NCT04395742

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 20, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

May 20, 2020

Status Verified

May 1, 2020

Enrollment Period

7 months

First QC Date

May 14, 2020

Last Update Submit

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

Other: Data collection

Tea and hot chocolate with milk

Other: Data collection

Interventions

Only data collection

Coffee:1,3,7-trimethylxanthineTea and hot chocolate with milk

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

MeSH Terms

Conditions

COVID-19

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Alexandre BLEIBTREU

CONTACT

Paul ROBLOT

CONTACT

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