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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04395768
Recruitment Status : Not yet recruiting
First Posted : May 20, 2020
Last Update Posted : May 20, 2020
Sponsor:
Collaborator:
Catholic Health Initiatives
Information provided by (Responsible Party):
National Institute of Integrative Medicine, Australia

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.

Condition or disease Intervention/treatment Phase
COVID19 Dietary Supplement: Vitamin C Drug: Hydroxychloroquine Drug: Azithromycin Dietary Supplement: Zinc Citrate Dietary Supplement: Vitamin D3 Dietary Supplement: Vitamin B12 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized investigator-blinded controlled
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: 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
Primary Purpose: Treatment
Official 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
Estimated Study Start Date : May 25, 2020
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 PO twice a day for 1 day, followed by 200mg PO two times a 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
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)
Other Name: Sodium ascorbate

Drug: Hydroxychloroquine
Active comparator group will receive: a combination of 2 drugs and 3 dietary supplements
Other Name: Plaquenil

Drug: Azithromycin
Active comparator group will receive: a combination of 2 drugs and 3 dietary supplements
Other Names:
  • Z-Pak
  • Zithromax

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

Dietary Supplement: Vitamin D3
Active comparator group will receive: a combination of 2 drugs and 3 dietary supplements
Other Name: Cholecalciferol

Dietary Supplement: Vitamin B12
Active comparator group will receive: a combination of 2 drugs and 3 dietary supplements
Other Name: Methylcobalmin

Active Comparator: Control
Hydroxychloroquine Hydroxychloroquine 400mg PO twice a day for 1 day, followed by 200mg PO two times a 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
Active comparator group will receive: a combination of 2 drugs and 3 dietary supplements
Other Name: Plaquenil

Drug: Azithromycin
Active comparator group will receive: a combination of 2 drugs and 3 dietary supplements
Other Names:
  • Z-Pak
  • Zithromax

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

Dietary Supplement: Vitamin D3
Active comparator group will receive: a combination of 2 drugs and 3 dietary supplements
Other Name: Cholecalciferol

Dietary Supplement: Vitamin B12
Active comparator group will receive: a combination of 2 drugs and 3 dietary supplements
Other Name: Methylcobalmin




Primary Outcome Measures :
  1. Symptoms [ Time Frame: once daily for 15 days since enrollment/baseline at admission to hospital ]
    Composite measure: Change in severity and duration of symptoms

  2. Length of hospital stay [ Time Frame: at 15 and 45 days since admission/ enrolment ]
    total number of days in hospital since admission

  3. invasive mechanical ventilation or mortality [ Time Frame: any time within 15 days from enrolment ]
    need for invasive mechanical ventilation or mortality within 15 days from enrolment


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 15 and 45 days since enrolment ]
    Death

  2. mechanical ventilation [ Time Frame: at 15 and 45 days since enrolment ]
    need for and number of days of invasive mechanical ventilation, in case of no need for mechanical ventilation: days=0

  3. oxygen [ Time Frame: 15 and 45 days since enrolment ]
    need for and number of days for humidified high-flow oxygen

  4. ICU [ Time Frame: 15 and 45 days since enrolment ]
    admission to ICU (intensive care unit)

  5. days in hospital [ Time Frame: 15 and 45 days since enrolment ]
    days in hospital

  6. days in ICU [ Time Frame: 15 and 45 days since enrolment ]
    days in ICU

  7. renal replacement therapy [ Time Frame: 15 and 45 days since enrolment ]
    need for and days of renal replacement therapy

  8. Extracorporeal support [ Time Frame: 15 and 45 days since enrolment ]
    need for and days of Extracorporeal support



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Provision of informed consent in writing, can be electronic
  3. Diagnosis of active COVID-19

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04395768


Contacts
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Contact: Karin Ried, PhD 0061399129545 karinried@niim.com.au
Contact: Taufiq Binjemain, MD 0061498049362 tbinjemain@gmail.com

Sponsors and Collaborators
National Institute of Integrative Medicine, Australia
Catholic Health Initiatives
Investigators
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Principal Investigator: Karin Ried, PhD National Institute of Integrative Medicine, Australia
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Responsible Party: National Institute of Integrative Medicine, Australia
ClinicalTrials.gov Identifier: NCT04395768    
Other Study ID Numbers: Alliance-COVID19
First Posted: May 20, 2020    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by National Institute of Integrative Medicine, Australia:
COVID19
hydroxychloroquine
azithromycin
zinc
Vit-D3
B12
C
Additional relevant MeSH terms:
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Disease Progression
Disease Attributes
Pathologic Processes
Vitamin D
Cholecalciferol
Vitamins
Ascorbic Acid
Vitamin B 12
Hydroxocobalamin
Azithromycin
Hydroxychloroquine
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Antirheumatic Agents
Antioxidants
Protective Agents
Vitamin B Complex
Hematinics