NCT04636554

Brief Summary

Phage Treatment in Covid-19 Patients with Bacterial Co-Infections

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 19, 2020

Completed
Last Updated

December 21, 2021

Status Verified

December 1, 2021

First QC Date

November 9, 2020

Last Update Submit

December 6, 2021

Conditions

Keywords

Covid19BacteriophagePhageBacteremiaSepticemiaAcinetobacterbaumanniiPseudomonasAeruginosaInfectionStaphAureus

Interventions

Personalized intravenous phage therapy in Covid-19 patients along with anti-microbial treatment for pneumonia, bacteremia or septicemia due to A. baumannii, P. aeruginosa or S. aureus.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Covid-19 patients with pneumonia or bacteremia/septicemia who have culture-confirmed bacterial co-infection with A. baumannii, P. aeruginosa or S. aureus.
  • Patient provided informed and signed consent.

You may not qualify if:

  • Patient eligible for another APT sponsored trial.
  • Patient participating in another clinical trial at the same time or patients \< 4 weeks from participating in an alternative investigational protocol/study
  • Patient with known allergy to infusion of phage products
  • Patients with a history of Meningitis or encephalitis at time of study entry, Primary immune deficiency disease or tuberculosis or Stroke, transient ischemic attack (TIA), or untreated deep vein thrombosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

COVID-19BacteremiaSepsisPseudomonas InfectionsInfectionsStaphylococcal Infections

Interventions

Phage Therapy

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesBacterial InfectionsBacterial Infections and MycosesSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsGram-Negative Bacterial InfectionsGram-Positive Bacterial Infections

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2020

First Posted

November 19, 2020

Last Updated

December 21, 2021

Record last verified: 2021-12