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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
44
100 milligram tablets
oral tablets, identical in size and shape
200 milligram tablets
KU Leuven
Leuven, Belgium
Time to first self-reported recovery within 30 days after randomisation
Time frame: within 30 days after randomisation
All-cause unplanned hospital admission for at least 24 hours
Time frame: within 30 days after randomisation
All-cause mortality
Time frame: within 30 days after randomisation
Health status
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.
Time frame: at 8 days and 30 days after randomization
Oxygen administration in the home setting
Number of patients who had oxygen at least once
Time frame: over a period of 30 days after randomization
All-cause mortality at 1 year after randomization
Time frame: at 1 year
Cardiovascular and thromboembolic complications
Number of events
Time frame: 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
Time frame: over a period of 30 days after randomization
Duration of hospital admission for those admitted to hospital
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Length of stay
Time frame: 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
Time frame: over a period of 30 days after randomization
Consumption of antibiotics
Antibiotic consumption expressed in defined daily dose
Time frame: 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
Time frame: 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.
Time frame: within 30 days after randomisation
At least once ventilated
Time frame: over a period of 30 days after randomization
Admission to ICU
Time frame: 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
Time frame: over a period of 30 days after randomization