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

Early Phase 1

Suspended

• Conditions: COVID-19
• Interventions: Drug: Hydroxychloroquine Sulfate; Drug: Azithromycin Tablets

• Registration Number: NCT04329572
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2020-03-29
• Study First Submitted QC: 2020-03-30
• Study First Posted: 2020-04-01
• Study Start: 2020-04-23
• Primary Completion: 2020-05-31
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-03
• Last Update Posted: 2022-11-07
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HCQ + AZT	Azithromycin Tablets	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.
HCQ + AZT	Hydroxychloroquine Sulfate	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.

Primary Outcome Measures

Name	Time	Method
Evolution of acute respiratory syndrome, oxygen saturation hemodynamic stability	28 days	Evaluation of change from baseline. Kaplan-meier method will be used.

Secondary Outcome Measures

Name	Time	Method
Viral load	Day 6	Evaluation of change in viral load
Change in Clinical Condition	28 days	Time for normalization of body temperature, respiratory rate and cough relief
Rate of mortality within 28-days	28 days	Evaluation of change in acute respiratory syndrome
Evolution of Acute Respiratory Syndrome	28 days	Time to wean off oxygen supplementation and / or invasive / non-invasive ventilatory support;
Hospital discharge	28 days	Time to be discharged from hospital

Trial Locations

Locations (1)

Prevent Senior Private Operadora de Saúde LTDA.; 🇧🇷 São Paulo, Brazil