18 and older, any sex, with Covid-19. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants Who Achieved Clinical Response by Day 15Primary· 15 days
Clinical response was defined as a) discharged alive; or b) No need for mechanical ventilation in any participants and no need for supplemental oxygen requirement (SpO2) in participants without pre-morbid O2 requirement.
Group
Value
95% CI
Arm 1: Hydroxychloroquine + Aithromycin Placebo
7
Arm 2: Hydroxychloroquine + Azithromycin
7
Arm 3: Hydroxychloroquine Placebo + Azithromycin Placebo
4
Number of Participants Who Achieved Viral ClearanceSecondary· 6 days and 10 Days
Number and percentage of participants with negative or below LLOQ SARS-COV-2 based on polymerase chain reaction (PCR) test
by 6 days
Group
Value
95% CI
Arm 1: Hydroxychloroquine + Aithromycin Placebo
2
Arm 2: Hydroxychloroquine + Azithromycin
3
Arm 3: Hydroxychloroquine Placebo + Azithromycin Placebo
3
by 10 days
Group
Value
95% CI
Arm 1: Hydroxychloroquine + Aithromycin Placebo
2
Arm 2: Hydroxychloroquine + Azithromycin
3
Arm 3: Hydroxychloroquine Placebo + Azithromycin Placebo
3
Number of Participants Discharged or Ready for DischargeSecondary· 15 days
Number of participants who received hydrochloroquine plus azithromycin relative to placebo who were discharged from hospital
Group
Value
95% CI
Arm 1: Hydroxychloroquine + Aithromycin Placebo
7
Arm 2: Hydroxychloroquine + Azithromycin
7
Arm 3: Hydroxychloroquine Placebo + Azithromycin Placebo
4
Time to Return to Pre-morbid Supplemental Oxygen Requirement in Participants Receiving Hydrochloroquine or Hydrochloroquine Plus Azithromycin Relative to PlaceboSecondary· 15 days
Number of participants requiring supplemental oxygen at the time of randomization who returned to pre-morbid supplemental oxygen
Group
Value
95% CI
Arm 1: Hydroxychloroquine + Aithromycin Placebo
7
Arm 2: Hydroxychloroquine + Azithromycin
6
Arm 3: Hydroxychloroquine Placebo + Azithromycin Placebo
4
Adverse events — posted to ClinicalTrials.gov
Time frame: at day 15.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06389201 — Pretreatment With HCQ Before Radiotherapy and Chemotherapy in Advanced NPC Patients
· NA
· recruiting
NCT04528927 — Evaluation of the Efficacy and Safety of Treatments for Patients Hospitalized for COVID-19 Infection Without Signs of Ac
· Phase 3
· withdrawn
NCT04491994 — Clearing the Fog: Is Hydroxychloroquine Effective in Reducing COVID-19 Progression
· Phase 3
· completed
NCT04408456 — Efficacy of Hydroxychloroquine (HCQ) as Post Exposure Prophylaxis (PEP) for Prevention of COVID-19
· Phase 3
· completed
NCT03855007 — The Clinical Efficacy and Safety of Iguratimod in RA and Early RA Patients for 6 Months Treatment
· Phase 4
· completed
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NCT04360538 — Long Term Outcomes of Patients With COVID-19
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Other Novartis Pharmaceuticals trials
Trials by the same sponsor.
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· Phase 3
· not yet recruiting
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· Phase 4
· not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
· not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy
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NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+
· Phase 1, PHASE2
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 11 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04358081.