Trial NCT04329923
Publication PATCH - 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
participants :
Hydroxychloroquine=17
Placebo=17
Characteristics of participants
N= 34
Mean age : NR
13 males
Severity : Mild: n= 34/ Asymptomatic: n=0
Number of vaccinated participants: NR
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 willing stated in the publication:

Not reported
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 pre-print article, the trial registry, study protocol, statistical analysis plan and supplementary material were used in data extraction and assessment of risk of bias. There were no substantive differences between the pre-print article and the trial registry, study protocol and statistical analysis plan. The trial was sub-study 1 of the PATCH trial, which consisted of 3 sub-studies: Cohort 1: a double-blind placebo controlled trial of high dose HCQ as a treatment for home bound COVID-19 positive patients; Cohort 2: a randomized study testing different doses of HCQ in hospitalized patients; Cohort 3: a double blind placebo controlled trial of low dose HCQ as a preventative medicine in health care workers. This sub-study was terminated at the first interim analysis due to the large numbers of patients screened with few enrolled and growing literature about the lack of efficacy of HCQ for COVID-19. As a result, the target sample size specified in the registry was not achieved, some efficacy outcomes were not reported.