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Single center study with low enrollment
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| Name | Class |
|---|---|
| Eiger BioPharmaceuticals | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peginterferon lambda alfa-1a | Experimental | peginterferon lambda-1a (Lambda) 180 micrograms by subcutaneous injection for participants who are not infected with SARS-CoV-2 |
|
| Placebo | Placebo Comparator | Placebo (saline) by subcutaneous injection for participants who are not infected with SARS-CoV-2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon lambda alfa-1a subcutaneous injection | Drug | Peginterferon lambda-1a 180 micrograms by subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Sulkowski, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29270173 | Background | Hemann EA, Gale M Jr, Savan R. Interferon Lambda Genetics and Biology in Regulation of Viral Control. Front Immunol. 2017 Dec 6;8:1707. doi: 10.3389/fimmu.2017.01707. eCollection 2017. | |
| 20335250 | Background | Mordstein M, Neugebauer E, Ditt V, Jessen B, Rieger T, Falcone V, Sorgeloos F, Ehl S, Mayer D, Kochs G, Schwemmle M, Gunther S, Drosten C, Michiels T, Staeheli P. Lambda interferon renders epithelial cells of the respiratory and gastrointestinal tracts resistant to viral infections. J Virol. 2010 Jun;84(11):5670-7. doi: 10.1128/JVI.00272-10. Epub 2010 Mar 24. |
| Label | URL |
|---|---|
| WHO COVID-19 landscape analysis of therapeutics. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Placebo | Placebo (saline) by subcutaneous injection for participants who are not infected with SARS-CoV-2 Saline: Saline subcutaneous injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Up to 28 days |
|
Adverse event data were collected from the time of informed consent through protocol Day 28
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Sulkowski | Johns Hopkins School of Medicine | 410-955-7538 | msulkowski@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 18, 2020 | Jul 12, 2022 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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Prospective, randomized, single-blind, controlled trial
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Single-blinded study
| Saline | Other | Saline subcutaneous injection |
|
| 14693875 | Background | Loutfy MR, Blatt LM, Siminovitch KA, Ward S, Wolff B, Lho H, Pham DH, Deif H, LaMere EA, Chang M, Kain KC, Farcas GA, Ferguson P, Latchford M, Levy G, Dennis JW, Lai EK, Fish EN. Interferon alfacon-1 plus corticosteroids in severe acute respiratory syndrome: a preliminary study. JAMA. 2003 Dec 24;290(24):3222-8. doi: 10.1001/jama.290.24.3222. |
| 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. |
Placebo (saline) by subcutaneous injection for participants who are not infected with SARS-CoV-2 Saline: Saline subcutaneous injection |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | 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. | 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. | Posted | Up to 14 days |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Placebo | Placebo (saline) by subcutaneous injection for participants who are not infected with SARS-CoV-2 Saline: Saline subcutaneous injection | 0 | 4 | 0 | 4 | 0 | 4 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D017670 |
| Sodium Compounds |