Kamran: Clearing the fog: Is HCQ effective in reducing COVID-19 progression: A randomized controlled trial

Clearing the fog: Is HCQ effective in reducing COVID-19 progression: A randomized controlled trial

Kamran et al., medRxiv, doi:10.1101/2020.07.30.20165365 (Preprint)

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)

Aug 2020 Source PDF

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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.

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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.

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.

risk of viral+ at day 7, 25.5% lower, RR 0.74, p = 0.001, treatment 349, control 151.

risk of viral+ at day 14, 10.0% higher, RR 1.10, p = 0.52, treatment 349, control 151.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

Kamran et al., 4 Aug 2020, prospective, Pakistan, preprint, 10 authors.

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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..

Late treatment
is less effective

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