TOGETHER - Toronto: Trial to Evaluate the Effect of Peginterferon Lambda for the Treatment of COVID-19

NCT04967430 | Unknown Phase 3 DMC

• 2 other identifiers: JF-12-202021-5018
• Study Type: interventional
• Target: 763
• Locations: 1 country
• Sites: 1

Brief Summary

Interferon (IFN) lambda is one of the fundamental responses of the innate immune system. Peginterferon lambda is a long-acting form that has been studied extensively in human trials in viral hepatitis, confirming it safety and tolerability. It is particularly attractive for consideration in the use of acute respiratory illness due to the high expression of the lambda receptor in lung epithelia. We propose to evaluate peginterferon-lambda in ambulatory patients with mild to moderate COVID-19.

Conditions

Sars-CoV2; Covid19

Keywords

Peginterferon lambda

Outcome Measures

Primary Outcomes (3)

• COVID-19 related urgent care visit, emergency room assessment, hospitalization or death by Day 28 (Primary efficacy endpoint)

  Proportion with COVID-19-related emergency room assessment, hospitalization, or death by Day 28

  At day 28

• SARS-CoV-2 RNA negativity (Primary virological endpoint)

  The time to SARS-CoV-2 RNA negativity.

  Day 0 to Day 28

• Treatment-emergent and treatment-related serious adverse events (Primary safety endpoint)

  The rate of treatment-emergent and treatment-related serious adverse events (SAEs) by Day 28.

  Day 0 to Day 28

Secondary Outcomes (27)

• Respiratory symptom resolution (Clinical Outcome #1)

  Day 0 to Day 28

• Hospitalization (Clinical outcome #2)

  Day 0 to Day 28

• Death (Clinical outcome #3)

  Day 0 to Day 28

• All symptom resolution (Clinical outcome #4)

  Day 0 to Day 28

• Oxygen saturation on room air (Clinical outcome #5)

  Day 0 to Day 14

Study Arms (2)

Treatment

EXPERIMENTAL

To receive a dose of peginterferon lambda 180mcg SC at baseline (Day 0).

Drug: Peginterferon Lambda-1A

Placebo

PLACEBO COMPARATOR

Patients in this arm will receive a single SC dose of 0.9% sodium chloride (normal saline) solution at baseline (Day 0). A plastic 1 mL syringe will be prefilled by the study pharmacy. Each syringe will contain 0.5 mL (0.45 mL to match the volume of the Interferon plus 0.05 mL overfill) to allow for needle priming by the unblinded study nurse.

Other: Placebo

Interventions

Peginterferon Lambda-1A DRUG

Peginterferon lambda is a covalent conjugate of human recombinant non-pegylated IFN lambda (IFN L) and a 20-kDa linear PEG chain. Peginterferon lambda Injection is a sterile, nonpyrogenic, ready-to-use solution (0.4 mg/mL) that is clear to opalescent, colorless to pale yellow, and essentially free of particles. Lambda Injection is provided in a 1-mL long Type I glass syringe (0.18 mg/syringe) with a staked 29-gauge, 1/2- inch, thin-walled needle. The syringe has a rigid needle shield and is stoppered with a plunger stopper. Syringes are prefilled with a solution of Peginterferon lambda Injection, mannitol, L-histidine, polysorbate 80, hydrochloric acid, and water for injection; they are intended for a single use at adjustable doses. The syringe is marked with dose indicator lines, which are used as a reference point for administering the correct dose.

Treatment

Placebo OTHER

The placebo will be 0.9% sodium chloride (normal saline) solution. A plastic 1 mL syringe will be prefilled by the study pharmacy. Each syringe will contain 0.5 mL (0.45 mL to match the volume of the Interferon plus 0.05 mL overfill) to allow for needle priming by the unblinded study nurse.

Placebo

Eligibility Criteria

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

You may qualify if:

• Adult 18 years of age or older.
• Symptomatic and within 7 days of symptom onset.
• High risk for severe disease (as defined by one or more of the following):
• Age \>50
• Diabetes mellitus requiring therapy
• Hypertension on medication
• BMI \>30 kg/m2
• Cardiovascular disease
• Asthma requiring chronic controller medication
• Symptomatic respiratory disease
• Immunosuppressed patients (to maximum of 10mg prednisone daily +/- other immunosuppressive agents)
• Documented fever (\>38C)
• One or more of the following symptoms: cough, shortness of breath (SOB), pleuritic chest pain and/or myalgias (to a maximum of 25% of enrollment)
• Discharged to home isolation.
• Willing and able to provide informed consent (including by substitute decision maker).

You may not qualify if:

• Pregnancy (or positive urine pregnancy test) or lactating.
• More than 14 days following completion of SARS-CoV-2 vaccition series
• The following pre-existing medical conditions:
• Known cirrhosis with any history of decompensation (ascites, variceal bleeding or hepatic encephalopathy)
• Known chronic kidney disease with estimated creatinine clearance \< 30 mL/minute or need for dialysis
• Uncontrolled severe psychiatric disorder - schizophrenia, bipolar disorder, depression with prior suicidality
• Uncontrolled seizures or seizure in the prior 1 month
• Any other underlying medical (cardiac, liver, renal, neurological, respiratory) or psychiatric condition that in the view of the investigator would preclude use of peginterferon lambda
• Known alcohol or drug dependence that in the opinion of the investigator would impair study participation.
• Known prior intolerance to interferon treatment.
• Enrolment in another clinical trial testing an antiviral agent or receipt of an antiviral agent for COVID-19 in the past 7 days.
• Use of investigational, off-label therapy for COVID-19, or unproven therapy for COVID-19.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

COVID-19

Interventions

peginterferon lambda-1a

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

• Jordan Feld, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 19, 2021
• Study Start: August 27, 2021
• Primary Completion: March 21, 2022
• Study Completion: June 30, 2022
• Last Updated: April 5, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)