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

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Integrative Medicine, Australia
• Collaborator: Catholic Health Initiatives
• Treatments: Ascorbic Acid; Azithromycin; Cholecalciferol; Hydroxocobalamin; Hydroxychloroquine; Vitamin B 12; Vitamin D; Vitamins

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