CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 20 enrolled
Drug / intervention
HCQ +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04358081
NCT04358081Phase 3Completed

A Multi-center, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of Hydroxychloroquine Monotherapy and in Combination With Azithromycin in Patients With Moderate and Severe COVID-19 Disease

Novartis Pharmaceuticals·interventional·Posted Apr 22, 2020·Updated Oct 11, 2021

In Brief

A Phase 3 clinical trial evaluating HCQ, HCQ+AZT, and 1 other intervention for Covid-19. Completed, enrolled 20 participants across 7 sites.

Detailed Summary

Two recent studies have suggested that in patients with Covid19, treatment with hydroxychloroquine may shorten the duration of symptoms and improve viral clearance, an effect that appears most pronounced when combined with azithromycin. Hydroxychloroquine treatment may inhibit viral nucleic acid-mediated activation of various innate immune pathways, as well as blockade of lysosomal functions in cell types relevant for viral entry and antigen presentation. The purpose of the study was to determine if oral hydroxychloroquine monotherapy, or in combination with azithromycin results in clinical benefit in patients hospitalized with COVID19 pneumonia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCovid-19
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedApr 22, 2020
Enrollment StartMay 1, 2020
Primary CompletionJul 27, 2020
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 6.2 years ago

Interventions

HCQdrug

Hydroxychloroquine Monotherapy

HCQ+AZTdrug

Hydroxychloroquine with azithromycin

Placebodrug

Placebo