Status:
TERMINATED
The DAWN Antivirals Trial for Ambulatory COVID-19 Patients
Lead Sponsor:
KU Leuven
Collaborating Sponsors:
Universiteit Antwerpen
University Ghent
Conditions:
Covid19
SARS-CoV Infection
Eligibility:
All Genders
40+ years
Phase:
PHASE3
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 rec...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 13 2022
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04730206
Start Date
June 15 2021
End Date
July 13 2022
Last Update
October 3 2022
Active Locations (1)
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1
KU Leuven
Leuven, Belgium, 3000