ArticleEClinicalMedicine2020
An open-label, randomized trial of the combination of IFN-κ plus TFF2 with standard care in the treatment of patients with moderate COVID-19.
Article in EClinicalMedicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 5 of them syntheses that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
23 citing papers in PubMed, 5 syntheses or guidelines pooled it.
- Drug treatments for mild or moderate covid-19: systematic review and network meta-analysis.BMJ (Clinical research ed.) · 2025Pooled it
- A systematic review of acute and emergency care interventions for adolescents and adults with severe acute respiratory infections including COVID-19 in low- and middle-income countries.Journal of global health · 2022Pooled it
- Immunomodulatory therapies for SARS-CoV-2 infection: a systematic literature review to inform EULAR points to consider.Annals of the rheumatic diseases · 2021Pooled it
- Current evidence for COVID-19 therapies: a systematic literature review.European respiratory review : an official journal of the European Respiratory Society · 2021Pooled it
- Treatment of severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), and coronavirus disease 2019 (COVID-19): a systematic review ofTheranostics · 2021Pooled it
- The effect of Fingolimod on patients with moderate to severe COVID-19.Pharmacology research & perspectives · 2023Trial
- Trefoil factor 2 interacts with A4GNT to regulate inflammation to protect against pneumonia during influenza virus infection.iScience · 2025Article
- Circulating eosinophils associated with responsiveness to COVID-19 vaccine and the disease severity in patients with SARS-CoV-2 omicron variant infection.BMC pulmonary medicine · 2023Article
- An overview on the treatments and prevention against COVID-19.Virology journal · 2023Review
- Correlation between Type I Interferon Associated Factors and COVID-19 Severity.International journal of molecular sciences · 2022Review
- Cytokines and microRNAs in SARS-CoV-2: What do we know?Molecular therapy. Nucleic acids · 2022Review
- Clinical characteristics with inflammation profiling of long COVID and association with 1-year recovery following hospitalisation in the UK: a prospective observational study.The Lancet. Respiratory medicine · 2022Observational
- Innate Immune Response in Respiratory System: A Double-edged Sword Against Virus Infection.Infectious diseases & immunity · 2022Article
- Triple jeopardy in ageing: COVID-19, co-morbidities and inflamm-ageing.Ageing research reviews · 2022Review
- A randomized, double-blind, placebo-controlled phase I trial of inhalation treatment of recombinant TFF2-IFN protein: A multifunctional candidate for the treatment of COVID-19.Frontiers in pharmacology · 2022Article
- COVID-19 as a mediator of interferon deficiency and hyperinflammation: Rationale for the use of JAK1/2 inhibitors in combination with interferon.Cytokine & growth factor reviews · 2021Review
- Response to pegylated interferon in a COVID-19 positive male with metastatic jejunal neuroendocrine tumor treated with everolimus.Clinical case reports · 2021Article
- Response to pegylated interferon in a COVID-19-positive elderly woman with primary myelofibrosis treated with ruxolitinib.Clinical case reports · 2021Article
- Beyond Vaccines: Clinical Status of Prospective COVID-19 Therapeutics.Frontiers in immunology · 2021Review
- Endothelium Infection and Dysregulation by SARS-CoV-2: Evidence and Caveats in COVID-19.Viruses · 2020Review
Corrections and comments
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Authors and funding
23 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEpidemic outbreaks caused by SARS-CoV-2 are worsening around the world, and there are no target drugs to treat COVID-19. IFN-κ inhibits the replication of SARS-CoV-2; and TFF2 is a small secreted polypeptide that promotes the repair of mucosal injury and reduces the inflammatory responses. We used the synergistic effect of both proteins to treat COVID-19.
methodsWe conducted an open-label, randomized, clinical trial involving patients with moderate COVID-19. Patients were assigned in a 1:1 ratio to receive either aerosol inhalation treatment with IFN-κ and TFF2 every 24 h for six consecutive dosages in addition to standard care (experimental group) or standard care alone (control group). The primary endpoint was the time until a viral RNA negative conversion for SARS-CoV-2 in all clinical samples. The secondary clinical endpoint was the time of CT imaging improvement. Data analysis was performed per protocol. This study was registered with chictr.org.cn, ChiCTR2000030262.
findingsBetween March 23 and May 23 of 2020, 86 COVID-19 patients with symptoms of moderate illness were recruited, and 6 patients were excluded due to not matching the inclusion criteria (patients with pneumonia through chest radiography). Among the remaining 80 patients, 40 patients were assigned to experimental group, and the others were assigned to control group to only receive standard care. Efficacy and safety were evaluated for both groups. The time of viral RNA negative conversion in experimental group (Mean, 3·80 days, 95% CI 2·07-5·53), was significantly shorter than that in control group (7·40 days, 95% CI 4·57 to 10·23) (
interpretationIn conclusion, we found that aerosol inhalation of IFN-κ plus TFF2 in combination with standard care is safe and superior to standard care alone in shortening the time up to viral RNA negative conversion in all clinical samples. In addition, the patients in experimental group had a significantly shortened CT imaging improvement time than those in control group. This study suggested that this combination treatment is able to facilitate clinical improvement (negative for virus, improvement by CT, reduced hospitalization stay) and thereby result in an early release from the hospital. These data support the need for exploration with a large-scale trial of IFN-κ plus TFF2 to treat COVID-19.
fundingFunding was provided by the National Natural Science Foundation of China, National Major Project for Control and Prevention of Infectious Disease in China, Shanghai Science and Technology Commission, Shanghai Municipal Health Commission.
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