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Experimental Trial of rhIFNα Nasal Drops to Prevent 2019-nCOV in Medical Staff
Plain-language guide to NCT04320238: phase 3 non-randomized trial of Thymosin Alpha-1, 2944 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04320238
- Phase
- phase 3
- Status
- status unknown
- Start
- 2020-01-21
- Completion (planned or actual)
- 2020-05
- Participants
- 2944 (estimated)
- Design
- non-randomized, open label (everyone knows who gets what), prevention
- Conditions studied
- 2019 Novel Coronavirus Infection
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 3 trial tested Thymosin Alpha-1.
It had two arms (groups): low-risk group (experimental) and high-risk group (experimental).
Medical staff work in non-isolated general wards or laboratories, not directly contact with COVID-19 patients.
Doctors and nurses work in isolated ward, directly contact with COVID-19 patients.
The registry classes the interventions as drug.
More on the Plan
The investigators plan to carry out an experimental study enrolling more than 2000 medical staff and divide participants into low-risk group and high-risk group according to whether they can directly exposed to 2019-nCOV infected patients.
Who Took Part
2944 planned participants were the target.
It was open to people of any sex aged from 18 years up to 65 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Formally serving medical staff in Taihe Hospital;.
The full record lists 1 inclusion and 3 exclusion criteria; among the exclusions: pregnant women;; severe chronic diseases who are unable to participate in daily routine work;; fever (temperature≥37.3 ° ) and / or respiratory symptoms.
How the Study Was Run
The set-up was non-randomized, parallel-group and open-label.
The Thymosin Alpha-1 group and the comparison group ran side by side rather than switching.
Everyone knew when Thymosin Alpha-1 was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 2020-01-21 with completion listed for 2020-05.
It ran at 1 site in China.
Its stated primary purpose is prevention.
What Was Measured
Primary outcome: new-onset COVID-19 (time frame: From date of randomization until the diagnosis of COVID-19, assessed up to 6 weeks).
It also tracked 2 secondary outcomes, for example Number of Participants with coronavirus related symptoms and Number of Participants with adverse effect.
What This Means in Plain Language
Put simply, this is a phase 3, non-randomized trial of Thymosin Alpha-1 in 2944 people.
With 2944 participants it is a large trial for this field.
Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Thymosin Alpha-1 compound page, all human trials.
Our Notes on the Compound
Thymosin Alpha-1: An immune-modulating thymic peptide that recalibrates T-cell function.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.