SPRINTER: Study to Assess Efficacy and Safety of Inhaled Interferon-β Therapy for COVID-19

Sponsor
Synairgen Research Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT04732949
Collaborator
(none)
623
112
2
12.9
5.6
0.4

Study Details

Study Description

Brief Summary

The purpose of this Phase III study is to confirm that SNG001 can accelerate the recovery of hospitalised patients receiving oxygen with confirmed Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2). Safety and other efficacy endpoints will also be assessed.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

Eligible patients with SARS-CoV-2 infection confirmed by a positive virus test and who are hospitalised due to COVID-19 and require oxygen therapy, will be randomised in a 1:1 ratio to receive SNG001 two syringes or placebo two syringes. SNG001 or placebo will be administered via the Ultra nebuliser. Patients will receive a dose of SNG001 or placebo once a day for 14 days and will be followed up for up to 90 days after the first dose of study medication. Study data will be collected from patients daily, as per the study schedule.

Study Design

Study Type:
Interventional
Actual Enrollment :
623 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
The study will be patient and investigator-blinded with regard to SNG001 or placebo but not the dose.
Primary Purpose:
Treatment
Official Title:
A Randomised, Double-blind, Placebo-controlled, Phase III Trial to Determine the Efficacy and Safety of Inhaled SNG001 for the Treatment of Patients Hospitalised Due to Moderate COVID-19
Actual Study Start Date :
Jan 12, 2021
Actual Primary Completion Date :
Feb 10, 2022
Actual Study Completion Date :
Feb 10, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: SNG001

SNG001 via inhalation using Ultra device, once a day for 14 days

Drug: SNG001
SNG001 nebuliser solution, 2 syringes each containing 0.65 mL once a day

Placebo Comparator: Placebo

Placebo via inhalation using Ultra device, once a day for 14 days

Drug: Placebo
Placebo nebuliser solution, 2 syringes each containing 0.65 mL solution containing excipients of the SNG001 solution

Outcome Measures

Primary Outcome Measures

  1. Time to hospital discharge [Day 1 until Day 28]

    To evaluate the time to hospital discharge in patients with moderate COVID-19 after administration of SNG001 compared to placebo. Here, hospital discharge can be considered when World Health Organization (WHO) Ordinal Scale for Clinical Improvement (OSCI) score of 2 (limitation of activities) or below, with no rebound at subsequent assessments. Improvement in clinical status is based on the 9-point OSCI score. The score ranges from 0 to 8, where lower score of 0 represents no clinical or virological evidence of infection and higher score of 8 represents death.

  2. Time to recovery [Day 1 until Day 28]

    To evaluate recovery in patients with moderate COVID-19 after administration of SNG001 compared to placebo by time to recovery. Here, recovery is defined as the WHO OSCI score of 1 (no limitation of activities) or below, with no rebound at subsequent assessments. Improvement in clinical status is based on the 9-point OSCI score. The score ranges from 0 to 8, where lower score of 0 represents no clinical or virological evidence of infection and higher score of 8 represents death.

Secondary Outcome Measures

  1. Progression to severe disease or death [Day 1 until Day 35 or randomisation date if the patient is not dosed]

    To evaluate the efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by assessing progression to severe disease or death. Progression to severe disease or death is defined by the WHO OSCI score of 5 (non-invasive ventilation or high-flow oxygen) or above within 35 days of first dose. Improvement in clinical status is based on the 9-point OSCI score. The score ranges from 0 to 8, where lower score of 0 represents no clinical or virological evidence of infection and higher score of 8 represents death. This is a key secondary endpoint.

  2. Progression to intubation or death [Day 1 until Day 35 or randomisation date if the patient is not dosed]

    To evaluate the efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by assessing progression to intubation or death. Here, progression to intubation or death defined by the WHO OSCI score of 6 (intubation and mechanical ventilation) or above within 35 days of first dose. Improvement in clinical status is based on the 9-point OSCI score. The score ranges from 0 to 8, where lower score of 0 represents no clinical or virological evidence of infection and higher score of 8 represents death. This is a key secondary endpoint.

