Use of hydroxychloroquine and chloroquine in COVID-19: How good is the quality of randomized controlled trials?

Mazhar, Faizan; Hadi, Muhammad Abdul; Kow, Chia Siang; Marran, Albaraa M.; Merchant, Hamid A.; Hasan, Syed Shahzad

doi:10.1016/j.ijid.2020.09.1470

Cited by 12 publications

(13 citation statements)

References 32 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…CQ is a proton-base that can concentrate in acidic organelles and have glycosylation interactions with the ACE-2 receptor, thus preventing viruses from binding and fusing into the cells ( 133 ). However, the results of clinical trials were conflicting due to the improper design of the studies and the small cohort of patients in most of these studies ( 137 ). Other anti-SARS-CoV-2 drug candidates, including umifenovir, lopinavir/ritonavir, darunavir, favipiravir, and nitazoxanide, have also been recently reviewed ( 138 ).…”

Section: Current Prevention and Treatments For Covid-19mentioning

confidence: 99%

SARS-CoV-2 Infection and Lung Regeneration

Zhao

Yue

et al. 2022

Clin Microbiol Rev

View full text Add to dashboard Cite

show abstract

Section: Current Prevention and Treatments For Covid-19mentioning

confidence: 99%

SARS-CoV-2 Infection and Lung Regeneration

Zhao

Yue

et al. 2022

Clin Microbiol Rev

View full text Add to dashboard Cite

show abstract

“…This tool is a standardized method for assessing potential bias in reports of randomized interventions, consisting of a fixed set domain of bias due to randomization process, deviations from intended interventions, missing outcome data, measurement of the outcomes, and selection of reported results. A proposed judgment about the risk of bias arising from each domain is generated by an algorithm, where judgment can be "low" or "high" risk of bias or can express "some concerns" [3,16].…”

Section: Risk Of Bias Assessmentmentioning

confidence: 99%

“…On the other hand, rapid diagnosis and an effective COVID-19 vaccine will complement the therapy and control the epidemic aroused by emerging viruses [2]. As announced by the WHO, there are now 284 COVID-19 vaccines under development, of which 104 are in clinical trials [3].…”

Section: Introductionmentioning

confidence: 99%

“…In 2004, the Consolidated Standards of Reporting Trials (CONSORT) Group produced an extension to its guidelines for reporting trial results to include the reporting of harms, but these guidelines are poorly implemented in practice [14]. The adverse events (AE) collection and presentation method highlighted inadequacies and inconsistencies in AE reporting described in various published clinical trials [3,14].…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Adverse Events Reporting Quality of Randomized Controlled Trials of COVID-19 Vaccine Using the CONSORT Criteria for Reporting Harms: A Systematic Review

et al. 2022

View full text Add to dashboard Cite

Background: Assessing the quality of evidence from vaccine clinical trials is essential to ensure the safety and efficacy of the vaccine and further enhance public acceptance. This study aims to summarize and critically evaluate the quality of harm reporting on randomized controlled trials for the COVID-19 vaccine and determine the factors associated with reporting quality. Methods: We systematically searched the literature using PRISMA guidelines for randomized controlled trials (RCT) on COVID-19 Vaccine until 30 December 2021. Published articles were searched from electronic databases such as PubMed, Science Direct, Google Scholar, and Bibliovid. Bias analysis was performed using RoB-2 tools. The quality of reporting was assessed by the Consolidated Standards of Reporting Trials (CONSORT) harm extension modified into 21 items. Results: A total of 61 RCT studies (402,014 patients) were analyzed. Over half the studies demonstrated adequate reporting (59.02%), and 21 studies (34.4%) reported a low risk of bias. All studies reported death and serious adverse events (AEs), but only six studies mentioned how to handle the recurrent AEs. Reporting of AEs in subgroup analysis was also poor (25%). Conclusion: The RCTs on the COVID-19 vaccine were less biased with good quality on reporting harm based on the modified CONSORT harm extension. However, study quality must be considered, especially for a balance of information between effectivity and safety.

show abstract

“…The immunomodulatory properties of HCQ have been ascribed to interference with lysosomal activity, resulting in the decreased expression of MHC-II and impaired antigen presentation, which subsequently reduces the release of a vast range of key proinflammatory cytokines [ 82 ]. Despite promising in vitro antiviral activity, no data support the efficacy of CQ and HCQ in the treatment of COVID-19 [ 89 , 90 ], and the latest largest international randomized controlled clinical trials, which were organized by the WHO to explore COVID-19 treatments, revealed no compensatory reductions in overall disease mortality following CQ or HCQ treatment [ 91 ].…”

Section: Introductionmentioning

confidence: 99%

Insight into the emerging role of SARS-CoV-2 nonstructural and accessory proteins in modulation of multiple mechanisms of host innate defense

Abdalla

Xie

Junaid

et al. 2021

Bosn J of Basic Med Sci

View full text Add to dashboard Cite

Coronavirus disease-19 (COVID-19) is an extremely infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that has become a major global health concern. The induction of a coordinated immune response is crucial to the elimination of any pathogenic infection. However, SARS-CoV-2 can modulate the host immune system to favor viral adaptation and persistence within the host. The virus can counteract type I interferon (IFN-I) production, attenuating IFN-I signaling pathway activation and disrupting antigen presentation. Simultaneously, SARS-CoV-2 infection can enhance apoptosis and the production of inflammatory mediators, which ultimately results in increased disease severity. SARS-CoV-2 produces an array of effector molecules, including nonstructural proteins (NSPs) and open-reading frames (ORFs) accessory proteins. We describe the complex molecular interplay of SARS-CoV-2 NSPs and accessory proteins with the host’s signaling mediating immune evasion in the current review. In addition, the crucial role played by immunomodulation therapy to address immune evasion is discussed. Thus, the current review can provide new directions for the development of vaccines and specific therapies.

show abstract

Use of hydroxychloroquine and chloroquine in COVID-19: How good is the quality of randomized controlled trials?

Cited by 12 publications

References 32 publications

SARS-CoV-2 Infection and Lung Regeneration

SARS-CoV-2 Infection and Lung Regeneration

Adverse Events Reporting Quality of Randomized Controlled Trials of COVID-19 Vaccine Using the CONSORT Criteria for Reporting Harms: A Systematic Review

Insight into the emerging role of SARS-CoV-2 nonstructural and accessory proteins in modulation of multiple mechanisms of host innate defense

Contact Info

Product

Resources

About