Status:
UNKNOWN
International ALLIANCE Study of Therapies to Prevent Progression of COVID-19
Lead Sponsor:
National Institute of Integrative Medicine, Australia
Conditions:
COVID19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
COVID-19 is a global pandemic. So far encouraging results have been shown in different parts of the world with the utilisation of hydroxycloroquine, zinc, and azithromycin, and early studies into some...
Detailed Description
Study Design Type of study A multi-centre, open-label, randomized controlled trial evaluating the efficacy and safety of therapy with azithromycin, hydroxychloroquine, zinc, vitamin D3/B12 and IV vit...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Provision of informed consent in writing, can be electronic
- Diagnosis of active COVID-19
Exclusion
- Known G6PD deficiency
- Contra-indication to hydroxychloroquine, azithromycin or Vitamin C: allergy to study interventions, epilepsy, serious hearing or visual problems, history of severe depression, calcium oxalate stones, advanced liver disease, pregnancy or lactating
- Already receiving chloroquine, azithromycin, \>3 grams Vitamin C daily or an experimental antiviral
- History of fever (e.g. night sweats, chills) and/or acute respiratory infection (e.g. cough, shortness of breath, sore throat) of more than 7 days' duration. Note, if study numbers not quickly reached, the investigators may decide to include those with symptoms of longer than 7 days
- Calculated creatinine clearance of \< 30 mL/minute
- Baseline ECG showing: QTc ≥470 for males, QTc ≥480 for females
- Receipt of a drug known to increase QTc: quetiapine, amiodarone, sotalol
Key Trial Info
Start Date :
September 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04395768
Start Date
September 9 2020
End Date
December 31 2021
Last Update
September 11 2020
Active Locations (1)
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1
National Institute of Integrative Medicine
Melbourne, Victoria, Australia, 3122