Interferon Lambda Therapy for COVID-19

NCT04388709 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: GCO 20-0820
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main purpose of this research study is to test the safety and effectiveness of an investigational drug peginterferon lambda-1a in treating COVID-19.

Conditions

SARS-CoV-2

Keywords

Peginterferon lambda-1a; Lambda; SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• Number of participants with resolution of hypoxia

  The clinical improvement as defined as resolution of hypoxia requiring supplemental oxygen to maintain SpO2\>92% at 7 days.

  7 days

Secondary Outcomes (6)

• Number of adverse events.

  until 90 days after receipt of treatment

• Days with fever

  during hospitalization, average of 7 days

• Time to resolution of fever

  during hospitalization, average of 7 days

• Rate of progression to requiring critical care

  during hospitalization, average of 5 days

• Overall survival

  until 90 days after receipt of treatment

Study Arms (2)

Peginterferon lambda-1a

EXPERIMENTAL

Peginterferon lambda-1a (Lambda) 180mcg subcutaneous injection once

Drug: Peginterferon Lambda-1A

Best supportive care

NO INTERVENTION

Best supportive care

Interventions

Peginterferon Lambda-1A DRUG

Peginterferon lambda-1a (Lambda) 180mcg subcutaneous injection once

Also known as: Lambda, Interferon Lambda

Peginterferon lambda-1a

Eligibility Criteria

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

You may qualify if:

• Confirmed diagnosis of SARS-CoV-2
• Hospitalization due to diagnosis with SARS-CoV-2
• Sp02 \< 93% on ambient air or PaO2/FiO2 \< 300 mmHg and requires supplemental oxygen

You may not qualify if:

• Patients must not be pregnant or nursing
• Patients cannot be admitted to intensive care unit at time of admission or require positive pressure ventilation
• Patients cannot be requiring continuous supplemental oxygen normally (pre-SARS-CoV-2)
• Patient is receiving steroids \>1mg/kg
• Has diagnosis of primary immunodeficiency
• Has active autoimmune disease that has required systemic treatment in the past year
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial
• Patients with ferritin \>2000ng/mL and/or C-reactive protein \>100mg/L
• History of allogeneic hematopoietic cell transplantation or solid organ transplantation
• Childs-Pugh class B or C cirrhosis or class A if portal hypertension is present
• Documented allergic or hypersensitivity response to protein therapeutics
• No serious disease requiring mechanical ventilation at time of enrollment

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Eiger BioPharmaceuticals: collaborator

Related Publications (1)

• Lee JS, Shin EC. The type I interferon response in COVID-19: implications for treatment. Nat Rev Immunol. 2020 Oct;20(10):585-586. doi: 10.1038/s41577-020-00429-3.

  PMID: 32788708 DERIVED

MeSH Terms

Interventions

peginterferon lambda-1a; Interferon Lambda

Intervention Hierarchy (Ancestors)

Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Thomas Marron, MD

  Icahn School of Medicine at Mount Sinai

  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: Assistant Professor

Model Details: Cohort A: Peginterferon lambda-1a (Lambda) 180mcg subcutaneous injection once Cohort B: Best supportive care

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 14, 2020
• Study Start: September 1, 2020
• Primary Completion: February 5, 2021
• Study Completion: February 5, 2021
• Last Updated: February 26, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share