E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
COVID-19, Corona |
COVID-19, Corona |
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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 |
To assess the effectiveness of early treatment with dexamethasone in preventing hospital admission/death in patients who are carefully monitored by their GP after a consultation for deteriorating COVID-19
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E.2.2 | Secondary objectives of the trial |
To assess the effectiveness of early treatment with dexamethasone in reducing time to recovery in patients who are carefully monitored by their GP after a consultation for deteriorating COVID-19
To assess the effectiveness of early treatment with dexamethasone in reducing COVID-19 disease severity in patients who are remotely monitored by their GP after a consultation for deteriorating symptoms |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
In order to be eligible to participate in the COPPER study, a patient has to meet all of the following criteria: - Age ≥18 years - A positive test for SARS-CoV-2 - A GP consultation for deteriorating COVID-19 symptoms
Additional inclusion criterion in order to be eligible for randomisation to the trial: - Exercise-induced desaturation, defined as a drop of ≥4% in SpO2 or to <92% after having performed a 1-minute sit-to-stand test.
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E.4 | Principal exclusion criteria |
- Inability to understand and sign the written consent form - Inability to perform saturation measurements or sit-to-stand test - Not willing to be admitted to hospital - On the discretion of the recruiting clinician if he or she deems a patient not eligible - Conta-indication for dexamethasone
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome will be time to first hospital admission. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
during the 28 days of follow-up |
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E.5.2 | Secondary end point(s) |
Secondary outcomes are time to self-reported recovery, COVID-19 severity and self-reported disease burden. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
During the 28 days of follow up and after 3, 6 and 12 months |
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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 | 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) | 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 | 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 |
Watchfull monitoring without treatment |
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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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LVLS. Early termination may occur at the discretion of the investigators/sponsor(Sp) for any reason that is believed to present a safety risk. If the investigator/Sp terminates the trial without prior- agreement of the subsidising party, the investigator/Sp should instantly inform the subsidising party and provide them with a detailed written explanation for the termination of the trial. If the subsidising party terminates the trial, the subiding party should instantly inform the investigator/Sp |
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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 | 12 |
E.8.9.1 | In the Member State concerned days | |