The DAWN antivirals trial: the efficacy of antivirals in ambulatory patients with confirmed COVID-19 infection compared to placebo.

Phase 1

• Conditions: COVID-19; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-005911-27-BE
• Lead Sponsor: KU Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-15
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 463

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 a 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 238
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 225

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 in the 7 days prior to recruitment;
-Participating in any other interventional drug clinical study at the time of enrolment in the study;
- Breastfeeding
-Known 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;
-Judgement of the recruiting clinician deems participant ineligible.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Assess the efficacy of antivirals on recovery;Secondary Objective: Assess the efficacy of antivirals on hospital admission or mortality over 30 days after randomisation, symptoms, cardiovascular events, Covid-19 severity, health care utilisation and quality of life over 30 days after randomisation, and all-cause mortality at 1 year after randomisation.;Primary end point(s): time to first self-reported recovery within 30 days after randomisation.;Timepoint(s) of evaluation of this end point: Within 30 days after randomization