Pegylated Interferon Lambda for Treatment of COVID-19 Infection
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|ClinicalTrials.gov Identifier: NCT04534673|
Recruitment Status : Recruiting
First Posted : September 1, 2020
Last Update Posted : September 1, 2020
A randomized, open-label, 2 arm, pilot trial of Lambda 180 mcg administered subcutaneously once weekly, for up to two weeks (2 injections at most), in addition to standard supportive care, compared to standard supportive care alone, in a population of COVID-19 infected patients.
patients will be randomized according to 1:1 ratio to one of the 2 trial arms: Lambda 180 mcg S.C + standard care (intervention arm) or standard care only (control arm).
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Lambda 180 mcg S.C||Phase 2|
Recently, a novel coronavirus (SARS-CoV-2) has been identified as the causative pathogen of a rapidly spreading infection associated with pneumonia and severe acute respiratory syndrome (COVID-19), for which there is currently no approved therapy. Interferon Lambda (IFN Lambda) is a type III interferon with broad anti-viral activity and receptor distribution limited to the respiratory and gastrointestinal epithelium. Studies in animal models suggest that IFN Lambda may ameliorate infection with respiratory viruses such as influenza coronaviruses. The WHO has recently included pegylated interferon lambda in its landscape analysis of potential therapeutics for COVID-19.
In this randomized, open-label, 2 arms, pilot trial, up to 40 patients diagnosed with COVID-19 and mild to moderate respiratory infection, will be randomized to one of 2 treatment arms in 1:1 ratio: 1. Lambda 180 mcg administered S.C once weekly, for up to two weeks (2 injections at most) + standard care, Or 2. Standard care alone.
Efficacy of Lambda will be assessed by PCR analysis for COVID-19 (Fluxergy, Irvine CA), from respiratory secretions obtained by nasopharyngeal and oropharyngeal swabs, collected consecutively at day 1, 3, 5, 7, 10, 14 and 21 following initial diagnosis or until patients are discharged following achievement of two consecutive PCR negative tests for COVID-19. Safety and tolerability of Lambda will be assessed by adverse event (AE) monitoring, vital signs assessment and clinical laboratory tests (CBC, and extended chemistry panel).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A randomized, open label, 2 arm, pilot trial|
|Masking:||None (Open Label)|
|Official Title:||Pegylated Interferon Lambda for Treatment of COVID-19 Infection- A Randomized Open Label Pilot Trial|
|Actual Study Start Date :||August 5, 2020|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Intervention group
Pegylated interferon lambda + Standard of care treatment
Drug: Lambda 180 mcg S.C
Prefilled injection syringe of 180 microgram Pegylated interferon lambda, administered on day 0 and if needed on day 7
Other Name: Lambda
No Intervention: Control group
Standard of care treatment
- Viral shedding in days since initial diagnosis [ Time Frame: 21 days ]The duration of viral shedding in days since initial diagnosis, as determined by RT-PCR to COVID-19.
- Rate of adverse events and severe adverse events [ Time Frame: 21 days from entry ]Rate of treatment-emergent and treatment-related severe adverse events (SAEs)
- Time to clinical recovery [ Time Frame: 72 Hours ]the time (in hours) from initiation of trial treatment (Lambda or standard care) until normalization of fever, respiratory rate, and oxygen saturation, and alleviation of cough, sustained for at least 72 hours.
- Rate of non-invasive or mechanical ventilation [ Time Frame: 28 Days ]Requirement for non-invasive (bipap) or mechanical ventilation
- Length of hospital stay [ Time Frame: 28 Days ]length of hospital stay from admission to discharge
- All-cause mortality [ Time Frame: At day 28 following admission to the hospital ]All-cause mortality
- Undetectable COVID-19 virus levels [ Time Frame: At days 7,14 and 21 from admission ]Rate of undetectable COVID-19 virus levels at different days
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): NCT04534673
|Contact: Ohad Etzion, MDfirstname.lastname@example.org|
|Contact: Ruthie Bekore||+972-8-6244240||Ruthieb@clalit.org.il|
|Be'er Sheva, Israel|
|Contact: Ohad Etion, MD +97286243330 email@example.com|
|Principal Investigator: Ohad Etzion, MD|
|Principal Investigator:||Ohad Etzion, MD||Soroka Univeersity Medical Center|