E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
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 |
Can inhalation treatment with ciclesonide decrease the number of days with oxygen therapy for hospitalized patients with Covid-19? |
Minskar inhalationsbehandling med ciklesonid antalet dygn med syrgasbehandling för sjukhusvårdade patienter med covid-19? |
|
E.2.2 | Secondary objectives of the trial |
- Can inhalation treatment with ciclesonide decrease the risk for intubation and/or death within 30 days?
- Can inhalation treatment with ciclesonide decrease respiratory symptoms after 1 month and 5-7 months? |
- Minskar inhalationsbehandling med ciklesonid risken för intubation och/eller död inom 30 dygn?
- Minskar inhalationsbehandling med ciklesonid respiratoriska besvär efter 1 månad respektive 5-7 månader? |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients 18 years or older, who have signed informed consent for participation in the study
2. Hospitalized patients who have received oxygen therapy for maximum 48 hours
3. Verified Covid-19: Positive test for Sars-Cov-2-RNA or a positive Sars-Cov2 antigen test from upper respiratory tract
4. Receives oxygen therapy
5. Negative pregnancy test (female subjects of childbearing potential)
6. Female subjects of childbearing potential must use contraceptive method categorized as "highly effective" according to CTFG during study treatment and 7 days after finished treatment. |
1. Patienter 18 år eller äldre, som har givit sitt skriftliga samtycke till att delta i studien.
2. Vårdas inneliggande på sjukhus och har haft behandling med syrgas i maximalt 48 timmar
3. Verifierad Covid-19: Positivt prov för Sars-Cov2-RNA eller ett positivt Sars-Cov2 antigentest från övre luftvägar, det vill säga nasofarynx eller sputa.
4. Erhåller syrgasbehandling.
5. Negativt graviditetsprov (kvinnliga forskningspersoner i fertil ålder)
6. Villig att utöva antikonception kategoriserat som ”mycket effektiva” enligt Clinical Trial Facilitation Group under pågående studiebehandling + 7 dygn. (kvinnliga forskningspersoner i fertil ålder) |
|
E.4 | Principal exclusion criteria |
1. Pregnancy, breast feeding or plans for pregnancy.
2. Known intolerance or hypersensitivity to ciclesonide or any of the other components of the study drug
3. Concomitant treatment with cortisone, ketoconazole, itraconazole, ritonavir or nelfinavir
4. Therapy with >8 L oxygen/min or therapy with >50 % oxygen through high flow nasal cannula
5. Ongoing palliative treatment or life expectancy less than 72 hours
6. Expected admission to ICU within 48 hours
7. Active or inactive tuberculosis
8. Severe liver disease (Child-Pugh C)
9. Pulmonary arterial hypertension (PAH) or fibrosis
10. Mental incapacity, unwillingness or language difficulties
11. Participation in another clinical trial within 30 days before inclusion in the present study. Earlier participation in the present study. |
1. Graviditet, amning eller planerad graviditet.
2. Överkänslighet mot ciklesonid eller mot något hjälpämne.
3. Samtidig medicinering med kortison, ketokonazol, itrakonazol, ritonavir eller nelfinavir.
4. Behandling med >8 l syrgas /min eller tillförsel av >50 % syrgas med nasal högflödesgrimma
5. Pågående palliativt inriktad vård eller förväntad överlevnad mindre än 72 timmar.
6. Förväntad inskrivning på intensivvårdsavdelning inom 48 timmar.
7. Aktiv eller inaktiv lungtuberkulos.
8. Grav leversvikt (Child-Pugh C)
9. Diagnosticerad med pulmonell arteriell hypertension (PAH) eller fibros.
10. Mental oförmåga, ovilja eller språksvårigheter som medför svårighet att förstå innebörden av att delta i studien.
11. Deltar eller nyligen deltagit eller i en klinisk läkemedelsprövning den senaste 30 dagarna. Tidigare deltagande i denna studie. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Number of days with oxygen therapy (30 days follow up after study inclusion). Terminated oxygen therapy is defined as discharge from hospital, without subsequent rehospitalization with oxygen therapy within 2 days, or at least 2 days without oxygen therapy for hospitalized patients. |
Antal dygn med syrgasbehandling (30 dagars uppföljning efter studieinklusion). Avslutad syrgasbehandling definieras som utskrivning till hemmet utan en återinskrivning med syrgasbehandling inom 2 dygn eller minst 2 dygn utan syrgasbehandling vid inneliggande vård. Det primära utfallsmåttet representerar ”klinisk förbättring” enligt en nominell skala som använts i tidigare studier på behandling av Covid-19 och som rekommenderas av WHO. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
30 days after inclusion |
30 dagar efter inklusion |
|
E.5.2 | Secondary end point(s) |
1. Rate of, and time to need for invasive mechanical ventilation and/or death
2. Rate of, and time to death
3. Rate of, and time to invasive mechanical ventilation
4. Need for intensive care (yes/no and time from inclusion to ICU admission)
5. Rate of, and time to discharge from hospital
6. Number of subjects with residual respiratory symptoms measured with the Modified Medical Research Council Dyspnea scale |
1. Tid till, respektive andel patienter med behov av respiratorvård och/eller dör inom 30 dygn från studieinklusion
2. Tid till, respektive andel patienter som dör inom 30 dygn från studieinklusion
3. Tid till, respektive andel patienter som erhåller respiratorvård inom 30 dygn från studieinklusion
4. Behov av intensivvård (ja/nej samt tid till IVA-vård från inklusion)
5. Andel som skrivs ut från sjukhus till hemmet eller boende samt tid till utskrivning
6. Andel patienter med kvarvarande respiratoriska besvär mätt med Modified Medical Research Council Dyspnea scale |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. 30 days after inclusion
2. 30 days after inclusion
3. 30 days after inclusion
4. 30 days after inclusion
5. 30 days after inclusion
6. 1 month and 5-7 months after inclusion |
1. 30 dagar efter inklusion
2. 30 dagar efter inklusion
3. 30 dagar efter inklusion
4. 30 dagar efter inklusion
5. 30 dagar efter inklusion
6. 1 månad och 5-7 månader efter inklusion |
|
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 | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Standardbehandling |
Standard treatment |
|
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 9 |
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 | No |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |