In adults with COVID-19 without criteria for hospitalization or oxygen therapy but with risk factors for aggravation, early treatment may avoid hospitalization, indication for oxygen therapy or death. No treatment is currently validated for this indication.
COVERAGE France is 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 will 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. The trial is a national platform with the vocation to open as many centers as possible, subject to criteria set by the Scientific Advisory Board.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
412
2 tablets daily from the first day (day 0) to day 9
1 tablet daily from the first day (day 0) to day 9
2 puffs twice a day in an inhalation chamber from the first day (day 0) to day 9
Bordeaux university Hospital
Bordeaux, France
CHU de Dijon-Bourgogne
Dijon, France
CHU de Montpellier
Montpellier, France
CHRU de Nancy
Nancy, France
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
Proportion of participants with an occurrence of death
Time frame: From inclusion (day0) to day 14
Efficacy phase: oxygen therapy
Proportion of participants who had an indication for oxygen therapy
Time frame: From inclusion (day0) to day 14
Efficacy phase: hospitalization
Proportion of participants who had an indication for hospitalization
Time frame: From inclusion (day0) to day 14
Proportion of hospitalizations, overall and by cause, in each group
Time frame: From inclusion (day0) to day 28
Death and causes of death
Proportion of deaths, overall and by cause, in each group
Time frame: From inclusion (day0) to day 28
Proportion of intensive care hospitalizations, overall and by cause, in each group
Time frame: From inclusion (day0) to day 28
Proportion of participants with negative SARS-CoV-2 RT-PCR
Time frame: day 7
Haematological markers evolution
Evolution of Haematological markers in each group : Complete Blood Count, prothrombin level, INR
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A 10-minute nebulization, once a day, from the first day (day 0) to day 4, of 9.6 MIU / 300 µg of IFN-β-1b (EXTAVIA®) diluted in 2 mL of water
Groupe hospitalier Paris Saint Joseph
Paris, France
CNGE
Paris, France
CHU de Toulouse
Toulouse, France
Time frame: from inclusion (day 0) to day 7
Inflammatory markers evolution
Evolution of Inflammatory markers in each group : PCT, CRP
Time frame: from inclusion (day 0) to day 7
Adverse events
Number and proportion of grade 1,2,3,4 adverse events in each group
Time frame: from inclusion (day 0) to day 28
Adverse reactions
Number and proportion of grade 1,2,3,4 adverse events in each group
Time frame: from inclusion (day 0) to day 28
Acceptability of the treatment
Acceptability of the treatment by participant will be assessed with an interview
Time frame: from inclusion (day 0) to day 10
Antibiotic consumption
Proportion of participants who received at least one day of antibiotic therapy
Time frame: from inclusion (day 0) to day 28
Oxygen saturation worsening
Proportion of participants who experienced a worsening of oxygen saturation
Time frame: from inclusion (day 0) to day 28
protocol follow-up
Proportion of participants who completed the prescribed protocol treatment
Time frame: from inclusion (day 0) to day 10