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 |
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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 |
Assess the efficacy of antivirals on recovery |
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E.2.2 | Secondary objectives of the trial |
Assess the efficacy of antivirals on hospital admission or mortality over 30 days after randomisation, symptoms, cardiovascular events, Covid-19 severity, health care utilisation and quality of life over 30 days after randomisation, and all-cause mortality at 1 year after randomisation. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Aged 40 years or older; - At least 2 Covid-19 suggestive symptoms at the time of inclusion, with onset of a maximum of 5 days prior to enrolment, and which cannot be explained by an alternative cause, and defined by the current Sciensano case definition; - Positive result on a PCR test or rapid Ag test in the 7 days before inclusion or at the time of inclusion; - Patient is community dwelling; - Participant or their proxy is willing and able to give informed consent for participation in the trial; - Participant is willing to comply with all trial procedures. |
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E.4 | Principal exclusion criteria |
- Hospital admission is required at the time of possible recruitment; - Positive PCR or rapid antigen test for SARS-CoV-2 in the last 2 months other than in the 7 days prior to recruitment; - Participating in any other interventional drug clinical study at the time of enrolment in the study; - Breastfeeding - Known seizures in the last 12 months; - Known allergy to camostat or molnupiravir; - Previous adverse reaction to, or currently taking, camostat or molnupiravir; - Patients in palliative care; - Pregnant women or women of childbearing potential who may become pregnant during the trial; - Judgement of the recruiting clinician deems participant ineligible.
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E.5 End points |
E.5.1 | Primary end point(s) |
time to first self-reported recovery within 30 days after randomisation. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Within 30 days after randomization |
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E.5.2 | Secondary end point(s) |
- All-cause unplanned hospital admission for at least 24 hours or all-cause mortality within 30 days after randomisation; - Time to sustained recovery within 14 days = time from randomisation to self-reported recovery within 14 days and remaining recovered until day 30 after randomisation; - All-cause unplanned hospital admission for at least 24 hours within 30 days after randomisation; - All-cause mortality within 30 days after randomisation; - WHO clinical progression scale at 8 days and 30 days after randomisation 0 Uninfected 1 Ambulatory, asymptomatic 2 Ambulatory, symptomatic independent 3 Ambulatory, symptomatic, assistance needed 4 Hospitalized, no oxygen therapy 5 Hospitalized, oxygen by mask or nasal prongs 6 Hospitalized, oxygen by NIV or high flow 7 Hospitalized, intubation and mechanical ventilation pO2/FiO2 ≥150 or SpO2/FiO2 ≥200 8 Hospitalized, mechanical ventilation pO2/FiO2 <150 or vasopressors 9 Hospitalized, mechanical ventilation pO2/FiO2 <150 and vasopressors, dialysis or ECMO 10 Dead
- At least once oxygen administration over a period of 30 days after randomisation; - At least once ventilated over a period of 30 days after randomisation; - Admission to ICU over a period of 30 days after randomisation; - All-cause mortality at 1 year after randomisation; - Cardiovascular and thromboembolic complications within 7 days and 30 days after randomisation; - Symptom duration for each individual symptom over a period of 30 days after randomisation; - Duration of hospital admission for those admitted to hospital over a period of 30 days after randomisation; - Number of contacts with health services including general practitioners, out-of-hours services, emergency department visits, specialist assessments over a period of 30 days after randomisation; - Number of hospital assessments without admission over a period of 30 days after randomisation; - Consumption of antibiotics over a period of 30 days after randomisation, expressed in defined daily dose; - Quality of life as measured by the EQ-5D-5L at 7 days and 30 days after randomisation.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Within 7 days, 30 days and 1 year after randomization |
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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 | 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 | Yes |
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) | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | 56 |
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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The end of trial is defined as the collection of follow-up data at 1 year after randomisation of the last patient. |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |