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3- Wednesday Research News – 15th September 


1 – The association between SARS-CoV-2 infection and neuronal damage: A population-based nested case-control study

  • This study aims to assess whether severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection is associated with changes in plasma levels of neurofilament light chain (NfL), an extremely sensitive marker of neuroaxonal damage, in community-dwelling individuals.
  • The findings indicate that mild-to-moderate coronavirus disease-19 is unlikely to be associated with a clinically relevant degree of neuroaxonal damage, even in those cases associated with neurological symptoms.

Source: MedRxiv


2- How Informative were Early SARS-CoV-2 Treatment and Prevention Trials? A longitudinal cohort analysis of trials registered on clinicaltrials.gov

  • Early in the SARS-CoV-2 pandemic, commentators warned that some COVID trials were inadequately conceived, designed and reported.
  • Here, they retrospectively assess the prevalence of informative COVID trials launched in the first 6 months of the pandemic.
  • Less than one third of COVID-19 trials registered on ClinicalTrials.gov during the first six months met all three criteria for informativeness.
  • Shortcomings in trial design, recruitment feasibility and redundancy reflect longstanding weaknesses in the clinical research enterprise that were likely amplified by the exceptional circumstances of a pandemic.

Source: MedRxiv


3- Immunogenicity and Safety of the inactivated SARS-CorV-2 vaccine (BBIBP-CoV) in patients with malignancy

  • Patients with malignancy suffer from a compromised immune system due to either the effects of malignancies or treatments.
  • Cancer patients are at higher risk of different infections particularly SARS-CoV2 and usually produce weaker response to vaccines.
  • The aim of this study was to evaluate the safety and immunogenicity of the inactivated SARS-CoV-2 vaccine (Sinopharm, BBIBP-CoV) in patients with malignancy.
  • The result of study confirmed the safety and short-term efficacy of Sinopharm inactivated vaccine (BBIBP-CorV) in patients with different type of malignancies.

Source: MedRxiv


4- A third dose of inactivated vaccine augments the potency, breadth, and duration of anamnestic responses against SARS-CoV-2

  • Emergence of variants of concern (VOC) with altered antigenic structures and waning humoral immunity to SARS-CoV-2 are harbingers of a long pandemic.
  • Administration of a third dose of an inactivated virus vaccine can boost the immune response.
  • Here, they have dissected the immunogenic profiles of antibodies from 3-dose vaccinees, 2-dose vaccinees and convalescents.
  • Better neutralization breadth to VOCs, expeditious recall and long-lasting humoral response bolster 3-dose vaccinees in warding off COVID-19.
  • Construction of immunogenic and mutational heat maps revealed a direct relationship between “hot” immunogenic sites and areas with high mutation frequencies.
  • The findings rationalize the use of 3-dose immunization regimens for inactivated vaccines.

Source: MedRxiv


5- Diagnostic performance of different sampling approaches for SARS-CoV-2 RT-PCR testing: a systematic review and meta-analysis

  • The comparative performance of different clinical sampling methods for diagnosis of SARS-CoV-2 infection by RT-PCR among populations with suspected infection remains unclear.
  • This meta-analysis aims to systematically compare the diagnostic performance of different clinical specimen collection methods.
  • This review suggests that, compared with the gold standard of nasopharyngeal swabs, pooled nasal and throat swabs offered the best diagnostic performance of the alternative sampling approaches for diagnosis of SARS-CoV-2 infection in ambulatory care.
  • Saliva and nasal swabs gave comparable and very good diagnostic performance and are clinically acceptable alternative specimen collection methods.
  • Throat swabs gave a much lower sensitivity and positive predictive value and should not be recommended.
  • Self-collection for pooled nasal and throat swabs and nasal swabs was not associated with any significant impairment of diagnostic accuracy.
  • These results also provide a useful reference framework for the proper interpretation of SARS-CoV-2 testing results using different clinical specimens.

Source: The Lancet


6- Safety and immunogenicity of SARS-CoV-2 recombinant protein vaccine formulations in healthy adults: interim results of a randomised, placebo-controlled, phase 1–2, dose-ranging study

  • CoV2 preS dTM is a stabilised pre-fusion spike protein vaccine produced in a baculovirus expression system being developed against SARS-CoV-2.
  • They present interim safety and immunogenicity results of the first-in-human study of the CoV2 preS dTM vaccine with two different adjuvant formulations.
  • The lower than expected immune responses, especially in the older age groups, and the high reactogenicity after dose two were probably due to higher than anticipated host-cell protein content and lower than planned antigen doses in the formulations tested, which was discovered during characterisation studies on the final bulk drug substance.
  • Further development of the AS03-adjuvanted candidate vaccine will focus on identifying the optimal antigen formulation and dose.

Source: The Lancet



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FADIC 2021 Clinical Research FNN E-News

Directed By/ Rasha Abdelsalam


The FADIC Pharmacy’s Clinical Research FNN E-News works like this:

  • Each business morning, you receive an email message with the text of that day’s FNN.
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  • Issues for the past reports.

Each and every business day, things change!!

  • More articles are published
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By subscribing to the FADIC 2020 Pharmacotherapy Daily News (FNN), a daily publication of the Daily News Network “FNN” will be sent to your Email.


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