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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04395742
Other study ID # TMX COVID
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 2020
Est. completion date December 2020

Study information

Verified date May 2020
Source Poitiers University Hospital
Contact Alexandre BLEIBTREU
Phone 142163303
Email alexandre.bleibtreu@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is observational study to assess the prognosis of patients hospitalized with COVID-19 confirmed by RT-PCR and exposed to trimethylxanthine (TMX).

Trimethylxanthine is the active molecule present in coffee. Due to the lack of etiologic treatments and considering interest about old treatments as an avenue for research, we conducted a comparative study aiming to evaluate the effect of 1,3,7-trimethylxanthine on COVID-19 infected patients. This is actually a study about methodology.

The objective of this study is therefore not to demonstrate the effect of the substance on the disease but the importance of a rigorous methodology in scientific research. This project is called "Method and Teaching of Scientific Studies".


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 93
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria:

- Age > 18,

- No Trimethylxanthine contraindications (defined as allergy, previous reported secondary effects),

- Infectious Disease Unit admission.

Exclusion Criteria:

- Secondary effects about Trimethylxanthine,

- Refuse to participate

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Data collection
Only data collection

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Poitiers University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of vital status the patient clinical status at day 6 after hospital admission, defined as alive, or dead. 6 days
Secondary Comparaison of duration of hospital stay 6 days
Secondary Comparaison of severity Evaluated by National Early Warning Score from 0 to 20, 20 being the worst score, with a high risk of death. 6 days
Secondary Comparaison of secondary effects (adverse events that needed disruption of treatment (anemia, tachycardia, osteoporosis) : secondary effects of coffee). with 6 days
Secondary Comparaison of use of antibiotics 14 days after hospital admission.
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