  3. Death within 35 days of first dose [Day 1 until Day 35 or randomisation date if the patient is not dosed]

    Death within 35 days of first dose, defined by the WHO OSCI score of 8 (death). This is a key secondary endpoint.

  4. Recovery as analysed at Days 7, 14, 21 and 28 [Days 7, 14, 21 and 28]

    To evaluate the efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by assessing recovery. Recovery is defined as the WHO OSCI score of 1 (no limitation of activities) or below, with no rebound at subsequent assessments. Improvement in clinical status is based on the 9-point OSCI score. The score ranges from 0 to 8, where lower score of 0 represents no clinical or virological evidence of infection and higher score of 8 represents death.

  5. Hospital discharge by days 7, 14, 21 and 28 [Days 7, 14, 21 and 28]

    To evaluate the efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by assessing hospital discharge on given days.

  6. Number of patients with improvement based on entire WHO OSCI score by days 7, 14, 21 and 28 [Days 7, 14, 21 and 28]

    To evaluate the efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by assessing improvement across the entire WHO OSCI. Improvement in clinical status is based on the 9-point OSCI score. The score ranges from 0 to 8, where lower score of 0 represents no clinical or virological evidence of infection and higher score of 8 represents death.Higher scores indicated worse outcome.

  7. Change in total score according to the breathlessness, cough and sputum scale (BCSS) and disaggregated breathlessness and cough scores [Day 1 until Day 28 and then on Day 60 and Day 90]

    To evaluate the efficacy of SNG001 compared with placebo in patients with moderate COVID-19 by assessing changes in daily breathlessness, cough and sputum scores on a scale of 0 (no symptoms) up to 4 (severe symptoms)

  8. Changes in National Early Warning Score (NEWS2) during the hospitalisation period [Day 1 until Day 28]

    To evaluate the efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by assessing changes in NEWS2 during hospitalisation period. The NEWS2 is a tool which is used in detection and response to clinical deterioration in adult patients and is a key element of patient safety and improving patient outcomes. Six physiological parameters such as: respiration rate, oxygen saturation, any supplementary oxygen, temperature, systolic blood pressure, heart rate, and alert, voice, pain, and unresponsive form the basis of the scoring system.

  9. Number of patients with presence of COVID-19 symptoms based on daily assessment [Day 1 until Day 28]

    To evaluate the efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by daily assessment of COVID-19 symptoms. The presence of COVID-19 symptoms will be assessed. Individual symptoms related to COVID-19/SARS-CoV-2 infection such as fever, breathlessness, and fatigue will be assessed.

  10. Number of patients with limitations of usual activities based on daily assessment [Day 1 until Day 28]

    To evaluate the efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by daily assessment of limitation of usual activities. The patients with limitations of usual activities will be patients who are unable to do usual activities (work, study, housework, family or leisure activities).

  11. Quality of life measured using EuroQol 5-dimension 5-level (EQ-5D-5L) [Day 0, Day 7, Day 15, Day 28, Day 60 and Day 90; Day 1 until Day 35 (mobility, self care and usual activities dimension)]

    To evaluate the efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by using EQ-5D-5L. The EQ-5D-5L provides a simple descriptive profile and a single index value for health status. The EQ-5D-5L self-rated questionnaire includes a visual analogue scale, which records the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher health-related quality of life. It also includes the EQ-5D-5L descriptive system, which comprises 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension. Here, 100 means the best health and 0 means the worst health. The mobility, self-care and usual activities dimensions of the questionnaire will be assessed daily from Day 1 to Day 35.

  12. Number of patients with long-COVID-19 symptoms based on General Anxiety Disorder 7 Questionnaire (GAD-7) [Day 15, Day 28, Day 60 and Day 90]

    To evaluate the efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by assessing long-COVID-19 symptoms. Assessment of long-COVID-19 symptoms based on GAD-7. Scoring will be done based on how often patients have been bothered by the problems as: feeling nervous, anxious or on edge; not being able to stop or control worrying; worrying too much about different things; trouble relaxing; being so restless that it's hard to sit still; becoming easily annoyed or irritable, and feeling afraid at if something awful might happen. The scores ranges from 0 to 4, where 0 represents not at all bothered by any of the above problems and 4 indicates nearly bothered every day by any of the above problems. Higher scores indicated worse outcome.

