COVID-19Phase 2NCT04343976

Pegylated Interferon Lambda Treatment for COVID-19

A Phase 2 study testing Pegylated interferon lambda in people with COVID-19 and COVID, run by Raymond Chung at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: COVID-19, COVID
What is being tested?: Pegylated interferon lambda
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 14 participants
Where: 1 siteUnited States
Study dates: 22 Jun 2020to 30 Jul 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 17Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Pegylated Interferon Lambda vs. Placebo in Subjects Infected With COVID-19

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.

Read the 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

Conditions: COVID-19, COVID
Being tested: Pegylated interferon lambda
Keywords: COVID, 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.

Pegylated interferon lambdaDrug
Also called Lambda
180 mcg subcutaneous injection of pegylated interferon lambda

Study groups in NCT04343976
Study group	Role	What they receive
Lambda Treatment	Experimental	Treatment with subcutaneous injection (180 mcg) of pegylated interferon lambda Receives: Drug: Pegylated interferon lambda
Saline Placebo	Placebo comparator	Subcutaneous injection of saline placebo Receives: Drug: Pegylated interferon lambda

What is being measured

The primary outcome is the main question the study is designed to answer.

Undetectable COVID PCR at Day 7
Negative COVID PCR testing 7 days after first lambda dose
Measured: 7 days

Secondary outcomes (4)

Undetectable COVID PCR at Day 3
Negative COVID PCR testing 3 days after first lambda dose
Measured: 3 days
Percentage of Subjects on Lambda vs Placebo With Symptomatic Improvement
Daily symptom score improvement during treatment period
Measured: 2 weeks
Percentage of Subjects on Lambda vs Placebo With Improved Clinical Outcomes
Time to event for death, intubation, hospital discharge
Measured: 2 weeks
Undetectable COVID PCR Testing at Day 14
Negative COVID PCR testing 14 days after first lambda dose
Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jun 202030 Jul 2021

First posted14 Apr 2020
Study start22 Jun 2020
Primary completion30 Jul 2021
Study completion30 Jul 2021

Why it stopped: Unable to meet enrollment goal, lack of funding.

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 (1)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies of the same condition, open and under way.
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
Masking: Single blind
Who is masked: Participant
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04343976
Sponsor's protocol ID: 2020P001083
Status last verified: Jun 2022
First submitted: 9 Apr 2020
Last updated: 21 Jul 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Coded data is anticipated to be shared with outside institutions. Safety data will be shared with the drug manufacturer

Publications

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.
PubMed 32788708

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All COVID-19 trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Pegylated Interferon Lambda vs. Placebo in Subjects Infected With COVID-19
ClinicalTrials.gov ID: NCT04343976
Acronym / sponsor ID: 2020P001083
Conditions: COVID-19, COVID
Keywords: COVID, Coronavirus
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Unable to meet enrollment goal, lack of funding.
Enrolment: 14 participants (actual)
Lead sponsor: Raymond ChungUniversity, hospital or other
Collaborators: Eiger BioPharmaceuticals
Study start: 22 Jun 2020 (actual)
Primary completion: 30 Jul 2021 (actual)
Study completion: 30 Jul 2021 (actual)
First posted: 14 Apr 2020 (actual)
Results: Posted 21 Jul 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Lambda Treatment	Experimental	Drug: Pegylated interferon lambdaTreatment with subcutaneous injection (180 mcg) of pegylated interferon lambda
Saline Placebo	Placebo comparator	Drug: Pegylated interferon lambdaSubcutaneous injection of saline placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (17 listed)

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

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
Pegylated interferon lambdaAlso: Lambda180 mcg subcutaneous injection of pegylated interferon lambda	Drug	Lambda Treatment, Saline Placebo

Primary outcome

Undetectable COVID PCR at Day 7
Time frame: 7 days
Negative COVID PCR testing 7 days after first lambda dose

4 secondary outcomes

Undetectable COVID PCR at Day 3
Time frame: 3 days
Percentage of Subjects on Lambda vs Placebo With Symptomatic Improvement
Time frame: 2 weeks
Percentage of Subjects on Lambda vs Placebo With Improved Clinical Outcomes
Time frame: 2 weeks
Undetectable COVID PCR Testing at Day 14
Time frame: 14 days

Results and safety

Results posted to the registry on 21 Jul 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lambda Treatment	7	7
Saline Placebo	7	6

Primary outcome: Undetectable COVID PCR at Day 7

Time frame: 7 days. Count of participants. Unit: Participants

Measure	Lambda Treatment n = 7	Saline Placebo n = 7
Value	1	4

Population analysed: Subjects with Day 7 qPCR result of NEG (negative), meaning that no amplification was observed.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collect beginning at time of consent (day 0) through study completion (day 14). Total period of 2 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lambda Treatment	2 of 7 (28.6%)	3 of 7 (42.9%)	0 of 7
Saline Placebo	0 of 7 (0%)	1 of 7 (14.3%)	0 of 7

Limitations and caveats (from the sponsor): Enrollment was slower than anticipated due to issues operationalizing outpatient follow-up for viremic subjects discharged from hospital prior to study completion, including lack of transportation and delays contracting with home health services to offer home visits. Also, study was terminated prior to meeting enrollment goal due to a decrease in eligible subjects and lack of funding.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Individual participant dataSharing planned: Yes. Coded data is anticipated to be shared with outside institutions. Safety data will be shared with the drug manufacturer

Related trials for COVID-19

RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingPhase 4
A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Formulations
SARS-CoV-2
Not yet recruitingPhase 2
Study of VYD2311 for the Treatment of Adults With Long-COVID or Post-Vaccination Syndrome
Long COVID, COVID-19 (SARS-CoV-2 Infection)
Active, not recruiting
Motivational Interviewing Intervention for Families With Overweight and Obesity
Obesity & Overweight

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.

Raymond Chung, MD principal investigator

Massachusetts General Hospital

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 Pegylated interferon lambda in people with COVID-19 and COVID, run by Raymond Chung 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 17 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 21 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 21 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?

Undetectable COVID PCR at Day 7 (time frame: 7 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 NCT04343976, which also lists 1 linked publication.

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 21 Jul 2022.