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: single blinding | |
| Location :
Single center / USA Follow-up duration (days): 28 | |
| Inclusion criteria | Report:
"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 Registry: Age ≥ 18 years and ≤ 75 years at the time of the assessment; Able and willing to understand the study, adhere to all study procedures, and provide written informed consent; Diagnosis of COVID-19 disease: If symptomatic, the presence of mild to moderate symptoms without signs of respiratory distress, with FDA-cleared molecular diagnostic assay positive for SARS-CoV-2 within 72 hours from swab to the time of commencing informed consent: If asymptomatic, initial diagnosis of SARS-CoV-2 infection with positive FDA-cleared molecular diagnostic assay obtained no more than 72 hours from initial swab to the time of commencing informed consent. |
| Exclusion criteria | Report:
"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, and prespecified lab abnormalities." Registry: Patients who are hospitalized for inpatient treatment or currently being evaluated for potential hospitalization at the time of initiation of informed consent ; Patients with a known allergy to Peginterferon Lambda-1a or any component thereof ; Display symptoms of respiratory distress (Respiratory rate >20, room air oxygen saturation of <94%.) ; Participation in a clinical trial with or use of any investigational agent within 30 days before screening ; Treatment with interferons (IFN) within 12 months before screening ; Previous use of Peginterferon Lambda-1a ; History or evidence of any intolerance or hypersensitivity to IFNs or other substances contained in the study medication. ; Female patients who are pregnant or breastfeeding. Male patients must confirm that their female sexual partners are not pregnant. ; Current or previous history of decompensated liver disease (Child-Pugh Class B or C) or hepatocellular carcinoma ; Co-infected with human immunodeficiency virus (HIV) ; Significant abnormal laboratory test results at screening. ; Other significant medical condition that may require intervention during the study ; Concurrent use of any of the following medications: Therapy with an immunomodulatory agent, Current use of heparin or Coumadin, Received blood products within 30 days before study randomization, Use of hematologic growth factors within 30 days before study randomization, Systemic antibiotics, antifungals, or antivirals for treatment of active infection within 24 hours before study randomization , Any prescription or herbal product that is not approved by the investigator , Long-term treatment (> 2 weeks) with agents that have a high risk for nephrotoxicity or hepatotoxicity unless it is approved by the medical monitor , Receipt of systemic immunosuppressive therapy within 3 months before screening. |
| Interventions | |
| Treatment
Placebo * |
|
| Control
Peginterferon Lambda-1a (180 mcg) Duration : 1 day | |
| Participants | |
| Randomized 120 participants (n1=60 / n2= 60) | |
| Characteristics of participants N=120 Mean age : NR 70 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=0 | |
| 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 NR Statistical plan NR Data-sharing stated 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 study registry and supplementary appendix were used in data extraction and risk of bias assessment. Protocol and statistical analysis plan were not available at the time of data collection. 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. |