E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Loss of smell after COVID-19 infection, persisting after 4 weeks |
Reukverlies na COVID-19 infecties, die na 4 weken blijft bestaan |
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E.1.1.1 | Medical condition in easily understood language |
Loss of smell after COVID-19 infection, persisting after 4 weeks |
Reukverlies na COVID-19 infecties, die na 4 weken blijft bestaan |
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E.1.1.2 | Therapeutic area | Diseases [C] - Ear, nose and throat diseases [C09] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine the efficacy of a short high-dose treatment of oral prednisolone for persistent loss of smell after COVID-19 infection. |
Bepalen van de effectiviteit van een stootkuur prednison voor blijvend reukverlies na COVID-19 infectie |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Recent COVID-19 infection (<3 months), confirmed with a positive test (PCR of antigen by GGD) • Persistent loss of smell after one month, objectified by TDI < 30.5 on Sniffin’ Stick test • Age 18 years or older, capable of giving informed consent • Good understanding of the dutch language |
• Recente COVID-19 infectie (<3 months), bewezen met positieve test (PCR of atigeen door GGD) • Blijvend reukverlies na 1 maand, geobjectiveerd met TDI < 30.5 op Sniffin’ Stick test • Leeftijd 18 jaar of ouder, capabel om informed consent (goedkeuring) te geven • Goed begrip van de nederlandse taal
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E.4 | Principal exclusion criteria |
• Pre-existing olfactory disorders • Chronic rhinitis or rhinosinusitis (with or without nasal polyps) • Corticosteroids (nasal, oral or intravenously) since positive test • Pregnancy • Contra-indications of steroid use (Insulin dependent diabetes mellitus, Ulcus pepticum)
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• Al bestaande reukstoornissen • Chronische rhinitis of rhinosinusitis (met/zonder poliepen) • Corticosteroiden (nasaal of systemisch) sinds positieve test • Zwanger • Contra-indicaties voor steroid gebruik (Insuline afhankelijke diabetes mellitus, ulcus pepticum) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Objective olfactory function bij means of Sniffin’Sticks, combining olfactory detection threshold (T), discrimination (D) and identification (I) ability into a composite TDI score (ranging from 1-48 points) that can be categorized into normosmia, hyposmia and anosmia . Clinical improvement is set at >5.5 points |
Reukverlies gemeten door Sniffin'Sticks, |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
• Objective gustatory function by means of Taste Strips, assessing recognition thresholds and identification for the four basis tastes (possible score range 0-16) . Clinical improvement is set at > 2 points. • Self-reported smell, taste, parosmia, trigeminal sensations by means of VAS ratings (parma). Recovery is considered an improvement of at least 80% of their pre-illness function • Quality of life, as measured by the Questionnaire of Olfactory disorders, an appropriate and valid measure of the impact of olfactory dysfunction on daily life
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• Functie van smaak gemeten met Taste Strips, • Zelfgerapporteerde functie van reuk, smaak, parosmie, trigeminus sensaties • Kwaliteit van leven (QOD- Questionnaire of Olfactory disorders)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |