Posted : April 1, 2020
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Azidus Brasil

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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Hydroxychloroquine Sulfate Drug: Azithromycin Tablets Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : April 23, 2020
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : June 30, 2020


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 Name: Reuquinol

Drug: Azithromycin Tablets
All patients included in the study will receive AZT 500 mg per day for 5 days.
Other Name: Azithromycin




Primary Outcome Measures :
  1. Evolution of acute respiratory syndrome, oxygen saturation hemodynamic stability [ Time Frame: 28 days ]
    Evaluation of change from baseline. Kaplan-meier method will be used.


Secondary Outcome Measures :
  1. Viral load [ Time Frame: Day 6 ]
    Evaluation of change in viral load

  2. Change in Clinical Condition [ Time Frame: 28 days ]
    Time for normalization of body temperature, respiratory rate and cough relief

  3. Evolution of Acute Respiratory Syndrome [ Time Frame: 28 days ]
    Time to wean off oxygen supplementation and / or invasive / non-invasive ventilatory support;

  4. Hospital discharge [ Time Frame: 28 days ]
    Time to be discharged from hospital

  5. Rate of mortality within 28-days [ Time Frame: 28 days ]
    Evaluation of change in acute respiratory syndrome



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  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

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): NCT04329572


Locations
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Brazil
Prevent Senior Private Operadora de Saúde LTDA.
São Paulo, Brazil
Sponsors and Collaborators
Azidus Brasil
Investigators
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Study Director: Luciana Ferrara Azidus Brasil
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Responsible Party: Azidus Brasil
ClinicalTrials.gov Identifier: NCT04329572    
Other Study ID Numbers: HIAPRE0320OR
First Posted: April 1, 2020    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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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