Clinical trial NCT04388709: Interferon Lambda Therapy for COVID-19
Official title: A Randomized Phase 2 Trial of Peginterferon Lambda-1a (Lambda) for the Treatment of Hospitalized Patients Infected With SARS-CoV-2 With Non-critical Illness
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: SARS-CoV-2
Keywords: Peginterferon lambda-1a
Lambda
SARS-CoV-2
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Eiger BioPharmaceuticals
First posted: 2020-05-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cohort A: Peginterferon lambda-1a (Lambda) 180mcg subcutaneous injection once Cohort B: Best supportive care
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with resolution of hypoxia
timeFrame: 7 days
Secondary outcomes:
measure: Number of adverse events.
timeFrame: until 90 days after receipt of treatment
measure: Days with fever
timeFrame: during hospitalization, average of 7 days
measure: Time to resolution of fever
timeFrame: during hospitalization, average of 7 days
measure: Rate of progression to requiring critical care
timeFrame: during hospitalization, average of 5 days
measure: Overall survival
timeFrame: until 90 days after receipt of treatment
measure: Time to discharge
timeFrame: average of 7 days
Other outcomes:
Locations:
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Thomas Marron, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.