- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04552379
The Containing Coronavirus Disease 19 (COVID-19) Trial (ConCorD-19)
A Cluster Randomised Trial of Interferon Versus Standard of Care in the Reduction of Transmission of SARS-Cov-2. The Containing Coronavirus Disease 19 Trial (ConCorD-19)
In recent months severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) has emerged as a novel human pathogen and, susceptibility amongst humans is presumed to be universal. Prevention measures of COVID-19 have included distancing, quarantines, use of facemasks in public places, and hand hygiene measures. Mandatory quarantines have also been applied on index cases and their contacts, as well as an active search for asymptomatic patients.
Current strategies to reduce the spread of SARS-CoV-2 do not include measures that could prevent transmission prior to the onset of symptoms. Subjects infected with SARS-CoV-2 have been known to shed virus and be contagious for up to 5 days prior to developing symptoms ('pre-symptomatic transmission'). In fact, nearly 60% of all infected subjects can shed virus pre-symptomatically. Pre- or even asymptomatic shedding occurs across all age groups, contributing to the rapidly expanding pandemic.
Post-exposure prophylaxis (PEP) using type 1 interferon (IFN) can potentially eliminate the spread of SARS-CoV-2. IFN could reduce the period of viral shedding by ~1 week. Since pre-symptomatic shedding of virus can start up to 5 days prior to symptom onset, our approach of a PEP intervention to all contacts recently exposed to a case could possibly entirely interrupt the spread of the virus, and with that, the pandemic. The current study focuses on prevention of the disease in addition to its treatment. Thus, the key distinction between these other trials and this study is that this study focuses on containing coronavirus (i.e. cause) in the community, rather than simply its treatment (i.e. consequence) in the individual.
Viral spread could be eliminated through interventions effective at abolishing viral transmission. However, such post-exposure prophylaxis interventions, that is initiation of antiviral therapy in pre-infectious contacts to reduce or even eliminate such spread, must be safe since they are given to asymptomatic and possibly uninfected subjects. In none of the previous clinical trials of IFN therapy for SARS-CoV-2 have serious adverse events been recorded. Furthermore, the IFN chosen for this study (pegylated IFN 1b) has been extensively studied in clinical trials, and has been in clinical use for years for multiple sclerosis. Pegylated IFN formulations allow for weekly injections while maintaining serum levels and limiting dose-dependent side effects. Together these data support a sound safety profile for the planned intervention.
The aim of this study is to ascertain whether IFN administered to index cases and household contacts of an index case, starting immediately following confirmed exposure (index case confirmed positive for SARS-CoV-2), will reduce duration of SARS-CoV-2 detectable by PCR in the index cases, and incidence of SARS-CoV-2 detectable by PCR in household contacts.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Santiago, Chile
- Pontificia Universidad Catolica de Chile
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Index Cases:
- Provided a signed and dated informed consent form
- Aged 18 to <80 years of age
- Confirmed SARS-CoV-2 diagnosis by PCR within 72 hours of first treatment dose
- The first known diagnosis in the household
- Not currently enrolled in a clinical trial and agree to not take any other investigational treatments over the next 28 days
- Must plan to remain resident in the household during the study
- Lives in household with at least one other 'treatment-eligible household contact'
Treatment-eligible Household Contacts:
- Provided a signed and dated informed consent form
- Aged 18 to <80 years of age,
- Not currently enrolled in a clinical trial and agree to not take any other investigational treatments over the next 28 days
- Must plan to remain resident in the household during the study
- No history of previously confirmed SARS-CoV-2 diagnosis
Treatment-ineligible Household Contacts:
- Provided a signed and dated informed consent form, parental informed consent, and assent if applicable
- Under 18 years OR ≥ 80 years of age OR aged 18 to <80 years with any contraindication for IFN treatment listed in 'exclusion criteria'
- Not currently enrolled in a clinical trial and agree to not take any other investigational treatments over the next 28 days
- Must plan to remain resident in the household during the study
- No history of previously confirmed SARS-CoV-2 diagnosis
Exclusion Criteria:
Index Cases and Treatment-eligible Household contacts:
- Inability to take medications orally or injected
- Known sensitivity/allergy to interferons or use of interferons for another indication
- Known adverse drug-drug interactions with any study drugs
- Malignancy
- Known clinical immune deficiency
- Pregnancy or unwillingness, of female participants of childbearing potential to use recognised methods of birth control/contraception during the trial period,
- Retinopathy,
- Known grade 4 or 5 chronic kidney or liver disease,
- Known arrhythmias,
- Known autoimmune diseases or chronic inflammatory disease,
- Chronic liver disease,
- Hospitalisation for depression in the last 3 months,
- Current suicidal ideation,
- Previous therapeutic use of IFN
All subjects:
- Declined participation,
- The index case has been in complete self-quarantine from other household members during the 48 hours prior to diagnosis of SARS-CoV-2 infection.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Interferon
Peginterferon beta-1alfa will be made available from Biogen Inc. Switzerland.
