COVID-19 trials registries data warehouse

https://anzctr.org.au/ACTRN12620000557932.aspx

Karin Ried, Prof.

karinried@niim.com.au

2020-05-11

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

Diagnosis of active COVID-19 Provision of informed consent in writing, can be electronic

1) Known G6PD deficiency 2) 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 3) Already receiving chloroquine, azithromycin, more than 3 grams Vitamin C daily or an experimental antiviral 4) 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 5) Calculated creatinine clearance of less than 30 mL/minute 6) Baseline ECG showing: QTc greater than or equal to (>=) 470 for males, QTc greater than or equal to (>=) 480 for females 7) Receipt of a drug known to increase QTc: quetiapine, amiodarone, sotalol

2

AProf Dr Karin Ried

18

100

Australia;Turkey

No restriction on type of patients

0: No restriction on type of patients

500

Composite: Change in severity and duration of symptoms; assessed by data linkage to patient medical records[once daily for 15 days since enrolment / baseline = admission to hospital];length of hospital stay = days discharge since hospital admissionassessed by data linkage to patient medical records[days in hospital since admission at hospital discharge];composite of need for invasive mechanical ventilation* or mortality within 15 days from enrolment assessed by data linkage to patient medical records*Participants intubated or requiring imminent intubation at the time of enrolment will only be followed for the primary outcome of death.[any time within 15 days from enrolment]

Not reported

[{"arm_notes": "", "treatment_id": 1369, "treatment_name": "Vitamin c", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]