Hydroxychloroquine plus personal protective equipment versus standard personal protective equipment alone for the prevention of COVID-19 infections among frontline healthcare workers: the HydrOxychloroquine Prophylaxis Evaluation(HOPE) trial: A structured summary of a study protocol for a randomized controlled trial

Vijayaraghavan, Bharath Kumar Tirupakuzhi; Venkatesh, Balasubramanian; Jha, Vivekanand; Myatra, Sheila Nainan; Rajbhandari, Dorrilyn; John, Oommen; Ghosh, Arpita; Bassi, Abhinav; Arfin, Sumaiya; Kunigari, Mallikarjuna; Joshi, Rohina; Donaldson, Lachlan; Hammond, Naomi; Nag, Santosh Kumar; Husaini, Syed Haider Mehdi; Kantro, Viny; Singh, Ashita; Mathew, Arpit

doi:10.1186/s13063-020-04679-3

Cited by 9 publications

(9 citation statements)

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“…In support of our contentions however other investigators from India assuming an attack rate of 10% and a modest but pragmatic and reasonable absolute risk reduction of 2.5% attest to needing a sample size of over 6000 participants to address the question of efficacy of HCQ as a prophylactic measure. 26 It is however surprising that the trialists here continue to adopt the dosing scheme of the ICMR which has no evidentiary basis whatsoever and is clearly considered to deliver suboptimal doses. Simulation from the University of Minnesota 27 used to drive the RCT reported in the New England Journal of Medicine from Minnesota 17 and other centres in North America is the only available pharmacologic basis to provide a trial prescription for appropriate testing.…”

Section: Discussionmentioning

confidence: 99%

“…It is therefore logical to ask as to whether or not HCQ imparts protection beyond that offered by standard measures such as use of personal protective equipment (PPE). The overall design of the HOPE trial 26 is therefore compelling as it seeks to evaluate comparative efficacy of a standard protective measure such as use of personal protective equipment (PPE) alone measured against use of PPE with HCQ as an adjunct.…”

Section: Discussionmentioning

confidence: 99%

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Waiting for Godot: A Cross Sectional Survey Based Analysis of the Hydroxychloroquine Prophylaxis Strategy against Covid-19 in India

Moni¹,

Madathil²,

Palabatla³

et al. 2020

Journal of Public Health Research

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Background: India currently has the second largest burden of infections due to COVID-19. Health Care Worker (HCW) shortages are endemic to Indian healthcare. It should therefore be a huge priority to protect this precious resource as a critical component of the systemic response to this pandemic. Advisories from the Indian Council of Medical Research (ICMR) have focused on using hydroxychloroquine prophylaxis against COVID-19 in at risk HCW. This prophylaxis strategy has no evidence. In further jeopardy there appear to insubstantial attempts to build this evidence as well. In this connection, we commissioned a survey within our Institution to estimate the penetration of hydroxychloroquine (HCQ) use and use this to statistically model the impact of current ongoing studies in India. We also briefly review the literature on HCQ prophylaxis for COVID-19. Design and methods: A structured survey designed using RedCAP application was disseminated among healthcare professionals employed at an academic referral tertiary care centre via online social media platforms. The survey was kept open for the entire month of June 2020. The survey was additionally used to statistically model the size of studies required to comprehensively address the efficacy of HCQ in this setting.Results: 522 responses were received, of which 4 were incomplete. The ICMR strategy of 4 or more doses of HCQ was complete only in 15% of HCW in our survey. The majority of respondents were doctors (238, 46%). Amongst all category of responders, only 12% (n=63) received the full course. A majority of those who initiated the chemoprophylaxis with HCQ turned out to be medical professionals (59/63) with neither nurse nor other categories of healthcare workers accessing the medication. The respondents of our institutional survey did not report any life-threatening side effects. Presuming efficacy as per ICMR modelling for new registry trial on the lines of the published case control study, equal allocation between cases and controls and assuming a RR of 1.3.6, the power of such a study would be very low for n=2000 for event rates from 2.5-12.5%. Conclusion: We report the low penetration of HCQ chemoprophylaxis among the healthcare workers of our institution. We highlight the inherent drawbacks in the study design of current national COVID related trial based on the statistical modelling of our survey results and published literature, and thereby emphasis the need of evidence-based strategies contributing to research policy at national level.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Waiting for Godot: A Cross Sectional Survey Based Analysis of the Hydroxychloroquine Prophylaxis Strategy against Covid-19 in India

