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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04329572
• Other study ID #: HIAPRE0320OR
• Status: Suspended
• Phase: Early Phase 1
• Start date: April 23, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: November 2022
• Source: Azidus Brasil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 400
• Est. completion date: June 30, 2023
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
Brazil	Prevent Senior Private Operadora de Saúde LTDA.	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Azidus Brasil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of acute respiratory syndrome, oxygen saturation hemodynamic stability	Evaluation of change from baseline. Kaplan-meier method will be used.	28 days
Secondary	Viral load	Evaluation of change in viral load	Day 6
Secondary	Change in Clinical Condition	Time for normalization of body temperature, respiratory rate and cough relief	28 days
Secondary	Evolution of Acute Respiratory Syndrome	Time to wean off oxygen supplementation and / or invasive / non-invasive ventilatory support;	28 days
Secondary	Hospital discharge	Time to be discharged from hospital	28 days
Secondary	Rate of mortality within 28-days	Evaluation of change in acute respiratory syndrome	28 days