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Cancelled by investigator Single arm study for the efficacy and safety of GD31 in patients with novel coronavirus pneumonia (COVID-19)

Single arm study for the efficacy and safety of GD31 in patients with novel coronavirus pneumonia (COVID-19)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029895
Enrollment
Unknown
Registered
2020-02-16
Start date
2020-02-16
Completion date
Unknown
Last updated
2020-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Novel Coronavirus Pneumonia (COVID-19)

Interventions

Case series:Routine treatment+GD31, GD31: D1: 200mg QD, dissolved in 100ml of saline, intravenous drip, about 60 minutes
D2 ~ 10: 100mg QD, dissolved in 100ml of saline, intravenous drip, 30 minutes.

Sponsors

Guangzhou Eighth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1)Aged >=18 years old, gender unlimited, inpatient; (2) Novel coronavirus nucleic acid positive in pharyngeal swab specimen by real-time fluorescent RT-PCR; (3) Clinical classification is ordinary or severe patients; (4) Informed consent has been signed.

Exclusion criteria

Exclusion criteria: (1) Known or suspected to be allergic to the components of GD31; (2) Mild or critical patients in clinical classification; (3) Severe liver diseases (such as child Pugh score >=C, TBIL >=2 ULN, AST >=5 ULN), or HBsAg positive (4) Patients with severe renal insufficiency (estimated glomerular filtration rate <=30ml/min/1.73m2) or undergoing continuous renal replacement therapy, hemodialysis and peritoneal dialysis; (5) Pregnant or lactating women or women with birth plan during or within 6 months after the trial; (6) According to the judgment of the researcher, there are other situation of the patient that are not suitable for attending the trial; (7) Patients who had received chloroquine treatment within 4 weeks.

Design outcomes

Primary

MeasureTime frame
The negative conversion rate and negative conversion time of novel coronavirus nucleic acid;

Secondary

MeasureTime frame
Time to Clinical recovery, TTCR;Improvement rate of lung CT;The frequency of exacerbation of respiration;Antipyretic time;Disappearance rate and disappearance time of cough;Proportion of cases from ordinary type to severe type;All-cause mortality;

Countries

China

Contacts

Public ContactWeiping Cai

Guangzhou Eighth People's Hospital

gz8hcwp@126.com+86 020-83710825

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026