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Peginterferon Lambda-1AWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (5)

Name (Synonyms) Correlation
drug246 Auricular neuromodulation Wiki 0.71
drug2430 TJ003234 Wiki 0.71
drug636 Control Wiki 0.27
drug2950 placebo Wiki 0.19
drug1822 Placebo Wiki 0.04

Correlated MeSH Terms (2)

Name (Synonyms) Correlation
D018352 Coronavirus Infections NIH 0.06
D045169 Severe Acute Respiratory Syndrome NIH 0.04

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There are 2 clinical trials

Clinical Trials

1 Interferon Lambda for Immediate Antiviral Therapy at Diagnosis (ILIAD): A Phase II Randomized, Double-blind, Placebo-controlled, Multicenter Trial to Evaluate the Effect of Peginterferon Lambda for the Treatment of COVID-19

Interferon lambda is one of the main arms of the innate antiviral immune response and is critical for controlling respiratory viral infections in mice. Interferon lambda has a better side effect profile than other interferons because of the limited tissue distribution of its receptor. Peginterferon lambda is a long-acting form that has been studied extensively in human trials in viral hepatitis, confirming its safety. We propose to evaluate peginterferon-lambda in ambulatory and hospitalized patients with mild to moderate COVID-19.

NCT04354259 Sars-CoV2 Covid-19 Drug: Peginterferon Lambda-1A Other: placebo

Primary Outcomes

Description: The proportion of participants with negative SARS-CoV-2 RNA on nasopharyngeal swab.

Measure: Cohort A (Ambulatory) - Proportion swab negative at day 7 (Primary efficacy endpoint)

Time: At day 7

Description: The rate of treatment-emergent and treatment-related serious adverse events (SAEs)

Measure: Cohort A (Ambulatory) - Treatment-emergent and treatment related serious adverse events (Primary Safety Endpoint)

Time: Day 0 to Day 30

Description: Time to SARS-CoV-2 RNA negativity.

Measure: Cohort B (Hospitalized) - Time to viral negativity (Primary Efficacy Endpoint)

Time: Day 0 to day 28

Description: The rate of treatment-emergent and treatment-related serious adverse events (SAEs)

Measure: Cohort B (Hospitalized) - treatment-emergent and treatment-related serious adverse events (Primary Safety Endpoint)

Time: Day 0 to Day 30

Secondary Outcomes

Description: Time to resolution of symptoms (fever, cough, diarrhea)

Measure: Cohort A (Ambulatory) - Symptom Resolution (Clinical Outcome #1)

Time: Day 0 to Day 14

Description: Change in relative categorical symptom scores (respiratory, gastrointestinal, fever) - none, mild, moderate, severe and no change, worse, better

Measure: Cohort A (Ambulatory) - Symptom severity scores (Clinical Outcome #2)

Time: Day 0 to Day 7

Description: Proportion with need for hospital admission

Measure: Cohort A (Ambulatory) - Hospitalization (Clinical Outcome #3)

Time: Day 0 to Day 14

Description: Adverse events and serious adverse events

Measure: Cohort A (Ambulatory) - Adverse and serious adverse events (Clinical Outcome #4)

Time: Day 0 to Day 14

Description: Proportion negative for SARS-CoV-2 RNA by nasopharyngeal swab

Measure: Cohort A (Ambulatory) - Swab negative at day 3 (Virologic/Immunological Outcome #1)

Time: At Day 3

Description: Time to SARS-CoV-2 RNA negativity on mid-turbinate nasal swab or saliva

Measure: Cohort A (Ambulatory) - Time RNA negativity (Virologic/Immunological Outcome #2)

Time: Day 0 to Day 14

Description: Proportion with SARS-CoV-2 RNA in blood.

Measure: Cohort A (Ambulatory) - Proportion viremic (Virologic/Immunological Outcome #3)

Time: Day 0 and Day 7

Description: Proportion with SARS-CoV-2 antibodies blood

Measure: Cohort A (Ambulatory) - Proportion with antibodies (Virologic/Immunological Outcome #4)

Time: Day 0 and Day 7

Description: Correlation of virologic response with interferon lambda 4 (IFNL4) genotype

Measure: Cohort A (Ambulatory) - Correlation with interferon lambda 4 genotype (Virologic/Immunological Outcome #5)

Time: Through day 7

Description: Proportion with symptom development in household contacts (categorical symptom type yes/no)

Measure: Cohort A (Ambulatory) - Symptoms in household contacts (Transmission Outcome #1)

Time: Day 0 to Day 14

Description: Proportion with confirmed diagnosis of COVID-19 in household contacts

Measure: Cohort A (Ambulatory) - COVID-19 in household contacts (Transmission Outcome #2)

Time: At Day 30

Description: Proportion with ICU admission during hospitalization

Measure: Cohort B (Hospitalized) - ICU admission (Clinical Outcome #1)

