Sars-CoV-2 Infection
Conditions
Keywords
SARS-CoV-2, COVID-19, Lambda interferon
Brief summary
This is a phase 2b prospective, randomized, single-blind, controlled trial of a single subcutaneous injection of peginterferon lambda-1a versus placebo for prevention of SARS-CoV-2 infection in non-hospitalized participants at high risk for infection due to household exposure to an individual with coronavirus disease (COVID-19). The study will also evaluate the regimens participants with asymptomatic SARS-CoV-2 infection detected at study entry. All participants will be followed for up to 12 weeks.
Interventions
DRUGPeginterferon lambda alfa-1a subcutaneous injection
Peginterferon lambda-1a 180 micrograms by subcutaneous injection
OTHERSaline
Saline subcutaneous injection
Sponsors
Eiger BioPharmaceuticals
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Single-blinded study
Intervention model description
Prospective, randomized, single-blind, controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Willing and able to provide written informed consent * Peripheral capillary oxygen saturation (SpO2) ≥ 95% on room air at screening * Age ≥18 years
Exclusion criteria
* Hospitalized or impending hospitalization at the time of screening * Symptoms of cough, fever or shortness of breath within 72 hours * Prior or current treatment with other experimental or approved agents targeting SARS-CoV-2 or SARS-CoV-1 * Positive pregnancy test * Active autoimmune disease or sarcoidosis (with the exception of controlled thyroid disease) * Active decompensated liver disease (ascites, encephalopathy) * Active congestive heart failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With no Evidence of SARS-CoV-2 Infection | Up to 28 days | Number of participants with no evidence of SARS-CoV-2 infection at or before study day 28. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to no Detection of SARS-CoV-2 | Up to 14 days | Resolution of SARS-CoV-2 infection in the upper respiratory tract as assessed by time (in days) to no detection of SARS-CoV-2 in two upper respiratory samples. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Peginterferon Lambda Alfa-1a peginterferon lambda-1a (Lambda) 180 micrograms by subcutaneous injection for participants who are not infected with SARS-CoV-2
Peginterferon lambda alfa-1a subcutaneous injection: Peginterferon lambda-1a 180 micrograms by subcutaneous injection | 2 |
| Placebo Placebo (saline) by subcutaneous injection for participants who are not infected with SARS-CoV-2
Saline: Saline subcutaneous injection | 4 |
| Total | 6 |
Baseline characteristics
| Characteristic | Peginterferon Lambda Alfa-1a | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 4 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 4 |
| other Total, other adverse events | 0 / 2 | 0 / 4 |
| serious Total, serious adverse events | 0 / 2 | 0 / 4 |
Outcome results
Primary
Number of Participants With no Evidence of SARS-CoV-2 Infection
Number of participants with no evidence of SARS-CoV-2 infection at or before study day 28.
Time frame: Up to 28 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Peginterferon Lambda Alfa-1a | Number of Participants With no Evidence of SARS-CoV-2 Infection | 2 Participants |
| Placebo | Number of Participants With no Evidence of SARS-CoV-2 Infection | 4 Participants |
Secondary
Time to no Detection of SARS-CoV-2
Resolution of SARS-CoV-2 infection in the upper respiratory tract as assessed by time (in days) to no detection of SARS-CoV-2 in two upper respiratory samples.
Time frame: Up to 14 days
Population: This outcome was not assessed because all participants were negative at the time of entering study and didn't test positive. No data was collected.