SARS-CoV-2Phase 2NCT04388709
Interferon Lambda Therapy for COVID-19
A Phase 2 study testing Peginterferon Lambda-1A in people with SARS-CoV-2, run by Icahn School of Medicine at Mount Sinai.
Trial summary
The main purpose of this research study is to test the safety and effectiveness of an investigational drug peginterferon lambda-1a in treating COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- Peginterferon Lambda-1A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2020to 5 Feb 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Confirmed diagnosis of SARS-CoV-2
- Hospitalization due to diagnosis with SARS-CoV-2
- Sp02 < 93% on ambient air or PaO2/FiO2 < 300 mmHg and requires supplemental oxygen
Who cannot join
- Patients must not be pregnant or nursing
- Patients cannot be admitted to intensive care unit at time of admission or require positive pressure ventilation
- Patients cannot be requiring continuous supplemental oxygen normally (pre-SARS-CoV-2)
- Patient is receiving steroids >1mg/kg
- Has diagnosis of primary immunodeficiency
- Has active autoimmune disease that has required systemic treatment in the past year
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- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial
- Patients with ferritin >2000ng/mL and/or C-reactive protein >100mg/L
- History of allogeneic hematopoietic cell transplantation or solid organ transplantation
- Childs-Pugh class B or C cirrhosis or class A if portal hypertension is present
- Documented allergic or hypersensitivity response to protein therapeutics
- No serious disease requiring mechanical ventilation at time of enrollment
About this study
Official title: A Randomized Phase 2 Trial of Peginterferon Lambda-1a (Lambda) for the Treatment of Hospitalized Patients Infected With SARS-CoV-2 With Non-critical Illness
The main purpose of this research study is to test the safety and effectiveness of an investigational drug peginterferon lambda-1a in treating COVID-19.
Read the detailed description
Primary Objective: Determine efficacy of pegylated interferon lambda as measured by clinical improvement. This will be defined as improvement in supplemental oxygen requirement.
Secondary Objectives:
- Determine safety and tolerability of pegylated interferon lambda
- Days with fever
- Time to resolution of fever
- Rate of progression to requiring critical care
- Overall survival
- Time to discharge
Exploratory Objectives: Determining the effect systemically on inflammatory markers in the blood, as well as viral load.
Diagnosis and Main Inclusion Criteria: Patients must have a confirmed diagnosis of infection with SARS-CoV-2 and be receiving supplemental oxygen. Many patients may be receiving hydroxychloroquine with or without other antimicrobials.
- Conditions
- SARS-CoV-2
- Being tested
- Peginterferon Lambda-1A
- Keywords
- Peginterferon lambda-1a, Lambda, SARS-CoV-2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon Lambda-1ADrug
Also called Lambda, Interferon Lambda
Peginterferon lambda-1a (Lambda) 180mcg subcutaneous injection once
| Study group | Role | What they receive |
|---|---|---|
| Peginterferon lambda-1a | Experimental | Peginterferon lambda-1a (Lambda) 180mcg subcutaneous injection once Receives: Drug: Peginterferon Lambda-1A |
| Best supportive care | No intervention | Best supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with resolution of hypoxia
The clinical improvement as defined as resolution of hypoxia requiring supplemental oxygen to maintain SpO2>92% at 7 days.
Measured: 7 days
Secondary outcomes (6)
Number of adverse events.
Number of Grade 3 or 4 adverse events as determined by the DAIDS criteria over the course of 3 months from initiation of trial to measure safety and tolerability of pegylated interferon lambda. Information on adverse events will be collected during hospitalization and then as an outpatient until 90 days from the time of receipt of treatment.
Measured: until 90 days after receipt of treatment
Days with fever
Number of days participant has a fever. Information on fever will be collected during hospitalization. Cessation of fever is defined as the beginning of the first 48 hour period without fever without the use of antipyretic drug.
Measured: during hospitalization, average of 7 days
Time to resolution of fever
This is defined as time from initial treatment with investigational agent, to the cessation of fever, defined as the beginning of the first 48 hour period without fever without the use of antipyretic drug.
Measured: during hospitalization, average of 7 days
Rate of progression to requiring critical care
Defined as time from initial treatment with investigational agent to deterioration of clinical condition necessitating transfer to a critical care unit and/or intubation.
Measured: during hospitalization, average of 5 days
Overall survival
Information on survival will be collected during hospitalization and then, for those patients discharged, will be collected as an outpatient until 90 days from the time of receipt of treatment
Measured: until 90 days after receipt of treatment
Time to discharge
This is defined as the amount of time (in days or fraction thereof) between the receipt of investigational agent and discharge from The Mount Sinai Hospital to home or nursing home, or censoring at time of death.
Measured: average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study startSep 2020 (estimated)
- Primary completion5 Feb 2021
- Study completion5 Feb 2021
Why it stopped: Due to the number of competing trials at their site, the study team has closed enrollment and withdrawn this trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Cohort A: Peginterferon lambda-1a (Lambda) 180mcg subcutaneous injection once Cohort B: Best supportive care
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Eiger BioPharmaceuticals
- Responsible party
- Principal investigator, Thomas Marron, Icahn School of Medicine at Mount Sinai
- Investigators
- Thomas Marron, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04388709
- Sponsor's protocol ID
- GCO 20-0820
- Status last verified
- Feb 2021
- First submitted
- 12 May 2020
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 2 Trial of Peginterferon Lambda-1a (Lambda) for the Treatment of Hospitalized Patients Infected With SARS-CoV-2 With Non-critical Illness
- ClinicalTrials.gov ID
- NCT04388709
- Acronym / sponsor ID
- GCO 20-0820
- Conditions
- SARS-CoV-2
- Keywords
- Peginterferon lambda-1a, Lambda, SARS-CoV-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to the number of competing trials at their site, the study team has closed enrollment and withdrawn this trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Eiger BioPharmaceuticals
- Study start
- Sep 2020 (estimated)
- Primary completion
- 5 Feb 2021 (actual)
- Study completion
- 5 Feb 2021 (actual)
- First posted
- 14 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this research study is to test the safety and effectiveness of an investigational drug peginterferon lambda-1a in treating COVID-19.
Detailed description
Primary Objective: Determine efficacy of pegylated interferon lambda as measured by clinical improvement. This will be defined as improvement in supplemental oxygen requirement.
Secondary Objectives:
- Determine safety and tolerability of pegylated interferon lambda
- Days with fever
- Time to resolution of fever
- Rate of progression to requiring critical care
- Overall survival
- Time to discharge
Exploratory Objectives: Determining the effect systemically on inflammatory markers in the blood, as well as viral load.
Diagnosis and Main Inclusion Criteria: Patients must have a confirmed diagnosis of infection with SARS-CoV-2 and be receiving supplemental oxygen. Many patients may be receiving hydroxychloroquine with or without other antimicrobials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cohort A: Peginterferon lambda-1a (Lambda) 180mcg subcutaneous injection once Cohort B: Best supportive care
| Arm | Type | Receives |
|---|---|---|
| Peginterferon lambda-1a | Experimental | Drug: Peginterferon Lambda-1APeginterferon lambda-1a (Lambda) 180mcg subcutaneous injection once |
| Best supportive care | No intervention | –Best supportive care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed diagnosis of SARS-CoV-2
- Hospitalization due to diagnosis with SARS-CoV-2
- Sp02 < 93% on ambient air or PaO2/FiO2 < 300 mmHg and requires supplemental oxygen
Key exclusion criteria (12 listed)
- Patients must not be pregnant or nursing
- Patients cannot be admitted to intensive care unit at time of admission or require positive pressure ventilation
- Patients cannot be requiring continuous supplemental oxygen normally (pre-SARS-CoV-2)
- Patient is receiving steroids >1mg/kg
- Has diagnosis of primary immunodeficiency
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-1AAlso: Lambda, Interferon LambdaPeginterferon lambda-1a (Lambda) 180mcg subcutaneous injection once | Drug | Peginterferon lambda-1a |
Primary outcome
Number of participants with resolution of hypoxia
Time frame: 7 days
The clinical improvement as defined as resolution of hypoxia requiring supplemental oxygen to maintain SpO2>92% at 7 days.
6 secondary outcomes
Number of adverse events.
Time frame: until 90 days after receipt of treatment
Days with fever
Time frame: during hospitalization, average of 7 days
Time to resolution of fever
Time frame: during hospitalization, average of 7 days
Rate of progression to requiring critical care
Time frame: during hospitalization, average of 5 days
Overall survival
Time frame: until 90 days after receipt of treatment
Time to discharge
Time frame: average of 7 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- 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: 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.
Thomas Marron, MD principal investigator
Icahn School of Medicine at Mount Sinai
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Peginterferon Lambda-1A in people with SARS-CoV-2, run by Icahn School of Medicine at Mount Sinai.
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 12 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: withdrawn, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 resolution of hypoxia (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 NCT04388709, 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 26 Feb 2021.