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Trial - NCT04778059


Column Value
Trial registration number NCT04778059
Full text link
Last imported at : March 4, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04778059

First author
Last imported at : Jan. 11, 2023, 8 a.m.
Source : ClinicalTrials.gov

Not reported

Contact
Last imported at : Jan. 11, 2023, 8 a.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : March 4, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-03-02

Recruitment status
Last imported at : April 23, 2023, midnight
Source : ClinicalTrials.gov

Terminated

Study design
Last imported at : March 4, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : March 4, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : March 4, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : March 4, 2021, 12:31 a.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 : March 4, 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: signed informed consent from patient or legal representative; age 18 or greater; positive reverse transcription polymerase chain reaction (rt-pcr) for sars-cov-2 (≤10 days); respiratory rate > 20 rr; spo2 < 94% on room air, requiring supplemental oxygen, requiring invasive mechanical ventilation, or requiring ecmo; chest x-ray confirming bilateral pulmonary infiltrates; body mass index of ≤ 40 units/kg/m2; adequate method of birth control.

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

terminally ill patients due to underlying cardiac, cancer or severe debilitating neurological disease including coma; hospitalization expected to be < 96 hours due to medical improvement; interstitial lung disease; correction of qtc values obtained by 12 lead ekg using fredericia's formula (qtcf) > 450 ms; history of hypotension (mean arterial blood pressure < 65 mmhg), unrelated to covid-19 infection; alanine aminotransferase (alt) or aspartate aminotransferase (ast) > 3 times upper limit of normal; participating concurrently on another clinical trial for the experimental treatment of covid-19; active chemotherapy use; pregnant and/or lactating women.

Number of arms
Last imported at : March 4, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : March 4, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

US Biotest, Inc.

Inclusion age min
Last imported at : March 4, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : March 4, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Aug. 5, 2021, 2:30 p.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : March 4, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Severe/critical disease at enrollment

Severity scale
Last imported at : March 4, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

7: Severe/critical disease at enrollment

Total sample size
Last imported at : Jan. 11, 2023, 8 a.m.
Source : ClinicalTrials.gov

21

primary outcome
Last imported at : March 4, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Number of participants with treatment emergent adverse events (TEAE)

Notes
Last imported at : March 4, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : March 4, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : March 4, 2021, 12:31 a.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"}]