The DAWN Antivirals Trial for Ambulatory COVID-19 Patients

NCT ID: NCT04730206

Last Updated: 2022-10-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-15
• Study Completion Date: 2022-07-13

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.

Conditions

Covid19; SARS-CoV Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Camostat

4 x 200 milligram per day for 7 days

Group Type: EXPERIMENTAL

Camostat

Intervention Type: DRUG

100 milligram tablets

Placebo

4 x per day for 7 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

oral tablets, identical in size and shape

Molnupiravir

2 x 800 milligram per day for 5 days

Group Type: EXPERIMENTAL

Molnupiravir

Intervention Type: DRUG

200 milligram tablets

Interventions

Camostat

100 milligram tablets

Intervention Type: DRUG

Placebo

oral tablets, identical in size and shape

Intervention Type: DRUG

Molnupiravir

200 milligram tablets

Intervention Type: DRUG

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universiteit Antwerpen

OTHER

Sponsor Role: collaborator

University Ghent

OTHER

Sponsor Role: collaborator

Université de Liège

OTHER

Sponsor Role: collaborator

Vrije Universiteit Brussel

OTHER

Sponsor Role: collaborator

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Ann Van den Bruel

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

KU Leuven

Leuven, , Belgium

Countries

Belgium

Other Identifiers

S64445

Identifier Type: -

Identifier Source: org_study_id