COVID-19NCT04337541
Reduction in COVID-19 Infection Using Surgical Facial Masks Outside the Healthcare System
A study testing Surgical facial mask in people with COVID-19, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
In the current COVID-19 pandemic with coronavirus, SARS-COV2, the Danish Health Authorities recommend using facial masks in the health care system when handling patients presumed or proven to be infected with the virus. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Surgical facial mask
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,000 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Apr 2020to 2 Jun 2020
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Older than 18 years of age and without symptoms associated with corona-virus (or previously tested positive for corona).
- Participant is outside their home more than 3 hours a day. E.g.for work or for other activities among other people.
- Do not normally wear a facial mask for daily work (e.g. healthcare personnel)
Who cannot join
- Previously tested positive for corona-virus
- Wear facial mask for work
Trial locations and contacts
1 site in 1 country.
About this study
In the current COVID-19 pandemic with coronavirus, SARS-COV2, the Danish Health Authorities recommend using facial masks in the health care system when handling patients presumed or proven to be infected with the virus. However, the use of facial masks outside the health care system is not recommended by the Danish Health Authorities. Here, Health Authorities in other countries have different recommendations for the use of facial masks.
Challenges when using facial masks outside the health care system include wearing the mask consistently, an efficacy of the mask of app. 8 hours necessitating a change of mask throughout the day, and that it is not sufficiently tight enough to safely keep the virus out. Moreover, the eyes (mucous membrane) remain exposed. Compliance could also be another challenge.
Read more
SARS-COV2 is assumed to primarily enter the body via the mouth through respiratory droplets - or possibly through inhalation of aerosol containing the virus. From the mouth the virus is assumed to spread to the airways and the gastro-intestinal tract. SARS-COV2 is also known to be transmitted via physical contact, helped along by the fact that the virus can survive on surfaces for at least 72 hours. Touching such a contaminated surface can transfer the virus to the mouth via the hand - and thus lead to infection of the person.
Facial masks are expected to protect against viral infection in two ways;
- By reducing the risk of getting the virus in via the mouth or nose via respiratory droplets or aerosol
- By reducing the transfer from virus-contaminated hands to the mouth or nose
Hypothesis The use of surgical facial masks outside the hospital will reduce the frequency of COVID-19 infection.
All participants will follow authority recommendations and be randomized to either wear facial masks or not. The participants will be screened for antibodies at study start and study end. They will perform swab-test if they experience symptoms during the study as well as the end of study.
Read the detailed description
Background In the current COVID-19 pandemic with coronavirus, SARS-COV2, the Danish Health Authorities recommend using facial masks in the health care sector when handling patients presumed or proven to be infected with the virus. However, the use of facial masks outside the healthcare system is not recommended by the Danish Health Authorities. Challenges when using facial masks outside the health care system include wearing the mask consistently, an efficacy of the mask of app. 8 hours necessitating a change of mask throughout the day, and that it is not sufficiently tight enough to safely keep the virus out. Moreover, the eyes (mucous membrane) remain exposed. Compliance could also be another challenge. Health Authorities in other countries have different recommendations for the use of facial masks and the authors of the Lancet study concluded; "Universal use of face masks could be considered if supplies permit. In parallel, urgent research on the duration of protection of face masks, the measures to prolong life of disposable masks, and the invention on reusable masks should be encouraged."
SARS-COV2 is assumed to primarily enter the body via the mouth through respiratory droplets or possibly through inhalation of aerosol containing the virus. From the mouth the virus is assumed to spread to the airways and the gastro-intestinal tract. SARS-COV2 is also known to be transmitted via physical contact, helped along by the fact that the virus can survive on surfaces for at least 72 hours. Touching such a contaminated surface can transfer the virus to the mouth via the hand - and thus lead to infection of the person. A study with 26 medical students showed that they touched their face on average 23 times per hour, and that in 44 % of the incidents they touched their mucous membranes3. A Japanese questionnaire study showed that facial masks reduced the risk for school children for getting influenza by 15 %4. N95 mask and surgical facial masks are presumed to have the same effect for healthcare personnel when providing protecting from infection with influenza.
Facial masks are assumed to protect against viral infection in two ways;
- By reducing the risk of getting the virus via mouth or nose through the air via respiratory droplets or aerosol
- By reducing the transfer from virus-contaminated hands to the mouth or nose
About 10 % of the Danish population is estimated to get COVID-19 during the present pandemic-wave; this corresponds to 600,000 Danes. Later COVID-19 waves are expected to occur. The epidemic in Denmark is expected to be at the highest point in medio April. In April and May it be estimated that >2 % of the population will be infected per month.
