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All Studies   Meta Analysis       

Low dose hydroxychloroquine prophylaxis for COVID-19 - a prospective study

Agarwal et al., medRxiv, doi:10.1101/2021.09.13.21262971
Sep 2021  
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Hospitalization 95% Improvement Relative Risk Severity 27% Case -5% HCQ for COVID-19  Agarwal et al.  Prophylaxis Is pre-exposure prophylaxis with HCQ beneficial for COVID-19? Prospective study of 484 patients in India Lower progression with HCQ (not stat. sig., p=0.21) c19hcq.org Agarwal et al., medRxiv, September 2021 FavorsHCQ Favorscontrol 0 0.5 1 1.5 2+
HCQ for COVID-19
1st treatment shown to reduce risk in March 2020, now with p < 0.00000000001 from 419 studies, recognized in 46 countries.
No treatment is 100% effective. Protocols combine treatments.
5,100+ studies for 109 treatments. c19hcq.org
Small prophylaxis trial with 29 low dose HCQ and 455 control healthcare workers in India, showing no statistically significant differences.
risk of hospitalization, 94.8% lower, RR 0.05, p = 0.61, treatment 0 of 29 (0.0%), control 17 of 455 (3.7%), NNT 27, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
relative severity, 26.9% better, RR 0.73, p = 0.21, treatment 29, control 455.
risk of case, 4.6% higher, RR 1.05, p = 0.81, treatment 6 of 29 (20.7%), control 90 of 455 (19.8%).
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Agarwal et al., 14 Sep 2021, prospective, India, preprint, 17 authors.
This PaperHCQAll
Low dose hydroxychloroquine prophylaxis for COVID-19 – a prospective study
Mayank Agarwal, Rajat Ranka, Prasan Kumar Panda, Ajay Kumar, Gaurav Chikara, Suresh K Sharma, Rizu Negi, Ramanuj Samanta, Rohit Walia, Yogesh Arvind Bahurupi, Sarama Saha, Minakshi Dhar, Prakhar Sharma, Arvind Kumar Gupta, U B Mishra, Manoj Kumar Gupta, Ravi Kant
doi:10.1101/2021.09.13.21262971
Background: Since the outbreak of COVID-19 pandemic, the world began a frantic search for possible prophylactic options. While trials on hydroxychloroquine (HCQ) prophylaxis are ongoing, concrete evidence is lacking. The study aimed to determine the relative efficacy of various doses of oral HCQ in prophylaxis and mitigating the severity of COVID-19 in healthcare workers. Methods: This was a prospective cohort with four arms (high, medium, low dose, and control) of HCQ prophylaxis, used by healthcare workers at a tertiary care center in India. Participants were grouped as per their opting for any one arm on a voluntary basis as per institute policy under the Government guidance. The outcomes studied were COVID-19 positivity by RT-PCR and its severity assessed by WHO COVID-19 severity scale. Results: Total 486 participants were enrolled, of which 29 (6%) opted for low dose, 2 (<1%) medium dose, and none for high dose HCQ while 455 (93.6%) were in the control arm. Of the 164 participants who underwent RT-PCR, 96 (58.2%) tested positive. Out of these 96 positive cases, the majority of them (79 of 96 [82.3%]) were ambulatory and were managed conservatively at home. Only 17.7% (17 of 96) participants, all of them from the control group, required hospitalization with the mild-moderate disease. None of the participants had severe disease, COVID-related complications, ICU stay, or death. The difference in the outcome assessed amongst the various arms was statistically insignificant (p value >0.05). Conclusion: This single-center study demonstrated that HCQ prophylaxis in healthcare workers does not cause a significant reduction in COVID-19 as well as mitigating its severity in those infected. At present, most of the trials have not shown any benefit. The debate continues to rage, should HCQ prophylaxis be given to healthcare workers for chemoprophylaxis? All rights reserved. No reuse allowed without permission. preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
Ever since the mass vaccinations roll out, an effective means of chemo-prophylaxis against the SARS-CoV2 may no longer be a critical need in the developed countries. However, in many low-and middle-income countries including India, the vaccination coverage is far from satisfactory and therefore, the search for a safe and reasonable chemoprophylaxis should continue until a large population of individuals gets vaccinated. Authors' contributions MA, RR, GC, RN, RS, RW, SS and YAB contributed to the data collection, analysis, and was involved in manuscript writing. PKP, AK, SKS, MD, PS, AKG, UBM, MKG, and RK gave the concept, critically reviewed the draft, approved for publication along with all authors including agreed to be accountable for all aspects of the work. Disclosure The author reports no conflicts of interest in this work. Ethics and Data sharing The study was done after institute ethical approval and as per declaration of Helsinki. After obtaining approval from corresponding author, de-identified data can be shared.
