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Trial - NCT04570501


Column Value
Trial registration number NCT04570501
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04570501

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

Kevin V Grimes, MD

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

Not reported

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

2020-09-30

Recruitment status
Last imported at : March 4, 2022, 9 p.m.
Source : ClinicalTrials.gov

Withdrawn

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

single-center

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

Treatment

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

inclusion criteria: - signs and symptoms suggestive of covid-19 infection including cough or dyspnea - laboratory-confirmed sars-cov-2 infection as determined by polymerase chain reaction (pcr) test ≤7 days before randomization - currently hospitalized or in an emergency department with planned hospitalization - peripheral capillary oxygen saturation (spo2) ≤93% on room air or partial pressure of oxygen (pao2)/fraction of inspired oxygen (fio2) <300 at screening

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

- simultaneous participation in any other clinical study incompatible with this one - treatment with an antibody immunotherapy that is not standard of care for covid-19 within 4 weeks of screening - requirement for mechanical ventilation or ecmo at screening - hypotension at screening, defined as supine bp <95 mm hg systolic or <55 mm hg diastolic - severe liver injury defined as ast or alt ≥5x the upper limit of normal - severe kidney failure defined as an estimated glomerular filtration rate (egfr) <30 ml/min - any known immune deficiency - pregnancy or breastfeeding

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

Stanford University

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

18

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

100

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

Severe disease at enrollment

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

6: Severe disease at enrollment

Total sample size
Last imported at : March 4, 2022, 9 p.m.
Source : ClinicalTrials.gov

0

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

Time to recovery

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 1/Phase 2

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

[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 85, "treatment_name": "Angiotensin 1-7", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}]