Hidroxicloroquina With Azitromicina Versus Hidroxicloroquina and Placebo Int Patients With Mild COVID-19
Status:
Recruiting
Trial end date:
2021-08-01
Target enrollment:
Participant gender:
Summary
Chloroquine and hydroxychloroquine are two antimalarial drugs that are also used in
autoimmune diseases. Chloroquine analogs have been shown to inhibit endosome acidification
and exhibit nonspecific antiviral activity at high micromolar concentration in vitro against
a wide range of emerging viruses (HIV, dengue, hepatitis C, chikungunya, influenza, Ebola,
SARS, and MERS ). virus) and more recently COVID-19. On the other hand, azithromycin is a
macrolide antibiotic indicated for infections caused by sensitive pathogens, but which in
combination with Hydroxychloroquine has shown a synergistic effect against the SARS-CoV-2
virus.
International studies show the lack of beneficial effect in hospitalized or mechanically
ventilated patients. Referring that because these medications reduce the in case of having a
beneficial effect it would be in the early onset, to avoid inflammation (cytokine storm), and
thus prevent hospitalizations.
The present study focuses on characterizing the possible synergy of the fixed combination of
hydroxychloroquine associated with azithromycin in the treatment of Covid-19 from mild to
moderate manifestations. Three treatment schemes are proposed with a 10-day follow-up, a) the
fixed combination of Hydroxychloroquine / Azithromycin (combination of interest), b)
Hydroxychloroquine (active comparison group) and c) non-active control group, using placebo.
A group of patients between 18 and 75 years old is considered, who may or may not present
other comorbidities. Follow-up will be carried out through quantification of viral load,
evaluation of the systemic inflammatory state, changes in clinical manifestations and
possible effect on the reduction of hospitalizations. Therefore, it is proposed to carry out
the following project.
objective To determine the efficacy and safety of Hydroxychloroquine / Azithromycin fixed
combination compared to Hydroxychloroquine or placebo in outpatients with Research design:
Phase II, multicenter, prospective, randomized, parallel, longitudinal, double-blind study.
Medications to use Group 1. Fixed combination of Hydroxychloroquine with Azithromycin 200 mg
/ 250 mg one tablet every 12 hours for five days and continue with Hydroxychloroquine 200 mg
one tablet every 12 hours for 5 more days.
Group 2. Hydroxychloroquine 200 mg, one tablet every 12 hours for ten days. Group 3. Placebo
one tablet every 12 hours for ten days.