Coronavirus Disease 2019 Clinical Trial
— TMX COVIDOfficial title:
1,3,7-Trimethylxanthine as a Treatment of COVID-19: Results of a Controlled Study
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 |
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".
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Poitiers University Hospital |
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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