Trial NCT04329923
Publication Amaravadi R, medRxiv, 2021 (preprint)
Dates: 2020-04-15 to 2020-07-14
Funding: Mixed (Leonard & Madlyn Abramson and Mark & Cecilia Vonderheide (philanthropic donations to the University of Pennsylvania) , iRhythm Technologies, Inc. (Cardiac arrhythmia monitoring provided as an in-kind gift))
Conflict of interest: No
| Methods | |
| RCT Blinding: | |
| Location :
Single center / USA Follow-up duration (days): 19 | |
| Inclusion criteria | 1) Age ≥40 years,
2) PCR-positive for the SARS-CoV-2 virus, 3) fever, or cough, or shortness of breath at the time of testing, 4) ≤4 days had elapsed since the first COVID-19 symptom and testing, 5) not taking azithromycin at the time of enrollment, 6) symptomatic at the time of enrollment, 7) did not require hospitalization, 8) lived within 30 miles of Hospital of the University of Pennsylvania, 9) had access to a working computer, or smartphone and have internet access, 10) willing to fill out a daily electronic symptom score, 11) available for a daily phone call, 12) willing to take their own temperature twice a day, 13) willing to report the observed symptoms and development of COVID-19 in co-habitants. |
| Exclusion criteria | 1) known history of allergy or sensitivity to HCQ,
2) history of glucose-6-phosphate dehydrogenase deficiency, 3) history of retinal disease, 4) history of significant cardiac disease, 5) current use of tricyclic antidepressants, and other medications known to prolong the QT interval, 6) history of psoriasis, 7) history of significant lung disease, 8) participation in any other pharmacologic research study for COVID-19, 9) pregnancy or intention to become pregnant within the study period. |
| Interventions | |
| Treatment
Hydroxychloroquine 400 mg (two 200 mg tablets) orally twice daily up to 14 days |
|
| Control
Placebo | |
| Participants | |
| Randomized 34 participants (n1=17 / n2= 17) | |
| Characteristics of participants N=34 Mean age : NR 13 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=0 | |
| Primary outcome | |
| In the register Time to Release From Quarantine Time [ Time Frame: until quarantine release or hospitalization ] | |
| In the report Median time to RFQ [Release From Quarantine] | |
| Documents available |
Protocol Yes. In English Statistical plan Yes Data-sharing stated
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| 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 |
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| General comment |