Inhaled Interferon α2b Treatment in Mild-to-moderate COVID-19 Infected Children

NCT05381363 | Terminated Phase 1

• 1 other identifier: CHFudanU_COVID19-1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

In the COVID-19 pandemic era, a convenient and effective treatment for pediatric patients is unavailable. A multi-center Chinese clinical trials with the aim to using Interferon-α2b spray inhalation to develop new treatment strategies for the treatment of pediatric patients with mild or moderate type of COVID-19. The purpose of this study is to determine the safety and efficacy for Interferon α2b spray inhalation as first line treatment.

Conditions

COVID-19; Children

Keywords

interferon α2b; Inhaled treatment

Outcome Measures

Primary Outcomes (1)

• Days requiring isolation (DRI)

  Efficacy of inhaled Interferon α2b by assessment of the Days requiring isolation (DRI). Patients will receive daily PCR. Nasal swab specimens were collected by standard procedures performed by trained nurses.

  from symptom onset to point of de-isolation (about 2-3 weeks)

Secondary Outcomes (9)

• Duration of fever

  from fever onset to free from fever (about 2-3 weeks)

• Proportions of COVID-19 symptoms

  from symptom onset to point of de-isolation (about 2-3 weeks)

• Blood test

  Every 3 days (from the date of hospitalization to point of de-isolation)

• C-reactive protein (CRP)

  Every 3 days (from the date of hospitalization to point of de-isolation)

• Interleukin 6 (IL-6)

  Every 3 days (from the date of hospitalization to point of de-isolation)

Study Arms (2)

Intervention: Inhaled Interferon α2b

EXPERIMENTAL

Inhaled Interferon α2b (10U/ml)

Drug: Inhaled Interferon α2b

Intervention: Standard of Care

OTHER

Standard of care treatment will be provided according to management guideline.

Other: Standard of Care

Interventions

Inhaled Interferon α2b DRUG

Drug: Inhaled Interferon α2b; 1-2 years old: 1 dose, three times per day; 3-7 years old: 1 dose, four times per day; 7-18 years old: 2 doses, four times per day

Also known as: IFN α2b

Intervention: Inhaled Interferon α2b

Standard of Care OTHER

Standard of care treatment will be provided based on the New Coronavirus Pneumonia Prevention and Control guideline (9th edition), published by National Health Commission of China

Also known as: SC

Intervention: Standard of Care

Eligibility Criteria

• Age: 12 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients diagnosed as mild to moderate COVID-19 infection with positive PCR test and symptoms (Ct \< 35)
• Parents and patients comprehend and welling to participate in this study.
• Agree to the collection of nasal swabs per day as protocol.

You may not qualify if:

• Patients evaluated as severe or critically severe type of COVID-19 infection (Individuals who have SpO2 \<94% on room air, oxygen treatment is necessary, respiratory failure, septic shock, and/or multiple organ dysfunction).
• Patients with comorbidities
• Decline to participate by parents or children
• Allergy to any study medication or usage of any kind of interferon treatment within 14 days before test
• Children cannot tolerate the inhalation treatment
• Any situation where the program cannot be carried out safely.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead
• RenJi Hospital: collaborator
• Shanghai Children's Hospital: collaborator
• Shanghai Children's Medical Center, affiliated to Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

Children Hospital of Fudan University

Shanghai, 201102, China

Location

Related Publications (12)

• Ramasamy S, Subbian S. Critical Determinants of Cytokine Storm and Type I Interferon Response in COVID-19 Pathogenesis. Clin Microbiol Rev. 2021 May 12;34(3):e00299-20. doi: 10.1128/CMR.00299-20. Print 2021 Jun 16.

  PMID: 33980688 BACKGROUND

• Lee JS, Shin EC. The type I interferon response in COVID-19: implications for treatment. Nat Rev Immunol. 2020 Oct;20(10):585-586. doi: 10.1038/s41577-020-00429-3.

  PMID: 32788708 BACKGROUND

• Nile SH, Nile A, Qiu J, Li L, Jia X, Kai G. COVID-19: Pathogenesis, cytokine storm and therapeutic potential of interferons. Cytokine Growth Factor Rev. 2020 Jun;53:66-70. doi: 10.1016/j.cytogfr.2020.05.002. Epub 2020 May 7.

  PMID: 32418715 BACKGROUND

• Zhou Q, Chen V, Shannon CP, Wei XS, Xiang X, Wang X, Wang ZH, Tebbutt SJ, Kollmann TR, Fish EN. Interferon-alpha2b Treatment for COVID-19. Front Immunol. 2020 May 15;11:1061. doi: 10.3389/fimmu.2020.01061. eCollection 2020.

  PMID: 32574262 BACKGROUND

• Li C, Luo F, Liu C, Xiong N, Xu Z, Zhang W, Yang M, Wang Y, Liu D, Yu C, Zeng J, Zhang L, Li D, Liu Y, Feng M, Liu R, Mei J, Deng S, Zeng Z, He Y, Liu H, Shi Z, Duan M, Kang D, Liao J, Li W, Liu L. Effect of a genetically engineered interferon-alpha versus traditional interferon-alpha in the treatment of moderate-to-severe COVID-19: a randomised clinical trial. Ann Med. 2021 Dec;53(1):391-401. doi: 10.1080/07853890.2021.1890329.

