Characteristics of published/registered clinical trials on COVID-19 treatment: A systematic review

Asili, Pooria; Mirahmad, Maryam; Tabatabaei‐Malazy, Ozra; Manayi, Azadeh; Haghighat, Elahe; Mahdavi, Mohammad; Larijani, Bagher

doi:10.1007/s40199-021-00422-8

Cited by 9 publications

(8 citation statements)

References 89 publications

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“…In comparison to the data collected from the CTRI, a study conducted on the collected data from the published literature and ClinicalTrials.gov database reveals that the majority of the studies were conducted on synthetic drugs unlike in our case [26]. In the same study of the published randomized controlled trials (RCTs), herbal medicines have been the subject of 23 trials (10.6%) and 357 registered RCTs (12.7%).…”

Section: Discussionmentioning

confidence: 95%

A Systematic Analysis of COVID-19 Clinical Trials Registered in the Clinical Trials Registry of India

Dutta,

Singhal,

Shah

2024

Cureus

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Background: The Clinical Trials Registry -India (CTRI) database is a registry of various trials conducted in India and this study scrutinized the studies registered for COVID-19 from the database to detect patterns in trial design, appraising the target regions of therapies and comprehending the terrain of research endeavors.Method: This was a cross-sectional study that analyzed the registered trials for COVID-19 between March 2020 and September 2023. A trial search was conducted on the CTRI database to include all types of studies registered for COVID-19 with keywords like "COVID" and "coronavirus" and studies conducted on conditions other than COVID-19 were excluded. The data regarding study characteristics were noted under various sections in a preformed proforma.Results: A total of 807 trials were taken for final analysis and there were about 344 prospective and 260 retrospective interventional trials, 35 prospective and 165 retrospective observational studies, and two prospective and one retrospective post-marketing surveillance study. The majority of the studies had duration under 12 months (91%). The maximum number of studies were registered from AYUSH (Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homeopathy) and allied therapies (n = 283), with about 104 types of interventions, followed by the drug category having 119 trials registered and about 57 types of interventions. Kabasura Kudineer and yoga in the AYUSH category, molnupiravir, colchicine, and favipiravir in the drug category, and tocilizumab and convalescent plasma among biologics were some common interventions used. The majority of trials did not mention the trial phase and declared it as not applicable (54%), whereas 15% were registered as phase 2 and 13% as phase 3. About 54% of the studies were randomized and randomized parallel-group design (20%) was the most common study design. Only 6% of the trials were post-graduate thesis and the majority of the trials (n = 535) denied sharing their individual participant data. Only 0.86% and 0.61% of the trials were terminated and suspended, respectively, denoting proper design and conduct of the trials. Conclusion:In the CTRI database, the majority of trials were prospective interventional studies, with a predominance of AYUSH therapies and drug interventions. Common interventions included Kabasura Kudineer and yoga in AYUSH, and molnupiravir, colchicine, and favipiravir in drugs. Most studies had durations under 12 months and randomized parallel-group design was the most common study design. The intention to use and promote an indigenous system of medicine looks promising in the absence of any definite therapy. A minute number of registered suspended and terminated trials might be a positive picture of meticulously designed and executed trials even during a pandemic situation in India.

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Section: Discussionmentioning

confidence: 95%

A Systematic Analysis of COVID-19 Clinical Trials Registered in the Clinical Trials Registry of India

Dutta,

Singhal,

Shah

2024

Cureus

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“…A comprehensive and systematic research about the repurposing of drugs in COVID-19 was conducted by Srivastava and Singh (2021), the results revealed that no drugs passed clinical trials or were approved by the FDA for COVID-19 [23]. In fact, various reports that clinical trials regarding the potential therapeutic possibilities, such as hydroxychloroquine, lopinavir-ritonavir, and ivermectin, showed that choices were unsuccessful in the treatment of COVID-19 patients [24][25][26][27]. Although COVID-19 vaccines were successfully developed and massively distributed, there is a lack of effective treatment [28].…”

Section: Introduction-covid-19 Options For Treatmentmentioning

confidence: 99%

Perspective Chapter: New Use of the SSRI Fluvoxamine in the Treatment of COVID-19 Symptoms

Al-sabhan¹,

Alshammari²

2023

COVID-19 Pandemic, Mental Health and Neuroscience - New Scenarios for Understanding and Treatment

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From the perspective of repurposing medication, recent evidence suggests that the use of selective serotonin reuptake inhibitor antidepressants (SSRIs) can help reduce the severity of symptoms and death associated with SARS-CoV-2 infection. To focus more, COVID-19 is a viral disease with potentially high risk of symptoms. There is presently no cure. However, there are specific treatments that may help manage the condition. Since the SSRI fluvoxamine has a unique mechanism of action in reducing cytokine production, researchers have started to relate the antiviral effects via modulation of sigma-1 receptors with the vision of treatment options for COVID-19 patients. The scope of this chapter is to examine different mechanisms of fluvoxamine in relation to immune response, including both the serotonin and the sigma-1 receptor-related mechanisms. Addressing the impact of fluvoxamine in minimizing possible complications during COVID-19 infection.

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“…Since the start of the coronavirus disease 2019 (COVID- 19) pandemic in 2020, there has been a proliferation of primary and secondary literature surrounding the topic. Strongly driven by the need for information vital for responding to this new disease, research on various topics, including treatment, prevention, diagnosis, and public health measures, have been conducted and published rapidly.…”

Section: Introductionmentioning

confidence: 99%

Herbal Medicine and COVID-19: Characteristics and Methodological Quality of Published Reviews

Lim,

Sa’at,

Mohd Rahim

et al. 2023

Natural Product Communications

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The literature on coronavirus disease 2019 (COVID-19) treatments, including herbal medicine, has expanded rapidly due to intense global interest. We conducted this scoping review to map the characteristics and assess the quality of systematically conducted reviews of herbal medicine and COVID-19 published during the pandemic era. Electronic databases were searched to identify published systematic reviews and other research synthesis articles relating to herbal medicine vis-a-vis COVID-19 from 2020 to 2022. Forty-eight articles were included. Most were systematic reviews (SR) and/or meta-analyses (MA) on Chinese herbal medicine for clinical treatment during the acute phases of COVID-19 (44%). Regarding adherence to a measurement tool to assess systematic reviews (AMSTAR-2) critical items, only one-third ( n = 15) reported an a priori protocol, while 21% ( n = 10) presented a comprehensive literature search strategy. When analysed by type of review, SR/MA ( n = 23) of clinical interventions had better than the overall average adherence rate in having a pre-registered protocol (87%, n = 20) and comprehensive literature search strategy (45%, n = 9). Exploratory analysis showed that most articles reported search results from at least two established electronic databases. Risk of bias assessment was performed in almost all SR/MA though there was limited exploration of any potential sources of heterogeneity. Overall, there is a need to improve the methodological design and implementation of systematically conducted reviews of herbal medicine in general to enhance the robustness and reliability of findings, especially given the rapid expansion of literature during unique circumstances such as the COVID-19 pandemic.

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Characteristics of published/registered clinical trials on COVID-19 treatment: A systematic review

Cited by 9 publications

References 89 publications

A Systematic Analysis of COVID-19 Clinical Trials Registered in the Clinical Trials Registry of India

A Systematic Analysis of COVID-19 Clinical Trials Registered in the Clinical Trials Registry of India

Perspective Chapter: New Use of the SSRI Fluvoxamine in the Treatment of COVID-19 Symptoms

Herbal Medicine and COVID-19: Characteristics and Methodological Quality of Published Reviews

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