Sars-CoV-2 InfectionPhase 2PROTECTNCT04344600
Peginterferon Lambda-1a for the Prevention and Treatment of SARS-CoV-2 (COVID-19) Infection
A Phase 2 study testing Peginterferon lambda alfa-1a subcutaneous injection and Saline in people with Sars-CoV-2 Infection, run by Johns Hopkins University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sars-CoV-2 Infection
- What is being tested?
- Peginterferon lambda alfa-1a subcutaneous injection and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2020to 24 Sep 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent
- Peripheral capillary oxygen saturation (SpO2) ≥ 95% on room air at screening
- Age ≥18 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peginterferon Lambda-1a for the Prevention and Treatment of SARS-CoV-2 Infection
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.
- Conditions
- Sars-CoV-2 Infection
- Being tested
- Peginterferon lambda alfa-1a subcutaneous injection, Saline
- Keywords
- SARS-CoV-2, COVID-19, Lambda interferon
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon lambda alfa-1a subcutaneous injectionDrug
Peginterferon lambda-1a 180 micrograms by subcutaneous injection
SalineOther
Saline subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Peginterferon lambda alfa-1a | Experimental | peginterferon lambda-1a (Lambda) 180 micrograms by subcutaneous injection for participants who are not infected with SARS-CoV-2 Receives: Drug: Peginterferon lambda alfa-1a subcutaneous injection |
| Placebo | Placebo comparator | Placebo (saline) by subcutaneous injection for participants who are not infected with SARS-CoV-2 Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 28 days
Secondary outcomes (1)
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.
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start29 Jun 2020
- Primary completion24 Sep 2021
- Study completion24 Sep 2021
Why it stopped: Single center study with low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sars-CoV-2 InfectionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, single-blind, controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Eiger BioPharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Mark Sulkowski, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344600
- Sponsor's protocol ID
- IRB00248163
- Acronym
- PROTECT
- Status last verified
- Jul 2022
- First submitted
- 10 Apr 2020
- Last updated
- 14 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29270173Mordstein 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.
PubMed 20335250Loutfy 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.
PubMed 14693875Lee 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.
PubMed 32788708
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peginterferon Lambda-1a for the Prevention and Treatment of SARS-CoV-2 Infection
- ClinicalTrials.gov ID
- NCT04344600
- Acronym / sponsor ID
- PROTECT / IRB00248163
- Conditions
- Sars-CoV-2 Infection
- Keywords
- SARS-CoV-2, COVID-19, Lambda interferon
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Single center study with low enrollment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Eiger BioPharmaceuticals
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 24 Sep 2021 (actual)
- Study completion
- 24 Sep 2021 (actual)
- First posted
- 14 Apr 2020 (actual)
- Results
- Posted 14 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective, randomized, single-blind, controlled trial
| Arm | Type | Receives |
|---|---|---|
| Peginterferon lambda alfa-1a | Experimental | Drug: Peginterferon lambda alfa-1a subcutaneous injectionpeginterferon lambda-1a (Lambda) 180 micrograms by subcutaneous injection for participants who are not infected with SARS-CoV-2 |
| Placebo | Placebo comparator | Other: SalinePlacebo (saline) by subcutaneous injection for participants who are not infected with SARS-CoV-2 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Willing and able to provide written informed consent
- Peripheral capillary oxygen saturation (SpO2) ≥ 95% on room air at screening
- Age ≥18 years
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peginterferon lambda alfa-1a subcutaneous injectionPeginterferon lambda-1a 180 micrograms by subcutaneous injection | Drug | Peginterferon lambda alfa-1a |
| SalineSaline subcutaneous injection | Other | Placebo |
Primary outcome
Number of Participants With no Evidence of SARS-CoV-2 Infection
Time frame: Up to 28 days
Number of participants with no evidence of SARS-CoV-2 infection at or before study day 28.
1 secondary outcome
Time to no Detection of SARS-CoV-2
Time frame: Up to 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29270173Hemann 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.
- Background: PubMed 20335250Mordstein 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.
- Background: PubMed 14693875Loutfy 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.
- Derived from this study: PubMed 32788708Lee 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.
- WHO COVID-19 landscape analysis of therapeutics.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Sulkowski, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Peginterferon lambda alfa-1a subcutaneous injection and Saline in people with Sars-CoV-2 Infection, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With no Evidence of SARS-CoV-2 Infection (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04344600, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2022.