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

Early Phase 1SuspendedNCT04329572

Azidus Brasil400 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

400

Conditions

COVID-19

Interventions

Hydroxychloroquine SulfateDRUG

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.

Azithromycin TabletsDRUG

All patients included in the study will receive AZT 500 mg per day for 5 days.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Prevent Senior Private Operadora de Saúde LTDA.

São Paulo, Brazil

Outcomes

Primary Outcomes

Evolution of acute respiratory syndrome, oxygen saturation hemodynamic stability

Evaluation of change from baseline. Kaplan-meier method will be used.

Time frame: 28 days

Secondary Outcomes

Viral load

Evaluation of change in viral load

Time frame: Day 6

Change in Clinical Condition

Time for normalization of body temperature, respiratory rate and cough relief

Time frame: 28 days

Evolution of Acute Respiratory Syndrome

Time to wean off oxygen supplementation and / or invasive / non-invasive ventilatory support;

Time frame: 28 days

Hospital discharge

Time to be discharged from hospital

Time frame: 28 days

Rate of mortality within 28-days

Evaluation of change in acute respiratory syndrome

Time frame: 28 days

Data from ClinicalTrials.gov

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