Interferon Lambda Therapy for COVID-19

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Mount Sinai Health System

Status and phase

Withdrawn
Phase 2

Conditions

SARS-CoV-2

Treatments

Drug: Peginterferon Lambda-1A

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04388709
GCO 20-0820

Details and patient eligibility

About

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.

Full description

Primary Objective: Determine efficacy of pegylated interferon lambda as measured by clinical improvement. This will be defined as improvement in supplemental oxygen requirement. Secondary Objectives: Determine safety and tolerability of pegylated interferon lambda Days with fever Time to resolution of fever Rate of progression to requiring critical care Overall survival Time to discharge Exploratory Objectives: Determining the effect systemically on inflammatory markers in the blood, as well as viral load. Diagnosis and Main Inclusion Criteria: Patients must have a confirmed diagnosis of infection with SARS-CoV-2 and be receiving supplemental oxygen. Many patients may be receiving hydroxychloroquine with or without other antimicrobials.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Peginterferon lambda-1a
Experimental group
Description:
Peginterferon lambda-1a (Lambda) 180mcg subcutaneous injection once
Treatment:
Drug: Peginterferon Lambda-1A
Best supportive care
No Intervention group
Description:
Best supportive care

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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