Clinical Trials
Several clinical trials that have completed recruitment evaluate the diagnostic utility of Congo Red, primarily investigating preeclampsia and uropathogenic Escherichia coli infections through protein misfolding assays and microbial biofilm identification. Functioning as observational or diagnostic validation studies rather than formal interventional phases, these research efforts are sponsored by academic and non-profit health organizations, including Suez Canal University, Gynuity Health Projects, the International Centre for Diarrhoeal Disease Research in Bangladesh, and Nationwide Children's Hospital.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06252428 | Completed | Escherichia Coli Infections |
Suez Canal University |
2022-12-20 | -- |
| NCT02610972 | Completed | Preeclampsia |
Gynuity Health Projects|International Centre for Diarrhoeal Disease Research Bangladesh |
2018-12-01 | -- |
| NCT02381210 | Completed | Preeclampsia |
Gynuity Health Projects|Nationwide Children''s Hospital |
2016-07 | -- |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Compliance for Clinical Use
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).