Official Title
The DAWN Antivirals Trial: the Efficacy of Antivirals for COVID-19 Infections Presenting to Ambulatory Care: a Randomized Controlled Trial
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.

Terminated
COVID19
SARS-CoV Infection

Drug: Camostat

100 milligram tablets

Drug: Placebo

oral tablets, identical in size and shape

Drug: Molnupiravir

200 milligram tablets

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 40 Years ~ Maximum: N/A
Countries
Belgium
Locations

KU Leuven
Leuven, Belgium

NCT Number
MeSH Terms
Infections
COVID-19
Severe Acute Respiratory Syndrome
Molnupiravir
Camostat