Publication Abella BS
Dates: 4/9/2020 to 7/14/2020
Funding: Private (Philanthropic donations from Leonard and Madlyn Abramson and Mark and Cecilia Vonderheide; Sandoz)
Conflict of interest: Conflicts of interest
Multicenter / USA |
Follow-up duration (days): 56
|Inclusion criteria||Health care workers at either study hospital were eligible for inclusion if they (1)worked 20 hours or more perweek in hospital- based units, (2) had no knownhistory of SARS-CoV-2 infection, and (3) did not have symptomssuggestive ofCOVID-19 in the 2 weeks before enrollment, including cough, fever, or shortness of breath. Physicians, nurses, certified nursing assistants, emergency technicians, and respiratory therapists were eligible. Enrollment was focused on staff members in the emergency department and dedicatedCOVID-19 units.|
|Exclusion criteria||<18 years of age
Prisoner or other detained person
Allergy to hydroxychloroquine, 4 aminoquinolines, or quinine
Patients with known history of G6PD deficiency
Pregnant and/or breastfeeding, see above
Receiving any treatment drug for 2019-ncov within 14 days prior to screening evaluation (off label, compassionate use or trial related).
Co-enrollment onto another interventional COVID-19 study is not allowed.
Known history of retinal disease, including but not limited to, macular degeneration, retinal vein occlusion, visual field defect, diabetic retinopathy
Known history of interstitial lung disease, severe emphysema or asthma, or chronic pneumonitis unrelated COVID-19.
Taking any of the following medications that prolong Qtc: Chlorpromazine, Haloperidol, Droperidol, Quetiapine, Olanzapine, Amisulpride, Thioridazine
Due to risk of disease exacerbation patients with known porphyria or psoriasis are ineligible unless the disease is well controlled and they are under the care of a specialist for the disorder who agrees to monitor the patient for exacerbations.
Patients with serious intercurrent illness that requires active infusional therapy, intense monitoring, or frequent dose adjustments for medication including but not limited to infectious disease, cancer, autoimmune disease, cardiovascular disease.
Patients who have undergone major abdominal, thoracic, spine or CNS surgery in the last 2 months, or plan to undergo surgery during study participation.
Patients receiving cytochrome P450 enzyme-inducing anticonvulsant drugs (i.e. phenytoin, carbamazepine, Phenobarbital, primidone or oxcarbazepine) within 4 weeks of the start of the study treatment
History or evidence of increased cardiovascular risk including any of the following:
Left ventricular ejection fraction (LVEF) < institutional lower limit of normal. Baseline echocardiogram is not required.
Current clinically significant uncontrolled arrhythmias. Exception: Participants with controlled atrial fibrillation
History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to enrollment
Current ? Class II congestive heart failure as defined by New York Association
Duration : 8 weeks
Duration : 8 weeks
132 participants (n1=66 / n2= 66)
|Characteristics of participants|
Mean age : NR
|In the register|
Rate of COVID-19 infection at 2 months
|In the report|
Rate of conversion to SARS-CoV-2positive status via NP swab
Yes. In Yes
|Risk of bias
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
|General comment||In addition to the published report, the trial registration, protocol and statistical plan analysis were used in data extraction and risk of bias assessment. This is the report of one out of three cohorts of The PATCH trial (Prevention And Treatment of COVID-19 with Hydroxychloroquine). Crossover from placebo to HCQ was allowed upon disease progression/ virus confirmation. The study did not achieve its planned sample size because after the first planned interim analysis the trial was halted on the basis of a very low incidence rate among study participants. There was no change from trial registration to report in the intervention and control treatments, as well as the outcomes.|