None listed
Conditions
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 of these, plus some with IV Vitamin C, have also proven beneficial. Vitamin D levels have also been shown to be an important indicator to the severity of symptoms in COVID-19 patients. Anticoagulation has also proven to be highly beneficial in patients hospitalized with COVID-19. This study aims to find the optimal treatment protocol for hospitals to consider in their treatment of COVID-19 patients and their endeavours to save lives. Stage 1 of the outpatient group in Australia is ongoing. Stage 1 of the inpatient/ hospitalised patient group in Turkey has now been published.
Interventions
Stage 1 - Inpatients (Turkey) and outpatients (Australia):
2 trial arms:
Stage 1- 1) Hydroxychloroquine plus zinc plus Vit D3 plus azithromycin
Stage 1 - 2) Hydroxychloroquine plus zinc plus Vit D3 plus azithromycin plus IV Vitamin C
Inpatients: Hydroxychloroquine 400mg PO once a day for 1 day, followed by 200mg PO once a day for 6 days*; *HCQ will be discontinued on the day of discharge
Outpatients: Hydroxychloroquine 400mg PO once
Azithromycin: 500 mg oral tablet on day 1 followed by 250 mg
Stage 1 - Inpatients (Turkey) and outpatients (Australia): 2 trial arms: Stage 1- 1) Hydroxychloroquine plus zinc plus Vit D3 plus azithromycin Stage 1 - 2) Hydroxychloroquine plus zinc plus Vit D3 plus azithromycin plus IV Vitamin C Inpatients: Hydroxychloroquine 400mg PO once a day for 1 day, followed by 200mg PO once a day for 6 days*; *HCQ will be discontinued on the day of discharge Outpatients: Hydroxychloroquine 400mg PO once Azithromycin: 500 mg oral tablet on day 1 followed by 250 mg oral tablet once daily for 4 days Zinc Citrate: 30mg elemental zinc oral tablet daily for 14 days Vitamin D3: 5,000iu oral capsule daily for 14 days Trial Arm 1 Plus Inpatients: IV Vitamin C (Sodium Ascorbate) 50mg/kg every 6hrs on day 1 followed by 100mg/kg every 6hrs (4x day, 400mg/kg/day) for 7 days (average 28g.day; maximum dose of 50g/24hrs for those weighing more than 125kg). Outpatients: Vitamin C (Sodium Ascorbate): 200mg/kg x1 IV, then 1 gram oral tablet three times per day for 7 days All treatments will be administered by medical staff briefed on the trial protocol. Adherence and fidelity will be assessed and recorded on the trial specific electronic data collection sheet by medical staff providing the trial treatment.
Sponsors
AProf Dr Karin Ried
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Diagnosis of active COVID-19 Provision of informed consent in writing, can be electronic
Exclusion criteria
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
Outcome results
None listed