The DAWN Antivirals Trial for Ambulatory COVID-19 Patients

NCT04730206 | Terminated Phase 3 DMC

• 1 other identifier: S64445
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; SARS-CoV Infection

Outcome Measures

Primary Outcomes (1)

• Time to first self-reported recovery within 30 days after randomisation

  within 30 days after randomisation

Secondary Outcomes (15)

• All-cause unplanned hospital admission for at least 24 hours

  within 30 days after randomisation

• All-cause mortality

  within 30 days after randomisation

• Health status

  at 8 days and 30 days after randomization

• Oxygen administration in the home setting

  over a period of 30 days after randomization

• All-cause mortality at 1 year after randomization

  at 1 year

Study Arms (3)

Camostat

EXPERIMENTAL

4 x 200 milligram per day for 7 days

Drug: Camostat

Placebo

PLACEBO COMPARATOR

4 x per day for 7 days

Drug: Placebo

Molnupiravir

EXPERIMENTAL

2 x 800 milligram per day for 5 days

Drug: Molnupiravir

Interventions

Camostat DRUG

100 milligram tablets

Camostat

Placebo DRUG

oral tablets, identical in size and shape

Placebo

Molnupiravir DRUG

200 milligram tablets

Molnupiravir

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 40 years or older;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• KU Leuven: lead
• Universiteit Antwerpen: collaborator
• University Ghent: collaborator
• Université de Liège: collaborator
• Vrije Universiteit Brussel: collaborator

Study Sites (1)

KU Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome

Interventions

camostat; molnupiravir

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be masked for camostat or placebo, molnupiravir is open label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: January 29, 2021
• Study Start: June 15, 2021
• Primary Completion: July 13, 2022
• Study Completion: July 13, 2022
• Last Updated: October 3, 2022

Record last verified: 2022-09

Locations

BE (1)