  PMID: 33620016 BACKGROUND

• Hung IF, Lung KC, Tso EY, Liu R, Chung TW, Chu MY, Ng YY, Lo J, Chan J, Tam AR, Shum HP, Chan V, Wu AK, Sin KM, Leung WS, Law WL, Lung DC, Sin S, Yeung P, Yip CC, Zhang RR, Fung AY, Yan EY, Leung KH, Ip JD, Chu AW, Chan WM, Ng AC, Lee R, Fung K, Yeung A, Wu TC, Chan JW, Yan WW, Chan WM, Chan JF, Lie AK, Tsang OT, Cheng VC, Que TL, Lau CS, Chan KH, To KK, Yuen KY. Triple combination of interferon beta-1b, lopinavir-ritonavir, and ribavirin in the treatment of patients admitted to hospital with COVID-19: an open-label, randomised, phase 2 trial. Lancet. 2020 May 30;395(10238):1695-1704. doi: 10.1016/S0140-6736(20)31042-4. Epub 2020 May 10.

  PMID: 32401715 BACKGROUND

• Monk PD, Marsden RJ, Tear VJ, Brookes J, Batten TN, Mankowski M, Gabbay FJ, Davies DE, Holgate ST, Ho LP, Clark T, Djukanovic R, Wilkinson TMA; Inhaled Interferon Beta COVID-19 Study Group. Safety and efficacy of inhaled nebulised interferon beta-1a (SNG001) for treatment of SARS-CoV-2 infection: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Respir Med. 2021 Feb;9(2):196-206. doi: 10.1016/S2213-2600(20)30511-7. Epub 2020 Nov 12.

  PMID: 33189161 BACKGROUND

• Mantlo E, Bukreyeva N, Maruyama J, Paessler S, Huang C. Antiviral activities of type I interferons to SARS-CoV-2 infection. Antiviral Res. 2020 Jul;179:104811. doi: 10.1016/j.antiviral.2020.104811. Epub 2020 Apr 29.

  PMID: 32360182 BACKGROUND

• Zhou Q, MacArthur MR, He X, Wei X, Zarin P, Hanna BS, Wang ZH, Xiang X, Fish EN. Interferon-alpha2b Treatment for COVID-19 Is Associated with Improvements in Lung Abnormalities. Viruses. 2020 Dec 30;13(1):44. doi: 10.3390/v13010044.

  PMID: 33396578 BACKGROUND

• Teraoka S, Sanaka T, Takahashi K, Toma H, Yamaguchi Y, Yagisawa T, Tanabe K, Sato H, Matsumura O, Nakajima I, et al. Stimulation of intrinsic prostacyclin synthesis and inhibition of thromboxane production to minimize cyclosporine nephrotoxicity. Transplant Proc. 1988 Jun;20(3 Suppl 3):638-45. No abstract available.

  PMID: 3291300 BACKGROUND

• Hoagland DA, Moller R, Uhl SA, Oishi K, Frere J, Golynker I, Horiuchi S, Panis M, Blanco-Melo D, Sachs D, Arkun K, Lim JK, tenOever BR. Leveraging the antiviral type I interferon system as a first line of defense against SARS-CoV-2 pathogenicity. Immunity. 2021 Mar 9;54(3):557-570.e5. doi: 10.1016/j.immuni.2021.01.017. Epub 2021 Jan 29.

  PMID: 33577760 BACKGROUND

• Kalil AC, Mehta AK, Patterson TF, Erdmann N, Gomez CA, Jain MK, Wolfe CR, Ruiz-Palacios GM, Kline S, Regalado Pineda J, Luetkemeyer AF, Harkins MS, Jackson PEH, Iovine NM, Tapson VF, Oh MD, Whitaker JA, Mularski RA, Paules CI, Ince D, Takasaki J, Sweeney DA, Sandkovsky U, Wyles DL, Hohmann E, Grimes KA, Grossberg R, Laguio-Vila M, Lambert AA, Lopez de Castilla D, Kim E, Larson L, Wan CR, Traenkner JJ, Ponce PO, Patterson JE, Goepfert PA, Sofarelli TA, Mocherla S, Ko ER, Ponce de Leon A, Doernberg SB, Atmar RL, Maves RC, Dangond F, Ferreira J, Green M, Makowski M, Bonnett T, Beresnev T, Ghazaryan V, Dempsey W, Nayak SU, Dodd L, Tomashek KM, Beigel JH; ACTT-3 study group members. Efficacy of interferon beta-1a plus remdesivir compared with remdesivir alone in hospitalised adults with COVID-19: a double-bind, randomised, placebo-controlled, phase 3 trial. Lancet Respir Med. 2021 Dec;9(12):1365-1376. doi: 10.1016/S2213-2600(21)00384-2. Epub 2021 Oct 18.

  PMID: 34672949 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 19, 2022
• Study Start: January 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)