1,3,7-Trimethylxanthine as a Treatment of COVID-19: Results of a Controlled Study

Coronavirus Disease 2019 Clinical Trial

— TMX COVID  

Official title:

1,3,7-Trimethylxanthine as a Treatment of COVID-19: Results of a Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04395742
• Other study ID #: TMX COVID
• Status: Not yet recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Coronavirus Disease 2019
• Coronavirus Infections

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.