COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05697029

Yongchang Sun, M.D.

suny@bjmu.edu

2023-01-25

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: sign informed consent form voluntarily for the trial. male or female aged between 18 and 85 years (inclusive). clinically or laboratory confirmed covid-19 within the past 7 days, as determined by a positive rt-pcr test or a positive antigen test. under resting conditions, oxygen saturation ≤93% when breathing air, or p/f value ≤ 300 mmhg (1 mmhg = 0.133 kpa). no birth plan and must agree to take effective contraceptive methods.

received a vaccine within 4 weeks prior to the study, or plan to receive a vaccine during the study period, or received treatment with tetrandrine tables prior to enrolling in the study. patient must be on invasive mechanical ventilation/ecmo at baseline. any clinically important serious diseases unstable or uncontrolled. allergy history to any biological or other agent. patient has severe mental or psychological abnormalities, cognitive impairment or intellectual disability before being diagnosed with covid-19. subjects who are pregnant or breastfeeding, or plan to become pregnant during the study. investigator think the subject should not participate in the study.

2

Peking University Third Hospital

18

85

China

Severe disease at enrollment

6: Severe disease at enrollment

414

Diagnosed with critical COVID-19 pneumonia

None

Phase 4

[{"arm_notes": "nan", "treatment_id": 1281, "treatment_name": "Tetrandrine", "treatment_type": "Anti-inflammatories", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]