References
Abella, Jolkovsky, Biney, Uspal, Hyman et al., Efficacy and Safety of Hydroxychloroquine vs Placebo for Pre-exposure SARS-CoV-2
Al-Kofahi, Jacobson, Boulware, Matas, Kandaswamy et al., Finding the Dose for Hydroxychloroquine Prophylaxis for COVID-19: The Desperate Search for Effectiveness, Clin Pharmacol Ther
Alavian, Kolahdouzan, Mortezazadeh, Torabi, Antiretrovirals for Prophylaxis Against COVID-19: A Comprehensive Literature Review, J Clin Pharmacol
Barnabas, Brown, Bershteyn, Karita, Johnston et al., Hydroxychloroquine as Postexposure Prophylaxis to Prevent Severe Acute Respiratory Syndrome Coronavirus 2 Infection : A Randomized Trial, Ann Intern Med
Borba, Val, Sampaio, Alexandre, Melo et al., Effect of High vs Low Doses of Chloroquine Diphosphate as Adjunctive Therapy for Patients Hospitalized With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection: A Randomized Clinical Trial, JAMA Netw Open
Boulware, Pullen, Bangdiwala, Pastick, Lofgren et al., A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19, N Engl J Med
Dhibar, Arora, Kakkar, Singla, Mohindra et al., Post-exposure prophylaxis with hydroxychloroquine for the prevention of COVID-19, a myth or a reality? The PEP-CQ Study, Int J Antimicrob Agents
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Rajasingham, Bangdiwala, Nicol, Skipper, Pastick et al., Hydroxychloroquine as pre-exposure prophylaxis for COVID-19 in healthcare workers: a randomized trial, medRxiv
Rathi, Ish, Kalantri, Kalantri, Hydroxychloroquine prophylaxis for COVID-19 contacts in India
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The study aimed to determine the relative efficacy of various doses of oral HCQ ' 'in prophylaxis and mitigating the severity of COVID-19 in healthcare ' 'workers.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>This was a ' 'prospective cohort with four arms (high, medium, low dose, and control) of HCQ prophylaxis, ' 'used by healthcare workers at a tertiary care center in India. Participants were grouped as ' 'per their opting for any one arm on a voluntary basis as per institute policy under the ' 'Government guidance. The outcomes studied were COVID-19 positivity by RT-PCR and its severity ' 'assessed by WHO COVID-19 severity ' 'scale.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Total 486 ' 'participants were enrolled, of which 29 (6%) opted for low dose, 2 (&lt;1%) medium dose, and ' 'none for high dose HCQ while 455 (93.6%) were in the control arm. Of the 164 participants who ' 'underwent RT-PCR, 96 (58.2%) tested positive. Out of these 96 positive cases, the majority of ' 'them (79 of 96 [82.3%]) were ambulatory and were managed conservatively at home. Only 17.7% ' '(17 of 96) participants, all of them from the control group, required hospitalization with ' 'the mild-moderate disease. None of the participants had severe disease, COVID-related ' 'complications, ICU stay, or death. The difference in the outcome assessed amongst the various ' 'arms was statistically insignificant (p value ' '&gt;0.05).</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>This ' 'single-center study demonstrated that HCQ prophylaxis in healthcare workers does not cause a ' 'significant reduction in COVID-19 as well as mitigating its severity in those infected. At ' 'present, most of the trials have not shown any benefit. 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