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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001435-27 | EudraCT Number |
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| Name | Class |
|---|---|
| University of Bordeaux | OTHER |
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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 :
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamins | Sham Comparator | Patients in this arm will receive a vitamin supplement ("AZINC forme et vitalité®") during 10 days |
|
| Telmisartan | Experimental | Patients in this arm will receive Telmisartan (Micardis® 20 mg) during 10 days |
|
| Ciclesonide | Experimental | Patients in this arm will receive ciclesonide (Alvesco® 160 µg ) during 10 days |
|
| interferon β-1b | Experimental | Patients in this arm will receive interferon β-1b (Extavia® 9,6 MUI/300 µg ) during 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamins | Dietary Supplement | 2 tablets daily from the first day (day 0) to day 9 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pilot Phase: Proportion of participants who had a Grade 3 or 4 adverse event | From inclusion (day0) to day 14 | |
| Efficacy phase: Death | Proportion of participants with an occurrence of death | From inclusion (day0) to day 14 |
| Efficacy phase: oxygen therapy | Proportion of participants who had an indication for oxygen therapy | From inclusion (day0) to day 14 |
| Efficacy phase: hospitalization | Proportion of participants who had an indication for hospitalization | From inclusion (day0) to day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of hospitalizations, overall and by cause, in each group | From inclusion (day0) to day 28 | |
| Death and causes of death | Proportion of deaths, overall and by cause, in each group | From inclusion (day0) to day 28 |
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Inclusion Criteria:
Clinical picture suggestive of COVID-19 dated 7 days or less.
Positivity of a test proving an acute SARS-CoV-2 infection, according to current recommendations.
Absence of criteria for hospitalization or oxygen therapy according to current recommendations.
Age :
greater than or equal to 60 years of age without any risk factor
or between 50 and 59 years of age and the presence of at least one of the following risk factors :
of therapeutic origin (solid organ transplant or hematopoietic stem cell transplant, cancer chemotherapy, immunosuppressive therapy, corticosteroids > 15 mg/d of prednisone equivalent taken for at least 2 months);
HIV infection with CD4<200/mm3.
Valid, ambulatory person, fully able to understand the issues of the trial
Beneficiary of a Social Security scheme
Signed informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Denis MALVY, Pr | University Hospital, Bordeaux | Principal Investigator |
| Xavier ANGLARET, Dr | Inserm 1219 | Study Director |
| Laura RICHERT, Dr | University Hospital, Bordeaux | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bordeaux university Hospital | Bordeaux | 33000 | France | |||
| CHU de Dijon-Bourgogne |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38454482 | Derived | Garcia G, Labrouche-Colomer S, Duvignaud A, Clequin E, Dussiau C, Tregouet DA, Malvy D, Prevel R, Zouine A, Pellegrin I, Goret J, Mamani-Matsuda M, Dewitte A, James C. Impaired balance between neutrophil extracellular trap formation and degradation by DNases in COVID-19 disease. J Transl Med. 2024 Mar 7;22(1):246. doi: 10.1186/s12967-024-05044-7. | |
| 34473343 |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D014815 | Vitamins |
| D000077333 | Telmisartan |
| C120481 | ciclesonide |
| ID | Term |
|---|---|
| D018977 | Micronutrients |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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Multicenter, randomized, controlled clinical trial with for each drug :
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| Telmisartan |
| Drug |
1 tablet daily from the first day (day 0) to day 9 |
|
| Ciclesonide | Drug | 2 puffs twice a day in an inhalation chamber from the first day (day 0) to day 9 |
|
| interferon β-1b | Drug | 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 |
|
| Proportion of intensive care hospitalizations, overall and by cause, in each group | From inclusion (day0) to day 28 |
| Proportion of participants with negative SARS-CoV-2 RT-PCR | day 7 |
| Haematological markers evolution | Evolution of Haematological markers in each group : Complete Blood Count, prothrombin level, INR | from inclusion (day 0) to day 7 |
| Inflammatory markers evolution | Evolution of Inflammatory markers in each group : PCT, CRP | from inclusion (day 0) to day 7 |
| Adverse events | Number and proportion of grade 1,2,3,4 adverse events in each group | from inclusion (day 0) to day 28 |
| Adverse reactions | Number and proportion of grade 1,2,3,4 adverse events in each group | from inclusion (day 0) to day 28 |
| Acceptability of the treatment | Acceptability of the treatment by participant will be assessed with an interview | from inclusion (day 0) to day 10 |
| Antibiotic consumption | Proportion of participants who received at least one day of antibiotic therapy | from inclusion (day 0) to day 28 |
| Oxygen saturation worsening | Proportion of participants who experienced a worsening of oxygen saturation | from inclusion (day 0) to day 28 |
| protocol follow-up | Proportion of participants who completed the prescribed protocol treatment | from inclusion (day 0) to day 10 |
| Dijon |
| France |
| CHU de Montpellier | Montpellier | 34295 | France |
| CHRU de Nancy | Nancy | France |
| Groupe hospitalier Paris Saint Joseph | Paris | 75014 | France |
| CNGE | Paris | France |
| CHU de Toulouse | Toulouse | France |
| Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2. |
| 33050924 | Derived | Duvignaud A, Lhomme E, Pistone T, Onaisi R, Sitta R, Journot V, Nguyen D, Peiffer-Smadja N, Cremer A, Bouchet S, Darnaud T, Poitrenaud D, Piroth L, Binquet C, Michel JF, Lefevre B, Lebeaux D, Lebel J, Dupouy J, Roussillon C, Gimbert A, Wittkop L, Thiebaut R, Orne-Gliemann J, Joseph JP, Richert L, Anglaret X, Malvy D; COVERAGE study group. Home Treatment of Older People with Symptomatic SARS-CoV-2 Infection (COVID-19): A structured Summary of a Study Protocol for a Multi-Arm Multi-Stage (MAMS) Randomized Trial to Evaluate the Efficacy and Tolerability of Several Experimental Treatments to Reduce the Risk of Hospitalisation or Death in outpatients aged 65 years or older (COVERAGE trial). Trials. 2020 Oct 13;21(1):846. doi: 10.1186/s13063-020-04619-1. |
| D007239 |
| Infections |
| D000078622 | Nutrients |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |