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NCT04313127: CTCOVID-19

Phase I Clinical Trial of a COVID-19 Vaccine in 18-60 Healthy Adults

Completed Phase 1 Last updated 4 August 2021
What this trial tests

Phase 1 trial testing Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in COVID-19 in 108 participants. Completed in 20 February 2021.

Timeline
16 March 2020
Primary endpoint
20 January 2021
20 February 2021

Quick facts

Lead sponsorCanSino Biologics Inc.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingnone
Primary purposeprevention
Enrollment108
Start date16 March 2020
Primary completion20 January 2021
Estimated completion20 February 2021
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

CanSino Biologics Inc. — full company profile →

Who can join

Adults 18 to 60, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The 2019 novel-coronavirus (2019-nCov) is the cause of a cluster of unexplained pneumonia that started in Hubei province in China. It has manifest into a global health crisis with escalating confirmed cases and spread across many countries. In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of diseases caused by COVID-19 can be tough for current treatment. This study is a phase I clinical trial. The investigators intent to evaluate the safety, reactogenicity and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) .

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Immunology of COVID-19: Current State of the Science.
    Vabret N, Britton GJ, Gruber C, Hegde S, et al · · 2020 · cited 1248× · PMID 32505227 · DOI 10.1016/j.immuni.2020.05.002
  2. Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial.
    Zhu FC, Li YH, Guan XH, Hou LH, et al · · 2020 · cited 1017× · PMID 32450106 · DOI 10.1016/s0140-6736(20)31208-3
  3. COVID-19 Vaccine: A comprehensive status report.
    Kaur SP, Gupta V. · · 2020 · cited 482× · PMID 32800805 · DOI 10.1016/j.virusres.2020.198114
  4. COVID-19: Transmission, prevention, and potential therapeutic opportunities.
    Lotfi M, Hamblin MR, Rezaei N. · · 2020 · cited 447× · PMID 32474009 · DOI 10.1016/j.cca.2020.05.044
  5. Impact of Vaccines; Health, Economic and Social Perspectives.
    Rodrigues CMC, Plotkin SA. · · 2020 · cited 394× · PMID 32760367 · DOI 10.3389/fmicb.2020.01526
  6. Diarrhea During COVID-19 Infection: Pathogenesis, Epidemiology, Prevention, and Management.
    D'Amico F, Baumgart DC, Danese S, Peyrin-Biroulet L. · · 2020 · cited 357× · PMID 32278065 · DOI 10.1016/j.cgh.2020.04.001
  7. Overview of Immune Response During SARS-CoV-2 Infection: Lessons From the Past.
    Shah VK, Firmal P, Alam A, Ganguly D, et al · · 2020 · cited 317× · PMID 32849654 · DOI 10.3389/fimmu.2020.01949
  8. Ongoing Clinical Trials for the Management of the COVID-19 Pandemic.
    Lythgoe MP, Middleton P. · · 2020 · cited 247× · PMID 32291112 · DOI 10.1016/j.tips.2020.03.006

Verify or expand the search:

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Other CanSino Biologics Inc. trials

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Verify against primary sources

Data sources for this page

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/NCT04313127.

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