  13. Number of patients with long-COVID-19 symptoms based on FACIT Fatigue Scale (Version 4) [Day 15, Day 28, Day 60 and Day 90]

    Assessment of long-COVID-19 symptoms based on FACIT Fatigue Scale (Version 4). The FACIT Fatigue Scale (Version 4) will include statements for patients such as: I feel fatigued; I feel weak all over; I feel listless ("washed out"); I feel tired; I have trouble starting things because I am tired; I have trouble finishing things because I am tired; I have energy; I am able to do my usual activities; I need to sleep during the day; I am too tired to eat; I need help doing my usual activities; and I am frustrated by being too tired to do the things I want to do. Based on responses on above statements, scoring will be done and scores ranges from 0 to 4, where 0 represents not at all bothered by any of the above problems and 4 indicates very much bothered every day by any of the above problems. Higher scores indicated worse outcome.

  14. Number of patients with long-COVID-19 symptoms based on Patient Health Questionnaire-9 (PHQ-9) [Day 15, Day 28, Day 60 and Day 90]

    Assessment of long-COVID-19 symptoms based on PHQ-9. Patient health questionnaire included: little interest or pleasure in doing things; feeling down, depressed, or hopeless; trouble falling asleep or staying asleep, or sleeping too much; feeling tired or having little energy; poor appetite or overeating; feeling bad about yourself - or that you are a failure of have let yourself or your family down; trouble concentrating on things, such as reading the newspaper or watching television; moving or speaking so slowly that other people could have noticed or so fidgety or restless that you have been moving a lot more than usual; and thoughts that you would be better off dead; or thoughts of hurting yourself in some way. Based on responses on questionnaire, scoring will be done and scores ranges from 0 to 4, where 0 represents not at all bothered by any of the above problems and 4 indicates nearly bothered every day by any of the above problems. Higher scores indicated worse outcome.

  15. Number of patients with long-COVID-19 symptoms based on Brief Pain Inventory (Short Form) [Day 15, Day 28, Day 60 and Day 90]

    Assessment of long-COVID-19 symptoms based on brief pain inventory form. Form include questionnaires as: did patient had pain other than everyday kinds of pain on assessment day; body part where patient feels pain; rate patient's pain: at worst, at least in the last 24 hours, at average, and at right now, by giving scores from 0 to 10, where 0 indicates no pain and 10 represents pain as bad as one can imagine; treatments or medications receiving for pain by patients; rate how much relief have pain treatments have provided from 0% to 100%, where 0% represents no relief and 100% indicates complete relief; assessment of interference of pain in following patients activity: general activity; mood; walking ability; normal work; relations with other people; sleep; enjoyment of life, and assessment will be done by scoring and scores ranges from 0 to 10, where 0 represents pain does not interfere and 10 indicates pain completely interferes in above activity.

  16. Number of patients with adverse events (AEs) and serious adverse events (SAEs) [Day 1 until Day 28]

    To assess the general safety and tolerability of SNG001 compared to placebo when administered to patients with moderate COVID-19 by assessing number of patients with AEs.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Admitted to hospital due to the severity of their COVID-19

  • Positive virus test for SARS-CoV-2 using a validated molecular assay or antigen assay. Patients who had a positive virus test for SARS-CoV-2 prior to hospitalisation will be randomised no later than 48 hours after hospital admission. If the virus test is performed more than 96 hours prior to hospitalisation, the test will have to be repeated in the hospital prior to randomisation. Only patients whose repeated virus test is positive will be randomised, no later than 48 hours after confirmation of SARS-CoV-2 infection. Patients who had their first positive virus test for SARS-CoV-2 after hospitalisation will be randomised no later than 48 hours after confirmation of SARS-CoV-2 infection

  • Require oxygen therapy via nasal prongs or mask (WHO OSCI score of 4)

  • Provided informed consent

  • Female patients must be ≥1 year post-menopausal, surgically sterile, or using a protocol defined highly effective method of contraception

  • Women of child bearing potential should have been stable on their chosen method of birth control for a minimum of 3 months before entering the trial and should continue with birth control for 1 month after the last dose of inhaled interferon-β (IFN-β1a)/matching placebo. In addition to the highly effective method of contraception (except for the practice of total sexual abstinence), a condom (in United Kingdom with spermicides) should be used by the male partner for sexual intercourse from randomisation (Visit 2) and for 1 month after the last dose of inhaled IFN-β1a/matching placebo to prevent pregnancy

  • Women not of childbearing potential are defined as women who are either permanently sterilised (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered post-menopausal if they have been amenorrhoeic for 12 months prior to the planned date of randomisation without an alternative medical cause. The following age specific requirements apply: women <50 years old will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatment and if follicle stimulating hormone (FSH) levels are in the postmenopausal range; women ≥50 years old will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatment. If, in the setting of the pandemic, the use of an acceptable birth control method is not possible, the decision to enrol a woman of childbearing potential should be based on the benefit-risk for the patient, which should be discussed with the patient at the time of the informed consent.

Exclusion Criteria:
  • Evidence of ongoing SARS-CoV-2 infection for more than 3 weeks, confirmed by a validated molecular assay or validated antigen assay

  • Non-invasive ventilation continuous positive airway pressure/bilevel positive airway pressure (CPAP/BiPAP) or high-flow nasal oxygen therapy (WHO OSCI score of 5)

  • Endotracheal intubation and invasive mechanical ventilation (WHO OSCI score of ≥6) or admission to intensive care

  • Previous SARS-CoV-2 infection confirmed by a validated molecular assay or validated antigen assay

  • Any condition, including findings in the patients' medical history or in the pre-randomisation study assessments that in the opinion of the Investigator, constitute a risk or a contraindication for the participation of the patient into the study or that could interfere with the study objectives, conduct or evaluation

  • Participation in previous clinical trials of SNG001

  • Current or previous participation in another clinical trial where the patient has received a dose of an Investigational Medicinal Product containing small molecules within 30 days or 5 half-lives (whichever is longer) prior to entry into this study or containing biologicals within 3 months prior to entry into this study

  • Inability to use a nebuliser with a mouthpiece

  • Inability to comply with the requirements for storage conditions of study medication in the home setting

  • History of hypersensitivity to natural or recombinant IFN-β or to any of the excipients in the drug preparation

  • Females who are breast-feeding, lactating, pregnant or intending to become pregnant.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Arizona Medi Tucson Arizona United States 85724
2 Professional Health Care of Pi Saint Petersburg Florida United States 33713
3 Henry Ford Health System Detroit Michigan United States 48202
4 University of Minnesota Minneapolis Minnesota United States 55455
5 Icahn School of Medicine at Mo New York New York United States 10029-6500
6 PharmaTex Research, LLC Amarillo Texas United States 79109
7 Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich Ciudad Autónoma De Buenos Air Buenos Aires Argentina C1426BOR
8 Hospital Universitario Austral Buenos Aires Argentina B1629ODT
9 Hospital Papa Francisco - Hosp Salta Argentina 4400
10 AZ Groeninge Kortrijk West-Vlaanderen Belgium 8500
11 UZ Brussel - Campus Jette - In Brussel Belgium 1090
12 Centre Hospitalier Universitai Bruxelles Belgium 1020
13 CHR de la Citadelle - Site Cit Liège Belgium 4000
14 CHU de Liège - Domaine Univers Liège Belgium 4000
15 Instituto Mederi de Pesquisa e Saúde Passo Fundo Rio Grande Do Sul Brazil 99010-120
16 Hospital Moinhos de Vento Porto Alegre Rio Grande Do Sul Brazil 90035-001
17 Clínica SUPERA Chapeco Santa Catarina Brazil 89801-355
18 Sociedade Literaria e Caritativa Santo Agostinho Criciúma Santa Catarina Brazil 88801-508
19 Instituto de Pesquisa Clínica Campinas São Paulo Brazil 13060-080
20 Fundacao Faculdade Regional de São José do Rio Preto São Paulo Brazil 15090-000
21 Clinica de la Mujer Bogotá Cundinamarca Colombia
22 FOSCAL Bucaramanga Santander Colombia 681004
23 Clinica de la Costa Barranquilla Colombia
24 CHU De Nantes - Infectious Dis Nantes Loire-Atlantique France 44093
25 CHU d'Angers Angers Pays-de-la-Loire France 49933
26 CHU de Grenoble - Hôpital Albe La Tronche France 38700
27 CHU Saint Antoine - Infectious Paris France 75012
28 Hôpital Européen Georges-Pompi Paris France 75015
29 Hopital Bichat - Infectious Di Paris France 75018
30 RoMed Medical Center Rosenheim Rosenheim Bayern Germany 83022
31 Universitätsklinikum Mannheim Mannheim Germany 68167
32 Krankenhaus Bethanien gGmbH Solingen Germany 42699
33 King George Hospital Visakhapatnam Andhra Pradesh India 530002
34 Unity Hospital Surat Gujarat India 395010
35 Rhythm Heart Institute Vadodara Gujarat India 390022
36 Bangalore Medical College and Research Institute Bangalore Karnataka India 560002
37 MS Ramaiah Medical College and Hospital Bangalore Karnataka India 560054
38 Oriion Citicare Super Speciality Hospital - Intern Aurangabad Maharashtra India 431005
39 Fortis Hospital Mulund - Inter Mumbai Maharashtra India 400078
40 Government Medical College Nag Nagpur Maharashtra India 440003
41 Suyog Hospital Nashik Maharashtra India 422003
42 Vishwa Raj Hospital Pune Maharashtra India 412201
43 Acharya Vinoba Bhave Rural Hos Wardha Maharashtra India 442004
44 Post Graduate Institute of Medical Education & Research, Chandigarh Chandigarh Punjab India 160012
45 Saveetha Medical College & Hospital Chennai India 602105
46 Assuta Ashdod University Hospi Ashdod HaDarom Israel 7747629
47 Rambam Health Care Campus Haifa Israel 3109601
48 Ziv Medical Center Safed Israel 131001
49 The Chaim Sheba Medical Center Tel Hashomer Israel 5265601
50 Sourasky Tel Aviv Medical Cent Tel-Aviv Israel 6423906
51 Assaf Harofeh Medical Center Zerifin Israel 7030000
52 Azienda Socio Sanitaria Territ Monza Lombardia Italy 20900
53 Azienda Ospedaliera Nazionale Alessandria Italy 15100
54 PO A.Manzoni di Lecco, ASST Le Lecco Italy 23900
55 Ospedale Luigi Sacco, AO-PU Milano Italy 20157
56 Azienda Ospedaliera Ospedale N Milano Italy 20162
57 AOU Federico II - Malattie Inf Napoli Italy 80131
58 IRCCS Policlinico San Matteo Pavia Italy 27100
59 AOU Pisana Pisa Italy 54124
60 Città della Salute e della Scienza Torino Italy 10139
61 Fundación Santos y de la Garza Evia, I.B.P Monterrey Nuevo León Mexico 64710
62 Hospital General de Culiacan D Culiacan Sinaloa Mexico 80230
63 EME RED Hospitalaria - COVID-1 Merida Yucatán Mexico 97000
64 Hospital General Regional O´Hu Merida Yucatán Mexico 97000
65 Clínica Sociedad Española de Beneficencia Veracruz Mexico 91700
66 Ziekenhuis St Jansdal Harderwijk Gelderland Netherlands 3844 DG
67 Gelre Ziekenhuis Zutphen Zutphen Gelderland Netherlands 7207 AE
68 Isala Klinieken Zwolle Overijssel Netherlands 8025 AB
69 Hospital Garcia da Orta, E.P.E Almada Lisboa Portugal 2805-267
70 C.H. de Vila Nova de Gaia/Espi Vila Nova de Gaia Porto Portugal 4434-502
71 Hospital de Braga Braga Portugal 4710-243
72 Hospital da Senhora de Oliveir Guimarães Portugal 4835-044
73 Centro Hospitalar de Entre Dou Rodrigues Portugal 4520-211
74 Sp. Clinic Boli Infectioase si Timisoara Timis Romania 300310
75 Spitalul Universitar de Urgent Bucuresti Romania 011461
76 Sp. Cl. de Boli Infectioase si Bucuresti Romania 030303
77 Spitalul Clinic de Boli Infect Craiova Romania 200446
78 Clinical Center Nis Nis Nišavski Okrug Serbia 18000
79 Clinical Center of Vojvodina Novi Sad Vojvodina Serbia 21000
80 University Clinical Center of Serbia Belgrade Serbia 11000
81 Clinical Center Kragujevac, Cl Kragujevac Serbia 34000
82 The Institute for Pulmonary Di Sremska Kamenica Serbia 21204
83 CHU A Coruña Madrid A Coruña Spain 15006
84 Hospital Universitario Son Esp Palma De Mallorca Baleares Spain 7120
85 Hospital Universitario Mutua d Terrassa Barcelona Spain 08221
86 Hospital Universitario de Puer Puerto Real Cádiz Spain 11510
87 Hospital Santa Creu i Sant Pau Barcelona Spain 08041
88 Hospital Universitario Infanta Madrid Spain 28031
89 Hospital Universitario Ramón y Madrid Spain 28034
90 H.Clinico San Carlos Madrid Spain 28040
91 Hospital Universitario de Sala Salamanca Spain 37007
92 H U Nuesta Señora de Valme - I Sevilla Spain
93 Wexham Park Hospital Slough Bracknell Forest United Kingdom SL2 4HL
94 Hull Royal Infirmary Hull, North Humberside East Riding Of Yorkshire United Kingdom HU3 2RW
95 Newcastle University - Institute of Cellular Medicine (ICM) Newcastle England United Kingdom NE2 4HH
96 Southampton General Hospital Southampton Hampshire United Kingdom SO16 6YD
97 Churchill Hospital Headington Oxfordshire United Kingdom OX3 9DU
98 Frimley Park Hospital Frimley Surrey United Kingdom GU16 7UJ
99 Queen Elizabeth Hospital Birmingham Birmingham United Kingdom B15 2TH
100 The Royal Bournemouth & Christ Bournemouth United Kingdom BH7 7DP
101 University Hospital of North D Durham United Kingdom DH1 5TW
102 Royal Devon & Exeter Hospital Exeter United Kingdom EX25DW
103 Glasgow Royal Infirmary Glasgow United Kingdom G4 0SF
104 Glenfield Hospital Leicester United Kingdom LE3 9QP
105 University Hospital Lewisham London United Kingdom SE13 6LH
106 Guy's Hospital London United Kingdom SE19RT
107 North Manchester General Hospi Manchester United Kingdom M8 5RB
108 The James Cook University Hosp Middlesbrough United Kingdom TS4 3BW
109 Nottingham University Hospital Nottingham United Kingdom NG51PB
110 Plymouth Hospitals NHS Trust Plymouth United Kingdom PL6 8DH
111 Morriston Hospital Swansea NHS Swansea United Kingdom SA6 6NL
112 University Hospital of Wales Swansea United Kingdom SA6 6NL

Sponsors and Collaborators

  • Synairgen Research Ltd.

Investigators

  • Principal Investigator: Professor Tom Wilkinson, University Hospital Southampton NHS Foundation Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Synairgen Research Ltd.
ClinicalTrials.gov Identifier:
NCT04732949
Other Study ID Numbers:
  • SG018
  • 2020-004743-83
First Posted:
Feb 1, 2021
Last Update Posted:
Mar 17, 2022
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Synairgen Research Ltd.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 17, 2022