International ALLIANCE Study of Therapies to Prevent Progression of COVID-19

NCT04395768 | Unknown Phase 2

• 1 other identifier: Alliance-COVID19
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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 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.

Conditions

COVID19

Keywords

COVID19; hydroxychloroquine; azithromycin; zinc; Vit-D3; B12; C

Outcome Measures

Primary Outcomes (3)

• Symptoms

  Composite measure: Change in severity and duration of symptoms

  once daily for 15 days since enrollment/baseline at admission to hospital

• Length of hospital stay

  total number of days in hospital since admission

  at 15 and 45 days since admission/ enrolment

• invasive mechanical ventilation or mortality

  need for invasive mechanical ventilation or mortality within 15 days from enrolment

  any time within 15 days from enrolment

Secondary Outcomes (8)

• Mortality

  15 and 45 days since enrolment

• mechanical ventilation

  at 15 and 45 days since enrolment

• oxygen

  15 and 45 days since enrolment

• ICU

  15 and 45 days since enrolment

• days in hospital

  15 and 45 days since enrolment

Study Arms (2)

Vitamin C

EXPERIMENTAL

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

Dietary Supplement: Vitamin C; Drug: Hydroxychloroquine; Drug: Azithromycin; Dietary Supplement: Zinc Citrate; Dietary Supplement: Vitamin D3; Dietary Supplement: Vitamin B12

Control

ACTIVE COMPARATOR

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

Drug: Hydroxychloroquine; Drug: Azithromycin; Dietary Supplement: Zinc Citrate; Dietary Supplement: Vitamin D3; Dietary Supplement: Vitamin B12

Interventions

Vitamin C DIETARY_SUPPLEMENT

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)

Also known as: Sodium ascorbate

Vitamin C

Hydroxychloroquine DRUG

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

Also known as: Plaquenil

Control; Vitamin C

Azithromycin DRUG

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

Also known as: Z-Pak, Zithromax

Control; Vitamin C

Zinc Citrate DIETARY_SUPPLEMENT

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

Control; Vitamin C

Vitamin D3 DIETARY_SUPPLEMENT

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

Also known as: Cholecalciferol

Control; Vitamin C

Vitamin B12 DIETARY_SUPPLEMENT

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

Also known as: Methylcobalmin

Control; Vitamin C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Provision of informed consent in writing, can be electronic
• Diagnosis of active COVID-19

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Integrative Medicine, Australia: lead

Study Sites (1)

National Institute of Integrative Medicine

Melbourne, Victoria, 3122, Australia

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Ascorbic Acid; Hydroxychloroquine; Azithromycin; Cholecalciferol; Vitamin B 12

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds, 4 or More Rings; Macrocyclic Compounds

Study Officials

• Karin Ried, PhD

  National Institute of Integrative Medicine, Australia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karin Ried, PhD

CONTACT

0061399129545; karinried@niim.com.au

Taufiq Binjemain, MD

CONTACT

0061498049362; tbinjemain@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants not blinded as they will know whether they are receiving the comparator vitamin c (either IVC) or oral in addition to treatments in the control group; outcomes assessor / investigators conducting statistical analysis will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized investigator-blinded controlled

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 20, 2020
• Study Start: September 9, 2020
• Primary Completion: September 30, 2021
• Study Completion: December 31, 2021
• Last Updated: September 11, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)