Covid19, SARS-CoV Infection
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGCamostat
100 milligram tablets
DRUGPlacebo
oral tablets, identical in size and shape
DRUGMolnupiravir
200 milligram tablets
Sponsors
Universiteit Antwerpen
University Ghent
Université de Liège
Vrije Universiteit Brussel
KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants will be masked for camostat or placebo, molnupiravir is open label
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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 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.
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 a test at recruitment or in the 7 days prior to recruitment; * Participating in any other interventional drug clinical study before enrolment in the study; * Breastfeeding; * Known severe neurological disorder, especially 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 and don't agree to use any of the effective contraceptive measures lised above; * Judgement of the recruiting clinician deems participant ineligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first self-reported recovery within 30 days after randomisation | within 30 days after randomisation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | within 30 days after randomisation | — |
| Health status | at 8 days and 30 days after randomization | 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. |
| Oxygen administration in the home setting | over a period of 30 days after randomization | Number of patients who had oxygen at least once |
| All-cause mortality at 1 year after randomization | at 1 year | — |
| Cardiovascular and thromboembolic complications | within 7 days and 30 days after randomization | Number of events |
| Symptom duration for each individual symptom | over a period of 30 days after randomization | Duration of symptoms reported by the patient in the patient diary as being present since randomisation |
| Duration of hospital admission for those admitted to hospital | over a period of 30 days after randomization | Length of stay |
| All-cause unplanned hospital admission for at least 24 hours | within 30 days after randomisation | — |
| Consumption of antibiotics | over a period of 30 days after randomisation | Antibiotic consumption expressed in defined daily dose |
| Participants' quality of life | at 7 days and 30 days after randomization | 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 to sustained recovery within 14 days | within 30 days after randomisation | time from randomization to self-reported recovery within 14 days and remaining recovered until day 30 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 | — |
| Health services usage | over a period of 30 days after randomization | Number of contacts with general practitioners, out-of-hours services, emergency department visits, specialist assessments |
Countries
Belgium
Outcome results
None listed