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

Not Applicable

Withdrawn

• Conditions: COVID-19; Infection - Other infectious diseases; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12622000309785
• Lead Sponsor: AProf Dr Karin Ried

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-18
• Last Update Posted: 27 March 2023

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mortality within 15 days from enrolment assessed by data linkage to patient medical records [daily for 15 days from enrolment];Composite: Change in severity and duration of symptoms, assessed by data linkage to patient medical records[at 7 days, 15, 30 and 45 days since enrolment / baseline = admission to hospital];length of hospital stay = days discharge since hospital admission assessed by data linkage to patient medical records[days in hospital since admission at hospital discharge]

Secondary Outcome Measures

Name	Time	Method
eed for and number of days for humidified high-flow oxygen assessed by linkage to patient medical records[at day 7, 15, 30 and 45 since enrolment];Admission to ICU assessed by data linkage to patient medical records[at day 7, 15, 30 and 45 since enrolment];Days in hospital assessed by data linkage to patient medical records[at day 7, 15, 30 and 45 since enrolment];Days in ICU assessed by data linkage to patient medical records[at day 7, 15, 30 and 45 since enrolment];required additional therapy, including anti-biotic, i.e. Azithromycin; anti-coagulalent, or steroid assessed by data linkage to patient medical records[at day 7, 15, 30 and 45 since enrolment];Need for and days of renal replacement therapy assessed by data linkage to patient medical records[at day 7, 15, 30 and 45 since enrolment];Need for and days of extracorporeal support assessed by data linkage to patient medical records[at day 7, 15, 30 and 45 since enrolment]