COVID-19: addition of azithromycin to chloroquine treatment

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49080

Enrollment

Registered

2020-04-06

Start date

2020-04-20

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

COVID-19 infection

Interventions

One group receives chloroquine: 600 mg (6 tablets A-CQ 100 mg), 12 hours later 300 mg (3 tablets A-CQ 100 mg), followed by 2dd 300 mg per os at day 2-5 and the other group receives chloroquine same

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Proven diagnosis of COVID-19 by positive PCR in any specimen < 48 hours prior to randomization. • Age >= 18 year • Hospitalized patients with illness of any duration, and SpO2

Exclusion criteria

Exclusion criteria: • Severe hypoxemic respiratory failure expected to die < 72 hours after admission • ICU admission < 72 hours • Allergy for chloroquine or azithromycin • Pregnancy • QT-prolongation: pre-existent: QTc males >450ms, QTc females > 470ms at day 1 and at day 2 • Myasthenia gravis • Epilepsy

Design outcomes

Primary

Measure	Time frame
The initial response to treatment will be evaluated during admission. 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	—

Secondary

Measure	Time frame
• 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. • Time of clinical cure (days) • Length of stay • Number of ICU admissions • Mortality • Adverse events Other study parameters (if applicable): - Medical history - Comorbidities - Smoking status - Weight	—

Measure

Time frame

• 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. • Time of clinical cure (days) • Length of stay • Number of ICU admissions • Mortality • Adverse events Other study parameters (if applicable): - Medical history - Comorbidities - Smoking status - Weight

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)