COVID, COVID-19
Conditions
Keywords
COVID, Coronavirus
Brief summary
Prospective randomized trial to assess the antiviral efficacy of Pegylated Interferon Lambda (180 mcg SC injection) vs.placebo in up to 20 subjects with COVID-19 infection.
Detailed description
The study objective is to assess the efficacy of Pegylated Interferon Lambda (180 mcg) vs. placebo in inducting quantitative PCR negativity at day 7
Interventions
180 mcg subcutaneous injection of pegylated interferon lambda
Sponsors
Eiger BioPharmaceuticals
Raymond Chung
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Single blind
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to provide informed consent * Confirmed COVID-19 diagnosis based on PCR analysis of respiratory secretions * Positive SARS-CoV-2 RT-PCR test must be within 48 hours of randomization
Exclusion criteria
* Clinically-significant illness or any other major medical disorder that in the opinion of the investigator, may interfere with subject treatment, assessment or compliance with the protocol * Treatment with IFN or other immunomodulatory/immunosuppressive agent within 12 months before screening. * Respiratory compromise requiring ventilatory support other than nasal cannula (mask, bipap or intubation and mechanical ventilation) * History of treatment with any of the following medications within five half-lives or 30 days before administration of the study drug (whichever is longer): anti-IL-6, anti-IL6R antagonists, Janus kinase inhibitors, ustekinumab (anti-IL-12/23), or anti IL-23 agents (guselkumab). * Life threatening SAE during the screening period * Pregnant or Nursing Females * Platelet count \<90,000 cells/mm3 * WBC count \<3,000 cells/mm3 * ANC \<1,500 cells/mm3 * Hb \<11 g/dL for women and \<12 g/dL for men * CrCl \< 50 mL/min * Bilirubin level ≥ 1.5x ULN * INR ≥1.5 (except in the setting of concomitant anticoagulant use) * CRP \> 200 mg/L * Clinically-relevant alcohol or drug abuse within 12 months of screening * Known hypersensitivity to Interferons * Current or planned participation in an investigational new drug (IND) trial from 30-days prior to randomization through Day 14 post treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Undetectable COVID PCR at Day 7 | 7 days | Negative COVID PCR testing 7 days after first lambda dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Undetectable COVID PCR at Day 3 | 3 days | Negative COVID PCR testing 3 days after first lambda dose |
| Percentage of Subjects on Lambda vs Placebo With Symptomatic Improvement | 2 weeks | Daily symptom score improvement during treatment period |
| Percentage of Subjects on Lambda vs Placebo With Improved Clinical Outcomes | 2 weeks | Time to event for death, intubation, hospital discharge |
| Undetectable COVID PCR Testing at Day 14 | 14 days | Negative COVID PCR testing 14 days after first lambda dose |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from inpatient admissions between June 2020 and July 2021.
Participants by arm
| Arm | Count |
|---|---|
| Lambda Treatment Treatment with subcutaneous injection (180 mcg) of pegylated interferon lambda
Pegylated interferon lambda: 180 mcg subcutaneous injection of pegylated interferon lambda | 7 |
| Saline Placebo Subcutaneous injection of saline placebo
Pegylated interferon lambda: 180 mcg subcutaneous injection of pegylated interferon lambda | 7 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Lambda Treatment | Saline Placebo |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 7 Participants | 6 Participants |
| Age, Continuous | 54.5 years | 54 years | 59 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 3 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 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 | 0 Participants | 0 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 | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 12 Participants | 7 Participants | 5 Participants |
| Region of Enrollment United States | 14 participants | 7 participants | 7 participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Male | 11 Participants | 5 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 7 |
| other Total, other adverse events | 3 / 7 | 1 / 7 |
| serious Total, serious adverse events | 2 / 7 | 0 / 7 |
Outcome results
Primary
Undetectable COVID PCR at Day 7
Negative COVID PCR testing 7 days after first lambda dose
Time frame: 7 days
Population: Subjects with Day 7 qPCR result of NEG (negative), meaning that no amplification was observed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lambda Treatment | Undetectable COVID PCR at Day 7 | 1 Participants |
| Saline Placebo | Undetectable COVID PCR at Day 7 | 4 Participants |
Secondary
Percentage of Subjects on Lambda vs Placebo With Improved Clinical Outcomes
Time to event for death, intubation, hospital discharge
Time frame: 2 weeks
Population: Data was not collected and therefor analysis not performed.
Secondary
Percentage of Subjects on Lambda vs Placebo With Symptomatic Improvement
Daily symptom score improvement during treatment period
Time frame: 2 weeks
Population: insufficient data, analysis not performed as there the symptom improvement score was not collected and not available for analysis.
Secondary
Undetectable COVID PCR at Day 3
Negative COVID PCR testing 3 days after first lambda dose
Time frame: 3 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lambda Treatment | Undetectable COVID PCR at Day 3 | 1 Participants |
| Saline Placebo | Undetectable COVID PCR at Day 3 | 4 Participants |
Secondary
Undetectable COVID PCR Testing at Day 14
Negative COVID PCR testing 14 days after first lambda dose
Time frame: 14 days
Population: All subjects providing NP swab samples at Day 14
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lambda Treatment | Undetectable COVID PCR Testing at Day 14 | 2 Participants |
| Saline Placebo | Undetectable COVID PCR Testing at Day 14 | 2 Participants |