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AzTrials

COVID19Phase 2/3CORIMUNO-VIRONCT04341870

Study of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients: Sarilumab, Azithromycin, Hydroxychloroquine Trial - CORIMUNO-19 - VIRO

A Phase 2/3 study testing Sarilumab, Azithromycin and Hydroxychloroquine in people with COVID19 and SARS-CoV-2 Infection, run by Assistance Publique - Hôpitaux de Paris at 5 sites in France.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

The overall objective of the study is to determine the therapeutic effect and tolerance of Sarilumab in combination with Azithromycin and Hydroxychloroquine, compared to Sarilumab only, patients with moderate, severe pneumonia associated with Coronavirus disease 2019 (COVID-19). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
COVID19, SARS-CoV-2 Infection
What is being tested?
Sarilumab, Azithromycin and Hydroxychloroquine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
5 sitesFrance
Study dates
11 Apr 2020to Aug 2020
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients included in the CORIMUNO-19 cohort (NCT04324047)
  • COVID-19 cases not requiring ICU at admission with moderate or severe pneumopathy according to the WHO Criteria of severity of COVID pneumopathy:
  • Moderate cases: Cases meeting all of the following criteria: [Showing fever and respiratory symptoms with radiological findings of pneumonia] AND [Requiring between 3L/min and 5L/min of oxygen to maintain SpO2>97%] OR
  • Severe cases: Cases meeting any of the following criteria: [Respiratory distress ( ≥ 30 breaths/ min)] OR [Oxygen saturation≤93% at rest in ambient air; or Oxygen saturation ≤97 % with O2 > 5L/min] OR [PaO2/FiO2 ≤ 300mmHg]

Who cannot join

  • Patients with exclusion criteria to the CORIMUNO-19 cohort.
  • Respiratory failure requiring non invasive or mechanical ventilation
  • Patients requiring intensive care
  • Do-not-resuscitate order (DNR order)
  • Known hypersensitivity to sarilumab or to any of their excipients.
  • Known contra-indication to hydroxychloroquine or chloroquine: including hypersensitivity/allergy, retinopathy, G6PD deficiency and QT prolongation
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  • Known contra-indication to azithromycin: including hypersensitivity/allergy and QT prolongation
  • Pregnancy or breastfeeding
  • Current documented bacterial infection.
  • Patient with any of following laboratory results out of the ranges detailed below at screening should be discussed depending of the medication:
  • Absolute neutrophil count (ANC) ≤ 1.0 x 109/L
  • Haemoglobin level: no limitation
  • Platelets (PLT) < 50 G /L
  • SGOT or SGPT > 5N

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

France5 sites

  • AP-HP Hôpital Avicenne

    Bobigny

  • AP-HP Hôpital Ambroise Paré

    Boulogne-Billancourt

  • AP-HP Hôpital Beaujon

    Clichy

  • AP-HP Hôpital Pitié Salpétrière

    Paris

  • AP-HP Hôpital Saint Antoine

    Paris

Other trials in France

About this study

Official title: Efficacy of Sarilumab + Azithromycin + Hydroxychloroquine, and Sarilumab Alone, for Adult Patients Hospitalized With Moderate to Severe COVID-19: a Multicenter Open-label 1:1 Randomized Controlled Trial

The overall objective of the study is to determine the therapeutic effect and tolerance of Sarilumab in combination with Azithromycin and Hydroxychloroquine, compared to Sarilumab only, patients with moderate, severe pneumonia associated with Coronavirus disease 2019 (COVID-19). Sarilumab is a human IgG1 monoclonal antibody that binds specifically to both soluble and membrane-bound IL-6Rs (sIL-6Rα and mIL-6Rα) and has been shown to inhibit IL-6-mediated signaling through these receptors. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering investigational treatments administration to patients enrolled in the CORIMUNO-19 cohort (NCT04324047). Sarilumab+Azithromycin+Hydroxychloroquine, or Sarilumab only will be administered to consenting adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation. All patients will receive standard of care along with randomized investigational treatments. Outcomes of included patients will be compared between groups as well as with outcomes of patients in the CORIMUNO-19 cohort treated with other immune modulators or standard of care.

Being tested
Sarilumab, Azithromycin, Hydroxychloroquine
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SarilumabDrug

    Sarilumab: 400 mg in a 1 hour - I.V. infusion on D1

  • AzithromycinDrug

    Azithromycin: oral administration, 500mg on D1 then 250mg QD on D2 to D5 (total duration 5 days)

  • HydroxychloroquineDrug

    Hydroxychloroquine: oral administration, 600mg QD (200mg TID) from D1 to D10 (total duration 10 days)

Study groups in NCT04341870
Study groupRoleWhat they receive
Sarilumab + Azithromycin + HydroxychloroquineExperimentalSarilumab combined with Azithromycin and Hydroxychloroquine
Receives: Drug: Sarilumab; Drug: Azithromycin; Drug: Hydroxychloroquine
SarilumabActive comparatorSarilumab only
Receives: Drug: Sarilumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Need for ventilation (including invasive and non invasive ventilation), intensive care or death

    Events considered are: need for ventilation (including invasive and non invasive ventilation), transfer to the Intensive Care Unit, death or new do-not-resuscitate (DNR) decision in the absence ventilation and outside ICU.

    Measured: 14 days

Secondary outcomes (9)

  1. Early improvement: OMS progression scale <= 5

    WHO progression scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10

    Measured: 4 days

  2. OMS progression scale

    WHO progression scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10

    Measured: 4, 7 and 14 days

  3. Survival

    Overall survival

    Measured: 14, 28 and 90 days

  4. ICU-free days alive

    Number of ICU-free days alive

    Measured: 14, 28 and 90 days

  5. Ventilation-free days alive

    Number of ventilation(invasive or non invasive)-free days alive

    Measured: 14 and 28 days

  6. Hospital-free days alive

    Number of hospital-free days alive

    Measured: 14, 28 and 90 days

  7. Oxygen therapy-free days alive

    Number of oxygen therapy-free days alive

    Measured: 14 and 28 days

  8. Time to negative viral excretion

    SARS-CoV-2 viral load measurement by rtPCR

    Measured: 90 days

  9. Immunophenotyping and multiplex cytokines

    Immunophenotyping and multiplex cytokines (blood sample)

    Measured: 8 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2020
  2. Study start11 Apr 2020
  3. Primary completion8 May 2020 (estimated)
  4. Study completionAug 2020 (estimated)

Why it stopped: DSMB recommendation (futility)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Bayesian open labelled randomized clinical trial
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04341870
Sponsor's protocol ID
APHP200375-3
Acronym
CORIMUNO-VIRO
Status last verified
Apr 2020
First submitted
6 Apr 2020
Last updated
6 May 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Sarilumab, Azithromycin and Hydroxychloroquine in people with COVID19 and SARS-CoV-2 Infection, run by Assistance Publique - Hôpitaux de Paris at 5 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Need for ventilation (including invasive and non invasive ventilation), intensive care or death (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04341870.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2020.

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