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Due to the number of competing trials at their site, the study team has closed enrollment and withdrawn this trial.
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| Name | Class |
|---|---|
| Eiger BioPharmaceuticals | INDUSTRY |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peginterferon lambda-1a | Experimental | Peginterferon lambda-1a (Lambda) 180mcg subcutaneous injection once |
|
| Best supportive care | No Intervention | Best supportive care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon Lambda-1A | Drug | Peginterferon lambda-1a (Lambda) 180mcg subcutaneous injection once |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events. | 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. | until 90 days after receipt of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Marron, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32788708 | Derived | 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. |
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| ID | Term |
|---|---|
| C000600496 | peginterferon lambda-1a |
| D000095022 | Interferon Lambda |
| ID | Term |
|---|---|
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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Cohort A: Peginterferon lambda-1a (Lambda) 180mcg subcutaneous injection once Cohort B: Best supportive care
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| Days with fever | 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. | during hospitalization, average of 7 days |
| Time to resolution of fever | 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. | during hospitalization, average of 7 days |
| Rate of progression to requiring critical care | Defined as time from initial treatment with investigational agent to deterioration of clinical condition necessitating transfer to a critical care unit and/or intubation. | during hospitalization, average of 5 days |
| Overall survival | 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 | until 90 days after receipt of treatment |
| Time to discharge | 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. | average of 7 days |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |