Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Antimetabolites, Antineoplastic
  • Analgesics
  • Respiratory Tract Infections
  • Anti-infective Agents
  • Antiviral Agents
  • ARDS
  • RNA Virus Infections
  • Nidovirales Infections
  • Coronaviridae Infections
  • Coronavirus
  • Coronavirus Infection
  • Pneumonia, Viral
  • Physiological Effects of Drugs
  • Severe Acute Respiratory Syndrome Coronavirus 2
  • Immunologic Disease
  • Immunologic Factors
  • Virus Disease
  • Lung Diseases
  • Pneumonia
  • Respiratory Tract Disease
Type
Interventional
Phase
Phase 1Phase 2
Design
Allocation: RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Phase I will evaluate the safety and efficacy of multiple doses of CYNK-001 (Days 1,4, and 7) in 14 patients. Phase II will utilize a randomized, open-label design; multiple doses of CYNK-001 will be compared to the control group: Best Supportive Care. Up to 72 patients will be included in the Phase II portion of the study with a 1:1 randomization ratio.Masking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Not Provided

Not Provided

Tracking Information

NCT #
NCT04365101
Collaborators
  • IDRI
  • Lung Biotechnology PBC
  • California Institute for Regenerative Medicine (CIRM)
Investigators
Principal Investigator: Corey Casper, MD MPH IDRI