Trial of COVID-19 Outpatient Treatment in Individuals With Risk Factors for Aggravation

NCT04356495 | Completed Phase 2 DMC

• 1 other identifier: CHUBX 2020/12
• Study Type: interventional
• Target: 412
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Corona Virus Infection; Sars-CoV2

Keywords

Corona virus; Sars-CoV2; telmisartan; ciclesonide; interferon β-1b

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (12)

• Proportion of hospitalizations, overall and by cause, in each group

  From inclusion (day0) to day 28

• Death and causes of death

  From inclusion (day0) to day 28

• 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

  from inclusion (day 0) to day 7

Study Arms (4)

Vitamins

SHAM COMPARATOR

Patients in this arm will receive a vitamin supplement ("AZINC forme et vitalité®") during 10 days

Dietary Supplement: Vitamins

Telmisartan

EXPERIMENTAL

Patients in this arm will receive Telmisartan (Micardis® 20 mg) during 10 days

Drug: Telmisartan

Ciclesonide

EXPERIMENTAL

Patients in this arm will receive ciclesonide (Alvesco® 160 µg ) during 10 days

Drug: Ciclesonide

interferon β-1b

EXPERIMENTAL

Patients in this arm will receive interferon β-1b (Extavia® 9,6 MUI/300 µg ) during 5 days

Drug: interferon β-1b

Interventions

Vitamins DIETARY_SUPPLEMENT

2 tablets daily from the first day (day 0) to day 9

Vitamins

Telmisartan DRUG

1 tablet daily from the first day (day 0) to day 9

Telmisartan

Ciclesonide DRUG

2 puffs twice a day in an inhalation chamber from the first day (day 0) to day 9

Ciclesonide

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

interferon β-1b

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 :
• Arterial hypertension under treatment (all stages)
• Obesity (BMI ≥30 kg/m2)
• Diabetes under treatment (all types)
• Ischemic heart disease (all stages)
• Heart failure (all stages)
• Stroke History
• Chronic Obstructive Pulmonary Disease (all stages)
• Stage 3 chronic renal failure (30 ≤ Estimated GFR \< 60 mL/min/1.73 m²)
• Malignancies (solid tumours or blood malignancies) that are progressive or were diagnosed less than 5 years ago.

You may not qualify if:

• Asymptomatic person
• Inability to make a decision to participate (dementia, person under legal protection, curatorship or guardianship)
• Ongoing illness or chronic treatment contraindicated by taking one of the trial drugs.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• University of Bordeaux: collaborator

Study Sites (7)

Bordeaux university Hospital

Bordeaux, 33000, France

Location

CHU de Dijon-Bourgogne

Dijon, France

Location

CHU de Montpellier

Montpellier, 34295, France

Location

CHRU de Nancy

Nancy, France

Location

Groupe hospitalier Paris Saint Joseph

Paris, 75014, France

Location

CNGE

Paris, France

Location

CHU de Toulouse

Toulouse, France

Location

Related Publications (3)

• 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.

  PMID: 38454482 DERIVED

• 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.

  PMID: 34473343 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.

  PMID: 33050924 DERIVED

MeSH Terms

Conditions

Coronavirus Infections

Interventions

Vitamins; Telmisartan; ciclesonide

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Denis MALVY, Pr

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Xavier ANGLARET, Dr

  Inserm 1219

  STUDY DIRECTOR

• Laura RICHERT, Dr

  University Hospital, Bordeaux

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 11, 2020
• First Posted: April 22, 2020
• Study Start: July 29, 2020
• Primary Completion: October 8, 2021
• Study Completion: October 22, 2021
• Last Updated: February 4, 2022

Record last verified: 2022-02

Locations

FR (7)