Time: Day 0 to day 30

Description: Proportion with need for intubation

Measure: Cohort B (Hospitalized) - Need for intubation (Clinical Outcome #2)

Time: Day 0 to Day 14

Description: Length of hospital stay (days)

Measure: Cohort B (Hospitalized) - Length of hospital stay (Clinical Outcome #3)

Time: Day 0 to Day 14

Description: Change in respiratory symptom score (score 0 to 7 with higher scores indicating more severe disease)

Measure: Cohort B (Hospitalized) - Change in respiratory symptom score (Clinical Outcome #4)

Time: Day 0 to 7 and Day 0 to 14

Description: Proportion with readmission to hospital

Measure: Cohort B (Hospitalized) - Readmission to hospital (Clinical Outcome #5)

Time: By day 30 and Day 90

Description: All-cause mortality

Measure: Cohort B (Hospitalized) - All-cause mortality (Clinical Outcome #6)

Time: At day 30 and day 90

Description: COVID-19-related mortality

Measure: Cohort B (Hospitalized) - COVID-19-related mortality (Clinical Outcome #7)

Time: At day 30

Description: Adverse (AEs) and Serious Adverse Events (SAEs)

Measure: Cohort B (Hospitalized) - Adverse (AEs) and Serious Adverse Events (SAEs) (Clinical Outcome #8)

Time: Day 0 to day 30

Description: Frequency of dose reduction or dose omission for the second dose of peginterferon lambda

Measure: Cohort B (Hospitalized) - Dose reduction or dose omission (Clinical Outcome #9)

Time: Day 7 to day 11

Description: Proportion negative for SARS-CoV-2 RNA by nasopharyngeal swab.

Measure: Cohort B (Hospitalized) - Proportion negative swab. (Virologic/Immunological Outcome #1)

Time: Day 7

Description: Proportion negative for SARS-CoV-2 by nasopharyngeal swab

Measure: Cohort B (Hospitalized) - Proportion negative by day 14 (Virologic/Immunological Outcome) #2)

Time: Day 14

Description: Time to SARS-CoV-2 RNA negativity by rectal swab

Measure: Cohort B (Hospitalized) - Time to negativity by rectal swab (Virologic/Immunological Outcome #3)

Time: Day 0 to day 14

Description: Correlation of virologic response with interferon lambda 4 (IFNL4) genotype

Measure: Cohort B (Hospitalized) - Correlation with interferon lambda 4 (IFNL4) genotype (Virologic/Immunological Outcome #4)

Time: Through Day 14

Description: Proportion with SARS-CoV-2 Antibody.

Measure: Cohort B (Hospitalized) - Proportion with Antibody (Virologic/Immunological Outcome #6)

Time: At Day 7 and Day 14

Description: Proportion with SARS-CoV-2 RNA in blood

Measure: Cohort B (Hospitalized) - Proportion with viremia (Virologic/Immunological Outcome #7)

Time: Day 0, Day 7, and Day 14

2 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

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.

NCT04388709 SARS-CoV-2 Drug: Peginterferon Lambda-1A

Primary Outcomes

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

Measure: Number of participants with resolution of hypoxia

Time: 7 days

Secondary Outcomes

Description: Number of Grade 3 or 4 adverse events as determined by the DAIDS criteria over the course of 3 months from initiation of trial to measure safety and tolerability of pegylated interferon lambda. Information on adverse events will be collected during hospitalization and then as an outpatient until 90 days from the time of receipt of treatment.

Measure: Number of adverse events.

Time: until 90 days after receipt of treatment

Description: Number of days participant has a fever. Information on fever will be collected during hospitalization. Cessation of fever is defined as the beginning of the first 48 hour period without fever without the use of antipyretic drug.

Measure: Days with fever

Time: during hospitalization, average of 7 days

Description: This is defined as time from initial treatment with investigational agent, to the cessation of fever, defined as the beginning of the first 48 hour period without fever without the use of antipyretic drug.

Measure: Time to resolution of fever

Time: during hospitalization, average of 7 days

Description: Defined as time from initial treatment with investigational agent to deterioration of clinical condition necessitating transfer to a critical care unit and/or intubation.

Measure: Rate of progression to requiring critical care

Time: during hospitalization, average of 5 days

Description: Information on survival will be collected during hospitalization and then, for those patients discharged, will be collected as an outpatient until 90 days from the time of receipt of treatment

Measure: Overall survival

Time: until 90 days after receipt of treatment

Description: This is defined as the amount of time (in days or fraction thereof) between the receipt of investigational agent and discharge from The Mount Sinai Hospital to home or nursing home, or censoring at time of death.

Measure: Time to discharge

Time: average of 7 days

No related HPO nodes (Using clinical trials)