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Trial - NCT04432298


Column Value
Trial registration number NCT04432298
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04432298

First author
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Gustavo Lorente

Contact
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

glorente@Fibrogen.com

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-06-16

Recruitment status
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Terminated

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.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 : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

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

inclusion criteria: confirmed sars-cov-2 infection respiratory compromise requiring hospitalization for covid-19 disease as evidenced by at least one (or more) of the following criteria: interstitial pneumonia on chest x-ray or high-resolution computed tomography (findings of consolidation or ground glass opacities), or peripheral capillary oxygen saturation < 94% on room air, or requiring non-invasive supplemental oxygen (such as, nasal cannula, face mask) to maintain spo2 not requiring mechanical ventilation and/or extracorporeal membrane oxygenation (ecmo) use at time of randomization not participating in another clinical trial for the treatment of covid-19 disease through day 28

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

female participants who are pregnant or nursing participation in a clinical trial with another investigational drug for covid-19 disease anticipated discharge from the hospital or transfer to another hospital or long-term care facility which is not a study site within 72 hours of randomization history of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

FibroGen

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

40

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

85

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Moderate/severe disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

22

primary outcome
Last imported at : July 19, 2022, noon
Source : ClinicalTrials.gov

Number of Participants Alive Who Never Received Mechanical Ventilation and/or Extracorporeal Membrane Oxygenation (ECMO) at Day 28

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 957, "treatment_name": "Pamrevlumab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]