Covid19Phase 3DAWNNCT04730206
The DAWN Antivirals Trial for Ambulatory COVID-19 Patients
A Phase 3 study testing Camostat and Molnupiravir in people with Covid19 and SARS-CoV Infection, run by KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Covid19, SARS-CoV Infection
- What is being tested?
- Camostat and Molnupiravir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Jun 2021to 13 Jul 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The DAWN Antivirals Trial: the Efficacy of Antivirals for COVID-19 Infections Presenting to Ambulatory Care: a Randomized Controlled Trial
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.
Read the 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
- Being tested
- Camostat, Placebo, Molnupiravir
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamostatDrug
100 milligram tablets
PlaceboDrug
oral tablets, identical in size and shape
MolnupiravirDrug
200 milligram tablets
| Study group | Role | What they receive |
|---|---|---|
| Camostat | Experimental | 4 x 200 milligram per day for 7 days Receives: Drug: Camostat |
| Placebo | Placebo comparator | 4 x per day for 7 days Receives: Drug: Placebo |
| Molnupiravir | Experimental | 2 x 800 milligram per day for 5 days Receives: Drug: Molnupiravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first self-reported recovery within 30 days after randomisation
Measured: within 30 days after randomisation
Secondary outcomes (15)
All-cause unplanned hospital admission for at least 24 hours
Measured: within 30 days after randomisation
All-cause mortality
Measured: within 30 days after randomisation
Health status
Score on the World Health Organisation (WHO) clinical progression scale: measure of illness severity across a range from 0 (not infected) to 10 (dead) where lower scores indicate a better outcome.
Measured: at 8 days and 30 days after randomization
Oxygen administration in the home setting
Number of patients who had oxygen at least once
Measured: over a period of 30 days after randomization
All-cause mortality at 1 year after randomization
Measured: at 1 year
Cardiovascular and thromboembolic complications
Number of events
Measured: within 7 days and 30 days after randomization
Symptom duration for each individual symptom
Duration of symptoms reported by the patient in the patient diary as being present since randomisation
Measured: over a period of 30 days after randomization
Duration of hospital admission for those admitted to hospital
Length of stay
Measured: over a period of 30 days after randomization
Health services usage
Number of contacts with general practitioners, out-of-hours services, emergency department visits, specialist assessments
Measured: over a period of 30 days after randomization
Consumption of antibiotics
Antibiotic consumption expressed in defined daily dose
Measured: over a period of 30 days after randomisation
Participants' quality of life
Euroqol EQ-5D-5L: The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems, where higher scores indicate a better outcome
Measured: at 7 days and 30 days after randomization
Time to sustained recovery within 14 days
time from randomization to self-reported recovery within 14 days and remaining recovered until day 30 after randomisation.
Measured: within 30 days after randomisation
At least once ventilated
Measured: over a period of 30 days after randomization
Admission to ICU
Measured: over a period of 30 days after randomization
All-cause unplanned hospital admission for at least 24 hours or all-cause mortality within 30 days of randomization
Measured: over a period of 30 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start15 Jun 2021
- Primary completion13 Jul 2022
- Study completion13 Jul 2022
Why it stopped: recruitment was too slow
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Universiteit Antwerpen, University Ghent, Université de Liège, Vrije Universiteit Brussel
- Responsible party
- Principal investigator, Ann Van den Bruel, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730206
- Sponsor's protocol ID
- S64445
- Acronym
- DAWN
- Status last verified
- Sep 2022
- First submitted
- 28 Jan 2021
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The DAWN Antivirals Trial: the Efficacy of Antivirals for COVID-19 Infections Presenting to Ambulatory Care: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04730206
- Acronym / sponsor ID
- DAWN / S64445
- Conditions
- Covid19, SARS-CoV Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment was too slow
- Enrolment
- 44 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Universiteit Antwerpen, University Ghent, Université de Liège, Vrije Universiteit Brussel
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 13 Jul 2022 (actual)
- Study completion
- 13 Jul 2022 (actual)
- First posted
- 29 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Camostat | Experimental | Drug: Camostat4 x 200 milligram per day for 7 days |
| Placebo | Placebo comparator | Drug: Placebo4 x per day for 7 days |
| Molnupiravir | Experimental | Drug: Molnupiravir2 x 800 milligram per day for 5 days |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Camostat100 milligram tablets | Drug | Camostat |
| Placebooral tablets, identical in size and shape | Drug | Placebo |
| Molnupiravir200 milligram tablets | Drug | Molnupiravir |
Primary outcome
Time to first self-reported recovery within 30 days after randomisation
Time frame: within 30 days after randomisation
15 secondary outcomes
All-cause unplanned hospital admission for at least 24 hours
Time frame: within 30 days after randomisation
All-cause mortality
Time frame: within 30 days after randomisation
Health status
Time frame: at 8 days and 30 days after randomization
Oxygen administration in the home setting
Time frame: over a period of 30 days after randomization
All-cause mortality at 1 year after randomization
Time frame: at 1 year
Cardiovascular and thromboembolic complications
Time frame: within 7 days and 30 days after randomization
Symptom duration for each individual symptom
Time frame: over a period of 30 days after randomization
Duration of hospital admission for those admitted to hospital
Time frame: over a period of 30 days after randomization
Health services usage
Time frame: over a period of 30 days after randomization
Consumption of antibiotics
Time frame: over a period of 30 days after randomisation
Participants' quality of life
Time frame: at 7 days and 30 days after randomization
Time to sustained recovery within 14 days
Time frame: within 30 days after randomisation
At least once ventilated
Time frame: over a period of 30 days after randomization
Admission to ICU
Time frame: over a period of 30 days after randomization
All-cause unplanned hospital admission for at least 24 hours or all-cause mortality within 30 days of randomization
Time frame: over a period of 30 days after randomization
Results and safety
The study was stopped early (reason given: recruitment was too slow). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Camostat and Molnupiravir in people with Covid19 and SARS-CoV Infection, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: recruitment was too slow). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first self-reported recovery within 30 days after randomisation (time frame: within 30 days after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2022.