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0 0.5 1 1.5 2+ Symptomatic case 27% Improvement Relative Risk Case, PCR+ 21% Case 8% Dhibar et al. NCT04858633 HCQ RCT PEP Is post-exposure prophylaxis with HCQ beneficial for COVID-19? Double-blind RCT 1,168 patients in India (March - June 2021) Fewer symptomatic cases (p=0.32) and cases (p=0.21), not stat. sig. Dhibar et al., Scientific Reports, doi:10.1038/s41598-022-26053-w Favors HCQ Favors control

The ‘myth of Hydroxychloroquine (HCQ) as post-exposure prophylaxis (PEP) for the prevention of COVID-19’ is far from reality

Dhibar et al., Scientific Reports, doi:10.1038/s41598-022-26053-w, NCT04858633 (history)
Dhibar et al., The ‘myth of Hydroxychloroquine (HCQ) as post-exposure prophylaxis (PEP) for the prevention of COVID-19’ is.., Scientific Reports, doi:10.1038/s41598-022-26053-w, NCT04858633
Jan 2023   Source   PDF  
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Low dose low-risk patient HCQ PEP RCT, showing lower symptomatic cases with treatment, without statistical significance. There were no moderate or severe cases. HCQ 800mg on day one followed by 400mg once weekly for 3 weeks.
risk of symptomatic case, 26.7% lower, RR 0.73, p = 0.32, treatment 17 of 574 (3.0%), control 24 of 594 (4.0%), NNT 93.
risk of case, 21.2% lower, RR 0.79, p = 0.21, treatment 16 of 574 (2.8%), control 21 of 594 (3.5%), NNT 134, PCR+.
risk of case, 8.0% lower, RR 0.92, p = 0.21, treatment 24 of 574 (4.2%), control 27 of 594 (4.5%), NNT 275.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Dhibar et al., 7 Jan 2023, Double Blind Randomized Controlled Trial, placebo-controlled, India, peer-reviewed, mean age 35.0, 14 authors, study period 22 March, 2021 - 17 June, 2021, trial NCT04858633 (history).
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The ‘myth of Hydroxychloroquine (HCQ) as post-exposure prophylaxis (PEP) for the prevention of COVID-19’ is far from reality
Deba Prasad Dhibar, Navneet Arora, Deepak Chaudhary, Ajay Prakash, Bikash Medhi, Neeraj Singla, Ritin Mohindra, Vikas Suri, Ashish Bhalla, Navneet Sharma, Mini P Singh, P V M Lakshmi, Kapil Goyal, Arnab Ghosh
Scientific Reports, doi:10.1038/s41598-022-26053-w
The efficacy of Hydroxychloroquine (HCQ) as post-exposure prophylaxis (PEP) for the prevention of COVID-19 was contentious. In this randomized control double-blind clinical trial, asymptomatic individuals with direct contact with laboratory-confirmed COVID-19 cases were randomized into PEP/ HCQ (N = 574) and control/placebo (N = 594) group. The PEP/HCQ group received tablet HCQ 400 mg q 12 hourly on day one followed by 400 mg once weekly for 3 weeks, and the control/Placebo group received matching Placebo. The incidence of COVID-19 was similar (p = 0.761) in PEP [N = 24 out of 574, (4.2%)] and control [N = 27 out of 594, (4.5%)] groups. Total absolute risk reduction for the incidence of new-onset COVID-19 was -0.3% points with an overall relative risk of 0.91 (95% confidence interval, 0.52 to 1.60) and the number needed to treat (NNT) was 333 to prevent the incident of one case of COVID-19. The study found that, PEP with HCQ was not advantageous for the prevention of COVID-19 in asymptomatic individuals with high risk for SARS-CoV-2 infection. Though HCQ is a safer drug, the practice of irrational and indiscriminate use of HCQ for COVID-19 should be restrained with better pharmacovigilance. The novel corona virus (SARS-CoV-2) pandemic affected more than 575 million people worldwide with more than 6.3 million loss of life, as of 2nd August 2022 1 . Globally, after the USA India is the second worst devastated country from COVID-19, with more than 44 million affected population and more than 526 thousand fatalities, as of 2nd August 2022 2 . The clinical presentation of the COVID-19 ranges from asymptomatic or mild influenzalike illness, isolated or associated thrombotic/ischemic events to severe pneumonia with acute respiratory distress syndrome (ARDS) and subsequent secondary infection, sepsis, and multi-organ dysfunction syndrome (MODS) contributing to the mortality 3 . When the study was carried out, there were no definitive therapeutic drugs available for the treatment of COVID-19. COVID-19 patients used to be managed with symptomatic and supportive care only, which includes mechanical ventilation, antibiotics for secondary infection, anti-inflammatory or immune-modulators for the hyperimmune response, and blood thinner to combat thrombotic events 4 . Many drugs, Ribavirin, Lopinavir, Remdesivir, Molnupiravir, Chloroquine, Hydroxychloroquine, Azithromycin, Ivermectin, Tocilizumab, were explored or investigated but the majority of them turned out to be ineffective or partially effective for the treatment of COVID-19 and prevention of mortality [5] [6] [7] . In late 2021, oral antiviral drugs like, Paxlovid, Molnupiravir received emergency use authorization from the US Food and Drug Administration (FDA) for mild to moderate cases of early COVID-19, as in randomized control clinical trials (RCT) it was found to reduce the risk of hospitalization or death 8, 9 . Sotrovimab, a monoclonal antibody also received emergency use authorization from.. Rajasingham et al., probably due to higher cumulative dose (3800 mg and 5600 mg to 10,400 mg respectively) of HCQ compared to the present study (2000 mg) 21, 35 . HCQ was also tried unsuccessfully against the previous corona virus pandemic (MARS) and perhaps COVID-19 is not the last corona virus pandemic either. Despite the unfavorable results of HCQ for the treatment and prevention of COVID-19, the practice of irrational use of HCQ for the prevention of COVID-19 still continues in many countries 31 . The advisory and indiscriminate use of HCQ for COVID-19 had been predominantly under the influence of fear for SARS-CoV-2 infection and social media forces rather than evidence based on clinical research outcomes. Perhaps, this study probably put an end to the era of controversy with HCQ for the prevention of COVID-19. With multiple clinical trials showing evidence against HCQ, the ICMR withdrew HCQ for the management or prevention of COVID-19 in August 2021 38 . HCQ remains a myth only as it couldn't produce sufficient in vivo evidence in favor of its benefit against COVID-19. But, at the same time it opens the gate for further research in search of newer and efficacious antiviral drugs or repurposing of the established drugs against SARS-CoV-2 making us more efficient in defeating this ongoing pandemic. Till then, vaccination, increasing social awareness about the disease and better adherence to the use of face mask, maintaining adequate..
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