Hypothesis The use of surgical facial masks outside the hospital will reduce the frequency of COVID-19 infection.
Method The participants recruited are people working outside of their home, who have not previously been infected with COVID-19 and who do not wear facial masks (e.g. healthcare personnel) when working. They will be randomized for
- Normal behavior according to the authority's recommendations or
- Normal behavior according to the authority's recommendations and use of facial masks
Participants will be instructed in using the facial mask consistently when outside their home (and at home when receiving visits from others. The instruction is given in writing and via an instruction video. The participants will be contacted once weekly to optimize compliance. It will be registered if the participants are diagnosed with COVID-19. Participants, who are not tested positive for COVID-19 in the study period will perform a self-test if having symptoms or when the study ends (instruction video).
Perspective The study can determine whether use of facial masks in the public is beneficial and if there is an effect this could have great impact on the current as well as any future, similar epidemics.
Interested participants can register through a link in the add to our research registration database RedCap. The participant will then receive written information and can then register. They will receive a COVID-19 screening test set and (+/-) facial masks ( 2 per day) for the first month. If the participant experience symptoms, he/she will register their symptoms in RedCap, test with a swab-test and send the swab-test to the study investigator for analyses. If negative, new test-sets are sent out - if positive, the participant will be referred to the hospital. This process continues until the participant is tested positive for COVID-19, the pandemic is considered finished by the Danish authorities or when the study ends on May 7 2020. At study end, all participants perform antibody screening and swab test, and send it to the study investigators.
Power calculation With an infection frequency of 2 % in the study period, an expected reduction of the risk to 1 % should be demonstratable with a power of 80 % and a p-value of 5 %, if including a total of 4,636 patients randomized 1:1. If the infection frequency is higher the power of the study will be higher. With an expected defection of 20 % a total of 6,000 participants will be included.
Authority approvals from The Danish National Committee On Health Research Ethics and The Data Protection Agency have been granted.
A detailed study analyses plan (SAP) will be finalized before data are analyzed.
Central registry data will be collected later when made available by national health authorities.
- Conditions
- COVID-19
- Being tested
- Surgical facial mask
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical facial maskOther
Participants will follow normal Authority recommendations AND wear mask outside their homes, or when receiving visits in their home.
| Study group | Role | What they receive |
|---|---|---|
| Normal recommendations, no mask | No intervention | Normal behavior according to the authority's recommendations or |
| Normal recommendations AND mask | Experimental | Normal behavior according to the authority's recommendations AND use of facial masks Receives: Other: Surgical facial mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the difference in SARS-CoV-2 infection between the two groups after 1 months and is a combined endpoint consisting of primary outcome components 1, 2 and/or 3:
Component 1 of primary endpoint: Positive oropharyngeal/nasal swab with SARS-CoV-2 (PCR) and/or
Measured: 1 month
The primary endpoint is the difference in SARS-CoV-2 infection between the two groups after 1 months and is a combined endpoint consisting of primary outcome components 1, 2 and/or 3:
Component 2 of primary endpoint: Antibody test; Development of positive SARS-CoV-2 antibody test (IgM and/or IgG) during the study period and/or
Measured: 1 month
The primary endpoint is the difference in SARS-CoV-2 infection between the two groups after 1 months and is a combined endpoint consisting of primary outcome components 1, 2 and/or 3:
Component 3 of primary endpoint: SARS-CoV-2 infection diagnosed in a hospital/health care facility
Measured: 1 month
Secondary outcomes (2)
Positive oropharyngeal/nasal swab (PCR);
Para-influenza-virus type 1, Para-influenza-virus type 2, Human coronavirus 229E, Human coronavirus OC43, Human coronavirus NL63, Human coronavirus HKU1, Respiratory Syncytial-Virus A, Respiratory Syncytial-Virus B, Influenza A virus or Influenza B virus
Measured: 1 month
Positive oropharyngeal/nasal swab (PCR);
SAR-CoV-2, Para-influenza-virus type 1, Para-influenza-virus type 2, Human coronavirus 229E, Human coronavirus OC43, Human coronavirus NL63, Human coronavirus HKU1, Respiratory Syncytial-Virus A, Respiratory Syncytial-Virus B, Influenza A virus or Influenza B virus
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start2 Apr 2020
- Primary completion2 Jun 2020
- Study completion2 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants recruited are people working outside of their home, who have not previously been infected with COVID-19 and who do not wear facial masks (e.g. healthcare personnel) when working. They will be randomized for 1. Normal behavior according to the authority's recommendations or 2. Normal behavior according to the authority's recommendations and use of facial masks Participants will be instructed in using the facial mask consistently when outside their home (and at home when receiving visits from others. The instruction is given in writing and via an instruction video. The participants will be contacted once weekly to optimize compliance. It will be registered if the participants are diagnosed with COVID-19. Participants will perform antibody screening at study start and end. Participants, who are not tested positive for COVID-19 in the study period will perform a swab self-test if experiencing symptoms or when the study ends (instruction video).
- Masking
- None (open label)
- Enrolment
- 6,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Nordsjaellands Hospital, Hvidovre University Hospital, Herlev Hospital, Technical University of Denmark
- Responsible party
- Principal investigator, Henning Bundgaard, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Henrik Ullum, Prof., DMSc, Principal investigator, Copenhagen University Hospital, RigshospitaletKasper Karmark Iversen, Prof., DMSc, Principal investigator, Herlev HospitalThomas Benfield, Prof., DMSc, Principal investigator, Hvidovre University HospitalChristian Torp-Pedersen, Prof., DMSc, Principal investigator, Nordsjaellands Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04337541
- Sponsor's protocol ID
- 2020-04-02
- Status last verified
- Jul 2020
- First submitted
- 2 Apr 2020
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Feng S, Shen C, Xia N, Song W, Fan M, Cowling BJ. Rational use of face masks in the COVID-19 pandemic. Lancet Respir Med. 2020 May;8(5):434-436. doi: 10.1016/S2213-2600(20)30134-X. Epub 2020 Mar 20. No abstract available.
PubMed 32203710van Doremalen N, Bushmaker T, Morris DH, Holbrook MG, Gamble A, Williamson BN, Tamin A, Harcourt JL, Thornburg NJ, Gerber SI, Lloyd-Smith JO, de Wit E, Munster VJ. Aerosol and Surface Stability of SARS-CoV-2 as Compared with SARS-CoV-1. N Engl J Med. 2020 Apr 16;382(16):1564-1567. doi: 10.1056/NEJMc2004973. Epub 2020 Mar 17. No abstract available.
PubMed 32182409Kwok YL, Gralton J, McLaws ML. Face touching: a frequent habit that has implications for hand hygiene. Am J Infect Control. 2015 Feb;43(2):112-4. doi: 10.1016/j.ajic.2014.10.015.
PubMed 25637115Uchida M, Kaneko M, Hidaka Y, Yamamoto H, Honda T, Takeuchi S, Saito M, Kawa S. Effectiveness of vaccination and wearing masks on seasonal influenza in Matsumoto City, Japan, in the 2014/2015 season: An observational study among all elementary schoolchildren. Prev Med Rep. 2016 Dec 6;5:86-91. doi: 10.1016/j.pmedr.2016.12.002. eCollection 2017 Mar.
PubMed 27981021Gralton J, McLaws ML. Protecting healthcare workers from pandemic influenza: N95 or surgical masks? Crit Care Med. 2010 Feb;38(2):657-67. doi: 10.1097/ccm.0b013e3181b9e8b3.
PubMed 20095070Bundgaard H, Bundgaard JS, Raaschou-Pedersen DET, von Buchwald C, Todsen T, Norsk JB, Pries-Heje MM, Vissing CR, Nielsen PB, Winslow UC, Fogh K, Hasselbalch R, Kristensen JH, Ringgaard A, Porsborg Andersen M, Goecke NB, Trebbien R, Skovgaard K, Benfield T, Ullum H, Torp-Pedersen C, Iversen K. Effectiveness of Adding a Mask Recommendation to Other Public Health Measures to Prevent SARS-CoV-2 Infection in Danish Mask Wearers : A Randomized Controlled Trial. Ann Intern Med. 2021 Mar;174(3):335-343. doi: 10.7326/M20-6817. Epub 2020 Nov 18.
