Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-31 @ 12:38 PM
Study NCT ID:
NCT04730206
Status:
TERMINATED
Last Update Posted:
2022-10-03
First Post:
2021-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The DAWN Antivirals Trial for Ambulatory COVID-19 Patients
Sponsor:
KU Leuven
Organization:
Study Overview
Official Title:
The DAWN Antivirals Trial: the Efficacy of Antivirals for COVID-19 Infections Presenting to Ambulatory Care: a Randomized Controlled Trial
Status:
TERMINATED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
recruitment was too slow
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DAWN
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: