COVID-19: addition of azithromycin to chloroquine treatment

COVID-19: addition of azithromycin to chloroquine treatment - CO VOR IT

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001527-14-NL

Enrollment

Registered

2020-04-06

Start date

2020-04-21

Completion date

Unknown

Last updated

2020-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Interventions

Product Name: chloroquine Product Code: RVG 106659 Pharmaceutical Form: Tablet Product Name: azithromycin Product Code: RVG 117670 Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Proven diagnosis of COVID-19 by positive PCR in any specimen =65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: • Severe hypoxemic respiratory failure expected to die 450ms, QTc females > 470ms at day 1 and at day 2 • Myasthenia gravis • Epilepsy

Design outcomes

Primary

Measure	Time frame
Main Objective: Does addition of azithromycin to standard chloroquine treatment result in a higher clinical cure rate at day 7 than treatment with chloroquine alone in patients with COVID-19. Cure is considered when 4 criteria are present: (1) O2 sat > 94% with room air (2) 24 hours without fever (=38°C) (3) Breathing frequency 94% with room air (2) 24 hours without fever (=38°C) (3) Breathing frequency < 24/min The percentage of patients with clinical cure at day 7 will be calculated ;Timepoint(s) of evaluation of this end point: days of admission to day of discharge primary endpoint will be determined at day 7	—

Measure

Time frame

Main Objective: Does addition of azithromycin to standard chloroquine treatment result in a higher clinical cure rate at day 7 than treatment with chloroquine alone in patients with COVID-19. Cure is considered when 4 criteria are present: (1) O2 sat > 94% with room air (2) 24 hours without fever (=38°C) (3) Breathing frequency 94% with room air (2) 24 hours without fever (=38°C) (3) Breathing frequency < 24/min The percentage of patients with clinical cure at day 7 will be calculated ;Timepoint(s) of evaluation of this end point: days of admission to day of discharge primary endpoint will be determined at day 7

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Secondary

Measure	Time frame
Secondary end point(s): • Does addition of azithromycin to standard chloroquine treatment result in a higher viral clearance rate at day 7 confirmed by a negative COVID-19 PCR than treatment with chloroquine alone in patients with COVID-19. • Day of normalisation of lymphocyte count • Time of clinical cure (days) • Length of stay • Number of ICU admissions • Mortality • Adverse events • CRP course ;Timepoint(s) of evaluation of this end point: days of admission to day of discharge secondary endpoint will be determined at day 7	—

Measure

Time frame

Secondary end point(s): • Does addition of azithromycin to standard chloroquine treatment result in a higher viral clearance rate at day 7 confirmed by a negative COVID-19 PCR than treatment with chloroquine alone in patients with COVID-19. • Day of normalisation of lymphocyte count • Time of clinical cure (days) • Length of stay • Number of ICU admissions • Mortality • Adverse events • CRP course ;Timepoint(s) of evaluation of this end point: days of admission to day of discharge secondary endpoint will be determined at day 7

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Countries

Netherlands

Contacts

Public ContactJ.G.J.V. Aerts

Erasmus MC

j.aerts@erasmusmc.nl00310107040704

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026