Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Ambulatory Patients With Mild COVID-19

• ClinicalTrials.gov Identifier: NCT04348474
• Recruitment Status: Suspended
• First Posted: April 16, 2020
• Last Update Posted: November 4, 2022
• Sponsor: Azidus Brasil
• Information provided by (Responsible Party): Azidus Brasil

Study Description

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.

Study Design

• 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
• Actual Study Start Date: April 20, 2020
• Actual Primary Completion Date: June 30, 2020
• Estimated Study Completion Date: July 2023

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

Brazil

Prevent Senior Private Operadora de Saúde LTDA.

São Paulo, Brazil

Sponsors and Collaborators

Azidus Brasil

More Information

• Responsible Party: Azidus Brasil
• ClinicalTrials.gov Identifier: NCT04348474
• Other Study ID Numbers: HIAPRE0420OR
• First Posted: April 16, 2020
• Last Update Posted: November 4, 2022
• Last Verified: November 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Azithromycin; Hydroxychloroquine; Anti-Bacterial Agents; Anti-Infective Agents; Antimalarials; Antiprotozoal Agents; Antiparasitic Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents