Trial NCT04329923
Publication Abella BS, JAMA Intern Med, 2020
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
| Methods | |
| RCT | |
| Location :
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 per week in hospital- based units, (2) had no known history of SARS-CoV-2 infection, and (3) did not have symptoms suggestive of COVID-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 dedicated COVID-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 |
| Interventions | |
| Treatment
Hydroxychloroquine (600mg OD) Duration : 8 weeks |
|
| Control
Placebo Duration : 8 weeks | |
| Participants | |
| Randomized 132 participants (n1=66 / n2= 66) | |
| Characteristics of participants N=132 Mean age : NR 41 males | |
| Primary outcome | |
| In the register Rate of COVID-19 infection at 2 months | |
| In the report | |
| Documents available |
Protocol Yes. In English Statistical plan Yes Data-sharing stated Yes |
| Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Some concerns |
| 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. |