125 micrograms of pegylated IFNß1alfa (PLEGRIDY, Biogen) administered on Study Days 1, 6 and 11 (i.e. for a total of 3 doses) via subcutaneous injection.
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Administration of trial drug: PLEGRIDY is given by an injection under the skin (subcutaneous injection). It will be administered to participants in accordance with product insert instructions by appropriately trained trial staff for whom administration of subcutaneous injections is within their normal scope of practice (e.g. RN or MD). They will wait for 20 mins after the last individual receives the interferon before leaving a residence. Administering staff will be supplied with appropriate PPE, trained in the use of this equipment and protocols for infection control, and will always attend in pairs. PLEGRIDY will be administered in the home of the participants. Due to the heat-labile nature of the trial product (storage required at ~4oC) a verified English Spanish version of the product label will be printed by a GMP certified company and applied to the product and patient band just at the time of use.
Other Names:
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No Intervention: Standard of Care
Standard of Care; following national guidelines regarding self-isolation and infection prevention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The proportion of index cases shedding SARS-CoV-2, at Day 11, in the active arm compared to the standard of care arm.
Time Frame: Day 11
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Day 11
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The proportion of household contacts shedding SARS-CoV-2, at Day 11, in the active arm compared to the standard of care arm.
Time Frame: Day 11
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Day 11
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration (in days) of SARS-CoV-2 by PCR of samples taken on study days 1, 6, 11, 16, 21, and 29.
Time Frame: Days 1,6,11, 21 and 29
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Days 1,6,11, 21 and 29
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Number of household contacts of participants in the IFN arm with positive upper airway PCR compared to that in the standard of care arm at day 1 & 11, and seroconversion (Ig) over the study period, up to day 29.
Time Frame: Days 1,11 and 29
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Days 1,11 and 29
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The proportion of infected cases in the active arm that are hospitalised or die due to COVID-19, as compared to the proportion in the standard of care arm.
Time Frame: Days 1 to 29
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Days 1 to 29
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Incidence and severity of reported adverse events in the interferon arm compared to the standard of care arm.
Time Frame: Days 1 to 29
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Days 1 to 29
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jose A Castro-Rodriguez, MD,PhD, Pontificia Universidad Catolica de Chile, Santiago, Chile
- Principal Investigator: Stephen Stick, MD,PhD, Telethon Kids Institute, University of Western Australia, Perth, Australia
- Study Director: Arturo Borzutzky, MD, Pontificia Universidad Catolica de Chile, Santiago, Chile
- Study Chair: Carolina Iturriaga, NP, Pontificia Universidad Catolica de Chile, Santiago, Chile
- Study Chair: Tobias Kollmann, MD,PhD, Telethon Kids Institute, University of Western Australia, Perth, Australia
- Study Chair: Eleanor N Fish, PhD, Department of Immunology, University of Toronto, Canada
- Study Chair: Cecilia Perret, MD, Pontificia Universidad Catolica de Chile, Santiago, Chile
- Study Chair: Diego Garcia-Huidobro, MD,PhD, Pontificia Universidad Catolica de Chile, Santiago, Chile
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200703013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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