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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04395768




Registration number
NCT04395768
Ethics application status
Date submitted
18/05/2020
Date registered
20/05/2020

Titles & IDs
Public title
International ALLIANCE Study of Therapies to Prevent Progression of COVID-19
Scientific title
Therapies to Prevent Progression of COVID-19, Including Hydroxychloroquine, Azithromycin, Zinc, Vitamin D, Vitamin B12 With or Without Vitamin C, a Multi-centre, International, Randomized Trial: The International ALLIANCE Study
Secondary ID [1] 0 0
Alliance-COVID19
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID19 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Vitamin C
Treatment: Drugs - Hydroxychloroquine
Treatment: Drugs - Azithromycin
Treatment: Other - Zinc Citrate
Treatment: Other - Vitamin D3
Treatment: Other - Vitamin B12

Experimental: Vitamin C - Participants will receive vitamin C in addition to active comparator treatment:

Inpatients: IV Vitamin C (Sodium Ascorbate) 50mg/kg every 6hrs on day 1 followed by 100mg/kg every 6hrs (4x per day; 400mg/kg/day) for 7 days (average 28g/day; maximum dose of 50g/24hrs for those weighing more than 125kg). Can be converted to 1 gram three times per day PO on hospital discharge) Outpatients: Vitamin C Outpatient trial: 200mg/kg x1 IV, then 1 gram PO three times per day for 7 days;

Plus Active Comparator treatment:

Hydroxychloroquine Hydroxychloroquine 400mg (2x200mg) PO for 1 day, followed by 200mg PO per day for 6 days Azithromycin 500 mg PO on day 1 followed by 250 mg PO once daily for 4 days Zinc Citrate 30mg elemental zinc PO daily Vitamin D3 5,000iu PO daily for 14 days Vitamin B12 (Methylcobalamin) 500mcg PO daily for 14 days

Active comparator: Control - Hydroxychloroquine Hydroxychloroquine 400mg (2x200mg) PO for 1 day, followed by 200mg PO per day for 6 days Azithromycin 500 mg PO on day 1 followed by 250 mg PO once daily for 4 days Zinc Citrate 30mg elemental zinc PO daily Vitamin D3 5,000iu PO daily for 14 days Vitamin B12 (Methylcobalamin) 500mcg PO daily for 14 days


Treatment: Other: Vitamin C
In addition to the active comparator, which is a combination of 2 drugs and 3 dietary supplements, the experimental treatment arm will also receive Vitamin C (intravenous or oral)

Treatment: Drugs: Hydroxychloroquine
Active comparator group will receive: a combination of 2 drugs and 3 dietary supplements

Treatment: Drugs: Azithromycin
Active comparator group will receive: a combination of 2 drugs and 3 dietary supplements

Treatment: Other: Zinc Citrate
Active comparator group will receive: a combination of 2 drugs and 3 dietary supplements

Treatment: Other: Vitamin D3
Active comparator group will receive: a combination of 2 drugs and 3 dietary supplements

Treatment: Other: Vitamin B12
Active comparator group will receive: a combination of 2 drugs and 3 dietary supplements
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Symptoms
Timepoint [1] 0 0
once daily for 15 days since enrollment/baseline at admission to hospital
Primary outcome [2] 0 0
Length of hospital stay
Timepoint [2] 0 0
at 15 and 45 days since admission/ enrolment
Primary outcome [3] 0 0
invasive mechanical ventilation or mortality
Timepoint [3] 0 0
any time within 15 days from enrolment
Secondary outcome [1] 0 0
Mortality
Timepoint [1] 0 0
15 and 45 days since enrolment
Secondary outcome [2] 0 0
mechanical ventilation
Timepoint [2] 0 0
at 15 and 45 days since enrolment
Secondary outcome [3] 0 0
oxygen
Timepoint [3] 0 0
15 and 45 days since enrolment
Secondary outcome [4] 0 0
ICU
Timepoint [4] 0 0
15 and 45 days since enrolment
Secondary outcome [5] 0 0
days in hospital
Timepoint [5] 0 0
15 and 45 days since enrolment
Secondary outcome [6] 0 0
days in ICU
Timepoint [6] 0 0
15 and 45 days since enrolment
Secondary outcome [7] 0 0
renal replacement therapy
Timepoint [7] 0 0
15 and 45 days since enrolment
Secondary outcome [8] 0 0
Extracorporeal support
Timepoint [8] 0 0
15 and 45 days since enrolment

Eligibility
Key inclusion criteria
1. Age = 18 years
2. Provision of informed consent in writing, can be electronic
3. Diagnosis of active COVID-19
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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, >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 < 30 mL/minute
6. Baseline ECG showing: QTc =470 for males, QTc =480 for females
7. Receipt of a drug known to increase QTc: quetiapine, amiodarone, sotalol

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
National Institute of Integrative Medicine - Melbourne
Recruitment postcode(s) [1] 0 0
3122 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
National Institute of Integrative Medicine, Australia
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Karin Ried, PhD
Address 0 0
National Institute of Integrative Medicine, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Karin Ried, PhD
Address 0 0
Country 0 0
Phone 0 0
0061399129545
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04395768