PubMed 33205991Bundgaard H, Bundgaard JS, Raaschou-Pedersen DET, Mariager AF, Schytte N, von Buchwald C, Todsen T, Skovgaard K, Trebbien R, Andersen MP, Benfield T, Ullum H, Torp-Pedersen C, Iversen K. Face masks for the prevention of COVID-19 - Rationale and design of the randomised controlled trial DANMASK-19. Dan Med J. 2020 Aug 18;67(9):A05200363.
PubMed 32829745
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction in COVID-19 Infection Using Surgical Facial Masks Outside the Healthcare System
- ClinicalTrials.gov ID
- NCT04337541
- Acronym / sponsor ID
- 2020-04-02
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,000 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Nordsjaellands Hospital, Hvidovre University Hospital, Herlev Hospital, Technical University of Denmark
- Study start
- 2 Apr 2020 (actual)
- Primary completion
- 2 Jun 2020 (actual)
- Study completion
- 2 Jun 2020 (actual)
- First posted
- 7 Apr 2020 (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.
In the current COVID-19 pandemic with coronavirus, SARS-COV2, the Danish Health Authorities recommend using facial masks in the health care system when handling patients presumed or proven to be infected with the virus. However, the use of facial masks outside the health care system is not recommended by the Danish Health Authorities. Here, Health Authorities in other countries have different recommendations for the use of facial masks.
Challenges when using facial masks outside the health care system include wearing the mask consistently, an efficacy of the mask of app. 8 hours necessitating a change of mask throughout the day, and that it is not sufficiently tight enough to safely keep the virus out. Moreover, the eyes (mucous membrane) remain exposed. Compliance could also be another challenge.
SARS-COV2 is assumed to primarily enter the body via the mouth through respiratory droplets - or possibly through inhalation of aerosol containing the virus. From the mouth the virus is assumed to spread to the airways and the gastro-intestinal tract. SARS-COV2 is also known to be transmitted via physical contact, helped along by the fact that the virus can survive on surfaces for at least 72 hours. Touching such a contaminated surface can transfer the virus to the mouth via the hand - and thus lead to infection of the person.
Facial masks are expected to protect against viral infection in two ways;
- By reducing the risk of getting the virus in via the mouth or nose via respiratory droplets or aerosol
- By reducing the transfer from virus-contaminated hands to the mouth or nose
Hypothesis The use of surgical facial masks outside the hospital will reduce the frequency of COVID-19 infection.
All participants will follow authority recommendations and be randomized to either wear facial masks or not. The participants will be screened for antibodies at study start and study end. They will perform swab-test if they experience symptoms during the study as well as the end of study.
Detailed description
Background In the current COVID-19 pandemic with coronavirus, SARS-COV2, the Danish Health Authorities recommend using facial masks in the health care sector when handling patients presumed or proven to be infected with the virus. However, the use of facial masks outside the healthcare system is not recommended by the Danish Health Authorities. Challenges when using facial masks outside the health care system include wearing the mask consistently, an efficacy of the mask of app. 8 hours necessitating a change of mask throughout the day, and that it is not sufficiently tight enough to safely keep the virus out. Moreover, the eyes (mucous membrane) remain exposed. Compliance could also be another challenge. Health Authorities in other countries have different recommendations for the use of facial masks and the authors of the Lancet study concluded; "Universal use of face masks could be considered if supplies permit. In parallel, urgent research on the duration of protection of face masks, the measures to prolong life of disposable masks, and the invention on reusable masks should be encouraged."
SARS-COV2 is assumed to primarily enter the body via the mouth through respiratory droplets or possibly through inhalation of aerosol containing the virus. From the mouth the virus is assumed to spread to the airways and the gastro-intestinal tract. SARS-COV2 is also known to be transmitted via physical contact, helped along by the fact that the virus can survive on surfaces for at least 72 hours. Touching such a contaminated surface can transfer the virus to the mouth via the hand - and thus lead to infection of the person. A study with 26 medical students showed that they touched their face on average 23 times per hour, and that in 44 % of the incidents they touched their mucous membranes3. A Japanese questionnaire study showed that facial masks reduced the risk for school children for getting influenza by 15 %4. N95 mask and surgical facial masks are presumed to have the same effect for healthcare personnel when providing protecting from infection with influenza.
Facial masks are assumed to protect against viral infection in two ways;
- By reducing the risk of getting the virus via mouth or nose through the air via respiratory droplets or aerosol
- By reducing the transfer from virus-contaminated hands to the mouth or nose
About 10 % of the Danish population is estimated to get COVID-19 during the present pandemic-wave; this corresponds to 600,000 Danes. Later COVID-19 waves are expected to occur. The epidemic in Denmark is expected to be at the highest point in medio April. In April and May it be estimated that >2 % of the population will be infected per month.
