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