COVID-19 trials registries data warehouse

https://anzctr.org.au/ACTRN12620000457943.aspx

Dr Alex Semprini

alex.semprini@mrinz.ac.nz

2020-04-08

Withdrawn

RCT

Randomized

Parallel

Blind label

single-center

Treatment

• 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.

• 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.

2

Medical Research Institute of New Zealand

18

75

New Zealand

Mild disease at enrollment

1: Mild disease at enrollment

70

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]

Phase 2

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]