Clearing the fog: Is HCQ effective in reducing COVID-19 progression: A randomized controlled trial
Kamran et al.,
Clearing the fog: Is HCQ effective in reducing COVID-19 progression: A randomized controlled trial,
medRxiv, doi:10.1101/2020.07.30.20165365 (Preprint)
Study of 349 low-risk hospitalized patients with 151 non-consenting or ineligible patients used as controls. SOC included zinc, vitamin C and vitamin D. A statistically significant improvement in PCR negativity is shown at day 7 with HCQ treatment, 52.1% (HCQ) versus 35.7% (control),
p=0.001, but no statistically significant difference at day 14, or in progression. Patients were relatively young and there was no mortality. Only 3% of patients had any disease progression and all patients recovered, so there is little if any room for treatment benefit. Progression among higher-risk patients with comorbidities was lower with treatment (12.9% versus 28.6%,
p=0.3, very few cases).
Despite the title, this is not an RCT since patients self-selected the arm, or were chosen based on allergies/contraindications. The treatment group had about twice the number of patients with comorbidities. Treatment delay is unknown - it was recorded but not reported in the paper.
Viral load was not measured. As with other studies, PCR may detect non-replicable viral nucleic acid, this is more likely at day 14. Details on the test accuracy are not provided, authors note that RT-PCR sensitivity ranges from 34-80%.
This study is excluded in the after exclusion results of meta
analysis:
excessive unadjusted differences between groups.
risk of progression, 5.0% lower, RR 0.95, p = 1.00, treatment 11 of 349 (3.2%), control 5 of 151 (3.3%), NNT 627.
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risk of progression, 54.8% lower, RR 0.45, p = 0.30, treatment 4 of 31 (12.9%), control 2 of 7 (28.6%), NNT 6.4, with comorbidities.
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risk of viral+ at day 7, 25.5% lower, RR 0.74, p = 0.001, treatment 349, control 151.
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risk of viral+ at day 14, 10.0% higher, RR 1.10, p = 0.52, treatment 349, control 151.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Kamran et al., 4 Aug 2020, prospective, Pakistan, preprint, 10 authors.
Abstract: medRxiv preprint doi: https://doi.org/10.1101/2020.07.30.20165365; this version posted October 11, 2020. The copyright holder for this preprint
(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
All rights reserved. No reuse allowed without permission.
1
Clearing the fog: Is Hydroxychloroquine effective in reducing Corona virus
disease-2019 progression: A randomized controlled trial
LIST OF AUTHORS
SN Full Name
1
Sultan
Mehmood
Kamran
2
Zill-eHumayun
Mirza
3
Arshad
Naseem
4
5
6
7
8
6
18
Qualifications
MBBS,FCPS Medicine, FACP,
Senior registrar Pulmonology
Affiliation
PEMH Pakistan
Email address
Sultanmajoka79@hotmail.com
MBBS,FCPS Medicine, FCPS
Pulmonology, FRCP (Ed)
PEMH Pakistan
zilno@hotmail.com
PEMH Pakistan
Ppc9119@yahoo.com
PEMH Pakistan
Rizwanazam51@hotmail.com
PEMH Pakistan
naqeeb_achakzai@yahoo.com
PEMH Pakistan
farrukhsaeed545@gmail.com
PEMH Pakistan
walamgir@gmail.com
PEMH Pakistan
salmansaleem2308@yahoo.com
PEMH Pakistan
Shazianisar.sn@gmail.com
PEMH
mehmoodamcolian@gmail.com
MBBS,FCPS Medicine, FCPS
Pulmonology, FCPS Critical care,
FRCP
Rizwan Azam MBBS, FCPS Medicine, Senior
registrar Pulmonology
Naqeeb Ullah MBBS, Senior registrar
Pulmonology
Farrukh Saeed MBBS, FCPS Medicine, FCPS
Gastroenterology
Wasim
MBBS, FCPS Medicine, MRCP
Alamgir
(UK), FRCP
Salman
MBBS, FCPS Medicine
Saleem
Shazia Nisar
MBBS,FCPS Medicine, MRCP
(UK)
Mehmood
MBBS, Senior Registrar General
Hussain
Medicine
Corresponding Author:
Dr. Sultan Mehmood Kamran, MBBS, FCPS medicine, Assistant Professor of medicine, FACP,
Senior Registrar Pulmonology Pak Emirates Military Hospital Rawalpindi, Punjab Pakistan.
Phone no; 00923008501100, Email; sultanmajoka79@hotmail.com
NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice.
medRxiv preprint doi: https://doi.org/10.1101/2020.07.30.20165365; this version posted October 11, 2020. The copyright holder for this preprint
(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
All rights reserved. No reuse allowed without permission.
2
Abstract:
Background: Hydroxychloroquine (HCQ) has been considered to treat Coronavirus disease
2019 (COVID-19) but data on efficacy is conflicting. we analyzed the efficacy of HCQ) in
addition to standard of care (SOC) compared with SOC alone in reducing disease progression in
Mild COVID-19
Methods: A single centre open label randomized controlled trial during 10th April to 31st May
2020 was conducted at Pak emirates Military Hospital (PEMH) Five hundred patients of both
genders having age between 18-80 years with Mild COVID-19 were enrolled. Patients assigned
to standard dose of HCQ plus SOC were 349 while 151 patients received SOC (control group).
Primary outcome was progression of disease while secondary outcome was PCR negativity on
day 7 and 14. The results were analyzed on SPSS version 23. P value <0.05 was considered
significant.
Results: Median age of intervention group (34 + 11.778 years) and control group (34 + 9.813
years). Disease progressed in 16 patients, 11 (3.15%) were in intervention group as compared to
5 (3.35%) in control group, (P value = 0.865). PCR negativity in intervention and control groups
were (day 7, 182 (52.1%) vs. 54 (35.7%) (P value = 0.001), (day 14, 244 (69.9%) vs. 110
(72.8%) (P..
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