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.
Drug: Camostat
100 milligram tablets
Drug: Placebo
oral tablets, identical in size and shape
Drug: Molnupiravir
200 milligram tablets
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.
KU Leuven
Leuven, Belgium