A Phase 3 interventional study of Peginterferon beta-1a in SARS-CoV Infection, Interferon and Covid19, sponsored by Pontificia Universidad Catolica de Chile. Completed at 1 site in Chile. Open to participants aged 18 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-10.
Sponsored by Pontificia Universidad Catolica de Chile · Phase 3, Interventional, and Treatment
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.
Participants with COVID-19 will be identified from lists of patients with positive SARS-CoV-2 PCR that is obtained daily from clinical laboratories, at COVID-19 outpatient and hospital clinics, or the Emergency Rooms in Chile. After telephonically pre-screening eligibility of the index case and his/her household, and participants providing informed consent, households will be randomized 1:1 to three doses of IFN beta 1a or standard of care. Only the index case and treatment-eligible household members will receive IFN if their household is assigned to treatment arm. Other non-eligible household participants (e.g. children) will be monitored by serial SARS-CoV-2 saliva PCR and diary cards, and at day 29 all participants will be evaluated for SARS-CoV-2 antibodies in blood.
7,641 studies on the registry are indexed under COVID-19; 487 are open to participants now.
This study's enrollment of 1,173 is above the median of 100 across 4,100 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Pontificia Universidad Catolica de Chile is the lead sponsor of 215 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Index Cases:
Treatment-eligible Household Contacts:
Treatment-ineligible Household Contacts:
Exclusion Criteria:
Index Cases and Treatment-eligible Household contacts:
All subjects:
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.
Biological: Peginterferon beta-1a
Standard of Care; following national guidelines regarding self-isolation and infection prevention
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.
Also known as: Plegridy
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
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
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
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
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
Incidence and severity of reported adverse events in the interferon arm compared to the standard of care arm.
Time frame: Days 1 to 29
Plan to share: Yes — We are evaluating the best way to share the information.
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Pontificia Universidad Catolica de Chile