E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
SARS-CoV-2 infection causing COVID-19 disease |
SARS-CoV-2 infectie die COVID-19 ziekte veroorzaakt |
|
E.1.1.1 | Medical condition in easily understood language |
Coronavirus infection |
Coronavirus infectie |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10022902 |
E.1.2 | Term | Iodide intoxication |
E.1.2 | System Organ Class | 100000004863 |
|
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 find out if iodine has a beneficial effect in the treatment of patiënts with COVID-19 disease
|
om uit te zoeken of jodium een gunstig effect heeft bij de behandeling van patiënten met COVID-19 ziekte |
|
E.2.2 | Secondary objectives of the trial |
not applicable |
niet van toepassing |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All patients 18 years of age and older, admitted to our hospital and who are tested positive for SARS-CoV-2 infection, are recruited for the study.
Patiënts must be legally competent and able to read the patient's information letter and sign the informed consent form. |
Alle patiënten van 18 jaar en ouder, die worden opgenomen in ons ziekenhuis en positief getest zijn voor SARS-CoV-2 infectie, worden geworven voor het onderzoek.
Patiënten moeten wilsbekwaam zijn en in staat om de patienten informatiebrief te lezen en het informed consent formulier te ondertekenen. |
|
E.4 | Principal exclusion criteria |
Thyroid disease or treatment, like goiter, thyroidectomie, radioactive iodine, medication related to thyroid dysfunction or the use of Amiodaron. |
Schildklieraandoening of behandeling, zoals struma, thyroidectomie, radioactief jodium, medicatie gerelateerd aan schildklierdisfunctie of het gebruik van Amiodaron. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
clinically relevant deterioration defined as:
1. transfer from regular ward to IC department
2. death in regular ward department
3. death in IC department |
klinisch relevante verslechtering gedefinieerd als:
1. overplaatsing van gewone verpleegafdeling naar IC afdeling
2. overlijden op gewone verpleegafdeling
3. overlijden op IC afdeling |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
after discharge from hospital or death. |
na ontslag uit ziekenhuis of overlijden. |
|
E.5.2 | Secondary end point(s) |
total number of days in hospital and total number of deaths. |
totaal aantal dagen opname in het ziekenhuis en totaal aantal overlijden. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
after discharge from hospital or death. |
na ontslag uit ziekenhuis of overlijden. |
|
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 | No |
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 | No |
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 | 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 | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 224 |
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 | 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
|
last subject released from hospital or deceased |
laatste proefpersoon ontslagen uit het ziekenhuis of overleden |
|
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 | |