Hydroxychloroquine for the Community-Based Treatment of COVID-19

Phase 2

Withdrawn

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

• Registration Number: ACTRN12620000457943
• Lead Sponsor: Medical Research Institute of New Zealand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-08
• Last Update Posted: 2 November 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

•Aged 18 to 75 years.
•Laboratory confirmed SARS-CoV2 infection.
•Advised to self-manage COVID-19 in the community by the regional public health team.
•In the Investigator’s opinion, is able and willing to comply with all trial requirements.
•Baseline Flu PRO score >1.3
•Able to receive and commence randomised treatment via courier the day after consent was obtained.

Exclusion Criteria

•Known pregnancy or planning to become pregnant during the study period
•Currently breastfeeding
•Known maculopathy or retinal disorder.
•Known cardiac disease/dysrhythmia or prolonged QTc
•Know renal disease
•Known hepatic disease
•Known hypomagnesaemia or hypokalaemia.
•Currently using hydroxychloroquine or any 4-aminoquinoline.
•Use of medications prolonging QTc including: Class IA (quinidine, procainamide, disopyramide) and III (amiodarone, sotalol, ibutilide, dofetilide) antiarrythmics, macrolides, methadone, fluoroquinolones, domperidone, fluconazole, ondansetron, tacrolimus, tramadol, anti-retrovirals.
•Current use of tamoxifen, digoxin, tricyclics, SSRIs, antipsychotics, halfantrine, cyclosporin and anti-epileptic medications
•Current use of oral hypoglycaemics including glipizide, glyburide, gliclazide, glimepiride, repaglinide, nateglinide, metformin, rosiglitazone, pioglitazone, acarbose, miglitol, voglibose, sitagliptin, saxagliptin, vildagliptin, linagliptin, alogliptin, dapagliflozin, canagliflozin, bromocriptine.
•Sensitivity or allergy to 4-aminoquinilone compounds or any excipients used in the study
•Unable to access digital consent forms or maintain remote contact with the study team
•Have any other condition which, at the investigator’s discretion, is believed may present a safety risk or impact the feasibility of the study or the study results.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of Hydroxychloroquine in the community-based management of COVID-19 assessed by the mean daily InFLUenza Patient-Reported Outcome (FLU-PRO) illness severity score[Day 5 of treatment administration]