COVID-19 trials registries data warehouse

 Return to trial list

Trial - NCT04780685


Column Value
Trial registration number NCT04780685
Full text link
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04780685

First author
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Lev Verkh, PhD/MS

Contact
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

lverkh@stemedica.com

Registration date
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-03-03

Recruitment status
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Recruiting

Study design
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: 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.

Exclusion criteria
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

- 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

Number of arms
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Stemedica Cell Technologies, Inc.

Inclusion age min
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Severe disease at enrollment

Severity scale
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

6: Severe disease at enrollment

Total sample size
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

40

primary outcome
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Survival

Notes
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 65, "treatment_name": "Allogeneic mesenchymal stem cell", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]