Hypothesis The use of surgical facial masks outside the hospital will reduce the frequency of COVID-19 infection.
Method The participants recruited are people working outside of their home, who have not previously been infected with COVID-19 and who do not wear facial masks (e.g. healthcare personnel) when working. They will be randomized for
- Normal behavior according to the authority's recommendations or
- Normal behavior according to the authority's recommendations and use of facial masks
Participants will be instructed in using the facial mask consistently when outside their home (and at home when receiving visits from others. The instruction is given in writing and via an instruction video. The participants will be contacted once weekly to optimize compliance. It will be registered if the participants are diagnosed with COVID-19. Participants, who are not tested positive for COVID-19 in the study period will perform a self-test if having symptoms or when the study ends (instruction video).
Perspective The study can determine whether use of facial masks in the public is beneficial and if there is an effect this could have great impact on the current as well as any future, similar epidemics.
Interested participants can register through a link in the add to our research registration database RedCap. The participant will then receive written information and can then register. They will receive a COVID-19 screening test set and (+/-) facial masks ( 2 per day) for the first month. If the participant experience symptoms, he/she will register their symptoms in RedCap, test with a swab-test and send the swab-test to the study investigator for analyses. If negative, new test-sets are sent out - if positive, the participant will be referred to the hospital. This process continues until the participant is tested positive for COVID-19, the pandemic is considered finished by the Danish authorities or when the study ends on May 7 2020. At study end, all participants perform antibody screening and swab test, and send it to the study investigators.
Power calculation With an infection frequency of 2 % in the study period, an expected reduction of the risk to 1 % should be demonstratable with a power of 80 % and a p-value of 5 %, if including a total of 4,636 patients randomized 1:1. If the infection frequency is higher the power of the study will be higher. With an expected defection of 20 % a total of 6,000 participants will be included.
Authority approvals from The Danish National Committee On Health Research Ethics and The Data Protection Agency have been granted.
A detailed study analyses plan (SAP) will be finalized before data are analyzed.
Central registry data will be collected later when made available by national health authorities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The participants recruited are people working outside of their home, who have not previously been infected with COVID-19 and who do not wear facial masks (e.g. healthcare personnel) when working. They will be randomized for 1. Normal behavior according to the authority's recommendations or 2. Normal behavior according to the authority's recommendations and use of facial masks Participants will be instructed in using the facial mask consistently when outside their home (and at home when receiving visits from others. The instruction is given in writing and via an instruction video. The participants will be contacted once weekly to optimize compliance. It will be registered if the participants are diagnosed with COVID-19. Participants will perform antibody screening at study start and end. Participants, who are not tested positive for COVID-19 in the study period will perform a swab self-test if experiencing symptoms or when the study ends (instruction video).
| Arm | Type | Receives |
|---|---|---|
| Normal recommendations, no mask | No intervention | –Normal behavior according to the authority's recommendations or |
| Normal recommendations AND mask | Experimental | Other: Surgical facial maskNormal behavior according to the authority's recommendations AND use of facial masks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Older than 18 years of age and without symptoms associated with corona-virus (or previously tested positive for corona).
- Participant is outside their home more than 3 hours a day. E.g.for work or for other activities among other people.
- Do not normally wear a facial mask for daily work (e.g. healthcare personnel)
Key exclusion criteria (2 listed)
- Previously tested positive for corona-virus
- Wear facial mask for work
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 |
|---|---|---|
| Surgical facial maskParticipants will follow normal Authority recommendations AND wear mask outside their homes, or when receiving visits in their home. | Other | Normal recommendations AND mask |
Primary outcome
The primary endpoint is the difference in SARS-CoV-2 infection between the two groups after 1 months and is a combined endpoint consisting of primary outcome components 1, 2 and/or 3:
Time frame: 1 month
Component 1 of primary endpoint: Positive oropharyngeal/nasal swab with SARS-CoV-2 (PCR) and/or
The primary endpoint is the difference in SARS-CoV-2 infection between the two groups after 1 months and is a combined endpoint consisting of primary outcome components 1, 2 and/or 3:
Time frame: 1 month
Component 2 of primary endpoint: Antibody test; Development of positive SARS-CoV-2 antibody test (IgM and/or IgG) during the study period and/or
The primary endpoint is the difference in SARS-CoV-2 infection between the two groups after 1 months and is a combined endpoint consisting of primary outcome components 1, 2 and/or 3:
Time frame: 1 month
Component 3 of primary endpoint: SARS-CoV-2 infection diagnosed in a hospital/health care facility
2 secondary outcomes
Positive oropharyngeal/nasal swab (PCR);
Time frame: 1 month
Positive oropharyngeal/nasal swab (PCR);
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
- Background: PubMed 32203710Feng S, Shen C, Xia N, Song W, Fan M, Cowling BJ. Rational use of face masks in the COVID-19 pandemic. Lancet Respir Med. 2020 May;8(5):434-436. doi: 10.1016/S2213-2600(20)30134-X. Epub 2020 Mar 20. No abstract available.
