NCT05190016: COVID-19

Efficacy of a Multiplex BangasureTM RT-PCR Kit for the Detection of COVID-19

Completed Last updated 27 September 2022

What this trial tests

trial in COVID-19 in 150 participants. Completed in 15 September 2022.

Timeline

1 June 2022

Primary endpoint
20 August 2022

15 September 2022

Quick facts

Lead sponsor	DR. MALA KHAN
Status	Completed
Study type	OBSERVATIONAL
Enrollment	150
Start date	1 June 2022
Primary completion	20 August 2022
Estimated completion	15 September 2022
Sites	1 location across Bangladesh

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

DR. MALA KHAN

Who can join

Adults 5 to 70, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The outbreak of the severe acute respiratory syndrome (SARS) corona virus (CoV)-2 continues to increase globally. To control the coronavirus disease 2019 (COVID-19) transmission, diagnose is very important step which would help in the process of quarantine, isolation of the infected person and also in contact tracing. Among the various techniques real-time reverse transcription polymerase chain reaction (rRT-PCR) is mostly used and considers as gold standard method for viral nucleic acid detection as per World Health Organization (WHO) and Centre for Diseases Control (CDC), USA. However, possible false-negative and false-positive results produce misleading consequences, making it necessary to improve existing methods. So, investigators need a robust and reliable PCR kit to detect different kinds of variant of SARS-CoV-2 virus to reduce its transmissibility and take preventive management plan. Beside that to manage the increasing number of testing, investigators are mostly dependent on imported test kit which seems to be very difficult at this pandemic situation and costly. Hence, virulence of SARS-CoV-2 virus may change rapidly due to mutation and country become hot spot so, gene detection RT-PCR kit is time demand. In this point of view, investigator's aim to develop an validate multiplex rRT-PCR qualitative diagnostic method, which targets two viral genes E (envelope protein), N (nucleocapsid gene, according to the CDC, USA guidelines for the development of RT-PCR kit and one human gene RNase P as internal control simultaneously.

This is a case control study where will analyze 120 samples (60 COVID-19 positive and 60 COVID-19 negative both fresh and frozen) from Institute of Epidemiology, Disease Control and Research (IEDCR). This specimen will be blinded before supplying over to NILMRC/Contact ROL/ Bangladesh Clinical Trail Limited (BCTL), Dhaka, Bangladesh for Bangladesh Reference Institute for Chemical Measurements (BRiCM) RT-PCR Kit. Required in house validation will also be conducted as per International Council for Harmonization (ICH) and FDA guideline and also external validation will be carried in different Director General of Health Service (DGHS), Bangladesh approved COVID-19 diagnostic laboratory. Data will be analyzed by computer using Statistical Package for the Social Sciences (SPSS) software and will be presented into the frequency table, graph and chart according to the requirements.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Performance Evaluation of Developed Bangasure™ Multiplex rRT-PCR Assay for SARS-CoV-2 Detection in Bangladesh: A Blinded Observational Study at Two Different Sites.
   Razu MH, Ahmed ZB, Hossain MI, Rabbi MFA, et al · · 2022 · PMID 36359461 · DOI 10.3390/diagnostics12112617