Pegylated Interferon Lambda for Treatment of COVID-19 Infection

NCT04534673 | Completed Phase 2 DMC

• 2 other identifiers: 0129-20-SORSCRC200006
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

COVID-19

Keywords

COVID-19; SARS-CoV-2; Pegylated interferon lambda

Outcome Measures

Primary Outcomes (2)

• Viral shedding in days since initial diagnosis

  The duration of viral shedding in days since initial diagnosis, as determined by RT-PCR to COVID-19.

  21 days

• Rate of adverse events and severe adverse events

  Rate of treatment-emergent and treatment-related severe adverse events (SAEs)

  21 days from entry

Secondary Outcomes (5)

• Time to clinical recovery

  72 Hours

• Rate of non-invasive or mechanical ventilation

  28 Days

• Length of hospital stay

  28 Days

• All-cause mortality

  At day 28 following admission to the hospital

• Undetectable COVID-19 virus levels

  At days 7,14 and 21 from admission

Study Arms (2)

Intervention group

EXPERIMENTAL

Pegylated interferon lambda + Standard of care treatment

Drug: Lambda 180 mcg S.C

Control group

NO INTERVENTION

Standard of care treatment

Interventions

Lambda 180 mcg S.C DRUG

Prefilled injection syringe of 180 microgram Pegylated interferon lambda, administered on day 0 and if needed on day 7

Also known as: Lambda

Intervention group

Eligibility Criteria

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

You may qualify if:

• Female and male patients over the age of 18.
• Confirmed COVID-19 infection by PCR analysis
• Hospitalized at Soroka University Medical Center.
• Display mild to moderate symptoms of respiratory infection (Temperature \<39.0 oC, respiratory rate \< 25, O2 % Sat \> 95% in room air or with supplemental oxygen through nasal cannula, P/F ratio \> 150).
• Willing and able to convey informed consent.
• Willing and able to comply with all study procedures
• Female patients of childbearing potential and male patients with partners of childbearing potential must agree to use adequate methods of contraception during the study and through 90 days after the last dose of study medication. Female patients of childbearing potential are all those except patients who are surgically sterile, who have medically documented ovarian failure, or who are at least 1 year postmenopausal.
• For females: 2 of the following contraceptive methods, with at least 1 being a barrier method:
• Hormonal contraceptives for ≥ 27 days before dosing
• Intrauterine device (IUD) in place ≥ 27 days before dosing
• Double-barrier methods (use of condom \[male partner\] with either diaphragm with spermicide or cervical cap with spermicide) from screening
• Surgical sterilization of the partner (vasectomy ≥ 1 month before screening) Female patients must have a negative urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[hCG\]) within 24 hours prior to the start of investigational product.
• For males:
• Surgical sterilization (vasectomy ≥ 1 month before screening) Or
• Both of the following contraceptive methods from screening:

You may not qualify if:

• Treatment with interferons (IFNs) immunomodulators and/or immunosuppressive or B-cell depleting medications within 12 months before screening.
• Previous use of Interferon Lambda. Patients who previously participated in a clinical trial of Interferon Lambda but are confirmed to have received placebo or another non-Lambda IFNs are allowed.
• History or evidence of any intolerance or hypersensitivity to IFNs.
• Patients with respiratory infection requiring invasive or non-invasive ventilatory support (bipap or intubation and mechanical ventilation).
• Participation in a clinical trial with use of any investigational drug within 30 days before screening.
• History of any of the following diseases or conditions:
• Advanced or decompensated liver disease (presence or history of bleeding varices, ascites, encephalopathy or hepato-renal syndrome)
• Immunologically mediated disease (e.g., rheumatoid arthritis, inflammatory bowel disease, severe psoriasis, systemic lupus erythematosus) that requires more than intermittent nonsteroidal anti-inflammatory medications for management or that requires use of systemic corticosteroids in the 6 months before screening (inhaled asthma medications are allowed).
• Retinal disorder or clinically relevant ophthalmic disorder.
• Any malignancy within 5 years before screening. Exceptions are superficial dermatologic malignancies (e.g., squamous cell or basal cell skin cancer treated with curative intent).
• Cardiomyopathy, significant ischemic cardiac or cerebrovascular disease (including history of angina, myocardial infarction, or interventional procedure for coronary artery disease), or cardiac rhythm disorder.
• Chronic pulmonary disease (e.g., chronic obstructive pulmonary disease) associated with functional impairment.
• Pancreatitis.
• Severe or uncontrolled psychiatric disorder, e.g., depression, manic condition, psychosis, acute and/or chronic cognitive dysfunction, suicidal behavior, and relapse of substance abuse.
• Active seizure disorder defined by either an untreated seizure disorder or continued seizure activity within the preceding year despite treatment with anti-seizure medication.

Sponsors & Collaborators

• Soroka University Medical Center: lead

Study Sites (1)

Soroka UMC

Beersheba, Israel

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ohad Etzion, MD

  Soroka Univeersity Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Gastroenterology & Liver Diseases

Model Details: A randomized, open label, 2 arm, pilot trial

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: September 1, 2020
• Study Start: April 7, 2020
• Primary Completion: February 16, 2023
• Study Completion: February 16, 2023
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

IL (1)