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Treatments to Decrease the Risk of Hospitalization or Death in Elderly Outpatients With Symptomatic SARS-CoV-2 Infection (COVID-19) (COVERAGE)

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ClinicalTrials.gov Identifier: NCT04356495
Recruitment Status : Recruiting
First Posted : April 22, 2020
Last Update Posted : June 29, 2020
Sponsor:
Collaborator:
University of Bordeaux
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:
This trial will estimate the efficacy and tolerance of several experimental treatments to prevent hospitalization or death in outpatients aged 65 years or above with Symptomatic SARS-CoV-2 Infection (COVID-19).

Condition or disease Intervention/treatment Phase
Corona Virus Infection Sars-CoV2 Dietary Supplement: Vitamins Drug: Imatinib Drug: Favipiravir Drug: Telmisartan Phase 3

Detailed Description:

This is a randomized controlled, open-label, multi-arm multi-stage (MAMS) trial.

Participants will be randomly allocated 1:1 to the following strategies:

  • Arm 1: control arm
  • Arms 2 to X (where X is the number of arms): Experimental treatment At the time of trial initiation: People in the control arm will receive a complex of vitamins; people in the experimental arms will receive hydroxychloroquine, or favipiravir, or imatinib, or telmisartan.

Once the trial begins:

  • If an experimental treatment proves to be effective before the end of the trial; it will become the new standard.
  • Any experimental arm fulfilling the criteria for futility, efficacy or toxicity before the end of the trial will be prematurely terminated.
  • New experimental arms may be added if new evidence suggests that other treatments should be tested.

Participants will be followed 28 days. The primary outcome will be the proportion of participants with an occurrence of hospitalization or death between D0 and D14.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 845 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase III multi-centre, open-label, randomized controlled superiority multi-arm multi-stage, (MAMS) trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Outpatient Treatment of Elderly People With Symptomatic SARS-CoV-2 Infection (COVID-19): a Multi-arm, Multi-stage (MAMS) Randomized Trial to Assess the Efficacy and Safety of Several Experimental Treatments to Decrease the Risk of Hospitalization or Death (COVERAGE Trial)
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : January 28, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Vitamins
Patients in this arm will receive a vitamin supplement ("AZINC forme et vitalité®") during 10 days
Dietary Supplement: Vitamins
2 tablets daily from the first day (day 0) to day 9

Experimental: Imatinib
Patients in this arm will receive Imatinib (Imatinib TEVA® 400 mg) during 10 days
Drug: Imatinib
1 tablet daily from the first day (day 0) to day 9

Experimental: Favipiravir
Patients in this arm will receive Favipiravir (Avigan® 200 mg) during 10 days
Drug: Favipiravir
12 tablets twice a day the first day (day 0) then 6 tablets twice a day from day 1 to day 9

Experimental: Telmisartan
Patients in this arm will receive Telmisartan (Micardis® 20 mg) during 10 days
Drug: Telmisartan
1 tablet daily from the first day (day 0) to day 9




Primary Outcome Measures :
  1. Proportion of participants with an occurrence of hospitalization [ Time Frame: From inclusion (day0) to day 14 ]
  2. Death [ Time Frame: From inclusion (day0) to day 14 ]
    Proportion of participants with an occurrence of death


Secondary Outcome Measures :
  1. Proportion of hospitalizations, overall and by cause, in each group [ Time Frame: From inclusion (day0) to day 28 ]
  2. Death and causes of death [ Time Frame: From inclusion (day0) to day 28 ]
    Proportion of deaths, overall and by cause, in each group

  3. Proportion of intensive care hospitalizations, overall and by cause, in each group [ Time Frame: From inclusion (day0) to day 28 ]
  4. Proportion of participants with negative nasopharyngeal SARS-CoV-2 RT-PCR [ Time Frame: day 7 and day 14 ]
  5. Proportion of participants with a loss of autonomy evaluated by the ADL and IADL scale [ Time Frame: day 14 and day 28 ]
  6. Haematological markers evolution [ Time Frame: from inclusion (day 0) to day 7 and day 14 ]
    Evolution of Haematological markers in each group : Complete Blood Count, prothrombin level, INR

  7. Biochemical markers evolution [ Time Frame: from inclusion (day 0) to day 7 and day 14 ]
    Evolution of Biochemical markers in each group : ferritin, serum creatinine, urea, sodium, potassium, chlorine, calcium, magnesium, albumin, bicarbonates / tCO2, LDH, CPK, ASAT, ALAT, uricemia

  8. Inflammatory markers evolution [ Time Frame: from inclusion (day 0) to day 7 and day 14 ]
    Evolution of Inflammatory markers in each group : PCT, CRP

  9. Immunological markers evolution [ Time Frame: from inclusion (day 0) to day 7 and day 14 ]
    Evolution of immunological markers in each group : B ans T Cells phenotypic profiles

  10. Adverse events [ Time Frame: from inclusion (day 0) to day 14 ]
    Number and proportion of grade 1,2,3,4 adverse events in each group

  11. Adverse reactions [ Time Frame: from inclusion (day 0) to day 14 ]
    Number and proportion of grade 1,2,3,4 adverse events in each group

  12. Plasma concentration [ Time Frame: day 7 ]
    Plasma concentration of the study drugs at D7

  13. Acceptability of the treatment [ Time Frame: from inclusion (day 0) to day 10 ]
    Acceptability of the treatment by participant will be assessed with an interview



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Positive SARS-CoV-2 infection virology test on nasopharyngeal swab
  • Onset of symptoms < 72 hours prior to nasopharyngeal swab sampling
  • Age ≥ 65 years
  • Valid, ambulatory person, fully capable of understanding the challenges of the tria
  • No hospitalization criteria according to current recommendations
  • Signed informed consent
  • Covered by Health Insurance

Exclusion Criteria:

  • Inability to make a decision to participate (dementia, guardianship)
  • Long QT syndrome, or QTc space > 500 ms
  • Presence of a pace maker
  • Heart rate <50 / min
  • Hyperkalemia > 5.5 mmol/L or hypokalemia < 3.5 mmol/L
  • Treatment with piperazine, halofantrine, dasatinib, nilotinib.citalopram, escitalopram, hydroxyzine, domperidone, potent inhibitors of cytochrome P450 CYP3A4 isoenzyme, potent inducers of cytochrome P450 CYP3A4 isoenzyme, repaglinide, azathioprine, 6-mercaptopurine, theophylline, pyrazinamide, warfarin.
  • Hypersensitivity to any of the trial drugs or to chloroquine and other 4-aminoquinolines, amodiaquine, mefloquine, glafenine, floctafenine, antrafenine, ARB2 or sartan.
  • Hepatic porphyria, obstructive hepato-biliary disease, liver failure (stage ≥ Child-Pugh B), stage 4 or 5 chronic kidney disease (DFG <30 mL/min/1.73 m²), person on dialysis, retinopathy, lactose hypersensitivity, abnormalities in galactose metabolism, lactase deficiency, malabsorption syndrome, glucose-6-phosphate dehydrogenase deficiency, symptomatic hyperuricemia, ileus, colitis or enterocolitis, hepatitis B virus chronic infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04356495


Contacts
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Contact: Denis MALVY, Pr 0557822796 ext +33 denis.malvy@chu-bordeaux.fr
Contact: Xavier ANGLARET, Dr 0557571258 ext +33 xavier.anglaret@u-bordeaux.fr

Locations
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France
Bordeaux university Hospital Recruiting
Bordeaux, France, 33000
Contact: Denis MALVY, Pr    05 57 82 27 96 ext +33    denis.malvy@chu-bordeaux.fr   
Contact: Xavier ANGLARET, Dr    0557571258 ext +33    xavier.anglaret@u-bordeaux.fr   
Sponsors and Collaborators
University Hospital, Bordeaux
University of Bordeaux
Investigators
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Principal Investigator: Denis MALVY, Pr University Hospital, Bordeaux
Study Director: Xavier ANGLARET, Dr Inserm 1219
Study Chair: Laura RICHERT, Dr University Hospital, Bordeaux
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04356495    
Other Study ID Numbers: CHUBX 2020/12
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
Corona virus
Sars-CoV2
hydroxychloroquine
favipiravir
imatinib
telmisartan
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Imatinib Mesylate
Telmisartan
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists