Pegylated Interferon Lambda Treatment for COVID-19

• Sponsor: Raymond Chung (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04343976
• Collaborator: Eiger BioPharmaceuticals (Industry)
• Enrollment: 14
• Location: 1
• Arms: 2
• Actual Duration (Months): 13.2
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19; COVID	Drug: Pegylated interferon lambda	Phase 2

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

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Masking Description: Single blind
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Pegylated Interferon Lambda vs. Placebo in Subjects Infected With COVID-19
• Actual Study Start Date: Jun 22, 2020
• Actual Primary Completion Date: Jul 30, 2021
• Actual Study Completion Date: Jul 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lambda Treatment Treatment with subcutaneous injection (180 mcg) of pegylated interferon lambda	Drug: Pegylated interferon lambda; 180 mcg subcutaneous injection of pegylated interferon lambda; Other Names: Lambda
Placebo Comparator: Saline Placebo Subcutaneous injection of saline placebo	Drug: Pegylated interferon lambda; 180 mcg subcutaneous injection of pegylated interferon lambda; Other Names: Lambda

Outcome Measures

Primary Outcome Measures

1. Undetectable COVID PCR at Day 7 [7 days]

   Negative COVID PCR testing 7 days after first lambda dose

Secondary Outcome Measures

1. Undetectable COVID PCR at Day 3 [3 days]

   Negative COVID PCR testing 3 days after first lambda dose

2. Percentage of Subjects on Lambda vs Placebo With Symptomatic Improvement [2 weeks]

   Daily symptom score improvement during treatment period

3. Percentage of Subjects on Lambda vs Placebo With Improved Clinical Outcomes [2 weeks]

   Time to event for death, intubation, hospital discharge

4. Undetectable COVID PCR Testing at Day 14 [14 days]

   Negative COVID PCR testing 14 days after first lambda dose

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Raymond Chung
• Eiger BioPharmaceuticals

Investigators

• Principal Investigator: Raymond Chung, MD, Massachusetts General Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 7, 2021

More Information

Publications

None provided.

• Responsible Party: Raymond Chung, Director of Hepatology, MGH, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT04343976
• Other Study ID Numbers: 2020P001083
• First Posted: Apr 14, 2020
• Last Update Posted: Jul 21, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Raymond Chung, Director of Hepatology, MGH, Massachusetts General Hospital: COVID; Coronavirus
• Additional relevant MeSH terms: COVID-19; Interferons

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from inpatient admissions between June 2020 and July 2021.

Arm/Group Title	Lambda Treatment	Saline Placebo
Arm/Group Description	Treatment with subcutaneous injection (180 mcg) of pegylated interferon lambda Pegylated interferon lambda: 180 mcg subcutaneous injection of pegylated interferon lambda	Subcutaneous injection of saline placebo Pegylated interferon lambda: 180 mcg subcutaneous injection of pegylated interferon lambda
Period Title: Overall Study
STARTED	7	7
COMPLETED	7	6
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Lambda Treatment	Saline Placebo	Total
Arm/Group Description	Treatment with subcutaneous injection (180 mcg) of pegylated interferon lambda Pegylated interferon lambda: 180 mcg subcutaneous injection of pegylated interferon lambda	Subcutaneous injection of saline placebo Pegylated interferon lambda: 180 mcg subcutaneous injection of pegylated interferon lambda	Total of all reporting groups
Overall Participants	7	7	14
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	7 100%	6 85.7%	13 92.9%
>=65 years	0 0%	1 14.3%	1 7.1%
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	54	59	54.5
Sex: Female, Male (Count of Participants)
Female	2 28.6%	1 14.3%	3 21.4%
Male	5 71.4%	6 85.7%	11 78.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 42.9%	6 85.7%	9 64.3%
Not Hispanic or Latino	3 42.9%	1 14.3%	4 28.6%
Unknown or Not Reported	1 14.3%	0 0%	1 7.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	7 100%	5 71.4%	12 85.7%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	2 28.6%	2 14.3%
Region of Enrollment (participants) [Number]
United States	7 100%	7 100%	14 100%

Outcome Measures

1. Primary Outcome

Title	Undetectable COVID PCR at Day 7
Description	Negative COVID PCR testing 7 days after first lambda dose
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Lambda Treatment	Saline Placebo
Arm/Group Description	Treatment with subcutaneous injection (180 mcg) of pegylated interferon lambda Pegylated interferon lambda: 180 mcg subcutaneous injection of pegylated interferon lambda	Subcutaneous injection of saline placebo Pegylated interferon lambda: 180 mcg subcutaneous injection of pegylated interferon lambda
Measure Participants	7	7
Count of Participants [Participants]	1 14.3%	4 57.1%

2. Secondary Outcome

Title	Undetectable COVID PCR at Day 3
Description	Negative COVID PCR testing 3 days after first lambda dose
Time Frame	3 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lambda Treatment	Saline Placebo
Arm/Group Description	Treatment with subcutaneous injection (180 mcg) of pegylated interferon lambda Pegylated interferon lambda: 180 mcg subcutaneous injection of pegylated interferon lambda	Subcutaneous injection of saline placebo Pegylated interferon lambda: 180 mcg subcutaneous injection of pegylated interferon lambda
Measure Participants	7	6
Count of Participants [Participants]	1 14.3%	4 57.1%

3. Secondary Outcome

Title	Percentage of Subjects on Lambda vs Placebo With Symptomatic Improvement
Description	Daily symptom score improvement during treatment period
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

insufficient data, analysis not performed as there the symptom improvement score was not collected and not available for analysis.

Arm/Group Title	Lambda Treatment	Saline Placebo
Arm/Group Description	Treatment with subcutaneous injection (180 mcg) of pegylated interferon lambda Pegylated interferon lambda: 180 mcg subcutaneous injection of pegylated interferon lambda	Subcutaneous injection of saline placebo Pegylated interferon lambda: 180 mcg subcutaneous injection of pegylated interferon lambda
Measure Participants	0	0

4. Secondary Outcome

Title	Percentage of Subjects on Lambda vs Placebo With Improved Clinical Outcomes
Description	Time to event for death, intubation, hospital discharge
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

Data was not collected and therefor analysis not performed.

Arm/Group Title	Lambda Treatment	Saline Placebo
Arm/Group Description	Treatment with subcutaneous injection (180 mcg) of pegylated interferon lambda Pegylated interferon lambda: 180 mcg subcutaneous injection of pegylated interferon lambda	Subcutaneous injection of saline placebo Pegylated interferon lambda: 180 mcg subcutaneous injection of pegylated interferon lambda
Measure Participants	0	0

5. Secondary Outcome

Title	Undetectable COVID PCR Testing at Day 14
Description	Negative COVID PCR testing 14 days after first lambda dose
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

All subjects providing NP swab samples at Day 14

Arm/Group Title	Lambda Treatment	Saline Placebo
Arm/Group Description	Treatment with subcutaneous injection (180 mcg) of pegylated interferon lambda Pegylated interferon lambda: 180 mcg subcutaneous injection of pegylated interferon lambda	Subcutaneous injection of saline placebo Pegylated interferon lambda: 180 mcg subcutaneous injection of pegylated interferon lambda
Measure Participants	6	6
Count of Participants [Participants]	2 28.6%	2 28.6%

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.
Arm/Group Title	Lambda Treatment		Saline Placebo
Arm/Group Description	Treatment with subcutaneous injection (180 mcg) of pegylated interferon lambda Pegylated interferon lambda: 180 mcg subcutaneous injection of pegylated interferon lambda		Subcutaneous injection of saline placebo Pegylated interferon lambda: 180 mcg subcutaneous injection of pegylated interferon lambda
All Cause Mortality
	Lambda Treatment		Saline Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/7 (0%)
Serious Adverse Events
	Lambda Treatment		Saline Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/7 (28.6%)		0/7 (0%)
Hepatobiliary disorders
Transaminitis	1/7 (14.3%)	1	0/7 (0%)	0
Respiratory, thoracic and mediastinal disorders
Worsening Pneumonia	1/7 (14.3%)	1	0/7 (0%)	0
Other (Not Including Serious) Adverse Events
	Lambda Treatment		Saline Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/7 (42.9%)		1/7 (14.3%)
Cardiac disorders
Chest Pain	0/7 (0%)	0	1/7 (14.3%)	1
Gastrointestinal disorders
Stomach Pain (unspecified)	1/7 (14.3%)	1	0/7 (0%)	0
Hepatobiliary disorders
Transaminitis	1/7 (14.3%)	1	0/7 (0%)	0
Psychiatric disorders
ICU Delirium	1/7 (14.3%)	1	0/7 (0%)	0
Respiratory, thoracic and mediastinal disorders
Shortness of Breath	0/7 (0%)	0	1/7 (14.3%)	1

Limitations/Caveats

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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.