COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=50696

Binghong Zhang

zbhong6288@163.com

2020-03-17

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

1. Aged 18 to 70 years old, inpatients, male or female, 2. Patients with severe COVID-19: confirmed cases shall be in compliance with guideline of Diagnosis and Treatment Plan for COVID-19 (Version 7) or updated versions.Confirmed cases can be defined if suspected cases have characteristic of following pathogeny or serology: 1) Detect nucleic acid of novel coronavirus positive by real-time fluorescence RT-PCR, 2) Have highly homologous to known novel coronavirus by sequencing, 3) Detect sero specific lgM and lgG positive, IgG specific against new coronavirus positive conversion or the titer of IgG is 4 times higher in convalescent period than in acute period, Adult patients with severe COVID-19 shall meet any of the following: 1) Respiratory distress, RR>=30 times / minute, 2) In the resting state, the oxygen saturation is <=93%, 3) For lung radiology, the lesion has obtained more than 50% obvious improvement within 24-48 hours, 4) Arterial blood oxygen partial pressure (PaO2) / oxygen concentration (FiO2) <=300 mmHg (1mm Hg = 0.133 kPa), 3. Subjects and / or legal guardians of the subjects volunteered to participate in the study and voluntarily signed informed consent.

The clinical classification of patients with severe novel coronavirus infection is to meet any of the following: 1) Respiratory failure occurs and requires mechanical ventilation, 2) Shock occurs, 3) Combined failure of other organs requires ICU monitoring and treatment, 2. Those who are allergic to blood products or plasma components and auxiliary materials (sodium citrate), 3. There is multiple organ failure, and the estimated survival time is less than 3 days, 4. Those who tested positive for HIV antibodies before enrollment, 5. Women who are pregnant or breastfeeding or have a birth plan within the past year, 6. Participants in other clinical trials within 1 months before screening, 7.Poor adherence or other conditions that the investigator believes are not suitable for inclusion (such as poor physical condition).

2

Renmin Hospital of Wuhan University

18

70

China

Severe disease at enrollment

6: Severe disease at enrollment

60

Improvement of clinical symptoms (Clinical improvement is defined as a reduction of 2 points on the 6-point scale of the patient's admission status or discharge from the hospital);

| Declared number of arm (2.0) differs from found arms (3.0)

Not reported

[{"arm_notes": "", "treatment_id": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]