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recruitment was too slow
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| Name | Class |
|---|---|
| Universiteit Antwerpen | OTHER |
| University Ghent | OTHER |
| Université de Liège | OTHER |
| Vrije Universiteit Brussel |
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This is a prospective, placebo controlled, individually randomized controlled phase III trial in Primary Care, assessing the efficacy of antivirals, i.e. camostat and molnupiravir, in accelerating recovery in Covid-19 patients.
In patients aged 40 years and above and diagnosed with Covid-19 upon study entry, we will evaluate the efficacy of camostat or molnupiravir on recovery within 30 days after randomisation. Participants will be randomly assigned to camostat, molnupiravir or placebo using a computer generated randomisation process. Participants will be treated for 7 days in case of camostat and 5 days in case of molnupiravir, and follow-up will be 30 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camostat | Experimental | 4 x 200 milligram per day for 7 days |
|
| Placebo | Placebo Comparator | 4 x per day for 7 days |
|
| Molnupiravir | Experimental | 2 x 800 milligram per day for 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camostat | Drug | 100 milligram tablets |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first self-reported recovery within 30 days after randomisation | within 30 days after randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause unplanned hospital admission for at least 24 hours | within 30 days after randomisation | |
| All-cause mortality | within 30 days after randomisation | |
| Health status |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KU Leuven | Leuven | 3000 | Belgium |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D045169 | Severe Acute Respiratory Syndrome |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C034532 | camostat |
| C000656703 | molnupiravir |
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| OTHER |
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Participants will be masked for camostat or placebo, molnupiravir is open label
| Drug |
oral tablets, identical in size and shape |
|
| Molnupiravir | Drug | 200 milligram tablets |
|
Score on the World Health Organisation (WHO) clinical progression scale: measure of illness severity across a range from 0 (not infected) to 10 (dead) where lower scores indicate a better outcome. |
| at 8 days and 30 days after randomization |
| Oxygen administration in the home setting | Number of patients who had oxygen at least once | over a period of 30 days after randomization |
| All-cause mortality at 1 year after randomization | at 1 year |
| Cardiovascular and thromboembolic complications | Number of events | within 7 days and 30 days after randomization |
| Symptom duration for each individual symptom | Duration of symptoms reported by the patient in the patient diary as being present since randomisation | over a period of 30 days after randomization |
| Duration of hospital admission for those admitted to hospital | Length of stay | over a period of 30 days after randomization |
| Health services usage | Number of contacts with general practitioners, out-of-hours services, emergency department visits, specialist assessments | over a period of 30 days after randomization |
| Consumption of antibiotics | Antibiotic consumption expressed in defined daily dose | over a period of 30 days after randomisation |
| Participants' quality of life | Euroqol EQ-5D-5L: The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems, where higher scores indicate a better outcome | at 7 days and 30 days after randomization |
| Time to sustained recovery within 14 days | time from randomization to self-reported recovery within 14 days and remaining recovered until day 30 after randomisation. | within 30 days after randomisation |
| At least once ventilated | over a period of 30 days after randomization |
| Admission to ICU | over a period of 30 days after randomization |
| All-cause unplanned hospital admission for at least 24 hours or all-cause mortality within 30 days of randomization | over a period of 30 days after randomization |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |