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Interferon ß-1a (IFNß-1a) in COVID-19 patients (INTERCOP): study protocol for a randomized controlled trial.
Bosi, Emanuele; Bosi, Carlo; Rovere Querini, Patrizia; Mancini, Nicasio; Calori, Giliola; Ruggeri, Annalisa; Canzonieri, Cecilia; Callegaro, Luciano; Clementi, Massimo; De Cobelli, Francesco; Filippi, Massimo; Bregni, Marco.
  • Bosi E; Unit of Internal Medicine, IRCCS Ospedale San Raffaele, Milan, Italy. bosi.emanuele@hsr.it.
  • Bosi C; Vita-Salute San Raffaele University, Milan, Italy. bosi.emanuele@hsr.it.
  • Rovere Querini P; University of Milan Medical School, Milan, Italy.
  • Mancini N; Unit of Internal Medicine, IRCCS Ospedale San Raffaele, Milan, Italy.
  • Calori G; Vita-Salute San Raffaele University, Milan, Italy.
  • Ruggeri A; Vita-Salute San Raffaele University, Milan, Italy.
  • Canzonieri C; Unit of Virology, IRCCS Ospedale San Raffaele, Milan, Italy.
  • Callegaro L; Clinical Trial Center, IRCCS Ospedale San Raffaele, Milan, Italy.
  • Clementi M; Clinical Trial Center, IRCCS Ospedale San Raffaele, Milan, Italy.
  • De Cobelli F; Clinical Trial Center, IRCCS Ospedale San Raffaele, Milan, Italy.
  • Filippi M; Clinical Trial Center, IRCCS Ospedale San Raffaele, Milan, Italy.
  • Bregni M; Vita-Salute San Raffaele University, Milan, Italy.
Trials ; 21(1): 939, 2020 Nov 23.
Article in English | MEDLINE | ID: covidwho-992534
ABSTRACT

BACKGROUND:

Pharmacological therapies of proven efficacy in coronavirus disease 2019 (COVID-19) are still lacking. We have identified IFNß-1a as the most promising drug to be repurposed for COVID-19. The rationale relies on the evidence of IFNß anti-viral activity in vitro against SARS-CoV-2 and animal models resembling SARS-CoV-2 infection and on a recent clinical trial where IFNß was indicated as the key component of a successful therapeutic combination.

METHODS:

This is a randomized, controlled, open-label, monocentric, phase II trial (INTERCOP trial). One hundred twenty-six patients with positive swab detection of SARS-CoV-2, radiological signs of pneumonia, and mild-to-moderate disease will be randomized 21 to IFNß-1a in addition to standard of care vs standard of care alone. No other anti-viral drugs will be used as part of the regimens, both in the control and the intervention arms. IFNß-1a will be administered subcutaneously at the dose of 44 mcg (equivalent to 12 million international units) three times per week, at least 48 h apart, for a total of 2 weeks. The primary outcome is the time to negative conversion of SARS-CoV-2 nasopharyngeal swabs. Secondary outcomes include improvement or worsening in a clinical severity score measured on a 7-point ordinal scale (including transfer to intensive care unit and death), oxygen- and ventilator-free days, mortality, changes in pulmonary computed tomography severity score, hospital stay duration, reduction of viral load measured on nasopharyngeal swabs, number of serious adverse events, and changes in biochemical markers of organ dysfunction. Exploratory outcomes include blood cell counts, cytokine and inflammatory profile, peripheral mRNA expression profiles of interferon-stimulated genes, and antibodies to SARS-CoV-2 and to IFNß-1a. INTERCOP is the first study to specifically investigate the clinical benefits of IFNß-1a in COVID-19 patients.

DISCUSSION:

Potential implications of this trial are multifaceted should the primary outcome be fulfilled and the treatment be safe, one may envisage that IFNß-1a be used to reduce the infectivity of patients with mild-to moderate disease. In case IFNß-1a reduced the duration of hospital stay and/or ameliorated the clinical status, it may become a cornerstone of COVID-19 treatment. TRIAL REGISTRATION EudraCT 2020-002458-25. Registered on May 11, 2020 ClinicalTrials.gov Identifier NCT04449380.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Antiviral Agents / Pneumonia, Viral / Coronavirus Infections / Interferon beta-1a / Betacoronavirus Type of study: Diagnostic study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Adult / Female / Humans / Male Country/Region as subject: Europa Language: English Journal: Trials Journal subject: Medicine / Therapeutics Year: 2020 Document Type: Article Affiliation country: S13063-020-04864-4

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Antiviral Agents / Pneumonia, Viral / Coronavirus Infections / Interferon beta-1a / Betacoronavirus Type of study: Diagnostic study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Adult / Female / Humans / Male Country/Region as subject: Europa Language: English Journal: Trials Journal subject: Medicine / Therapeutics Year: 2020 Document Type: Article Affiliation country: S13063-020-04864-4