Trial · NCT04331899
Single-Blind Study of a Single Dose of Peginterferon Lambda-1a Compared With Placebo in Outpatients With Mild COVID-19
NCT04331899, Phase 2, Completed, Stanford University; results first posted 2021-04-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Single-Blind Study of a Single Dose of Peginterferon Lambda-1a Compared With Placebo in Outpatients With Mild COVID-19. Trials, record NCT04331899. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04331899
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Single-Blind Study of a Single Dose of Peginterferon Lambda-1a Compared With Placebo in Outpatients With Mild COVID-19
- NCT number
- NCT04331899
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 120 participants, actual
- Lead sponsor
- Stanford University
- Conditions
- COVID-19
- Interventions
- Peginterferon Lambda-1a, Placebo
- First posted
- 2020-04-02
- Last updated
- 2021-11-30
- Results first posted
- 2021-04-22
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Duration Until Viral Shedding Cessation | 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. |
| Secondary | Change in Sars-CoV-2 Viral Load | 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. |
| Secondary | Area Under the Curve of SARS-COV-2 Viral Load | 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. |
| Secondary | Duration Until Resolution of Symptoms | 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. |
| Secondary | Count of Participants Requiring Emergency Department Visits or Hospitalizations Within 28 Days of Initiation of Treatment | 28 days |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Duration Until Viral Shedding Cessation | Assessed for up to 28 days | days | MEDIAN | |
| SECONDARY | Change in Sars-CoV-2 Viral Load | baseline, day 14 | Log10 copies per mL | MEAN | |
| SECONDARY | Area Under the Curve of SARS-COV-2 Viral Load | baseline through day 14 | Log10 copies*days/ml | MEDIAN | |
| SECONDARY | Duration Until Resolution of Symptoms | Up to 28 days | days | MEDIAN | |
| SECONDARY | Count of Participants Requiring Emergency Department Visits or Hospitalizations Within 28 Days of Initiation of Treatment | 28 days | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Duration Until Viral Shedding Cessation | Lambda | 7 | 95% Confidence Interval 5 to 13 | days | |
| Duration Until Viral Shedding Cessation | Placebo | 7 | 95% Confidence Interval 5 to 10 | days | |
| Change in Sars-CoV-2 Viral Load | Lambda | -4.3 | Standard Deviation 1.3 | Log10 copies per mL | |
| Change in Sars-CoV-2 Viral Load | Placebo | -4.9 | Standard Deviation 4.7 | Log10 copies per mL | |
| Area Under the Curve of SARS-COV-2 Viral Load | Lambda | 28.5 | Inter-Quartile Range 18.6 to 39.1 | Log10 copies*days/ml | |
| Area Under the Curve of SARS-COV-2 Viral Load | Placebo | 29.6 | Inter-Quartile Range 19.6 to 38.7 | Log10 copies*days/ml | |
| Duration Until Resolution of Symptoms | Lambda | 8 | 95% Confidence Interval 6 to 11 | days | |
| Duration Until Resolution of Symptoms | Placebo | 9 | 95% Confidence Interval 5 to 11 | days | |
| Count of Participants Requiring Emergency Department Visits or Hospitalizations Within 28 Days of Initiation of Treatment | Lambda | Hospitalizations | 2 | Participants | |
| Count of Participants Requiring Emergency Department Visits or Hospitalizations Within 28 Days of Initiation of Treatment | Placebo | Hospitalizations | 2 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Trial Period (28 Days) | STARTED | Lambda | 60 | |
| Trial Period (28 Days) | STARTED | Placebo | 60 | |
| Trial Period (28 Days) | COMPLETED | Lambda | 58 | |
| Trial Period (28 Days) | COMPLETED | Placebo | 58 | |
| Trial Period (28 Days) | NOT COMPLETED | Lambda | 2 | |
| Trial Period (28 Days) | NOT COMPLETED | Placebo | 2 | |
| Follow-up Period (10 Months) | STARTED | Lambda | 42 | |
| Follow-up Period (10 Months) | STARTED | Placebo | 43 | |
| Follow-up Period (10 Months) | COMPLETED | Lambda | 42 | |
| Follow-up Period (10 Months) | COMPLETED | Placebo | 43 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Elevated liver function test | Hepatobiliary disorders | Lambda | 15 | 60 | |
| other | Elevated liver function test | Hepatobiliary disorders | Placebo | 5 | 60 | |
| serious | Hypoxia (hospital admission) | Respiratory, thoracic and mediastinal disorders | Lambda | 2 | 60 | |
| serious | Hypoxia (hospital admission) | Respiratory, thoracic and mediastinal disorders | Placebo | 2 | 60 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lambda | 0 | 60 |
| Total, all-cause mortality | Placebo | 0 | 60 |
| Total, other adverse events | Lambda | 15 | 60 |
| Total, other adverse events | Placebo | 5 | 60 |
| Total, serious adverse events | Lambda | 2 | 60 |
| Total, serious adverse events | Placebo | 2 | 60 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lambda vs Placebo: deaths from any cause | Trial comparisons |
| Lambda vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04331899
GET https://conductscience.org/api/trials/v1/NCT04331899/registered