COVID-19

Bordeaux University Hospital

Denis MALVY MD, PhD – Bordeaux University Hospital / Xavier ANGLARET MD – Bordeaux University Hospital

COVERAGE trial is a multicentric adaptative randomized controlled clinical trial platform evaluating several treatment strategies against COVID19 in outpatients with aggravating risk factors.

Multicenter, randomized, controlled clinical trial with for each drug :

• A safety study pilot phase
• An efficacy study phase. The data collected during the pilot phase, combined with new external data that emerged during the period, will be used to position treatments for the efficacy phase

• Pilot phase : Evaluate the tolerance of experimental treatments for drugs given for the first time (« first in home-based care ») in ambulatory individuals with COVID-19 with aggravating risk factors.
• Efficacy Phase : To estimate the effectiveness of experimental ambulatory treatments, compared to vitamin supplementation, in reducing the risk of hospitalization, oxygen therapy indication or death in ambulatory individuals with COVID-19 with aggravating risk factors.

• Pilot Phase : Proportion of participants who had a Grade 3 or 4 adverse event [ Time Frame: From inclusion (day0) to day 14 ]
• Efficacy phase : Death [ Time Frame: From inclusion (day0) to day 14 ]
  Proportion of participants with an occurrence of death
• Efficacy phase : oxygen therapy [ Time Frame: From inclusion (day0) to day 14 ]
  Proportion of participants who had an indication for oxygen therapy
• Efficacy phase : hospitalization [ Time Frame: From inclusion (day0) to day 14 ]
  Proportion of participants who had an indication for hospitalization

Corona Virus Infection, Sars-CoV2

Vitamins, Telmisartan, Ciclesonide, interferon β-1b

412 participants

France, 7 sites

436 days

French Ministry of Health and labeled France National Research Priority

Methodology, Statistical aspects, Data management, Global coordination of the trial

https://clinicaltrials.gov/ct2/show/NCT04356495