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

• Conditions: Coronavirus Disease 2019
• Interventions: Other: Data collection

• Registration Number: NCT04395742
• Lead Sponsor: Poitiers University Hospital

Brief 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".

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-05
• Study Start: 2020-05
• Study First Submitted: 2020-05-14
• Study First Submitted QC: 2020-05-19
• Last Update Submitted: 2020-05-19
• Study First Posted: 2020-05-20
• Last Update Posted: 2020-05-20
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 93

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tea and hot chocolate with milk	Data collection	-
Coffee:1,3,7-trimethylxanthine	Data collection	-

Primary Outcome Measures

Name	Time	Method
Comparison of vital status	6 days	the patient clinical status at day 6 after hospital admission, defined as alive, or dead.

Secondary Outcome Measures

Name	Time	Method
Comparaison of duration of hospital stay	6 days
Comparaison of severity	6 days	Evaluated by National Early Warning Score from 0 to 20, 20 being the worst score, with a high risk of death.
Comparaison of secondary effects (adverse events that needed disruption of treatment (anemia, tachycardia, osteoporosis) : secondary effects of coffee).	6 days	with
Comparaison of use of antibiotics	14 days after hospital admission.