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NCT04344600: PROTECT

Peginterferon Lambda-1a for the Prevention and Treatment of SARS-CoV-2 (COVID-19) Infection

Terminated Phase 2 Results posted Last updated 14 July 2022
What this trial tests

Phase 2 trial testing Peginterferon lambda alfa-1a subcutaneous injection in Sars-CoV-2 Infection in 6 participants. Terminated before completion.

Timeline
29 June 2020
Primary endpoint
24 September 2021
24 September 2021

Quick facts

Lead sponsorJohns Hopkins University
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment6
Start date29 June 2020
Primary completion24 September 2021
Estimated completion24 September 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Johns Hopkins University

Who can join

Adults 18 to 80, any sex, with Sars-CoV-2 Infection. 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.

Number of Participants With no Evidence of SARS-CoV-2 Infection Primary · Up to 28 days

Number of participants with no evidence of SARS-CoV-2 infection at or before study day 28.

GroupValue95% CI
Peginterferon Lambda Alfa-1a2
Placebo4

Sponsor's own description

This is a phase 2b prospective, randomized, single-blind, controlled trial of a single subcutaneous injection of peginterferon lambda-1a versus placebo for prevention of SARS-CoV-2 infection in non-hospitalized participants at high risk for infection due to household exposure to an individual with coronavirus disease (COVID-19). The study will also evaluate the regimens participants with asymptomatic SARS-CoV-2 infection detected at study entry. All participants will be followed for up to 12 weeks.

Publications & conference data

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

  1. 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
  2. The type I interferon response in COVID-19: implications for treatment.
    Lee JS, Shin EC. · · 2020 · cited 313× · PMID 32788708 · DOI 10.1038/s41577-020-00429-3
  3. Pharmaco-Immunomodulatory Therapy in COVID-19.
    Rizk JG, Kalantar-Zadeh K, Mehra MR, Lavie CJ, et al · · 2020 · cited 190× · PMID 32696108 · DOI 10.1007/s40265-020-01367-z
  4. Viral Respiratory Pathogens and Lung Injury.
    Clementi N, Ghosh S, De Santis M, Castelli M, et al · · 2021 · cited 127× · PMID 33789928 · DOI 10.1128/cmr.00103-20
  5. Peginterferon Lambda-1a for treatment of outpatients with uncomplicated COVID-19: a randomized placebo-controlled trial.
    Jagannathan P, Andrews JR, Bonilla H, Hedlin H, et al · · 2021 · cited 115× · PMID 33785743 · DOI 10.1038/s41467-021-22177-1
  6. Flattening the COVID-19 Curve With Natural Killer Cell Based Immunotherapies.
    Market M, Angka L, Martel AB, Bastin D, et al · · 2020 · cited 115× · PMID 32655581 · DOI 10.3389/fimmu.2020.01512
  7. COVID-19: lambda interferon against viral load and hyperinflammation.
    Andreakos E, Tsiodras S. · · 2020 · cited 111× · PMID 32333818 · DOI 10.15252/emmm.202012465
  8. SARS-CoV-2 Infection Boosts <i>MX1</i> Antiviral Effector in COVID-19 Patients.
    Bizzotto J, Sanchis P, Abbate M, Lage-Vickers S, et al · · 2020 · cited 99× · PMID 32989429 · DOI 10.1016/j.isci.2020.101585

Verify or expand the search:

Other recruiting trials for Sars-CoV-2 Infection

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Other Johns Hopkins University trials

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Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04344600.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing