COVID-19Phase 2COVID-LambdaNCT04331899
Single-Blind Study of a Single Dose of Peginterferon Lambda-1a Compared With Placebo in Outpatients With Mild COVID-19
A Phase 2 study testing Peginterferon Lambda-1a in people with COVID-19, run by Stanford University at 1 site in United States.
Trial summary
To evaluate the efficacy of a single dose of subcutaneous injections of 180 ug of Peginterferon Lambda-1a, compared with placebo in reducing the duration of viral shedding of SARS-CoV-2 virus in patients with uncomplicated COVID-19 disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Peginterferon Lambda-1a
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2020to 6 May 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and ≤ 75 years at the time of the assessment
- Able and willing to understand the study, adhere to all study procedures, and provide written informed consent
- Diagnosis of COVID-19 disease:
- If symptomatic, the presence of mild to moderate symptoms without signs of respiratory distress, with FDA-cleared molecular diagnostic assay positive for SARS-CoV-2 within 72 hours from swab to the time of commencing informed consent:
- If asymptomatic, initial diagnosis of SARS-CoV-2 infection with positive FDA-cleared molecular diagnostic assay obtained no more than 72 hours from initial swab to the time of commencing informed consent
Who cannot join
- Patients who are hospitalized for inpatient treatment or currently being evaluated for potential hospitalization at the time of initiation of informed consent
- Patients with a known allergy to Peginterferon Lambda-1a or any component thereof
- Display symptoms of respiratory distress (Respiratory rate >20, room air oxygen saturation of <94%.)
- Participation in a clinical trial with or use of any investigational agent within 30 days before screening
- Treatment with interferons (IFN) within 12 months before screening
- Previous use of Peginterferon Lambda-1a
Show all 21Show fewer
- History or evidence of any intolerance or hypersensitivity to IFNs or other substances contained in the study medication.
- Female patients who are pregnant or breastfeeding. Male patients must confirm that their female sexual partners are not pregnant.
- Current or previous history of decompensated liver disease (Child-Pugh Class B or C) or hepatocellular carcinoma
- Co-infected with human immunodeficiency virus (HIV)
- Significant abnormal laboratory test results at screening.
- Other significant medical condition that may require intervention during the study
- Concurrent use of any of the following medications:
- Therapy with an immunomodulatory agent
- Current use of heparin or Coumadin
- Received blood products within 30 days before study randomization
- Use of hematologic growth factors within 30 days before study randomization
- Systemic antibiotics, antifungals, or antivirals for treatment of active infection within 24 hours before study randomization
- Any prescription or herbal product that is not approved by the investigator
- Long-term treatment (> 2 weeks) with agents that have a high risk for nephrotoxicity or hepatotoxicity unless it is approved by the medical monitor
- Receipt of systemic immunosuppressive therapy within 3 months before screening
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: A Phase 2 Randomized, Single-Blind Study of a Single Dose of Peginterferon Lambda-1a (Lambda) Compared With Placebo in Outpatients With Mild COVID-19
To evaluate the efficacy of a single dose of subcutaneous injections of 180 ug of Peginterferon Lambda-1a, compared with placebo in reducing the duration of viral shedding of SARS-CoV-2 virus in patients with uncomplicated COVID-19 disease.
Read the detailed description
Patients will attend up to 9 study visits over a period of up to 28 days.
- Conditions
- COVID-19
- Being tested
- Peginterferon Lambda-1a, Placebo
- Keywords
- Coronavirus
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon Lambda-1aDrug
Peginterferon Lambda-1a (180 ug subcutaneous injection) single dose along with Standard of Care
PlaceboOther
Placebo subcutaneous injection along with Standard of Care Treatment for COVID-19 Infection
| Study group | Role | What they receive |
|---|---|---|
| Study drug Peginterferon Lambda-1a | Experimental | Study participants assigned to study drug will receive a single subcutaneous dose of Peginterferon Lambda-1a in addition to standard of care treatment. Receives: Drug: Peginterferon Lambda-1a |
| Placebo injection | Placebo comparator | Study participants will receive a placebo along with the standard of care treatment. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration Until Viral Shedding Cessation
Time to first of two consecutive negative respiratory secretions obtained by oropharyngeal and/or anterior nare swabs for SARS-CoV-2 by qRT-PCR.
Measured: Assessed for up to 28 days
Secondary outcomes (4)
Change in Sars-CoV-2 Viral Load
Log10 Oropharyngeal viral load over time, mean change at day 14 (SD). Sars-CoV-2 RNA level in oropharyngeal and/or anterior nare swabs collected daily.
Measured: baseline, day 14
Area Under the Curve of SARS-COV-2 Viral Load
Log10 viral load area under the curve through day 14, median (IQR). Area under the curve of SARS-CoV-2 viral load in oropharyngeal and/or anterior nare swabs collected daily.
Measured: baseline through day 14
Duration Until Resolution of Symptoms
Duration until resolution of symptoms in days, median (95% CI). Time to alleviation of all symptoms (fever, chills, cough, nasal congestion, muscle pains), defined as the time from initiation of treatment until all symptoms are rated as absent or mild in symptomatic patients.
Measured: Up to 28 days
Count of Participants Requiring Emergency Department Visits or Hospitalizations Within 28 Days of Initiation of Treatment
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start25 Apr 2020
- Primary completion14 Aug 2020
- Study completion6 May 2021
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 COVID-19Studies of the same condition, open and under way.
- More trials run by Stanford 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An open-label, single-blind randomized controlled trial. Study participants will be randomly assigned 1:1 to a single subcutaneous dose of Peginterferon Lambda-1a or placebo along with the standard of care.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Upinder Singh, Principal investigator, Professor (Medicine-Infectious Diseases)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331899
- Sponsor's protocol ID
- 55619
- Acronym
- COVID-Lambda
- Status last verified
- Nov 2021
- First submitted
- 27 Mar 2020
- Last updated
- 30 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing of generated and analyzed datasets.
Publications
Jagannathan P, Andrews JR, Bonilla H, Hedlin H, Jacobson KB, Balasubramanian V, Purington N, Kamble S, de Vries CR, Quintero O, Feng K, Ley C, Winslow D, Newberry J, Edwards K, Hislop C, Choong I, Maldonado Y, Glenn J, Bhatt A, Blish C, Wang T, Khosla C, Pinsky BA, Desai M, Parsonnet J, Singh U. Peginterferon Lambda-1a for treatment of outpatients with uncomplicated COVID-19: a randomized placebo-controlled trial. Nat Commun. 2021 Mar 30;12(1):1967. doi: 10.1038/s41467-021-22177-1.
PubMed 33785743McCarthy MW. Interferon lambda as a potential treatment for COVID-19. Expert Opin Biol Ther. 2023 May;23(5):389-394. doi: 10.1080/14712598.2023.2211709. Epub 2023 May 8.
PubMed 37147857van der Ploeg K, Kirosingh AS, Mori DAM, Chakraborty S, Hu Z, Sievers BL, Jacobson KB, Bonilla H, Parsonnet J, Andrews JR, Press KD, Ty MC, Ruiz-Betancourt DR, de la Parte L, Tan GS, Blish CA, Takahashi S, Rodriguez-Barraquer I, Greenhouse B, Singh U, Wang TT, Jagannathan P. TNF-alpha+ CD4+ T cells dominate the SARS-CoV-2 specific T cell response in COVID-19 outpatients and are associated with durable antibodies. Cell Rep Med. 2022 Jun 21;3(6):100640. doi: 10.1016/j.xcrm.2022.100640. Epub 2022 May 3.
PubMed 35588734Jacobson KB, Rao M, Bonilla H, Subramanian A, Hack I, Madrigal M, Singh U, Jagannathan P, Grant P. Patients With Uncomplicated Coronavirus Disease 2019 (COVID-19) Have Long-Term Persistent Symptoms and Functional Impairment Similar to Patients with Severe COVID-19: A Cautionary Tale During a Global Pandemic. Clin Infect Dis. 2021 Aug 2;73(3):e826-e829. doi: 10.1093/cid/ciab103.
PubMed 33624010
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Single-Blind Study of a Single Dose of Peginterferon Lambda-1a (Lambda) Compared With Placebo in Outpatients With Mild COVID-19
- ClinicalTrials.gov ID
- NCT04331899
- Acronym / sponsor ID
- COVID-Lambda / 55619
- Conditions
- COVID-19
- Keywords
- Coronavirus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 25 Apr 2020 (actual)
- Primary completion
- 14 Aug 2020 (actual)
- Study completion
- 6 May 2021 (actual)
- First posted
- 2 Apr 2020 (actual)
- Results
- Posted 22 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy of a single dose of subcutaneous injections of 180 ug of Peginterferon Lambda-1a, compared with placebo in reducing the duration of viral shedding of SARS-CoV-2 virus in patients with uncomplicated COVID-19 disease.
Detailed description
Patients will attend up to 9 study visits over a period of up to 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- An open-label, single-blind randomized controlled trial. Study participants will be randomly assigned 1:1 to a single subcutaneous dose of Peginterferon Lambda-1a or placebo along with the standard of care.
| Arm | Type | Receives |
|---|---|---|
| Study drug Peginterferon Lambda-1a | Experimental | Drug: Peginterferon Lambda-1aStudy participants assigned to study drug will receive a single subcutaneous dose of Peginterferon Lambda-1a in addition to standard of care treatment. |
| Placebo injection | Placebo comparator | Other: PlaceboStudy participants will receive a placebo along with the standard of care treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years and ≤ 75 years at the time of the assessment
- Able and willing to understand the study, adhere to all study procedures, and provide written informed consent
- Diagnosis of COVID-19 disease:
Key exclusion criteria (21 listed)
- Patients who are hospitalized for inpatient treatment or currently being evaluated for potential hospitalization at the time of initiation of informed consent
- Patients with a known allergy to Peginterferon Lambda-1a or any component thereof
- Display symptoms of respiratory distress (Respiratory rate >20, room air oxygen saturation of <94%.)
- Participation in a clinical trial with or use of any investigational agent within 30 days before screening
- Treatment with interferons (IFN) within 12 months before screening
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-1aPeginterferon Lambda-1a (180 ug subcutaneous injection) single dose along with Standard of Care | Drug | Study drug Peginterferon Lambda-1a |
| PlaceboPlacebo subcutaneous injection along with Standard of Care Treatment for COVID-19 Infection | Other | Placebo injection |
Primary outcome
Duration Until Viral Shedding Cessation
Time frame: Assessed for up to 28 days
Time to first of two consecutive negative respiratory secretions obtained by oropharyngeal and/or anterior nare swabs for SARS-CoV-2 by qRT-PCR.
4 secondary outcomes
Change in Sars-CoV-2 Viral Load
Time frame: baseline, day 14
Area Under the Curve of SARS-COV-2 Viral Load
Time frame: baseline through day 14
Duration Until Resolution of Symptoms
Time frame: Up to 28 days
Count of Participants Requiring Emergency Department Visits or Hospitalizations Within 28 Days of Initiation of Treatment
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33785743Jagannathan P, Andrews JR, Bonilla H, Hedlin H, Jacobson KB, Balasubramanian V, Purington N, Kamble S, de Vries CR, Quintero O, Feng K, Ley C, Winslow D, Newberry J, Edwards K, Hislop C, Choong I, Maldonado Y, Glenn J, Bhatt A, Blish C, Wang T, Khosla C, Pinsky BA, Desai M, Parsonnet J, Singh U. Peginterferon Lambda-1a for treatment of outpatients with uncomplicated COVID-19: a randomized placebo-controlled trial. Nat Commun. 2021 Mar 30;12(1):1967. doi: 10.1038/s41467-021-22177-1.
- Derived from this study: PubMed 37147857McCarthy MW. Interferon lambda as a potential treatment for COVID-19. Expert Opin Biol Ther. 2023 May;23(5):389-394. doi: 10.1080/14712598.2023.2211709. Epub 2023 May 8.
- Derived from this study: PubMed 35588734van der Ploeg K, Kirosingh AS, Mori DAM, Chakraborty S, Hu Z, Sievers BL, Jacobson KB, Bonilla H, Parsonnet J, Andrews JR, Press KD, Ty MC, Ruiz-Betancourt DR, de la Parte L, Tan GS, Blish CA, Takahashi S, Rodriguez-Barraquer I, Greenhouse B, Singh U, Wang TT, Jagannathan P. TNF-alpha+ CD4+ T cells dominate the SARS-CoV-2 specific T cell response in COVID-19 outpatients and are associated with durable antibodies. Cell Rep Med. 2022 Jun 21;3(6):100640. doi: 10.1016/j.xcrm.2022.100640. Epub 2022 May 3.
- Derived from this study: PubMed 33624010Jacobson KB, Rao M, Bonilla H, Subramanian A, Hack I, Madrigal M, Singh U, Jagannathan P, Grant P. Patients With Uncomplicated Coronavirus Disease 2019 (COVID-19) Have Long-Term Persistent Symptoms and Functional Impairment Similar to Patients with Severe COVID-19: A Cautionary Tale During a Global Pandemic. Clin Infect Dis. 2021 Aug 2;73(3):e826-e829. doi: 10.1093/cid/ciab103.
- Individual participant dataSharing planned: Yes. Sharing of generated and analyzed datasets.
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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.
Upinder Singh principal investigator
Professor (Medicine-Infectious Diseases)
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-1a in people with COVID-19, run by Stanford 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 5 inclusion and 21 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: finished, as of the sponsor's last update on 30 Nov 2021. 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 22 Apr 2021). 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?
Duration Until Viral Shedding Cessation (time frame: Assessed for 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 NCT04331899, 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 30 Nov 2021.