Moni¹,

Madathil²,

Palabatla³

et al. 2020

Journal of Public Health Research

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“…There are also multiple trials studying the role of hydroxychloroquine in the prophylaxis of COVID-19. 31 – 37 Two randomized controlled trials did not show any benefit to pre- or postexposure prophylaxis with hydroxychloroquine. 38 , 39 Thus, we do not recommend hydroxychloroquine or azithromycin for this purpose at this time.…”

Section: Questionsmentioning

confidence: 99%

Pragmatic Recommendations for Therapeutics of Hospitalized COVID-19 Patients in Low- and Middle-Income Countries

Shetty

Brotherton

Achilleos

et al. 2020

The American Journal of Tropical Medicine and Hygiene

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The therapeutic options for COVID-19 patients are currently limited, but numerous randomized controlled trials are being completed, and many are on the way. For COVID-19 patients in low- and middle-income countries (LMICs), we recommend against using remdesivir outside of a clinical trial. We recommend against using hydroxychloroquine ± azithromycin or lopinavir–ritonavir. We suggest empiric antimicrobial treatment for likely coinfecting pathogens if an alternative infectious cause is likely. We suggest close monitoring without additional empiric antimicrobials if there are no clinical or laboratory signs of other infections. We recommend using oral or intravenous low-dose dexamethasone in adults with COVID-19 disease who require oxygen or mechanical ventilation. We recommend against using dexamethasone in patients with COVID-19 who do not require supplemental oxygen. We recommend using alternate equivalent doses of steroids in the event that dexamethasone is unavailable. We also recommend using low-dose corticosteroids in patients with refractory shock requiring vasopressor support. We recommend against the use of convalescent plasma and interleukin-6 inhibitors, such as tocilizumab, for the treatment of COVID-19 in LMICs outside of clinical trials.

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“…These drugs have demonstrated to be effective in inhibiting the replication of SARS-CoV-2 in experimental models (figure 2) (Italian Medicine Agency) and have been increasingly tested for COVID-19 in many clinical studies. Specifically, many studies, which are currently ongoing, are evaluating the effects of hydroxychloroquine as prophylactic agent (Lother et al, 2020;Niriella et al, 2020;Tirupakuzhi Vijayaraghavan et al, 2020). At the moment, only one randomized, double-blind, placebo-controlled study on the prophylactic role of hydroxychloroquine was concluded.…”

Section: Clinical Evidence Of Immunomodulatory and Anti-inflammatory mentioning

confidence: 99%

Therapeutic strategies to fight COVID-19: which is the status artis?

Scavone

Mascolo

Rafaniello

et al. 2021

Preprint

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COVID-19 is a complex disease and many difficulties are faced today especially in the proper choice of pharmacological treatments. The role of antiviral agents for COVID-19 is still being investigated. The evidence for immunomodulatory and anti-inflammatory drugs is quite conflicting, while the use of corticosteroids is supported by robust evidence. The use of heparins in hospitalized critically ill patients is preferred over other anticoagulants. Lastly, conflicting data were found regarding to the use of convalescent plasma and vitamin D. According to data shared by the WHO, many vaccines are under phase 3 clinical trials and some of them already received the marketing approval in EU countries and in the US. In conclusion, drugs repurposing has represented the main approach recently used in the treatment of patients with COVID-19. At this moment, the analysis of efficacy and safety data of drugs and vaccines used in real life context is strongly needed.

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Cited by 9 publications

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Waiting for Godot: A Cross Sectional Survey Based Analysis of the Hydroxychloroquine Prophylaxis Strategy against Covid-19 in India

Waiting for Godot: A Cross Sectional Survey Based Analysis of the Hydroxychloroquine Prophylaxis Strategy against Covid-19 in India

Pragmatic Recommendations for Therapeutics of Hospitalized COVID-19 Patients in Low- and Middle-Income Countries

Therapeutic strategies to fight COVID-19: which is the status artis?

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