COVID-19Phase 1/2NCT05381363

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

A Phase 1/2 study testing Inhaled Interferon α2b in people with COVID-19 and Children, run by Children's Hospital of Fudan University at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 12 months to 18 years
Conditions the study is for: COVID-19, Children
What is being tested?: Inhaled Interferon α2b
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteChina
Study dates: 1 Jan 2022to 1 Jan 2023
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 months to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Children Hospital of Fudan University
Shanghai, 201102

Other trials in China

About this study

Read the detailed description

This project aims to improve the treatment of pediatric patients infected with COVID-19. Interferon has antiviral property and is approved to be used in treatment in hepatitis B and hepatitis C virus infections. Interferon α2b, β1a and lambda are under evaluation in clinical trials for the treatment of COVID-19 in adult. As upper respiratory tract infection is the dominant characteristic of most infected children, topical treatment may be a better way to increase the safety and efficacy than oral or intravenous medication. This study aims to obtain essential data regarding the efficacy and safety of inhaled Interferon α2b in children with mild to moderate COVID-19 infection. Subjects will be enrolled with COVID-19 infection diagnoses by ORF1ab gene and N gene PCR test. Standard evaluation process will be applied to identify mild and moderate patients. Patients will be randomized into interferon group and non-interferon group. Patients in interferon group will receive inhalation treatment within the first five days since the symptom onset. Patients will receive daily PCR test. Cycle threshold (Ct) values over 35 is considered as de-isolation criterion. Days requiring isolation (from symptom onset to de-isolation time point) is the major index to evaluate efficacy. Clinical manifestations and test results from clinical recording system will be collected to evaluate the side effects.

Conditions: COVID-19, Children
Being tested: Inhaled Interferon α2b, Standard of Care
Keywords: interferon α2b, Inhaled treatment
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Inhaled Interferon α2bDrug
Also called IFN α2b
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
Standard of CareOther
Also called SC
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

Study groups in NCT05381363
Study group	Role	What they receive
Intervention: Inhaled Interferon α2b	Experimental	Inhaled Interferon α2b (10U/ml) Receives: Drug: Inhaled Interferon α2b
Intervention: Standard of Care	Other	Standard of care treatment will be provided according to management guideline. Receives: Other: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (9)

Duration of fever
Efficacy of inhaled Interferon α2b by assessment of the duration of fever.
Measured: from fever onset to free from fever (about 2-3 weeks)
Proportions of COVID-19 symptoms
Efficacy of inhaled Interferon α2b by assessment of the duration of COVID-10 symptoms including fever, cough, sore throat, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell.
Measured: from symptom onset to point of de-isolation (about 2-3 weeks)
Blood test
This test including the count of leukocytes, neutrophils, lymphocytes, platelets, and hemoglobin in plasma. Inflammatory Biomarker.
Measured: Every 3 days (from the date of hospitalization to point of de-isolation)
C-reactive protein (CRP)
Inflammatory Biomarker
Measured: Every 3 days (from the date of hospitalization to point of de-isolation)
Interleukin 6 (IL-6)
Inflammatory Biomarker
Measured: Every 3 days (from the date of hospitalization to point of de-isolation)
Chest imaging findings
Imaging evaluation methods
Measured: once on admission
Number of Adverse Events (Abnormal Appearance)
This is a composition of obviously severe flu-like symptoms, including nausea, fatigue, weight loss.
Measured: From Day 1 to time point of de-isolation post-dose in each period (about 2-3 weeks)
Number of Adverse Events (Abnormal Hematology)
Safety of inhaled Interferon α2b by assessment of safety laboratory tests.
Measured: From Day 1 to time point of de-isolation post-dose in each period (about 2-3 weeks)
Number of Adverse Events (Abnormal Clinical Chemistry)
Safety of inhaled Interferon α2b by assessment of safety laboratory tests.
Measured: From Day 1 to time point of de-isolation post-dose in each period (about 2-3 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20221 Jan 2023

First posted19 May 2022
Study start1 Jan 2022
Primary completion1 Jan 2023
Study completion1 Jan 2023

Why it stopped: The study was concluded as planned upon reaching its predetermined endpoint, which included the completion of data collection and achievement of the necessary sample size for statistical significance.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies of the same condition, open and under way.
More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05381363
Sponsor's protocol ID: CHFudanU_COVID19-1
Status last verified: Dec 2023
First submitted: 18 May 2022
Last updated: 29 Dec 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 33980688
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.
PubMed 32788708
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.
PubMed 32418715
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.
PubMed 32574262
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.
PubMed 33620016
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.
PubMed 32401715
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.
PubMed 33189161
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.
PubMed 32360182
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.
PubMed 33396578
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.
PubMed 3291300
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.
PubMed 33577760
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.
PubMed 34672949

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Inhaled Interferon α2b Treatment in Mild-to-moderate COVID-19 Infected Children
ClinicalTrials.gov ID: NCT05381363
Acronym / sponsor ID: CHFudanU_COVID19-1
Conditions: COVID-19, Children
Keywords: interferon α2b, Inhaled treatment
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was concluded as planned upon reaching its predetermined endpoint, which included the completion of data collection and achievement of the necessary sample size for statistical significance.
Enrolment: 24 participants (actual)
Lead sponsor: Children's Hospital of Fudan UniversityUniversity, hospital or other
Collaborators: RenJi Hospital, Shanghai Children's Hospital, Shanghai Children's Medical Center, affiliated to Shanghai Jiao Tong University School of Medicine
Study start: 1 Jan 2022 (actual)
Primary completion: 1 Jan 2023 (actual)
Study completion: 1 Jan 2023 (actual)
First posted: 19 May 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intervention: Inhaled Interferon α2b	Experimental	Drug: Inhaled Interferon α2bInhaled Interferon α2b (10U/ml)
Intervention: Standard of Care	Other	Other: Standard of CareStandard of care treatment will be provided according to management guideline.

Who may qualify

Ages: 12 months to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Inhaled Interferon α2bAlso: IFN α2bDrug: 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	Drug	Intervention: Inhaled Interferon α2b
Standard of CareAlso: SCStandard 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	Other	Intervention: Standard of Care

Primary outcome

Days requiring isolation (DRI)
Time frame: from symptom onset to point of de-isolation (about 2-3 weeks)
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.

9 secondary outcomes

Duration of fever
Time frame: from fever onset to free from fever (about 2-3 weeks)
Proportions of COVID-19 symptoms
Time frame: from symptom onset to point of de-isolation (about 2-3 weeks)
Blood test
Time frame: Every 3 days (from the date of hospitalization to point of de-isolation)
C-reactive protein (CRP)
Time frame: Every 3 days (from the date of hospitalization to point of de-isolation)
Interleukin 6 (IL-6)
Time frame: Every 3 days (from the date of hospitalization to point of de-isolation)
Chest imaging findings
Time frame: once on admission
Number of Adverse Events (Abnormal Appearance)
Time frame: From Day 1 to time point of de-isolation post-dose in each period (about 2-3 weeks)
Number of Adverse Events (Abnormal Hematology)
Time frame: From Day 1 to time point of de-isolation post-dose in each period (about 2-3 weeks)
Number of Adverse Events (Abnormal Clinical Chemistry)
Time frame: From Day 1 to time point of de-isolation post-dose in each period (about 2-3 weeks)

Results and safety

The study was stopped early (reason given: The study was concluded as planned upon reaching its predetermined endpoint, which included the completion of data collection and achievement of the necessary sample size for statistical significance.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
Background: PubMed 33980688Ramasamy 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.
Background: PubMed 32788708Lee 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.
Background: PubMed 32418715Nile 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.
Background: PubMed 32574262Zhou 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.
Background: PubMed 33620016Li 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.
Background: PubMed 32401715Hung 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.
Background: PubMed 33189161Monk 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.
Background: PubMed 32360182Mantlo 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.
Background: PubMed 33396578Zhou 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.
Background: PubMed 3291300Teraoka 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.
Background: PubMed 33577760Hoagland 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.
Background: PubMed 34672949Kalil 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Inhaled Interferon α2b in people with COVID-19 and Children, run by Children's Hospital of Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Days requiring isolation (DRI) (time frame: from symptom onset to point of de-isolation (about 2-3 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05381363, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2023.