Trial NCT04331899
Publication Jagannathan P, Nature (2021) (published paper)
Dates: 2020-04-25 to 2020-07-17
Funding: Mixed (Anonymous donors to Stanford University; Eiger BioPharmaceuticals (drug))
Conflict of interest: Yes

Methods
RCT
Blinding: double blinding
Location : Single center / USA
Follow-up duration (days): 28
Inclusion criteria
  • Adults aged 18-65 years with an FDA emergency use authorized reverse transcription-polymerase chain reaction (RT-PCR) positive for SARS-CoV-2 within 72 hours from swab to the time of enrolment were eligible for participation in this study
  • both symptomatic and asymptomatic patients were included given reports finding that both CT values and presence of infectious virus were similar in samples from asymptomatic and symptomatic persons
  • symptomatic individuals were eligible given the presence of mild to moderate symptoms without signs of respiratory distress
  • asymptomatic individuals were eligible if infection was initial diagnosis of SARS-CoV-2 infection
Exclusion criteria
  • Current or imminent hospitalization
  • respiratory rate >20 breaths per minute
  • room air oxygen saturation <94%
  • pregnancy or breastfeeding
  • history of decompensated liver disease
  • recent use of interferons, antibiotics, anticoagulants or other investigational and/or immunomodulatory agents for treatment of COVID-19
  • prespecified lab abnormalities
Interventions
Treatment
Peginterferon Lambda-1
180 mcg subcutaneous injection once off
Control
Placebo

Participants
Randomized
participants :
Peginterferon Lambda-1=60
Placebo=60
Characteristics of participants
N= 120
Mean age : NR
70 males
Severity : Mild: n= 112/ Asymptomatic: n=8
Number of vaccinated participants: NR
Primary outcome
In the register
Duration of Viral shedding of SARS-CoV-2 by qRT-PCR [ Time Frame: 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
In the report
Time to first of two consecutive negative oropharyngeal tests for SARS-CoV-2 by RT-PCR
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing willing stated in the publication:

Yes
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Some concerns
General comment In addition to the preprint article, the protocol, SAP, the study registry and supplementary appendix were used in data extraction and risk of bias assessment. The study achieved the target sample size specified in the trial registry. There is no change from the trial registration in the intervention and control treatments. The primary outcome indicated in the trial registry reflects the primary outcome reported in the paper. All secondary outcomes were added to the trial registration after completion of study recruitment and follow up, and the design was changed from open-label to single-blind.
Quote: "The protocol was amended on June 16th, 2020 after 54 participants were enrolled but before results were available to include adults up to 75 years of age and eliminate exclusion criteria for low white blood cell and lymphocyte count."
On 12th of April, 2021, this study was updated based on the published report.
This study was updated on September 28th, 2022 with data extracted from the registry.