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Trial record 1 of 1 for:    NCT04348474
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Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Ambulatory Patients With Mild COVID-19

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ClinicalTrials.gov Identifier: NCT04348474
Recruitment Status : Suspended (Azidus, the CRO hired for this study by Prevent Senior has lost the interest to conduct this study.)
First Posted : April 16, 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 D7) and azithromycin (500 mg/ 5 days) to treat mild ambulatory COVID-19 patients.

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

Detailed Description:

This is an exploratory study to evaluate the efficacy of hydroxychloroquine (400 mg BID on D1 and 400 mg/day on D2 to D7) and azithromycin (500 mg/ 5 days) to treat mild ambulatory COVID-19 patients.

We aim to demonstrate decrease in hospital related complications among ambulatory patients with mild COVID-19 by treating them with HCQ and AZT on top of standard care compared to patients who receive standard care only.

Ambulatory patients on day 3 of symptoms and 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 : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label, Multicentric, Non Randomized, Exploratory Clinical Trial to Assess the Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Mild Acute Respiratory Syndrome (COVID-19) Caused by SARS-CoV-2 Virus
Estimated Study Start Date : April 20, 2020
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : July 31, 2020


Arm Intervention/treatment
Experimental: HCQ + AZT
All patients included in the study will receive hydroxychloroquine (HCQ) 400 mg (00 mg BID on D1 and 400 mg/day on D2 to D7) and azithromycin (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 D7) for 7 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. Change in Clinical Condition [ Time Frame: 28 days ]
    Ordinal scale (7 points ordinal scale that measures illness severity over time)


Secondary Outcome Measures :
  1. Hospitalization [ Time Frame: 28 days ]
    Number of patients that needed to be hospitalized

  2. Change in Clinical Condition [ Time Frame: 28 days ]
    Time for normalization of body temperature

  3. Change in Clinical Condition [ Time Frame: 28 days ]
    Time for normalization of of respiratory rate

  4. Change in Clinical Condition [ Time Frame: 28 days ]
    Time for cough relief

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

  6. Change in Clinical Condition related to comorbidity [ Time Frame: 28 days ]
    Subgroup analysis by comorbidities



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:

  1. Informed consent from patient or legal representative.
  2. Male or female, and:

    1. aged ≥ 70 years; or
    2. aged < 70 with associated risk factors (chronic obstructive pulmonary disease; heart failure, immunosuppressed, obesity (BMI ≥ 35) uncontrolled diabetes and uncontrolled systemic arterial hypertension)
  3. One or more mild symptoms characteristic of COVID-19 for 3 days, such as fever, cough and signs of respiratory distress, which do not require hospitalization.

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): NCT04348474


Locations
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Brazil
Prevent Senior Private Operadora de Saúde LTDA.
São Paulo, Brazil
Sponsors and Collaborators
Azidus Brasil
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Responsible Party: Azidus Brasil
ClinicalTrials.gov Identifier: NCT04348474    
Other Study ID Numbers: HIAPRE0420OR
First Posted: April 16, 2020    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 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