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

Not Applicable

Completed

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

• Registration Number: ACTRN12620000557932
• Lead Sponsor: AProf Dr Karin Ried

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-11
• Study Completion: 2023-03-02
• Last Update Posted: 27 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 446

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 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, 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
6) Baseline ECG showing: QTc greater than or equal to (>=) 470 for males, QTc greater than or equal to (>=) 480 for females
7) Receipt of a drug known to increase QTc: quetiapine, amiodarone, sotalol

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite: Change in severity and duration of symptoms, <br>assessed by data linkage to patient medical records<br><br>[once daily for 15 days since enrolment / baseline = admission to hospital];length of hospital stay = days discharge since hospital admission<br>assessed by data linkage to patient medical records<br>[days in hospital since admission at hospital discharge];composite of need for invasive mechanical ventilation* or mortality within 15 days from enrolment assessed by data linkage to patient medical records<br>*Participants intubated or requiring imminent intubation at the time of enrolment will only be followed for the primary outcome of death.<br><br><br><br>[any time within 15 days from enrolment]