The DAWN Antivirals Trial for Ambulatory COVID-19 Patients

Catholic University (KU) of Leuven

Status and phase: Terminated; Phase 3

Conditions: SARS-CoV Infection; Covid19

Treatments: Drug: Molnupiravir; Drug: Camostat; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04730206

S64445

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

44 participants in 3 patient groups, including a placebo group

Camostat

Experimental group

Description:

4 x 200 milligram per day for 7 days

Treatment:

Drug: Camostat

Placebo

Placebo Comparator group

Description:

4 x per day for 7 days

Treatment:

Drug: Placebo

Molnupiravir

Experimental group

Description:

2 x 800 milligram per day for 5 days

Treatment:

Drug: Molnupiravir