A Phase II Study in Patients With Moderate to Severe ARDS Due to COVID-19

Status unconfirmed · Phase 2

Conditions studied: Covid19

In brief

This is a Phase II multi-center, double-blind, placebo-controlled, randomized study in Patients with moderate to severe lung injury due to COVID-19 or other potential viral and bacterial pathogens.

Key facts

Study ID: NCT04780685
Run by: Stemedica Cell Technologies, Inc.
People needed: 40
Starts: 2021-03-20
Expected to finish: 2022-12-31
Last updated by the study team: 2022-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Laboratory-confirmed diagnosis of COVID-19 <= 14 days prior to randomization
The presence of moderate to severe Acute Respiratory Distress Syndrome (ARDS) as defined by the Berlin Definition:
Bilateral chest radiograph infiltrates.
PaO2:FiO2 ratio of less than 200.
Absence of other clinical conditions that could present in a similar manner (non-infectious pneumonitis, cardiogenic pulmonary edema)
Absence of moribund state that would indicate imminent demise and poor chance of survival.

You may not qualify if…

Females of childbearing potential who are pregnant or unwilling to undergo pregnancy testing; females with a positive pregnancy test on screening day will be excluded.
Breastfeeding mothers
Patients on ECMO
Receiving concurrent treatment with an investigational agent in a clinical trial.
Exception: Use of COVID-19 convalescent plasma is permitted.
More than 72hrs on mechanical ventilation before randomization
Receiving concurrent investigational vaccine

Where it is running

Providence Medical Foundation — Fullerton, California, United States (enrolling)
Providence Saint John's Health Center - Saint John's Cancer Institute — Santa Monica, California, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.