☆ 4.7 Review

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

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A phase III, observer-blind, randomized, placebo-controlled study of the efficacy, safety, and immunogenicity of SARS-CoV-2 inactivated vaccine in healthy adults aged 18-59 years: An interim analysis in Indonesia

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Summary: The RNActive technology platform was used to prepare CVnCoV, a COVID-19 vaccine containing optimized mRNA encoding for a stabilized form of SARS-CoV-2 spike protein. The dosage escalation phase 1 study showed that 12 µg of CVnCoV vaccine elicited immune responses comparable to those seen in convalescent sera from COVID-19 patients, with acceptable safety and reactogenicity.

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Randomized, Double-Blinded, Placebo-Controlled Phase 2 Trial of an Inactivated Severe Acute Respiratory Syndrome Coronavirus 2 Vaccine in Healthy Adults

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A phase 2/3, participant-blind, observer-blind, randomised, controlled study to assess the safety and immunogenicity of SII-ChAdOx1 nCoV-19 (COVID-19 vaccine) in adults in India

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Safety and immunogenicity of a recombinant interferon-armed RBD dimer vaccine (V-01) for COVID-19 in healthy adults: a randomized, double-blind, placebo-controlled, Phase I trial

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Summary: Safe and effective V-01 vaccine has been developed and progressed to Phase I clinical trials, showing promising safety profile and rapid, strong immune responses. The vaccine induced high-titre neutralizing antibodies and anti-RBD IgG, with encouraging immunogenicity in low dose subgroup and elderly participants, indicating great potential as a vaccine against COVID-19 for all-aged population.

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Safety and immunogenicity of a recombinant COVID-19 vaccine (Sf9 cells) in healthy population aged 18 years or older: two single-center, randomised, double-blind, placebo-controlled, phase 1 and phase 2 trials

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Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial

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Review Infectious Diseases

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

Faizan Mazhar et al.

INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES (2020)

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Article Medicine, General & Internal

Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomised, controlled, phase 2/3 trial

Maheshi N. Ramasamy et al.

LANCET (2020)

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Review Medicine, General & Internal

Analysis and reporting of adverse events in randomised controlled trials: a review

Rachel Phillips et al.

BMJ OPEN (2019)

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Article Cardiac & Cardiovascular Systems

Assessment of the reporting quality of RCTs for novel oral anticoagulants in venous thromboembolic disease based on the CONSORT statement

Ioannis Liampas et al.

JOURNAL OF THROMBOSIS AND THROMBOLYSIS (2019)

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Article Medicine, Research & Experimental

No improvement in the reporting of clinical trial subgroup effects in high-impact general medical journals

Nicole B. Gabler et al.

TRIALS (2016)

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Review Medicine, General & Internal

Reporting quality of randomised controlled trial abstracts among high-impact general medical journals: a review and analysis

Meredith Hays et al.

BMJ OPEN (2016)

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Article Anesthesiology

Adverse event reporting in randomised controlled trials of neuropathic pain: Considerations for future practice

Victoria R. Cornelius et al.

PAIN (2013)

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Review Medicine, Research & Experimental

Drug safety assessment in clinical trials: methodological challenges and opportunities

Sonal Singh et al.

TRIALS (2012)

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Article Clinical Neurology

Reporting of adverse events in randomised controlled trials of antiepileptic drugs using the CONSORT criteria for reporting harms

Arif A. Shukralla et al.

EPILEPSY RESEARCH (2011)

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Article Medicine, General & Internal

The Cochrane Collaboration's tool for assessing risk of bias in randomised trials

Julian P. T. Higgins et al.

BMJ-BRITISH MEDICAL JOURNAL (2011)

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Article Pharmacology & Pharmacy

STATISTICAL METHODS TO ANALYZE ADVERSE EVENTS DATA OF RANDOMIZED CLINICAL TRIALS

Ohidul Siddiqui

JOURNAL OF BIOPHARMACEUTICAL STATISTICS (2009)

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Article Medicine, General & Internal

Better reporting of harms in randomized trials: An extension of the CONSORT statement

JPA Ioannidis et al.

ANNALS OF INTERNAL MEDICINE (2004)

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