SARS-CoV-2
Conditions
Keywords
Peginterferon lambda-1a, Lambda, SARS-CoV-2
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.
Interventions
Peginterferon lambda-1a (Lambda) 180mcg subcutaneous injection once
Sponsors
Eiger BioPharmaceuticals
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Cohort A: Peginterferon lambda-1a (Lambda) 180mcg subcutaneous injection once Cohort B: Best supportive care
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with resolution of hypoxia | 7 days | The clinical improvement as defined as resolution of hypoxia requiring supplemental oxygen to maintain SpO2\>92% at 7 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events. | until 90 days after receipt of treatment | 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. |
| Days with fever | during hospitalization, average of 7 days | 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. |
| Time to resolution of fever | during hospitalization, average of 7 days | 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. |
| Overall survival | until 90 days after receipt of treatment | 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 |
| Time to discharge | average of 7 days | 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. |
| Rate of progression to requiring critical care | during hospitalization, average of 5 days | Defined as time from initial treatment with investigational agent to deterioration of clinical condition necessitating transfer to a critical care unit and/or intubation. |
Outcome results
None listed