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A multi-center study on the efficacy and safety of suramin sodium in adult patients with novel coronavirus pneumonia (COVID-19)

A multi-center study on the efficacy and safety of suramin sodium in adult patients with novel coronavirus pneumonia (COVID-19)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030029
Enrollment
Unknown
Registered
2020-02-21
Start date
2020-02-20
Completion date
Unknown
Last updated
2020-02-25

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:Suramin( IV.)

Sponsors

The First Affiliated Hospital of Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years male or female, willing to sign the informed consent; 2. Patients with novel coronavirus infection pneumonia were confirmed by epidemiology and clinical symptoms. The diagnostic criteria refer to "Pneumonitis Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 6)"; 3.Tested positive for novel coronavirus infection using a real time polymerase chain reaction (RT-PCR)-based diagnostic assay; or highly homologous to COVID-19 according to Virus gene sequencing; 4. Patients with pneumonia were confirmed by Chest imaging; 5. Enrollment and initiation of study drug treatment <=10 days after onset of symptoms; Symptom are mainly fever, or cough on patients without fever; 6. Willing to abide by the protocol according investigators.

Exclusion criteria

Exclusion criteria: 1. Hypersensitive to suramin or 2 or more drugs or food; 2. Body weight <40 kg; 3. Considered as severe disease: has an ongoing respiratory deficiency and subjected to invasive mechanical ventilation; or presence of shock; or admitted to the ICU due to complications; 4. Has known kidney dysfunction determined as CLcr<60 mL/min; 5. Increase in alanine aminotransferase (ALT) / aspartate aminotransferase (AST) is more than 5 times the upper limit of normal; or increase in ALT or AST is more than 3 ULN and increase in total bilirubin more than 2 ULN; 6. Pregnancy or breastfeeding, or positive pregnancy test in a predose examination, or have a plan to be pregnant within 3 months after the study; 7. Physician judged the patient was not suitable for this clinical trial (for example, patient with severe abnormality laboratory indexes; patient with multiple basic diseases, etc.).

Design outcomes

Primary

MeasureTime frame
clinical cure rate;Incidence of mechanical ventilation by day28;All-cause mortality by day28;Incidence of ICU admission by day28;

Countries

China

Contacts

Public ContactShentu Jianzhong?Wu Lihua

The First Affiliated Hospital of Zhejiang University School of Medicine

stjz@zju.edu.cn13957111817

Outcome results

None listed

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