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Clinical study of arbidol hydrochloride tablets in the treatment of novel coronavirus pneumonia (COVID-19)

Multicenter, randomized, open-label, controlled trial for the efficacy and safety of arbidol hydrochloride tablets in the treatment of novel coronavirus pneumonia (COVID-19)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029621
Enrollment
Unknown
Registered
2020-02-07
Start date
2020-02-07
Completion date
Unknown
Last updated
2020-02-17

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

Experimental group:Arbidol tablets + basic treatment
Control group:Basic treatment

Sponsors

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Sign the informed consent form; 2. Aged >=18 years; 3. Subjects diagnosed as 2019-nCoV pneumonia; (1) Detection of 2019-nCoV nucleic acid positive by RT-PCR in respiratory tract or blood samples; (2) The virus gene sequence of respiratory tract or blood samples is highly homologous to the known 2019-nCoV; 4. According to the standard of "2019-nCoV pneumonia diagnosis and treatment Program of New Coronavirus infection (trial Fifth Edition)" issued by National Health Commission of China, clinical classification: mild, ordinary subjects; (1) Mild type, the clinical symptoms were mild and no pneumonia was found in imaging; (2) Common type, With fever, respiratory tract and other symptoms, the manifestations of pneumonia can be seen on imaging.

Exclusion criteria

Exclusion criteria: 1. Critical type: If one of the following conditions is met (1) Respiratory failure occurs and mechanical ventilation is needed; (2) Shock occurred; (3) Patients with other organ failure need ICU monitoring treatment; 2. Severe type: If one of the following conditions is met (1) Respiratory distress, RR >= 30 beats / min; (2) In resting state, finger oxygen saturation (SaO2) 2 ULN; 2) The levels of aspartate aminotransferase (AST) and Alanine transaminase (ALT)>3 ULN; 3) Definition of renal dysfunction: Serum creatinine>1.5 ULN, or calculated creatinine clearance1.5 ULN, and the prothrombin time ((PT)) or activated partial thromboplastin time (aPTT) 1.5 ULN, unless the subject is receiving anticoagulant therapy; 5. Abidor was used before inclusion(Tablets, capsules, granules); 6. Women who are nursing or pregnant; 7. Serum or urine pregnancy tests were positive for women of child-bearing age; 8. Immunodeficient patient(Patients with malignant tumors, Organ or bone marrow transplant, HIV patient, those who took immunosuppressive drugs within 3 months before the screening test ); 9. With the following history of present illness: (1) Neurological and neurodevelopmental disorders, These include diseases of the brain, spinal cord, peripheral nerves and muscles(Such as cerebral palsy, epilepsy, stroke, mental retardation, moderate to severe developmental delay, muscular malnutrition or spinal cord injury ); (2) Circulation system disease( congenital heart disease, Congestive heart failure or coronary artery disease); (3) Severe heart disease or a history of clinically significant arrhythmias that the researchers believe will affect participants' safety (According to the ECG or medical history); 10. Other patients considered ineligible for this study were considered ineligible by the investigators.

Design outcomes

Primary

MeasureTime frame
Virus negative conversion rate in the first week;

Secondary

MeasureTime frame
Virus negative conversion rate;Symptom relief time;Antipyretic rate;Finger oxygen improvement rate;Disease progression rate;Mortality rate;Change curve of peripheral blood lymphocyte count;Incidence of severe adverse reactions;

Countries

China

Contacts

Public ContactQu Jieming

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

jmqu0906@163.com+86 21 64370045

Outcome results

None listed

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