Coronavirus Disease 2019TMX COVIDNCT04395742
1,3,7-Trimethylxanthine as a Treatment of COVID-19: Results of a Controlled Study
An observational study of Coronavirus Disease 2019, run by Poitiers University Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Coronavirus Disease 2019
- What is being tested?
- Data collection
- How many people
- 93 participants
- Where
- No sites listed yet
- Study dates
- May 2020to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
Study population: All patients meeting the eligibility criteria and wishing to participate in the study
Who may be able to join
- Age > 18,
- No Trimethylxanthine contraindications (defined as allergy, previous reported secondary effects),
- Infectious Disease Unit admission.
Who cannot join
- Secondary effects about Trimethylxanthine,
- Refuse to participate
Trial locations and contacts
No sites are listed yet.
Paul ROBLOT contact
About this study
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".
- Conditions
- Coronavirus Disease 2019
- Being tested
- Data collection
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Only data collection
| Study group | Role | What they receive |
|---|---|---|
| Coffee:1,3,7-trimethylxanthine | Not described Receives: Other: Data collection | |
| Tea and hot chocolate with milk | Not described Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of vital status
the patient clinical status at day 6 after hospital admission, defined as alive, or dead.
Measured: 6 days
Secondary outcomes (4)
Comparaison of duration of hospital stay
Measured: 6 days
Comparaison of severity
Evaluated by National Early Warning Score from 0 to 20, 20 being the worst score, with a high risk of death.
Measured: 6 days
Comparaison of secondary effects (adverse events that needed disruption of treatment (anemia, tachycardia, osteoporosis) : secondary effects of coffee).
with
Measured: 6 days
Comparaison of use of antibiotics
Measured: 14 days after hospital admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study startMay 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronavirus Disease 2019Studies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04395742
- Sponsor's protocol ID
- TMX COVID
- Acronym
- TMX COVID
- Status last verified
- May 2020
- First submitted
- 14 May 2020
- Last updated
- 20 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33213035
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1,3,7-Trimethylxanthine as a Treatment of COVID-19: Results of a Controlled Study
- ClinicalTrials.gov ID
- NCT04395742
- Acronym / sponsor ID
- TMX COVID / TMX COVID
- Conditions
- Coronavirus Disease 2019
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- May 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 20 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coffee:1,3,7-trimethylxanthine | – | Other: Data collection |
| Tea and hot chocolate with milk | – | Other: Data collection |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients meeting the eligibility criteria and wishing to participate in the study
Key inclusion criteria (3 listed)
- Age > 18,
- No Trimethylxanthine contraindications (defined as allergy, previous reported secondary effects),
- Infectious Disease Unit admission.
Key exclusion criteria (2 listed)
- Secondary effects about Trimethylxanthine,
- Refuse to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionOnly data collection | Other | Coffee:1,3,7-trimethylxanthine, Tea and hot chocolate with milk |
Primary outcome
Comparison of vital status
Time frame: 6 days
the patient clinical status at day 6 after hospital admission, defined as alive, or dead.
4 secondary outcomes
Comparaison of duration of hospital stay
Time frame: 6 days
Comparaison of severity
Time frame: 6 days
Comparaison of secondary effects (adverse events that needed disruption of treatment (anemia, tachycardia, osteoporosis) : secondary effects of coffee).
Time frame: 6 days
Comparaison of use of antibiotics
Time frame: 14 days after hospital admission.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
- Derived from this study: PubMed 33213035Belaroussi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul ROBLOT contact
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Disease 2019, run by Poitiers University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandre BLEIBTREU (142163303 ext. 0033, alexandre.bleibtreu@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of vital status (time frame: 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04395742, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2020.