International ALLIANCE Study of Therapies to prevent progression of COVID-19, a randomized trial - Stage 2

Therapies to prevent progression of COVID-19, including Quercetin, Zinc, high dose Vitamin D with or without Intravenous Vitamin C, a multi-centre, international, randomized trial: The International ALLIANCE Study - Stage 2

Status

Withdrawn

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12622000309785

Enrollment

200

Registered

2022-02-18

Start date

2022-03-21

Completion date

2023-02-17

Last updated

2023-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Stage 2 of this study is linked to Stage 1 - ACTRN12620000557932 COVID-19 is a global pandemic. So far encouraging results have been shown in different parts of the world with the utilisation of quercetin, zinc, and intravenous Vitamin C. Vitamin D levels have also been shown to be an important indicator to the severity of symptoms in COVID-19 patients. 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.

Interventions

Stage 2: In and Outpatients in Turkey Arm 1) Quercetin plus zinc plus Vit D3 Arm 2) Quercetin plus zinc plus Vit D3 plus intravenous (IV) Vitamin C Trial Arm 1: Quercetin : 500mg oral twice a day for 7 day Zinc Citrate: 30mg elemental zinc oral daily for 7 days Vitamin D3 high dose: 600,000 IU intra-muscular bolus once on day 1 after Vitamin D level blood test, followed up by 50,000IU orally weekly for 4 weeks Trial Arm 2: Quercetin : 500mg oral twice a day for 7 day Zinc Citrate: 30mg elemental zinc oral daily for 7 days Vitamin D3 high dose: 600,000 IU intra-muscular bolus once on day 1 after Vitamin D level blood test, followed up by 50,000IU orally weekly for 4 weeks Plus IV Vitamin C (Sodium Ascorbate): 30g /day for 4 days; equivalent to 50mg/kg every 6hrs on day 1 followed by 100mg/kg every 6hrs (4x day, 400mg/kg/day) for 4 days (average 28g/day; maximum dose of 50g/24hrs for those weighing more than 125kg). 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.

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

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 quercetin 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 quercetin, or 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

Outcome results