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Trial · Interventional

Status unknownPhase 3Registry data

Experimental Trial of rhIFNα Nasal Drops to Prevent 2019-nCOV in Medical Staff

NCTNCT04320238 (opens ClinicalTrials.gov in a new tab)Other idInterferon_prophylaxis
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 3
Enrollment
2,944 participants (estimated)
Sponsor
Shanghai Jiao Tong University School of Medicine · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

China

Start
21 Jan 2020
Primary completion
May 2020 (estimated)
Completion
Jun 2020 (estimated)
First posted
24 Mar 2020
Last update posted
31 Mar 2020
Conditions
2019 Novel Coronavirus Infection

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20202021
  1. Ph 3

    Experimental Trial of rhIFNα Nasal Drops to Prevent 2019-nCOV in Medical Staff

    NCT04320238

    21 Jan 2020 to est. Jun 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The investigators plan to carry out an experimental study on the preventive effect of recombinant human interferon alpha nasal drops on the infection of 2019 new coronavirus in medical staff.

Interventions

  • recombinant human interferon Alpha-1bDrug
  • thymosin alpha 1Drug

Arms2

  • Experimental

    low-risk group

    medical staff work in non-isolated general wards or laboratories, not directly contact with COVID-19 patients.

  • Experimental

    high-risk group

    doctors and nurses work in isolated ward, directly contact with COVID-19 patients.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. new-onset COVID-19

    Time frame · From date of randomization until the diagnosis of COVID-19, assessed up to 6 weeks.

    Registry description

    new-onset coronavirus disease-2019

Secondary outcomes(2)

  1. Number of Participants with coronavirus related symptoms

    Time frame · during 28-day intervention.

    Registry description

    new-onset fever or respiratory symptoms but with negative pulmonary images evidence.

  2. Number of Participants with adverse effect

    Time frame · during 28-day intervention.

    Registry description

    adverse effect of interferon α

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Formally serving medical staff in Taihe Hospital; Exclusion Criteria: * pregnant women; * severe chronic diseases who are unable to participate in daily routine work; * fever (temperature≥37.3 ° ) and / or respiratory symptoms.

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