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NCT04823351
Clinical Efficiency of Surgical Masks and Filtering Face-piece 2 Masks
NA trial testing Surgical Mask in Covid19 in 1,200 participants. Status unknown.
8 July 2021
Quick facts
| Lead sponsor | University of Zurich |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 1,200 |
| Start date | 8 April 2021 |
| Primary completion | 8 July 2021 |
| Estimated completion | 1 November 2021 |
| Sites | 1 location across Switzerland |
Drugs / interventions tested
- Surgical Mask
Conditions studied
- Covid19 — all drugs for Covid19 →
Sponsor
University of Zurich
Who can join
Adults 18 to 65, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Recent results demonstrated an increased risk of COVID-19 infection among healthcare workers (HCW), particularly when access to personal protective equipment (PPE) was inadequate. (ref). During the COVID-19 pandemic, access to PPE has become complicated by a surge in worldwide demand combined with production limitations and logistical barriers. Since their introduction in hospitals in the 1990s, filtering facepiece (FFP) masks, mostly of the FFP2 type, are used by HCWs to protect themselves against bioaerosols due to tuberculosis, measles, and selected respiratory viruses. The COVID-19 pandemic has sparked debate around reasonable and safe use of the different types of face masks to protect the HCWs who provide direct care for COVID-19 patients. At the heart of the discussion are the respective contributions to SARS-CoV-2 transmissions by droplets and aerosols, and the corresponding risk levels resulting in COVID-19 infection. The objective is to perform a cluster-randomized, parallel, controlled, non-inferiority study among Swiss nursing and retirement homes to evaluate the efficacy of surgical masks vs. FFP2 masks during patient care and prospectively observe possible infections amongst both vaccinated and unvaccinated staff. Staff in nursing homes will be randomized to use either surgical or FFP2 masks for patient care consistently. Considering an attack rate of 0.8% over three months among healthcare workers, a non-inferiority margin of 5%, and an intracluster variability of 0.01, - we require a minimum of 625 participants per group. The COVID-19 attack rate will be tested by initial serology testing and weekly pooled saliva specimen for SARS-CoV-2 testing. (Re)-Infections will be tracked by weekly pooled saliva-based PCR testing. Exposure to COVID-19 other than during work time will be explored by questionnaires and focus group discussions.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04823351
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other trials of Surgical Mask
Trials testing the same drug.
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- NCT04771585 — Quantification of Exhaled Particles to Identify Airborne Transmission Risks of COVID-19 · NA · completed
- NCT04629989 — Comparison of the Surgical Facemask With the Double-trunk Mask on Oxygenation in COVID-19 · NA · completed
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04823351 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Zurich
- Last refreshed: 30 March 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04823351.
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