None listed
Conditions
Brief summary
The COVID-19 pandemic continues to escalate in terms of morbidity and mortality worldwide. Evidenced-based treatment strategies are lacking and currently focused on managing severe disease in hospitalised patients. With most infected patients self-managing in the community there is potential to minimise symptoms, viral load and transmissibility of COVID-19 through effective interventions in this setting. Hydroxychloroquine (HCQ) is an affordable, available and safe drug with demonstrable inhibitory effect in vitro against the virus causing COVID-19. Participants will administer HCQ or placebo for five days, completing daily diary entries to assess their symptoms as well as measuring tympanic temperature twice daily. This national, randomised, placebo-controlled trial of hydroxychloroquine in the community-based management of confirmed COVID-19 patients will provide evidence of efficacy and inform a definitive study to assess high priority clinical outcomes such as relative reduction in hospital admission rates and mortality.
Interventions
Oral administration of Hydroxychloroquine capsules for five days.
Day 1: 800mg (4 capsules) Hydroxychloroquine stat
Days 2 - 5: 400mg (2 capsules) Hydroxychloroquine once daily
Adherence to trial treatment will be assessed through the study diaries which will require the participant to complete the time of administration and number of tablets taken each day. Participants will not be required to return used study treatments to the research office but encouraged to dispose of any unused medicatio
Oral administration of Hydroxychloroquine capsules for five days. Day 1: 800mg (4 capsules) Hydroxychloroquine stat Days 2 - 5: 400mg (2 capsules) Hydroxychloroquine once daily Adherence to trial treatment will be assessed through the study diaries which will require the participant to complete the time of administration and number of tablets taken each day. Participants will not be required to return used study treatments to the research office but encouraged to dispose of any unused medication via their community pharmacy or general practice.
Sponsors
Medical Research Institute of New Zealand
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Outcome results
None listed