Clinical trial NCT04348474: Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Ambulatory Patients With Mild COVID-19
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
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: EARLY_PHASE1
Conditions: Covid-19
Lead sponsor: Azidus Brasil
Sponsor class: INDUSTRY
First posted: 2020-04-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Clinical Condition
timeFrame: 28 days
Secondary outcomes:
measure: Hospitalization
timeFrame: 28 days
measure: Change in Clinical Condition
timeFrame: 28 days
measure: Change in Clinical Condition
timeFrame: 28 days
measure: Change in Clinical Condition
timeFrame: 28 days
measure: Rate of mortality within 28-days
timeFrame: 28 days
measure: Change in Clinical Condition related to comorbidity
timeFrame: 28 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Prevent Senior Private Operadora de Saúde LTDA.
Study officials:
References: