NCT04331899: COVID-Lambda

Single-Blind Study of a Single Dose of Peginterferon Lambda-1a Compared With Placebo in Outpatients With Mild COVID-19

Completed Phase 2 Results posted Last updated 30 November 2021

What this trial tests

Phase 2 trial testing Peginterferon Lambda-1a in COVID-19 in 120 participants. Completed in 6 May 2021.

Timeline

25 April 2020

Primary endpoint
14 August 2020

6 May 2021

Quick facts

Lead sponsor	Stanford University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	120
Start date	25 April 2020
Primary completion	14 August 2020
Estimated completion	6 May 2021
Sites	1 location across United States

Drugs / interventions tested

• Peginterferon Lambda-1a — full drug profile →
• Placebo

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

Stanford University

Who can join

Adults 18 to 75, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Duration Until Viral Shedding Cessation Primary · 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.

Group	Value	95% CI
Lambda	7	5 – 13
Placebo	7	5 – 10

Change in Sars-CoV-2 Viral Load Secondary · baseline, day 14

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.

Group	Value	95% CI
Lambda	-4.3	± 1.3
Placebo	-4.9	± 4.7

Area Under the Curve of SARS-COV-2 Viral Load Secondary · baseline through day 14

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.

Group	Value	95% CI
Lambda	28.5	18.6 – 39.1
Placebo	29.6	19.6 – 38.7

Duration Until Resolution of Symptoms Secondary · Up to 28 days

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.

Group	Value	95% CI
Lambda	8	6 – 11
Placebo	9	5 – 11

Count of Participants Requiring Emergency Department Visits or Hospitalizations Within 28 Days of Initiation of Treatment Secondary · 28 days

Hospitalizations

Group	Value	95% CI
Lambda	2
Placebo	2

Emergency Department Visits

Group	Value	95% CI
Lambda	5
Placebo	3

Adverse events — posted to ClinicalTrials.gov

Time frame: 11 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Lambda

Serious: 2/60 (3%)

Deaths: 0/60

Placebo

Serious: 2/60 (3%)

Deaths: 0/60

Serious adverse events (1 terms)

Reaction	System	Lambda	Placebo
Hypoxia (hospital admission)	Respiratory, thoracic and mediastinal disorders	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Lambda	Placebo
Elevated liver function test	Hepatobiliary disorders	—	—

Most-reported serious reactions: Hypoxia (hospital admission).

Data from ClinicalTrials.gov NCT04331899 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immunology of COVID-19: Current State of the Science.
   Vabret N, Britton GJ, Gruber C, Hegde S, et al · · 2020 · cited 1248× · PMID 32505227 · DOI 10.1016/j.immuni.2020.05.002
2. Type I and Type III Interferons - Induction, Signaling, Evasion, and Application to Combat COVID-19.
   Park A, Iwasaki A. · · 2020 · cited 739× · PMID 32464097 · DOI 10.1016/j.chom.2020.05.008
3. A mouse-adapted model of SARS-CoV-2 to test COVID-19 countermeasures.
   Dinnon KH, Leist SR, Schäfer A, Edwards CE, et al · · 2020 · cited 610× · PMID 32854108 · DOI 10.1038/s41586-020-2708-8
4. The signal pathways and treatment of cytokine storm in COVID-19.
   Yang L, Xie X, Tu Z, Fu J, et al · · 2021 · cited 429× · PMID 34234112 · DOI 10.1038/s41392-021-00679-0
5. Gastrointestinal symptoms and fecal shedding of SARS-CoV-2 RNA suggest prolonged gastrointestinal infection.
   Natarajan A, Zlitni S, Brooks EF, Vance SE, et al · · 2022 · cited 296× · PMID 35434682 · DOI 10.1016/j.medj.2022.04.001
6. Proinflammatory IgG Fc structures in patients with severe COVID-19.
   Chakraborty S, Gonzalez J, Edwards K, Mallajosyula V, et al · · 2021 · cited 281× · PMID 33169014 · DOI 10.1038/s41590-020-00828-7
7. Contribution of monocytes and macrophages to the local tissue inflammation and cytokine storm in COVID-19: Lessons from SARS and MERS, and potential therapeutic interventions.
   Jafarzadeh A, Chauhan P, Saha B, Jafarzadeh S, et al · · 2020 · cited 246× · PMID 32687918 · DOI 10.1016/j.lfs.2020.118102
8. An update on drugs with therapeutic potential for SARS-CoV-2 (COVID-19) treatment.
   Drożdżal S, Rosik J, Lechowicz K, Machaj F, et al · · 2021 · cited 186× · PMID 34991982 · DOI 10.1016/j.drup.2021.100794