Covid-19 living Data

Peginterferon Lambda-1 vs Placebo (RCT)

Hospitalized patients

FOREST PLOTS -2022-08-18

Studies description

Trial NCT04343976
Publication Chung R, Unpublished (2022) (results posted on registry)

Funding: Not reported/unclear
Conflict of interest: *

Methods
	RCT Blinding: single blinding
	Location : Single center / USA Follow-up duration (days): 14
Inclusion criteria	Willing and able to provide informed consent Male or female age > 18 years at time of consent Hospitalized with confirmed COVID-19 Historic diagnosis by PCR test may be at any time prior to hospitalization but subject must have documentation of a positive SARS-CoV-2 RT-PCR test within 72 hours of randomization. Female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessmentsinfection by PCR analysis of respiratory secretions
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
Interventions
	Treatment Peginterferon Lambda-1 180 mcg subcutaneously single dose.
	Control Placebo
Participants
	Randomized participants : Placebo=7 Peginterferon Lambda-1=7
	Characteristics of participants N= 14 Mean age : NR 11 males Severity : Mild: n=* / Moderate: n=* / Severe: n=* Critical: n=0
Primary outcome
	In the register Undetectable COVID PCR at Day 7 [ Time Frame: 7 days ] Negative COVID PCR testing 7 days after first lambda dose
	In the report NR
Documents avalaible	Protocol Yes. In English Statistical plan Yes Data-sharing willing stated in the publication: Not reported
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	The trial registry, protocol and statistical analysis plan were used in data extraction and assessment of risk of bias. This is an unpublished study whose results have been reported in ClinicalTrials.gov. The trial was registered prospectively and no important changes were made to primary or secondary outcomes after recruitment start. The trial (n = 14) did not achieve its target sample size (n = 20). The study was terminated due to a decrease in eligible subjects and lack of funding.