1,3,7-Trimethylxanthine as a Treatment of COVID-19: Results of a Controlled Study
TMX COVID
1 other identifier
observational
93
0 countries
N/A
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".
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2020
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2020
CompletedFirst Submitted
Initial submission to the registry
May 14, 2020
CompletedFirst Posted
Study publicly available on registry
May 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedMay 20, 2020
May 1, 2020
7 months
May 14, 2020
May 19, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Comparison of vital status
the patient clinical status at day 6 after hospital admission, defined as alive, or dead.
6 days
Secondary Outcomes (4)
Comparaison of duration of hospital stay
6 days
Comparaison of severity
6 days
Comparaison of secondary effects (adverse events that needed disruption of treatment (anemia, tachycardia, osteoporosis) : secondary effects of coffee).
6 days
Comparaison of use of antibiotics
14 days after hospital admission.
Study Arms (2)
Coffee:1,3,7-trimethylxanthine
Tea and hot chocolate with milk
Interventions
Only data collection
Eligibility Criteria
All patients meeting the eligibility criteria and wishing to participate in the study
You may qualify if:
- Age \> 18,
- No Trimethylxanthine contraindications (defined as allergy, previous reported secondary effects),
- Infectious Disease Unit admission.
You may not qualify if:
- Secondary effects about Trimethylxanthine,
- Refuse to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Belaroussi Y, Roblot P, Peiffer-Smadja N, Delaye T, Mathoulin-Pelissier S, Lemeux J, Le Moal G, Caumes E, Roblot F, Bleibtreu A. Why Methodology Is Important: Coffee as a Candidate Treatment for COVID-19? J Clin Med. 2020 Nov 17;9(11):3691. doi: 10.3390/jcm9113691.
PMID: 33213035DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2020
First Posted
May 20, 2020
Study Start
May 1, 2020
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
May 20, 2020
Record last verified: 2020-05