- Background: PubMed 32182409van Doremalen N, Bushmaker T, Morris DH, Holbrook MG, Gamble A, Williamson BN, Tamin A, Harcourt JL, Thornburg NJ, Gerber SI, Lloyd-Smith JO, de Wit E, Munster VJ. Aerosol and Surface Stability of SARS-CoV-2 as Compared with SARS-CoV-1. N Engl J Med. 2020 Apr 16;382(16):1564-1567. doi: 10.1056/NEJMc2004973. Epub 2020 Mar 17. No abstract available.
- Background: PubMed 25637115Kwok YL, Gralton J, McLaws ML. Face touching: a frequent habit that has implications for hand hygiene. Am J Infect Control. 2015 Feb;43(2):112-4. doi: 10.1016/j.ajic.2014.10.015.
- Background: PubMed 27981021Uchida M, Kaneko M, Hidaka Y, Yamamoto H, Honda T, Takeuchi S, Saito M, Kawa S. Effectiveness of vaccination and wearing masks on seasonal influenza in Matsumoto City, Japan, in the 2014/2015 season: An observational study among all elementary schoolchildren. Prev Med Rep. 2016 Dec 6;5:86-91. doi: 10.1016/j.pmedr.2016.12.002. eCollection 2017 Mar.
- Background: PubMed 20095070Gralton J, McLaws ML. Protecting healthcare workers from pandemic influenza: N95 or surgical masks? Crit Care Med. 2010 Feb;38(2):657-67. doi: 10.1097/ccm.0b013e3181b9e8b3.
- Derived from this study: PubMed 33205991Bundgaard H, Bundgaard JS, Raaschou-Pedersen DET, von Buchwald C, Todsen T, Norsk JB, Pries-Heje MM, Vissing CR, Nielsen PB, Winslow UC, Fogh K, Hasselbalch R, Kristensen JH, Ringgaard A, Porsborg Andersen M, Goecke NB, Trebbien R, Skovgaard K, Benfield T, Ullum H, Torp-Pedersen C, Iversen K. Effectiveness of Adding a Mask Recommendation to Other Public Health Measures to Prevent SARS-CoV-2 Infection in Danish Mask Wearers : A Randomized Controlled Trial. Ann Intern Med. 2021 Mar;174(3):335-343. doi: 10.7326/M20-6817. Epub 2020 Nov 18.
- Derived from this study: PubMed 32829745Bundgaard H, Bundgaard JS, Raaschou-Pedersen DET, Mariager AF, Schytte N, von Buchwald C, Todsen T, Skovgaard K, Trebbien R, Andersen MP, Benfield T, Ullum H, Torp-Pedersen C, Iversen K. Face masks for the prevention of COVID-19 - Rationale and design of the randomised controlled trial DANMASK-19. Dan Med J. 2020 Aug 18;67(9):A05200363.
- Individual participant dataSharing planned: No
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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.
Henrik Ullum, Prof., DMSc principal investigator
Copenhagen University Hospital, Rigshospitalet
Kasper Karmark Iversen, Prof., DMSc principal investigator
Herlev Hospital
Thomas Benfield, Prof., DMSc principal investigator
Hvidovre University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical facial mask in people with COVID-19, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 3 Aug 2020. 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 Denmark. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary endpoint is the difference in SARS-CoV-2 infection between the two groups after 1 months and is a combined endpoint consisting of primary outcome components 1, 2 and/or 3: (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04337541, which also lists 7 linked publications.
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 Aug 2020.